ASA Annual Meeting

SAN DIEGO – Routine preoperative use of genetic testing to detect mutations implicated in thyroid carcinogenesis can help guide perioperative decision making, though risks associated with mutations are not always clear-cut.

For individuals with thyroid cancer (TC), the presence of certain mutations was associated with higher risk of early recurrence of cancer as well as distant metastases, according to a recent study presented by Dr. Linwah Yip at the annual meeting of the American Surgical Association. She and her colleagues at the University of Pittsburgh built on their previous work to characterize how thyroid cancer genotype relates both to cancer histology and to disease-related outcomes.

Using data from the electronic medical record of a single institution, Dr. Yip and her colleagues examined data from consecutive patients who had initial surgery for histologically confirmed TC. Of the 1,510 patients in the study cohort, 77% were women, and patients had a mean age of 49 years. All of the cancers in the study were tested for mutations in seven genes known to be associated with thyroid carcinogenesis. Mutation testing was a routine part of preoperative care for thyroid cancer patients, often performed on preoperative fine needle aspiration (FNA) biopsy.

Outcomes tracked in the study, Dr. Yip said, included the type and stage of thyroid cancer identified and whether the cancer recurred.

Mutations were found in 1,039 patients (69%), and no more than one mutation was found in any one tumor. No tumor genotype was specifically associated with tumor size or whether the tumor was multifocal.

Overall, BRAF V600E was the most common mutation associated with TC, and patients with this mutation were the ones most likely to have a recurrence (P = .001). However, Dr. Yip noted that there is phenotypic heterogeneity in how the recurrences present. More distant metastatic disease and lateral lymph node metastases were most likely with RET/PTC1 and three mutations (P = .02).

By contrast, about 25% of thyroid cancers in the study showed mutations in RAS, PAX8/PPARG, or BRAF K601E. These mutations were associated with a more indolent disease course, with more encapsulated tumors and an overall disease-free survival of nearly 100% at 5 years after diagnosis. Dr. Yip said, “However, RAS variations can be associated with any histologic type of thyroid cancer, including anaplastic.”

Dr. Yip said that clinicians should consider conducting perioperative neck ultrasound with lymph node mapping if BRAF V600E or RET/PTC mutations are found. Her recommendation for these patients was a total thyroidectomy, with consideration of a central compartment neck dissection performed prophylactically, in light of the > 50% chance for lymph node involvement. Additionally, surveillance for distant metastases in the form of a chest CT should be considered when tumors are REC/PTC positive.

Study limitations include its retrospective nature and the fact that the treating physicians were not blinded to mutation testing results. Additionally, Dr. Yip noted, in patients with multifocal disease, only the most aggressive tumor was included.

Dr. Chris McHenry of Case Western Reserve University, Cleveland, noted in discussion that disease-specific survival was not related to mutation testing in this study. For patients with advanced thyroid cancer who have limited treatment options, however, mutation testing may help direct specific adjuvant therapies based on risk.

Dr. Nikiforov is a consultant for Quest Diagnostics. The others reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Routine preoperative use of genetic testing to detect mutations implicated in thyroid carcinogenesis can help guide perioperative decision making, though risks associated with mutations are not always clear-cut.

For individuals with thyroid cancer (TC), the presence of certain mutations was associated with higher risk of early recurrence of cancer as well as distant metastases, according to a recent study presented by Dr. Linwah Yip at the annual meeting of the American Surgical Association. She and her colleagues at the University of Pittsburgh built on their previous work to characterize how thyroid cancer genotype relates both to cancer histology and to disease-related outcomes.

Using data from the electronic medical record of a single institution, Dr. Yip and her colleagues examined data from consecutive patients who had initial surgery for histologically confirmed TC. Of the 1,510 patients in the study cohort, 77% were women, and patients had a mean age of 49 years. All of the cancers in the study were tested for mutations in seven genes known to be associated with thyroid carcinogenesis. Mutation testing was a routine part of preoperative care for thyroid cancer patients, often performed on preoperative fine needle aspiration (FNA) biopsy.

Outcomes tracked in the study, Dr. Yip said, included the type and stage of thyroid cancer identified and whether the cancer recurred.

Mutations were found in 1,039 patients (69%), and no more than one mutation was found in any one tumor. No tumor genotype was specifically associated with tumor size or whether the tumor was multifocal.

Overall, BRAF V600E was the most common mutation associated with TC, and patients with this mutation were the ones most likely to have a recurrence (P = .001). However, Dr. Yip noted that there is phenotypic heterogeneity in how the recurrences present. More distant metastatic disease and lateral lymph node metastases were most likely with RET/PTC1 and three mutations (P = .02).

By contrast, about 25% of thyroid cancers in the study showed mutations in RAS, PAX8/PPARG, or BRAF K601E. These mutations were associated with a more indolent disease course, with more encapsulated tumors and an overall disease-free survival of nearly 100% at 5 years after diagnosis. Dr. Yip said, “However, RAS variations can be associated with any histologic type of thyroid cancer, including anaplastic.”

Dr. Yip said that clinicians should consider conducting perioperative neck ultrasound with lymph node mapping if BRAF V600E or RET/PTC mutations are found. Her recommendation for these patients was a total thyroidectomy, with consideration of a central compartment neck dissection performed prophylactically, in light of the > 50% chance for lymph node involvement. Additionally, surveillance for distant metastases in the form of a chest CT should be considered when tumors are REC/PTC positive.

Study limitations include its retrospective nature and the fact that the treating physicians were not blinded to mutation testing results. Additionally, Dr. Yip noted, in patients with multifocal disease, only the most aggressive tumor was included.

Dr. Chris McHenry of Case Western Reserve University, Cleveland, noted in discussion that disease-specific survival was not related to mutation testing in this study. For patients with advanced thyroid cancer who have limited treatment options, however, mutation testing may help direct specific adjuvant therapies based on risk.

Dr. Nikiforov is a consultant for Quest Diagnostics. The others reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Routine preoperative use of genetic testing to detect mutations implicated in thyroid carcinogenesis can help guide perioperative decision making, though risks associated with mutations are not always clear-cut.

For individuals with thyroid cancer (TC), the presence of certain mutations was associated with higher risk of early recurrence of cancer as well as distant metastases, according to a recent study presented by Dr. Linwah Yip at the annual meeting of the American Surgical Association. She and her colleagues at the University of Pittsburgh built on their previous work to characterize how thyroid cancer genotype relates both to cancer histology and to disease-related outcomes.

Using data from the electronic medical record of a single institution, Dr. Yip and her colleagues examined data from consecutive patients who had initial surgery for histologically confirmed TC. Of the 1,510 patients in the study cohort, 77% were women, and patients had a mean age of 49 years. All of the cancers in the study were tested for mutations in seven genes known to be associated with thyroid carcinogenesis. Mutation testing was a routine part of preoperative care for thyroid cancer patients, often performed on preoperative fine needle aspiration (FNA) biopsy.

Outcomes tracked in the study, Dr. Yip said, included the type and stage of thyroid cancer identified and whether the cancer recurred.

Mutations were found in 1,039 patients (69%), and no more than one mutation was found in any one tumor. No tumor genotype was specifically associated with tumor size or whether the tumor was multifocal.

Overall, BRAF V600E was the most common mutation associated with TC, and patients with this mutation were the ones most likely to have a recurrence (P = .001). However, Dr. Yip noted that there is phenotypic heterogeneity in how the recurrences present. More distant metastatic disease and lateral lymph node metastases were most likely with RET/PTC1 and three mutations (P = .02).

By contrast, about 25% of thyroid cancers in the study showed mutations in RAS, PAX8/PPARG, or BRAF K601E. These mutations were associated with a more indolent disease course, with more encapsulated tumors and an overall disease-free survival of nearly 100% at 5 years after diagnosis. Dr. Yip said, “However, RAS variations can be associated with any histologic type of thyroid cancer, including anaplastic.”

Dr. Yip said that clinicians should consider conducting perioperative neck ultrasound with lymph node mapping if BRAF V600E or RET/PTC mutations are found. Her recommendation for these patients was a total thyroidectomy, with consideration of a central compartment neck dissection performed prophylactically, in light of the > 50% chance for lymph node involvement. Additionally, surveillance for distant metastases in the form of a chest CT should be considered when tumors are REC/PTC positive.

Study limitations include its retrospective nature and the fact that the treating physicians were not blinded to mutation testing results. Additionally, Dr. Yip noted, in patients with multifocal disease, only the most aggressive tumor was included.

Dr. Chris McHenry of Case Western Reserve University, Cleveland, noted in discussion that disease-specific survival was not related to mutation testing in this study. For patients with advanced thyroid cancer who have limited treatment options, however, mutation testing may help direct specific adjuvant therapies based on risk.

Dr. Nikiforov is a consultant for Quest Diagnostics. The others reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Clear resection margins, no matter how narrow, are associated with increased survival when surgeons excise liver tumors from metastatic colorectal cancer (MCRC).

When colorectal cancer metastasizes to the liver, tumor resection can be a safe intervention that improves long-term survival and contributes to cure. Previous studies have shown that any amount of negative margin had a positive impact on overall survival, but these smaller studies were hampered by lack of uniformity in definitions and in surgical technique. Additionally, new developments in chemotherapy have changed the treatment course and overall survival for those with MCRC and need to be taken into account.

©Eraxion/thinkstockphotos.com

Dr. Michael D’Angelica and his colleagues at Memorial Sloan Kettering Cancer Center, New York, presented findings from a large, single-center cohort of patients with MCRC at the annual meeting of the American Surgical Association. The aims of the study, he said, were to analyze the association between margin width of tumor resection and survival in an updated cohort receiving modern therapies, and to account for potentially confounding factors.

The study included 2,368 patients who had hepatic resection for MCRC from 1992 to 2012; patients had the same liver transection method and had high-resolution microscopic pathologic measurement of tumor margins, which allowed submillimeter assessment of margin width. Dr. D’Angelica said that the study captured clinical and patient characteristics, including the number and size of tumors, clinical risk scores, and the presence of any extrahepatic disease.

About half of all patients (n = 1,191) had tumor margins between 1 and 9 mm; one-third (n = 765) had tumor margins of 10 mm or more. One in 10 patients (n = 245) had positive tumor margins, while the remaining 7% (n = 160) had negative tumor margins of 0.9 mm or less.

The study cohort was followed for a median 55 months; a significant relationship between margin width and survival emerged, with all negative margins widths being associated with significantly longer overall survival than the survival curve for those with positive margins (P < .01). This was true even for the narrowest margin widths. Factors associated with submillimeter tumor margins included tumor ablation, having more than three tumors, or tumor size over 5 cm.

Survival differences seen with submillimeter differences in tumor margin are likely attributable to currently unknown tumor growth properties, rather than actual margin width, Dr. D’Angelica said. In response to a question from Dr. Jean-Nicolas Vauthey of MD Anderson Cancer Center, Houston, Dr. D’Angelica speculated that the future of treating MCRC may rely on microscopic determination of tumor growth patterns, as well as better understanding of underlying gene patterns.

“Negative histologic margins, at all widths, including submillimeter margins, are independently associated with improved overall survival,” said Dr. D’Angelica. A significant difference was seen between patients with positive margins and any negative margin width, and between patients with submillimeter vs. 1 mm or greater margins. Beyond 1 mm, however, increasing margins widths were not associated with increased survival benefit.

Dr. D’Angelica noted that surgeons should not fear that a surgery with anticipated close margins would not benefit the patient, since any amount of clear margin confers a survival benefit. Wide margins, however, should be attempted when the approach is safe and feasible because it is the best-known technical approach to ensure a negative tumor margin. Very narrow margins, he noted, are probably a marker for an unknown biological factor rather than a true reflection of surgical technique.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Clear resection margins, no matter how narrow, are associated with increased survival when surgeons excise liver tumors from metastatic colorectal cancer (MCRC).

When colorectal cancer metastasizes to the liver, tumor resection can be a safe intervention that improves long-term survival and contributes to cure. Previous studies have shown that any amount of negative margin had a positive impact on overall survival, but these smaller studies were hampered by lack of uniformity in definitions and in surgical technique. Additionally, new developments in chemotherapy have changed the treatment course and overall survival for those with MCRC and need to be taken into account.

©Eraxion/thinkstockphotos.com

Dr. Michael D’Angelica and his colleagues at Memorial Sloan Kettering Cancer Center, New York, presented findings from a large, single-center cohort of patients with MCRC at the annual meeting of the American Surgical Association. The aims of the study, he said, were to analyze the association between margin width of tumor resection and survival in an updated cohort receiving modern therapies, and to account for potentially confounding factors.

The study included 2,368 patients who had hepatic resection for MCRC from 1992 to 2012; patients had the same liver transection method and had high-resolution microscopic pathologic measurement of tumor margins, which allowed submillimeter assessment of margin width. Dr. D’Angelica said that the study captured clinical and patient characteristics, including the number and size of tumors, clinical risk scores, and the presence of any extrahepatic disease.

About half of all patients (n = 1,191) had tumor margins between 1 and 9 mm; one-third (n = 765) had tumor margins of 10 mm or more. One in 10 patients (n = 245) had positive tumor margins, while the remaining 7% (n = 160) had negative tumor margins of 0.9 mm or less.

The study cohort was followed for a median 55 months; a significant relationship between margin width and survival emerged, with all negative margins widths being associated with significantly longer overall survival than the survival curve for those with positive margins (P < .01). This was true even for the narrowest margin widths. Factors associated with submillimeter tumor margins included tumor ablation, having more than three tumors, or tumor size over 5 cm.

Survival differences seen with submillimeter differences in tumor margin are likely attributable to currently unknown tumor growth properties, rather than actual margin width, Dr. D’Angelica said. In response to a question from Dr. Jean-Nicolas Vauthey of MD Anderson Cancer Center, Houston, Dr. D’Angelica speculated that the future of treating MCRC may rely on microscopic determination of tumor growth patterns, as well as better understanding of underlying gene patterns.

“Negative histologic margins, at all widths, including submillimeter margins, are independently associated with improved overall survival,” said Dr. D’Angelica. A significant difference was seen between patients with positive margins and any negative margin width, and between patients with submillimeter vs. 1 mm or greater margins. Beyond 1 mm, however, increasing margins widths were not associated with increased survival benefit.

Dr. D’Angelica noted that surgeons should not fear that a surgery with anticipated close margins would not benefit the patient, since any amount of clear margin confers a survival benefit. Wide margins, however, should be attempted when the approach is safe and feasible because it is the best-known technical approach to ensure a negative tumor margin. Very narrow margins, he noted, are probably a marker for an unknown biological factor rather than a true reflection of surgical technique.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Clear resection margins, no matter how narrow, are associated with increased survival when surgeons excise liver tumors from metastatic colorectal cancer (MCRC).

When colorectal cancer metastasizes to the liver, tumor resection can be a safe intervention that improves long-term survival and contributes to cure. Previous studies have shown that any amount of negative margin had a positive impact on overall survival, but these smaller studies were hampered by lack of uniformity in definitions and in surgical technique. Additionally, new developments in chemotherapy have changed the treatment course and overall survival for those with MCRC and need to be taken into account.

©Eraxion/thinkstockphotos.com

Dr. Michael D’Angelica and his colleagues at Memorial Sloan Kettering Cancer Center, New York, presented findings from a large, single-center cohort of patients with MCRC at the annual meeting of the American Surgical Association. The aims of the study, he said, were to analyze the association between margin width of tumor resection and survival in an updated cohort receiving modern therapies, and to account for potentially confounding factors.

The study included 2,368 patients who had hepatic resection for MCRC from 1992 to 2012; patients had the same liver transection method and had high-resolution microscopic pathologic measurement of tumor margins, which allowed submillimeter assessment of margin width. Dr. D’Angelica said that the study captured clinical and patient characteristics, including the number and size of tumors, clinical risk scores, and the presence of any extrahepatic disease.

About half of all patients (n = 1,191) had tumor margins between 1 and 9 mm; one-third (n = 765) had tumor margins of 10 mm or more. One in 10 patients (n = 245) had positive tumor margins, while the remaining 7% (n = 160) had negative tumor margins of 0.9 mm or less.

The study cohort was followed for a median 55 months; a significant relationship between margin width and survival emerged, with all negative margins widths being associated with significantly longer overall survival than the survival curve for those with positive margins (P < .01). This was true even for the narrowest margin widths. Factors associated with submillimeter tumor margins included tumor ablation, having more than three tumors, or tumor size over 5 cm.

Survival differences seen with submillimeter differences in tumor margin are likely attributable to currently unknown tumor growth properties, rather than actual margin width, Dr. D’Angelica said. In response to a question from Dr. Jean-Nicolas Vauthey of MD Anderson Cancer Center, Houston, Dr. D’Angelica speculated that the future of treating MCRC may rely on microscopic determination of tumor growth patterns, as well as better understanding of underlying gene patterns.

“Negative histologic margins, at all widths, including submillimeter margins, are independently associated with improved overall survival,” said Dr. D’Angelica. A significant difference was seen between patients with positive margins and any negative margin width, and between patients with submillimeter vs. 1 mm or greater margins. Beyond 1 mm, however, increasing margins widths were not associated with increased survival benefit.

Dr. D’Angelica noted that surgeons should not fear that a surgery with anticipated close margins would not benefit the patient, since any amount of clear margin confers a survival benefit. Wide margins, however, should be attempted when the approach is safe and feasible because it is the best-known technical approach to ensure a negative tumor margin. Very narrow margins, he noted, are probably a marker for an unknown biological factor rather than a true reflection of surgical technique.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Treating gut failure after bariatric surgery involves meeting patients’ nutritional needs while avoiding a recurrence of morbid obesity, according to Dr. Kareem Abu-Elmagd of the Cleveland Clinic.

Surgeons must be flexible, and should be familiar with a variety of reconstructive techniques to restore patients to nutritional autonomy while minimizing the need for visceral transplantation, he said.

Gut failure is a rare but serious and potentially life-threatening complication of bariatric surgery. When it occurs, the patient can no longer meet nutritional needs autonomously, but rather requires total parenteral nutrition (TPN). Although comprehensive medical management including TPN is necessary when gut failure occurs, reconstructive surgery or visceral transplantation is the only means to allow patients to regain nutritional autonomy.

Dr. Abu-Elmagd reported the results of 2 decades of experience with post–bariatric surgery gut failure at the Cleveland Clinic and the University of Pittsburgh Medical Center at the annual meeting of the American Surgical Association. He and his coinvestigators at the two facilities assessed a total of 131 patients who were referred for gut failure from 1995 to 2015. The number of referrals, said Dr. Abu-Elmagd, has been increasing sharply, with nearly two-thirds of patients referred over the past 5 years.

The study sought to identify the types and causes of gut failures seen, to describe surgical techniques used for repair or transplant, and to track outcomes for patients after surgical repair for gut failure. Of the 131 patients in the study, 100 had a Roux-en-Y or similar combined malabsorptive and restrictive surgery as their primary bariatric procedure. Overall, 85% of patients were female.

Dr. Abu-Elmagd classified gut failure into three major groups: 55 patients (42%) had type I or catastrophic gut loss, which included strangulation and vascular occlusion; 43 patients (33%) had type II gut failure, caused by technical complications such as loss of gut continuity, strictures, and fistulae; and 33 patients (25%) had type III gut failure, caused by dysfunctional syndromes such as dysmotility, restriction, or absorption.

Of the 131 patients referred, 116 went on to have a total of 317 restorative procedures. Most (n = 84, 72%) needed reversal of their primary bariatric procedure. Patients received a total of 198 autologous reconstruction procedures, while 10 intestinal-lengthening procedures and 25 visceral transplantations were performed.

Dr. Abu-Elmagd and his colleagues characterized the reconstruction procedures according to the embryonic origins of the structures repaired. Seventy-eight patients had major reconstruction of the foregut, “the most tedious and technically challenging procedure … to restore normal gut anatomy and physiology,” said Dr. Abu-Elmagd. Three other patients had gastroplasty to restore the foregut, and seven needed to have an alimentary conduit interposed in order to restore normal alimentary flow. Mid- and hindgut reconstructions (n = 110) were essential to maximize absorption and restore nutritional autonomy, he said.

If patients had less than 100 cm of small bowel remaining, they received serial transverse enteroplasty, an intestinal-lengthening procedure. The few patients who needed intestinal, liver-intestine, or multivisceral transplantations had ultrashort gut syndrome and could not be maintained on TPN.

Five-year cumulative survival for those receiving reconstruction or transplantation was 84%, and plateaued at 72% at 10 and 15 years post restoration. For the subset who received transplantation, the 5-year survival was 69%. Among the first 100 surviving surgical patients, 83% retained full nutritional autonomy.

Bariatric surgery, noted discussant Dr. Debra Sudan of Duke University, “is clearly the most effective treatment for obesity and has tremendous impact on comorbidities,” but, since it is an elective procedure, “it’s devastating when complications develop.” She asked what considerations were specific to the bariatric population when dealing with gut failure.

Bariatric patients, said Dr. Abu-Elmegd, have the advantage that they do not have an underlying disease process, and overall they have the ability to adapt and return to more normal gut function very quickly. From a surgical perspective, the solutions must be flexible and tailored to the patient. He said, “Whatever the patient has, you fix it.”

The authors reported no relevant financial disclosures.

SAN DIEGO – Treating gut failure after bariatric surgery involves meeting patients’ nutritional needs while avoiding a recurrence of morbid obesity, according to Dr. Kareem Abu-Elmagd of the Cleveland Clinic.

Surgeons must be flexible, and should be familiar with a variety of reconstructive techniques to restore patients to nutritional autonomy while minimizing the need for visceral transplantation, he said.

Gut failure is a rare but serious and potentially life-threatening complication of bariatric surgery. When it occurs, the patient can no longer meet nutritional needs autonomously, but rather requires total parenteral nutrition (TPN). Although comprehensive medical management including TPN is necessary when gut failure occurs, reconstructive surgery or visceral transplantation is the only means to allow patients to regain nutritional autonomy.

Dr. Abu-Elmagd reported the results of 2 decades of experience with post–bariatric surgery gut failure at the Cleveland Clinic and the University of Pittsburgh Medical Center at the annual meeting of the American Surgical Association. He and his coinvestigators at the two facilities assessed a total of 131 patients who were referred for gut failure from 1995 to 2015. The number of referrals, said Dr. Abu-Elmagd, has been increasing sharply, with nearly two-thirds of patients referred over the past 5 years.

The study sought to identify the types and causes of gut failures seen, to describe surgical techniques used for repair or transplant, and to track outcomes for patients after surgical repair for gut failure. Of the 131 patients in the study, 100 had a Roux-en-Y or similar combined malabsorptive and restrictive surgery as their primary bariatric procedure. Overall, 85% of patients were female.

Dr. Abu-Elmagd classified gut failure into three major groups: 55 patients (42%) had type I or catastrophic gut loss, which included strangulation and vascular occlusion; 43 patients (33%) had type II gut failure, caused by technical complications such as loss of gut continuity, strictures, and fistulae; and 33 patients (25%) had type III gut failure, caused by dysfunctional syndromes such as dysmotility, restriction, or absorption.

Of the 131 patients referred, 116 went on to have a total of 317 restorative procedures. Most (n = 84, 72%) needed reversal of their primary bariatric procedure. Patients received a total of 198 autologous reconstruction procedures, while 10 intestinal-lengthening procedures and 25 visceral transplantations were performed.

Dr. Abu-Elmagd and his colleagues characterized the reconstruction procedures according to the embryonic origins of the structures repaired. Seventy-eight patients had major reconstruction of the foregut, “the most tedious and technically challenging procedure … to restore normal gut anatomy and physiology,” said Dr. Abu-Elmagd. Three other patients had gastroplasty to restore the foregut, and seven needed to have an alimentary conduit interposed in order to restore normal alimentary flow. Mid- and hindgut reconstructions (n = 110) were essential to maximize absorption and restore nutritional autonomy, he said.

If patients had less than 100 cm of small bowel remaining, they received serial transverse enteroplasty, an intestinal-lengthening procedure. The few patients who needed intestinal, liver-intestine, or multivisceral transplantations had ultrashort gut syndrome and could not be maintained on TPN.

Five-year cumulative survival for those receiving reconstruction or transplantation was 84%, and plateaued at 72% at 10 and 15 years post restoration. For the subset who received transplantation, the 5-year survival was 69%. Among the first 100 surviving surgical patients, 83% retained full nutritional autonomy.

Bariatric surgery, noted discussant Dr. Debra Sudan of Duke University, “is clearly the most effective treatment for obesity and has tremendous impact on comorbidities,” but, since it is an elective procedure, “it’s devastating when complications develop.” She asked what considerations were specific to the bariatric population when dealing with gut failure.

Bariatric patients, said Dr. Abu-Elmegd, have the advantage that they do not have an underlying disease process, and overall they have the ability to adapt and return to more normal gut function very quickly. From a surgical perspective, the solutions must be flexible and tailored to the patient. He said, “Whatever the patient has, you fix it.”

The authors reported no relevant financial disclosures.

SAN DIEGO – Treating gut failure after bariatric surgery involves meeting patients’ nutritional needs while avoiding a recurrence of morbid obesity, according to Dr. Kareem Abu-Elmagd of the Cleveland Clinic.

Surgeons must be flexible, and should be familiar with a variety of reconstructive techniques to restore patients to nutritional autonomy while minimizing the need for visceral transplantation, he said.

Gut failure is a rare but serious and potentially life-threatening complication of bariatric surgery. When it occurs, the patient can no longer meet nutritional needs autonomously, but rather requires total parenteral nutrition (TPN). Although comprehensive medical management including TPN is necessary when gut failure occurs, reconstructive surgery or visceral transplantation is the only means to allow patients to regain nutritional autonomy.

Dr. Abu-Elmagd reported the results of 2 decades of experience with post–bariatric surgery gut failure at the Cleveland Clinic and the University of Pittsburgh Medical Center at the annual meeting of the American Surgical Association. He and his coinvestigators at the two facilities assessed a total of 131 patients who were referred for gut failure from 1995 to 2015. The number of referrals, said Dr. Abu-Elmagd, has been increasing sharply, with nearly two-thirds of patients referred over the past 5 years.

The study sought to identify the types and causes of gut failures seen, to describe surgical techniques used for repair or transplant, and to track outcomes for patients after surgical repair for gut failure. Of the 131 patients in the study, 100 had a Roux-en-Y or similar combined malabsorptive and restrictive surgery as their primary bariatric procedure. Overall, 85% of patients were female.

Dr. Abu-Elmagd classified gut failure into three major groups: 55 patients (42%) had type I or catastrophic gut loss, which included strangulation and vascular occlusion; 43 patients (33%) had type II gut failure, caused by technical complications such as loss of gut continuity, strictures, and fistulae; and 33 patients (25%) had type III gut failure, caused by dysfunctional syndromes such as dysmotility, restriction, or absorption.

Of the 131 patients referred, 116 went on to have a total of 317 restorative procedures. Most (n = 84, 72%) needed reversal of their primary bariatric procedure. Patients received a total of 198 autologous reconstruction procedures, while 10 intestinal-lengthening procedures and 25 visceral transplantations were performed.

Dr. Abu-Elmagd and his colleagues characterized the reconstruction procedures according to the embryonic origins of the structures repaired. Seventy-eight patients had major reconstruction of the foregut, “the most tedious and technically challenging procedure … to restore normal gut anatomy and physiology,” said Dr. Abu-Elmagd. Three other patients had gastroplasty to restore the foregut, and seven needed to have an alimentary conduit interposed in order to restore normal alimentary flow. Mid- and hindgut reconstructions (n = 110) were essential to maximize absorption and restore nutritional autonomy, he said.

If patients had less than 100 cm of small bowel remaining, they received serial transverse enteroplasty, an intestinal-lengthening procedure. The few patients who needed intestinal, liver-intestine, or multivisceral transplantations had ultrashort gut syndrome and could not be maintained on TPN.

Five-year cumulative survival for those receiving reconstruction or transplantation was 84%, and plateaued at 72% at 10 and 15 years post restoration. For the subset who received transplantation, the 5-year survival was 69%. Among the first 100 surviving surgical patients, 83% retained full nutritional autonomy.

Bariatric surgery, noted discussant Dr. Debra Sudan of Duke University, “is clearly the most effective treatment for obesity and has tremendous impact on comorbidities,” but, since it is an elective procedure, “it’s devastating when complications develop.” She asked what considerations were specific to the bariatric population when dealing with gut failure.

Bariatric patients, said Dr. Abu-Elmegd, have the advantage that they do not have an underlying disease process, and overall they have the ability to adapt and return to more normal gut function very quickly. From a surgical perspective, the solutions must be flexible and tailored to the patient. He said, “Whatever the patient has, you fix it.”

The authors reported no relevant financial disclosures.

SAN DIEGO – More nurses, robust ancillary services, and an electronic medical record (EMR) helped reduce hospital length of stay when an urgent general surgery procedure was performed on the weekend. When these surgeon-independent resources were present, hospitals were able to overcome the weekend effect.

When a patient needs urgent surgery over the weekend, the result can be increased length of stay, higher charges, increased major and minor complications, and even increased mortality. Overall, patients admitted on the weekend have worse outcomes than do those admitted on a weekday. Factors contributing to the weekend effect for hospitals in one state were explored in a presentation at the American Surgical Association annual meeting.

©Stevan Ovicigor/thinkstockphotos.com

“Not all hospitals are created equal in their ability to avoid the weekend effect,” noted presenter Matthew Zapf, a second-year medical student at Stritch School of Medicine, Loyola University Chicago. The work of Mr. Zapf and his colleagues at the university showed that hospitals with full electronic medical records, increased nurse-to-bed ratios, pain and wound management services, and home health programs were more likely to overcome the weekend effect, as defined by length of stay for specific urgent and emergent surgical procedures.

The study used Florida’s Healthcare Cost and Utilization Project State Inpatient Dataset (HCUP-SID), an all-payer dataset, and linked that information to Florida’s American Hospital Association annual survey database, which assesses hospital characteristics. Outcomes were assessed for cholecystectomy, hernia repair for obstructed or gangrenous hernias, and appendectomy for 126,666 people aged 18-90 years. To ensure that the study captured just urgent or emergency procedures, only procedures performed within 2 days of hospital admission were included.

By assessing whether length of stay was longer for weekend vs. weekday admissions for these procedures, the researchers identified which hospitals demonstrated the weekend effect. Of the 197 acute care hospitals identified, 117 performed more than 10 emergent cases per year and were included in the analysis. The presence or absence of a weekend effect was recorded for each hospital for each year of the study. Hospital characteristics were assessed for association with the weekend effect for a given facility in a given year.

None of the 117 hospitals were free of the weekend effect – an outcome that had not been anticipated by the study authors. “I was shocked by the fact that nobody was immune to the weekend effect,” Dr. Anai Kothari said in an interview. Dr. Kothari, also of Loyola University Chicago and first author of the study, said that 41 of the hospitals had a persistent weekend effect through all years of the study. Seventeen hospitals overcame the weekend effect during the time period studied, while 21 others developed the weekend effect during this time. Most hospitals (n = 87) oscillated between states, exhibiting a weekend effect only in some years.

Institutions with an EMR in place during the study period had an odds ratio (OR) of nearly 5 of being able to overcome the weekend effect (P = .010). The EMR, said Dr. Kothari, is especially helpful in effecting safe care transitions. “We are going to see a strong effect, especially in situations where there’s a care transition” as institutions learn how to make full use of the EMR, he said.

Inpatient resources linked with overcoming the weekend effect included a higher ratio of registered nurses to beds (P = .0036), a physical rehabilitation program (P = .017), and a pain management program (P = .001). After-care resources in the form of home health (P = .001) and wound management (P = .043) also contributed significantly to being able to overcome the weekend effect.

Discussant Dr. Lena Napolitano of the University of Michigan commented on the “incredibly robust statistical analysis” performed by the study investigators.

How, she asked, did investigators select median length of stay as the marker for outcomes, when an extended stay over the weekend may just represent poor discharge planning, and not really represent increased adverse outcomes? Senior author Dr. Paul Kuo of Loyola University Chicago replied: “We put a lot of thought into this. We found that length of stay was predictive of each outcome during modeling.”

Study limitations included the fact that data were administrative and were drawn from a single state. It was not possible, for example, to differentiate weekend vs. weekday distribution of resources at a given institution. The next steps will include searching for richer data sources to explore the full set of hospital resources that contribute to patient outcomes for urgent surgeries, said Dr. Kothari.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – More nurses, robust ancillary services, and an electronic medical record (EMR) helped reduce hospital length of stay when an urgent general surgery procedure was performed on the weekend. When these surgeon-independent resources were present, hospitals were able to overcome the weekend effect.

When a patient needs urgent surgery over the weekend, the result can be increased length of stay, higher charges, increased major and minor complications, and even increased mortality. Overall, patients admitted on the weekend have worse outcomes than do those admitted on a weekday. Factors contributing to the weekend effect for hospitals in one state were explored in a presentation at the American Surgical Association annual meeting.

©Stevan Ovicigor/thinkstockphotos.com

“Not all hospitals are created equal in their ability to avoid the weekend effect,” noted presenter Matthew Zapf, a second-year medical student at Stritch School of Medicine, Loyola University Chicago. The work of Mr. Zapf and his colleagues at the university showed that hospitals with full electronic medical records, increased nurse-to-bed ratios, pain and wound management services, and home health programs were more likely to overcome the weekend effect, as defined by length of stay for specific urgent and emergent surgical procedures.

The study used Florida’s Healthcare Cost and Utilization Project State Inpatient Dataset (HCUP-SID), an all-payer dataset, and linked that information to Florida’s American Hospital Association annual survey database, which assesses hospital characteristics. Outcomes were assessed for cholecystectomy, hernia repair for obstructed or gangrenous hernias, and appendectomy for 126,666 people aged 18-90 years. To ensure that the study captured just urgent or emergency procedures, only procedures performed within 2 days of hospital admission were included.

By assessing whether length of stay was longer for weekend vs. weekday admissions for these procedures, the researchers identified which hospitals demonstrated the weekend effect. Of the 197 acute care hospitals identified, 117 performed more than 10 emergent cases per year and were included in the analysis. The presence or absence of a weekend effect was recorded for each hospital for each year of the study. Hospital characteristics were assessed for association with the weekend effect for a given facility in a given year.

None of the 117 hospitals were free of the weekend effect – an outcome that had not been anticipated by the study authors. “I was shocked by the fact that nobody was immune to the weekend effect,” Dr. Anai Kothari said in an interview. Dr. Kothari, also of Loyola University Chicago and first author of the study, said that 41 of the hospitals had a persistent weekend effect through all years of the study. Seventeen hospitals overcame the weekend effect during the time period studied, while 21 others developed the weekend effect during this time. Most hospitals (n = 87) oscillated between states, exhibiting a weekend effect only in some years.

Institutions with an EMR in place during the study period had an odds ratio (OR) of nearly 5 of being able to overcome the weekend effect (P = .010). The EMR, said Dr. Kothari, is especially helpful in effecting safe care transitions. “We are going to see a strong effect, especially in situations where there’s a care transition” as institutions learn how to make full use of the EMR, he said.

Inpatient resources linked with overcoming the weekend effect included a higher ratio of registered nurses to beds (P = .0036), a physical rehabilitation program (P = .017), and a pain management program (P = .001). After-care resources in the form of home health (P = .001) and wound management (P = .043) also contributed significantly to being able to overcome the weekend effect.

Discussant Dr. Lena Napolitano of the University of Michigan commented on the “incredibly robust statistical analysis” performed by the study investigators.

How, she asked, did investigators select median length of stay as the marker for outcomes, when an extended stay over the weekend may just represent poor discharge planning, and not really represent increased adverse outcomes? Senior author Dr. Paul Kuo of Loyola University Chicago replied: “We put a lot of thought into this. We found that length of stay was predictive of each outcome during modeling.”

Study limitations included the fact that data were administrative and were drawn from a single state. It was not possible, for example, to differentiate weekend vs. weekday distribution of resources at a given institution. The next steps will include searching for richer data sources to explore the full set of hospital resources that contribute to patient outcomes for urgent surgeries, said Dr. Kothari.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – More nurses, robust ancillary services, and an electronic medical record (EMR) helped reduce hospital length of stay when an urgent general surgery procedure was performed on the weekend. When these surgeon-independent resources were present, hospitals were able to overcome the weekend effect.

When a patient needs urgent surgery over the weekend, the result can be increased length of stay, higher charges, increased major and minor complications, and even increased mortality. Overall, patients admitted on the weekend have worse outcomes than do those admitted on a weekday. Factors contributing to the weekend effect for hospitals in one state were explored in a presentation at the American Surgical Association annual meeting.

©Stevan Ovicigor/thinkstockphotos.com

“Not all hospitals are created equal in their ability to avoid the weekend effect,” noted presenter Matthew Zapf, a second-year medical student at Stritch School of Medicine, Loyola University Chicago. The work of Mr. Zapf and his colleagues at the university showed that hospitals with full electronic medical records, increased nurse-to-bed ratios, pain and wound management services, and home health programs were more likely to overcome the weekend effect, as defined by length of stay for specific urgent and emergent surgical procedures.

The study used Florida’s Healthcare Cost and Utilization Project State Inpatient Dataset (HCUP-SID), an all-payer dataset, and linked that information to Florida’s American Hospital Association annual survey database, which assesses hospital characteristics. Outcomes were assessed for cholecystectomy, hernia repair for obstructed or gangrenous hernias, and appendectomy for 126,666 people aged 18-90 years. To ensure that the study captured just urgent or emergency procedures, only procedures performed within 2 days of hospital admission were included.

By assessing whether length of stay was longer for weekend vs. weekday admissions for these procedures, the researchers identified which hospitals demonstrated the weekend effect. Of the 197 acute care hospitals identified, 117 performed more than 10 emergent cases per year and were included in the analysis. The presence or absence of a weekend effect was recorded for each hospital for each year of the study. Hospital characteristics were assessed for association with the weekend effect for a given facility in a given year.

None of the 117 hospitals were free of the weekend effect – an outcome that had not been anticipated by the study authors. “I was shocked by the fact that nobody was immune to the weekend effect,” Dr. Anai Kothari said in an interview. Dr. Kothari, also of Loyola University Chicago and first author of the study, said that 41 of the hospitals had a persistent weekend effect through all years of the study. Seventeen hospitals overcame the weekend effect during the time period studied, while 21 others developed the weekend effect during this time. Most hospitals (n = 87) oscillated between states, exhibiting a weekend effect only in some years.

Institutions with an EMR in place during the study period had an odds ratio (OR) of nearly 5 of being able to overcome the weekend effect (P = .010). The EMR, said Dr. Kothari, is especially helpful in effecting safe care transitions. “We are going to see a strong effect, especially in situations where there’s a care transition” as institutions learn how to make full use of the EMR, he said.

Inpatient resources linked with overcoming the weekend effect included a higher ratio of registered nurses to beds (P = .0036), a physical rehabilitation program (P = .017), and a pain management program (P = .001). After-care resources in the form of home health (P = .001) and wound management (P = .043) also contributed significantly to being able to overcome the weekend effect.

Discussant Dr. Lena Napolitano of the University of Michigan commented on the “incredibly robust statistical analysis” performed by the study investigators.

How, she asked, did investigators select median length of stay as the marker for outcomes, when an extended stay over the weekend may just represent poor discharge planning, and not really represent increased adverse outcomes? Senior author Dr. Paul Kuo of Loyola University Chicago replied: “We put a lot of thought into this. We found that length of stay was predictive of each outcome during modeling.”

Study limitations included the fact that data were administrative and were drawn from a single state. It was not possible, for example, to differentiate weekend vs. weekday distribution of resources at a given institution. The next steps will include searching for richer data sources to explore the full set of hospital resources that contribute to patient outcomes for urgent surgeries, said Dr. Kothari.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – A combination of bowel cleansing and oral antibiotics nearly halved the risk of common and troublesome complications in colorectal surgery. Infections, leaks, and postsurgical ileus were all significantly less likely with the combined regime, according to a study reported at the annual meeting of the American Surgical Association.

Patients preparing for colorectal surgery routinely received mechanical bowel preparation in combination with oral antibiotics in the 1970s. However, since then, the availability of IV antibiotics combined with concerns about complications from bowel preparation have contributed to a decline in use of the regime. Consensus is lacking about best practices for preparation for colorectal surgery.

Dr. P. Ravi Kiran, chief and program director of Columbia University Medical Center’s division of colorectal surgery, presented findings from a large retrospective study that addressed whether oral antibiotics and mechanical bowel preparation reduced the risk of complications from colorectal surgery. Drawing from targeted colectomy data, available from 2012 onward through the large American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, Dr. Kiran and associates compared three groups of patients undergoing elective colectomy. Of the total 8,644 patients, 2,498 (28.9%) received no preparation, 3,822 (44.2%) received mechanical bowel preparation alone, and 2,324 (26.9%) received both oral antibiotics and mechanical bowel preparation.

Primary outcome measures included the presence of anastomotic leak from the surgery, surgical site infections, ileus, and all-cause mortality. The patients were well matched by age and gender, and surgery type; case complexity and degree of resident physician involvement in the surgical procedures were also similar between arms.

On multivariable analysis, patients who received mechanical bowel preparation and oral antibiotics were significantly less likely to have surgical site infections (odds ratio, 0.43), to sustain ileus (OR, 0.71), or to have anastomotic leak (OR, 0.56). Postoperatively, those who had received no bowel preparation were also significantly more likely to have pneumonia, to require reintubation, and to fail to wean from the ventilator. They also were more likely to have deep vein thrombosis and sepsis. All-cause 30-day mortality was also significantly less likely in the group receiving both bowel preparation and oral antibiotics.

Dr. Kiran noted that investigators were not able to determine the type of mechanical bowel preparation patients received, and likely could not control for all confounders.

Discussant Dr. Heidi Nelson of the Mayo Clinic, Rochester, Minn., noted that despite the study’s strengths, including its large size and the real-world nature of the investigation, she doubts that the study will be considered definitive. Limitations that critics might point out, she noted, are the retrospective nature of the study and the possibility that the three groups studied were not really comparable because of subtle selection biases on the part of the treating surgeons. Dr. Kiran conceded that though multivariable analysis attempted to account and control for as many between-group differences as they could identify, differences probably did persist.

Dr. Hiram Polk of the University of Louisville (Ky.) commented that studies such as these using massive databases, though they may show what is true, may not always point to what is clinically relevant. Overall, it’s been shown that about one in four patients given systemic antibiotics are given the wrong drug, he said; further, “the only place you can truly sterilize a colon is in an autoclave.” Dr. Kiran did note that the combined oral preparation regime was successful in reducing the incidence of the most common complications by about 50%.

Following with more real-world observations, Dr. Mary Otterson of the Medical College of Wisconsin, Milwaukee, commented that the effective dose of preoperative erythromycin is very close to doses that cause significant nausea and vomiting. In her experience, “If we went any higher, they vomited. We also had unplanned admits with electrolyte abnormalities.” The best-tolerated and most effective regime, she said, should be identified by a prospective, randomized, controlled trial.

The authors reported no conflicts of interest.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – A combination of bowel cleansing and oral antibiotics nearly halved the risk of common and troublesome complications in colorectal surgery. Infections, leaks, and postsurgical ileus were all significantly less likely with the combined regime, according to a study reported at the annual meeting of the American Surgical Association.

Patients preparing for colorectal surgery routinely received mechanical bowel preparation in combination with oral antibiotics in the 1970s. However, since then, the availability of IV antibiotics combined with concerns about complications from bowel preparation have contributed to a decline in use of the regime. Consensus is lacking about best practices for preparation for colorectal surgery.

Dr. P. Ravi Kiran, chief and program director of Columbia University Medical Center’s division of colorectal surgery, presented findings from a large retrospective study that addressed whether oral antibiotics and mechanical bowel preparation reduced the risk of complications from colorectal surgery. Drawing from targeted colectomy data, available from 2012 onward through the large American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, Dr. Kiran and associates compared three groups of patients undergoing elective colectomy. Of the total 8,644 patients, 2,498 (28.9%) received no preparation, 3,822 (44.2%) received mechanical bowel preparation alone, and 2,324 (26.9%) received both oral antibiotics and mechanical bowel preparation.

Primary outcome measures included the presence of anastomotic leak from the surgery, surgical site infections, ileus, and all-cause mortality. The patients were well matched by age and gender, and surgery type; case complexity and degree of resident physician involvement in the surgical procedures were also similar between arms.

On multivariable analysis, patients who received mechanical bowel preparation and oral antibiotics were significantly less likely to have surgical site infections (odds ratio, 0.43), to sustain ileus (OR, 0.71), or to have anastomotic leak (OR, 0.56). Postoperatively, those who had received no bowel preparation were also significantly more likely to have pneumonia, to require reintubation, and to fail to wean from the ventilator. They also were more likely to have deep vein thrombosis and sepsis. All-cause 30-day mortality was also significantly less likely in the group receiving both bowel preparation and oral antibiotics.

Dr. Kiran noted that investigators were not able to determine the type of mechanical bowel preparation patients received, and likely could not control for all confounders.

Discussant Dr. Heidi Nelson of the Mayo Clinic, Rochester, Minn., noted that despite the study’s strengths, including its large size and the real-world nature of the investigation, she doubts that the study will be considered definitive. Limitations that critics might point out, she noted, are the retrospective nature of the study and the possibility that the three groups studied were not really comparable because of subtle selection biases on the part of the treating surgeons. Dr. Kiran conceded that though multivariable analysis attempted to account and control for as many between-group differences as they could identify, differences probably did persist.

Dr. Hiram Polk of the University of Louisville (Ky.) commented that studies such as these using massive databases, though they may show what is true, may not always point to what is clinically relevant. Overall, it’s been shown that about one in four patients given systemic antibiotics are given the wrong drug, he said; further, “the only place you can truly sterilize a colon is in an autoclave.” Dr. Kiran did note that the combined oral preparation regime was successful in reducing the incidence of the most common complications by about 50%.

Following with more real-world observations, Dr. Mary Otterson of the Medical College of Wisconsin, Milwaukee, commented that the effective dose of preoperative erythromycin is very close to doses that cause significant nausea and vomiting. In her experience, “If we went any higher, they vomited. We also had unplanned admits with electrolyte abnormalities.” The best-tolerated and most effective regime, she said, should be identified by a prospective, randomized, controlled trial.

The authors reported no conflicts of interest.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – A combination of bowel cleansing and oral antibiotics nearly halved the risk of common and troublesome complications in colorectal surgery. Infections, leaks, and postsurgical ileus were all significantly less likely with the combined regime, according to a study reported at the annual meeting of the American Surgical Association.

Patients preparing for colorectal surgery routinely received mechanical bowel preparation in combination with oral antibiotics in the 1970s. However, since then, the availability of IV antibiotics combined with concerns about complications from bowel preparation have contributed to a decline in use of the regime. Consensus is lacking about best practices for preparation for colorectal surgery.

Dr. P. Ravi Kiran, chief and program director of Columbia University Medical Center’s division of colorectal surgery, presented findings from a large retrospective study that addressed whether oral antibiotics and mechanical bowel preparation reduced the risk of complications from colorectal surgery. Drawing from targeted colectomy data, available from 2012 onward through the large American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, Dr. Kiran and associates compared three groups of patients undergoing elective colectomy. Of the total 8,644 patients, 2,498 (28.9%) received no preparation, 3,822 (44.2%) received mechanical bowel preparation alone, and 2,324 (26.9%) received both oral antibiotics and mechanical bowel preparation.

Primary outcome measures included the presence of anastomotic leak from the surgery, surgical site infections, ileus, and all-cause mortality. The patients were well matched by age and gender, and surgery type; case complexity and degree of resident physician involvement in the surgical procedures were also similar between arms.

On multivariable analysis, patients who received mechanical bowel preparation and oral antibiotics were significantly less likely to have surgical site infections (odds ratio, 0.43), to sustain ileus (OR, 0.71), or to have anastomotic leak (OR, 0.56). Postoperatively, those who had received no bowel preparation were also significantly more likely to have pneumonia, to require reintubation, and to fail to wean from the ventilator. They also were more likely to have deep vein thrombosis and sepsis. All-cause 30-day mortality was also significantly less likely in the group receiving both bowel preparation and oral antibiotics.

Dr. Kiran noted that investigators were not able to determine the type of mechanical bowel preparation patients received, and likely could not control for all confounders.

Discussant Dr. Heidi Nelson of the Mayo Clinic, Rochester, Minn., noted that despite the study’s strengths, including its large size and the real-world nature of the investigation, she doubts that the study will be considered definitive. Limitations that critics might point out, she noted, are the retrospective nature of the study and the possibility that the three groups studied were not really comparable because of subtle selection biases on the part of the treating surgeons. Dr. Kiran conceded that though multivariable analysis attempted to account and control for as many between-group differences as they could identify, differences probably did persist.

Dr. Hiram Polk of the University of Louisville (Ky.) commented that studies such as these using massive databases, though they may show what is true, may not always point to what is clinically relevant. Overall, it’s been shown that about one in four patients given systemic antibiotics are given the wrong drug, he said; further, “the only place you can truly sterilize a colon is in an autoclave.” Dr. Kiran did note that the combined oral preparation regime was successful in reducing the incidence of the most common complications by about 50%.

Following with more real-world observations, Dr. Mary Otterson of the Medical College of Wisconsin, Milwaukee, commented that the effective dose of preoperative erythromycin is very close to doses that cause significant nausea and vomiting. In her experience, “If we went any higher, they vomited. We also had unplanned admits with electrolyte abnormalities.” The best-tolerated and most effective regime, she said, should be identified by a prospective, randomized, controlled trial.

The authors reported no conflicts of interest.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – More women with triple negative breast cancer are able to have breast-conserving therapy (BCT) when they receive neoadjuvant systemic chemotherapy.

In a recent trial, 42% of women who were considered ineligible for BCT became eligible for the tissue-sparing surgery after their course of neoadjuvant chemotherapy (NACT) was administered. However, surgeons and patients must work together to decide on the best course of action, according to Dr. David Ollila of the University of North Carolina, Chapel Hill.

UNC Lineberger Comprehensive Cancer Center

The relationship between NACT and the option to have breast-sparing surgery had not been well understood previously, especially for women with aggressive triple negative breast cancer, Dr. Ollila said at the annual meeting of the American Surgical Association.

What has been known is that women with breast cancer who receive NACT show overall improved pathological complete response (Lancet 2014;384:164-72), which is associated with better event-free and overall survival.

The current study, conducted within the larger CALGB 40603 randomized phase II clinical trial, captured the number of patients who converted from BCT-ineligible to BCT-eligible after NACT and before surgery. Investigators also tracked pathological complete response, defined as tumor-free margins on pathologic examination, for those receiving each type of surgery. Dr. Ollila presented his findings on behalf of his coinvestigators in the Alliance for Clinical Trials in Oncology.

The study used a 2x2 factorial design to compare paclitaxel with and without carboplatin followed by doxorubicin plus cyclophosphamide with and without bevacizumab. Before NACT, the surgeon determined whether or not the patient was a candidate for BCT and if not, why not. The process was repeated after NACT, with the surgeon again documenting his or her reasoning for the choice.

Complete data were available for 404 women, distributed evenly across chemotherapy treatment arms. Before NACT, 219 (54%) were judged by their surgeons to be BCT candidates, and 197 (90%) were still deemed eligible for BCT after NACT. Of the 185 (46%) judged ineligible for BCT before chemotherapy, 72 (42%) became eligible for tissue sparing surgery after NACT. “We achieved a very high conversion rate ... from BCT ineligible to eligible,” Dr. Ollila noted.

Overall, just over two-thirds of the 404 women (n = 275, 68%) became candidates for BCT before surgery, and of those, about two-thirds (n = 191, 69%) went on to have an attempted BCT surgery. Surgery was successful for 178 of these women. “Neoadjuvant chemotherapy led to BCT in 93% of selected triple negative patients,”said Dr. Ollila.

Pathological complete response did not differ significantly among the women who received BCT or mastectomy, whether the decision was made before or after chemotherapy.

Discussant Dr. Lisa Newman of the University of Michigan observed that NACT allows some breathing space for the patient and her surgeon to weigh choices, and when indicated, to receive genetic testing.

“We know from numerous population-based and institutional studies that many are opting for bilateral mastectomy, even if a lumpectomy would be optimal,”said Dr. Newman.

She asked whether patient decision making was tracked for this study. Dr. Ollila replied, “We did not include patient factors. We do not have prospective data on what the patient was thinking because we focused on the surgeon.” However, he said, plans are underway to quantify the patient perspective during the decision-making process.

The takeaway message, said Dr. Ollila, is that “We are letting people think that mastectomy is the best option; I think that sequential surgery is all right. I think we just need to try breast conserving therapy more often than we are.”

The study was partially sponsored by the Breast Cancer Research Foundation. The authors reported no conflicts of interest.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – More women with triple negative breast cancer are able to have breast-conserving therapy (BCT) when they receive neoadjuvant systemic chemotherapy.

In a recent trial, 42% of women who were considered ineligible for BCT became eligible for the tissue-sparing surgery after their course of neoadjuvant chemotherapy (NACT) was administered. However, surgeons and patients must work together to decide on the best course of action, according to Dr. David Ollila of the University of North Carolina, Chapel Hill.

UNC Lineberger Comprehensive Cancer Center

The relationship between NACT and the option to have breast-sparing surgery had not been well understood previously, especially for women with aggressive triple negative breast cancer, Dr. Ollila said at the annual meeting of the American Surgical Association.

What has been known is that women with breast cancer who receive NACT show overall improved pathological complete response (Lancet 2014;384:164-72), which is associated with better event-free and overall survival.

The current study, conducted within the larger CALGB 40603 randomized phase II clinical trial, captured the number of patients who converted from BCT-ineligible to BCT-eligible after NACT and before surgery. Investigators also tracked pathological complete response, defined as tumor-free margins on pathologic examination, for those receiving each type of surgery. Dr. Ollila presented his findings on behalf of his coinvestigators in the Alliance for Clinical Trials in Oncology.

The study used a 2x2 factorial design to compare paclitaxel with and without carboplatin followed by doxorubicin plus cyclophosphamide with and without bevacizumab. Before NACT, the surgeon determined whether or not the patient was a candidate for BCT and if not, why not. The process was repeated after NACT, with the surgeon again documenting his or her reasoning for the choice.

Complete data were available for 404 women, distributed evenly across chemotherapy treatment arms. Before NACT, 219 (54%) were judged by their surgeons to be BCT candidates, and 197 (90%) were still deemed eligible for BCT after NACT. Of the 185 (46%) judged ineligible for BCT before chemotherapy, 72 (42%) became eligible for tissue sparing surgery after NACT. “We achieved a very high conversion rate ... from BCT ineligible to eligible,” Dr. Ollila noted.

Overall, just over two-thirds of the 404 women (n = 275, 68%) became candidates for BCT before surgery, and of those, about two-thirds (n = 191, 69%) went on to have an attempted BCT surgery. Surgery was successful for 178 of these women. “Neoadjuvant chemotherapy led to BCT in 93% of selected triple negative patients,”said Dr. Ollila.

Pathological complete response did not differ significantly among the women who received BCT or mastectomy, whether the decision was made before or after chemotherapy.

Discussant Dr. Lisa Newman of the University of Michigan observed that NACT allows some breathing space for the patient and her surgeon to weigh choices, and when indicated, to receive genetic testing.

“We know from numerous population-based and institutional studies that many are opting for bilateral mastectomy, even if a lumpectomy would be optimal,”said Dr. Newman.

She asked whether patient decision making was tracked for this study. Dr. Ollila replied, “We did not include patient factors. We do not have prospective data on what the patient was thinking because we focused on the surgeon.” However, he said, plans are underway to quantify the patient perspective during the decision-making process.

The takeaway message, said Dr. Ollila, is that “We are letting people think that mastectomy is the best option; I think that sequential surgery is all right. I think we just need to try breast conserving therapy more often than we are.”

The study was partially sponsored by the Breast Cancer Research Foundation. The authors reported no conflicts of interest.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – More women with triple negative breast cancer are able to have breast-conserving therapy (BCT) when they receive neoadjuvant systemic chemotherapy.

In a recent trial, 42% of women who were considered ineligible for BCT became eligible for the tissue-sparing surgery after their course of neoadjuvant chemotherapy (NACT) was administered. However, surgeons and patients must work together to decide on the best course of action, according to Dr. David Ollila of the University of North Carolina, Chapel Hill.

UNC Lineberger Comprehensive Cancer Center

The relationship between NACT and the option to have breast-sparing surgery had not been well understood previously, especially for women with aggressive triple negative breast cancer, Dr. Ollila said at the annual meeting of the American Surgical Association.

What has been known is that women with breast cancer who receive NACT show overall improved pathological complete response (Lancet 2014;384:164-72), which is associated with better event-free and overall survival.

The current study, conducted within the larger CALGB 40603 randomized phase II clinical trial, captured the number of patients who converted from BCT-ineligible to BCT-eligible after NACT and before surgery. Investigators also tracked pathological complete response, defined as tumor-free margins on pathologic examination, for those receiving each type of surgery. Dr. Ollila presented his findings on behalf of his coinvestigators in the Alliance for Clinical Trials in Oncology.

The study used a 2x2 factorial design to compare paclitaxel with and without carboplatin followed by doxorubicin plus cyclophosphamide with and without bevacizumab. Before NACT, the surgeon determined whether or not the patient was a candidate for BCT and if not, why not. The process was repeated after NACT, with the surgeon again documenting his or her reasoning for the choice.

Complete data were available for 404 women, distributed evenly across chemotherapy treatment arms. Before NACT, 219 (54%) were judged by their surgeons to be BCT candidates, and 197 (90%) were still deemed eligible for BCT after NACT. Of the 185 (46%) judged ineligible for BCT before chemotherapy, 72 (42%) became eligible for tissue sparing surgery after NACT. “We achieved a very high conversion rate ... from BCT ineligible to eligible,” Dr. Ollila noted.

Overall, just over two-thirds of the 404 women (n = 275, 68%) became candidates for BCT before surgery, and of those, about two-thirds (n = 191, 69%) went on to have an attempted BCT surgery. Surgery was successful for 178 of these women. “Neoadjuvant chemotherapy led to BCT in 93% of selected triple negative patients,”said Dr. Ollila.

Pathological complete response did not differ significantly among the women who received BCT or mastectomy, whether the decision was made before or after chemotherapy.

Discussant Dr. Lisa Newman of the University of Michigan observed that NACT allows some breathing space for the patient and her surgeon to weigh choices, and when indicated, to receive genetic testing.

“We know from numerous population-based and institutional studies that many are opting for bilateral mastectomy, even if a lumpectomy would be optimal,”said Dr. Newman.

She asked whether patient decision making was tracked for this study. Dr. Ollila replied, “We did not include patient factors. We do not have prospective data on what the patient was thinking because we focused on the surgeon.” However, he said, plans are underway to quantify the patient perspective during the decision-making process.

The takeaway message, said Dr. Ollila, is that “We are letting people think that mastectomy is the best option; I think that sequential surgery is all right. I think we just need to try breast conserving therapy more often than we are.”

The study was partially sponsored by the Breast Cancer Research Foundation. The authors reported no conflicts of interest.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Patients hoping to avoid a permanent stoma by having a salvage surgery to repair or replace a failing ileal pouch–anal anastomosis (IPAA) achieved good functional outcomes and quality of life in one institution’s long-term experience.

A large case series drawn from IPAA re-dos at the Cleveland Clinic over a 20-year span showed that the procedure was successful for four in five patients, and more than 90% were satisfied with their quality of life, despite some functional limitations. Dr. Feza Remzi, chairman of the department of colorectal surgery at the Cleveland Clinic, presented findings from 500 patients undergoing IPAA re-dos via the transabdominal approach. In this group, 80% (401) of transabdominally revised IPAAs were successful.

IPAA is a procedure indicated for patients with Crohn’s disease, ulcerative or indeterminate colitis, or familial adenomatous polyposis. The surgery preserves the capacity for anal defecation with intestinal continuity after proctocolectomy by fashioning a reservoir for stool from the small intestine. However, up to 15% of patients will have pouch failure, necessitating a permanent stoma unless the pouch is surgically revised, he said at  the annual meeting of the American Surgical Association.

To determine outcomes for patients having a re-do of a failed IPAA, Dr. Remzi and colleagues assessed 502 IPAA re-do patients (215, male; median age, 38 years) who received their procedure at the Cleveland Clinic from 1983 to 2014. Crohn’s disease was the primary diagnosis for 419 patients (84%); just over half (n = 263) had anastomotic leak or fistula as the cause of first pouch failure, followed by pouch-vaginal fistula in 85 women (17%) and obstruction in 116 patients (23%).

The primary endpoints of the study were surgery morbidity, how many patients had a functioning pouch after re-do, pouch function, and quality of life.

Surgeon discretion dictated whether the pouch was revised, as it was in 295 patients (59%), or whether a new pouch was created. Overall, just over half of patients (n = 270) had postoperative complications, though there were no short-term deaths. Ileus and pelvic sepsis were the most common short-term complications, occurring in 81 (16%) and 50 (10%) patients, respectively. All of the other complications occurred in less than 10% of patients. Patients stayed in the hospital a median of 7 days, and 63 (13%) were readmitted.

Over the duration of the study, 101 patients (20%) had failure of their redone IPAA pouches, and pelvis sepsis and anastomotic stricture each occurred in more than 10% of patients. Short-term postoperative morbidity and occurrence of pelvic sepsis at any point after re-do surgery were associated with failure of the redone IPAA based on a Cox regression model (P = .035 and P < .0001, respectively).

Patients were overall very satisfied with their quality of life after IPAA re-do surgery; 92% of the 261 respondents said they would undergo the surgery again, and 93% would recommend the surgery. This was true although patients reported a mean of six daytime bowel movements, about half of patients reported having stool seepage or requiring pad use, and a third of patients reported dietary restrictions related to their bowel function.

Study limitations included the lack of information regarding patients in whom the re-do attempt was abandoned, or for those referred for surgery who did not have an IPAA re-do. Another limitation was the relatively low number of patients who completed all items on the function and quality of life questionnaires; investigators decided that the most robust analysis would flow from including only data for those who had completed all forms.

Discussion focused on the real-world and technical aspects of lessons learned from this large single-institution data set. Dr. David Rothenberger, Jay Phillips Professor and Chair of the department of surgery at the University of Minnesota, Minneapolis, asked whether patients had been carefully selected for this salvage procedure. In his experience, he said, obese patients or those with a heavily muscled pelvis, as well as those with a significant history of prior pelvic infections, would not necessarily be good candidates for a re-do. He suggested that an intention-to-treat analysis might give a truer denominator, and might even change the conclusion that the salvage surgery has a high likelihood of success. Dr. Remzi agreed that obesity or a high body mass index in a patient “is a very good reason not to do the surgery.”

Dr. Neil Hyman, codirector of the digestive diseases center at the University of Chicago Medicine, asked whether Dr. Remzi preferred to do an S pouch rather than a J pouch. In response, Dr. Remzi said, “We have to think about what the patient will give us. Throughout the years, I’ve learned that I like to divert the patient for 6 months before surgery. This gets them and their family engaged in the process. … It also elongates the mesentery to give you that reach. But I don’t necessarily do an intentional S pouch if the J pouch gives me what I need for the health of that patient.”

The authors reported no relevant financial disclosures.

SAN DIEGO – Patients hoping to avoid a permanent stoma by having a salvage surgery to repair or replace a failing ileal pouch–anal anastomosis (IPAA) achieved good functional outcomes and quality of life in one institution’s long-term experience.

A large case series drawn from IPAA re-dos at the Cleveland Clinic over a 20-year span showed that the procedure was successful for four in five patients, and more than 90% were satisfied with their quality of life, despite some functional limitations. Dr. Feza Remzi, chairman of the department of colorectal surgery at the Cleveland Clinic, presented findings from 500 patients undergoing IPAA re-dos via the transabdominal approach. In this group, 80% (401) of transabdominally revised IPAAs were successful.

IPAA is a procedure indicated for patients with Crohn’s disease, ulcerative or indeterminate colitis, or familial adenomatous polyposis. The surgery preserves the capacity for anal defecation with intestinal continuity after proctocolectomy by fashioning a reservoir for stool from the small intestine. However, up to 15% of patients will have pouch failure, necessitating a permanent stoma unless the pouch is surgically revised, he said at  the annual meeting of the American Surgical Association.

To determine outcomes for patients having a re-do of a failed IPAA, Dr. Remzi and colleagues assessed 502 IPAA re-do patients (215, male; median age, 38 years) who received their procedure at the Cleveland Clinic from 1983 to 2014. Crohn’s disease was the primary diagnosis for 419 patients (84%); just over half (n = 263) had anastomotic leak or fistula as the cause of first pouch failure, followed by pouch-vaginal fistula in 85 women (17%) and obstruction in 116 patients (23%).

The primary endpoints of the study were surgery morbidity, how many patients had a functioning pouch after re-do, pouch function, and quality of life.

Surgeon discretion dictated whether the pouch was revised, as it was in 295 patients (59%), or whether a new pouch was created. Overall, just over half of patients (n = 270) had postoperative complications, though there were no short-term deaths. Ileus and pelvic sepsis were the most common short-term complications, occurring in 81 (16%) and 50 (10%) patients, respectively. All of the other complications occurred in less than 10% of patients. Patients stayed in the hospital a median of 7 days, and 63 (13%) were readmitted.

Over the duration of the study, 101 patients (20%) had failure of their redone IPAA pouches, and pelvis sepsis and anastomotic stricture each occurred in more than 10% of patients. Short-term postoperative morbidity and occurrence of pelvic sepsis at any point after re-do surgery were associated with failure of the redone IPAA based on a Cox regression model (P = .035 and P < .0001, respectively).

Patients were overall very satisfied with their quality of life after IPAA re-do surgery; 92% of the 261 respondents said they would undergo the surgery again, and 93% would recommend the surgery. This was true although patients reported a mean of six daytime bowel movements, about half of patients reported having stool seepage or requiring pad use, and a third of patients reported dietary restrictions related to their bowel function.

Study limitations included the lack of information regarding patients in whom the re-do attempt was abandoned, or for those referred for surgery who did not have an IPAA re-do. Another limitation was the relatively low number of patients who completed all items on the function and quality of life questionnaires; investigators decided that the most robust analysis would flow from including only data for those who had completed all forms.

Discussion focused on the real-world and technical aspects of lessons learned from this large single-institution data set. Dr. David Rothenberger, Jay Phillips Professor and Chair of the department of surgery at the University of Minnesota, Minneapolis, asked whether patients had been carefully selected for this salvage procedure. In his experience, he said, obese patients or those with a heavily muscled pelvis, as well as those with a significant history of prior pelvic infections, would not necessarily be good candidates for a re-do. He suggested that an intention-to-treat analysis might give a truer denominator, and might even change the conclusion that the salvage surgery has a high likelihood of success. Dr. Remzi agreed that obesity or a high body mass index in a patient “is a very good reason not to do the surgery.”

Dr. Neil Hyman, codirector of the digestive diseases center at the University of Chicago Medicine, asked whether Dr. Remzi preferred to do an S pouch rather than a J pouch. In response, Dr. Remzi said, “We have to think about what the patient will give us. Throughout the years, I’ve learned that I like to divert the patient for 6 months before surgery. This gets them and their family engaged in the process. … It also elongates the mesentery to give you that reach. But I don’t necessarily do an intentional S pouch if the J pouch gives me what I need for the health of that patient.”

The authors reported no relevant financial disclosures.

SAN DIEGO – Patients hoping to avoid a permanent stoma by having a salvage surgery to repair or replace a failing ileal pouch–anal anastomosis (IPAA) achieved good functional outcomes and quality of life in one institution’s long-term experience.

A large case series drawn from IPAA re-dos at the Cleveland Clinic over a 20-year span showed that the procedure was successful for four in five patients, and more than 90% were satisfied with their quality of life, despite some functional limitations. Dr. Feza Remzi, chairman of the department of colorectal surgery at the Cleveland Clinic, presented findings from 500 patients undergoing IPAA re-dos via the transabdominal approach. In this group, 80% (401) of transabdominally revised IPAAs were successful.

IPAA is a procedure indicated for patients with Crohn’s disease, ulcerative or indeterminate colitis, or familial adenomatous polyposis. The surgery preserves the capacity for anal defecation with intestinal continuity after proctocolectomy by fashioning a reservoir for stool from the small intestine. However, up to 15% of patients will have pouch failure, necessitating a permanent stoma unless the pouch is surgically revised, he said at  the annual meeting of the American Surgical Association.

To determine outcomes for patients having a re-do of a failed IPAA, Dr. Remzi and colleagues assessed 502 IPAA re-do patients (215, male; median age, 38 years) who received their procedure at the Cleveland Clinic from 1983 to 2014. Crohn’s disease was the primary diagnosis for 419 patients (84%); just over half (n = 263) had anastomotic leak or fistula as the cause of first pouch failure, followed by pouch-vaginal fistula in 85 women (17%) and obstruction in 116 patients (23%).

The primary endpoints of the study were surgery morbidity, how many patients had a functioning pouch after re-do, pouch function, and quality of life.

Surgeon discretion dictated whether the pouch was revised, as it was in 295 patients (59%), or whether a new pouch was created. Overall, just over half of patients (n = 270) had postoperative complications, though there were no short-term deaths. Ileus and pelvic sepsis were the most common short-term complications, occurring in 81 (16%) and 50 (10%) patients, respectively. All of the other complications occurred in less than 10% of patients. Patients stayed in the hospital a median of 7 days, and 63 (13%) were readmitted.

Over the duration of the study, 101 patients (20%) had failure of their redone IPAA pouches, and pelvis sepsis and anastomotic stricture each occurred in more than 10% of patients. Short-term postoperative morbidity and occurrence of pelvic sepsis at any point after re-do surgery were associated with failure of the redone IPAA based on a Cox regression model (P = .035 and P < .0001, respectively).

Patients were overall very satisfied with their quality of life after IPAA re-do surgery; 92% of the 261 respondents said they would undergo the surgery again, and 93% would recommend the surgery. This was true although patients reported a mean of six daytime bowel movements, about half of patients reported having stool seepage or requiring pad use, and a third of patients reported dietary restrictions related to their bowel function.

Study limitations included the lack of information regarding patients in whom the re-do attempt was abandoned, or for those referred for surgery who did not have an IPAA re-do. Another limitation was the relatively low number of patients who completed all items on the function and quality of life questionnaires; investigators decided that the most robust analysis would flow from including only data for those who had completed all forms.

Discussion focused on the real-world and technical aspects of lessons learned from this large single-institution data set. Dr. David Rothenberger, Jay Phillips Professor and Chair of the department of surgery at the University of Minnesota, Minneapolis, asked whether patients had been carefully selected for this salvage procedure. In his experience, he said, obese patients or those with a heavily muscled pelvis, as well as those with a significant history of prior pelvic infections, would not necessarily be good candidates for a re-do. He suggested that an intention-to-treat analysis might give a truer denominator, and might even change the conclusion that the salvage surgery has a high likelihood of success. Dr. Remzi agreed that obesity or a high body mass index in a patient “is a very good reason not to do the surgery.”

Dr. Neil Hyman, codirector of the digestive diseases center at the University of Chicago Medicine, asked whether Dr. Remzi preferred to do an S pouch rather than a J pouch. In response, Dr. Remzi said, “We have to think about what the patient will give us. Throughout the years, I’ve learned that I like to divert the patient for 6 months before surgery. This gets them and their family engaged in the process. … It also elongates the mesentery to give you that reach. But I don’t necessarily do an intentional S pouch if the J pouch gives me what I need for the health of that patient.”

The authors reported no relevant financial disclosures.

SAN DIEGO – A surgical technique for ablating pancreatic tumors improved overall survival for individuals with locally advanced pancreatic cancer when combined with optimized chemotherapy and radiation therapy.

Pancreatic cancer is the fourth-leading cause of cancer death in the United States. It often is not detected until disease is advanced, with a 5-year survival rate of less than 6%. Further, the pancreas has tight anatomic association with such major vessels as the superior mesenteric artery and the celiac trunk, meaning that the primary tumor of advanced pancreatic cancer is difficult to resect with conventional surgical techniques.

Irreversible electroporation (IRE) is an Food and Drug Administration–approved surgical technique that delivers multiple targeted high-voltage charges of short duration – 70-90 microseconds – to tumor tissue. Cell death occurs slowly by apoptosis over 6-8 weeks, thus avoiding a large inflammatory response and allowing macrophages to help clear cell debris, Dr. Robert Martin of the University of Louisville (Ky.) said at the annual meeting of the American Surgical Association.

Previous work by Dr. Martin and others showed IRE to be safe for appropriately selected patients with locally advanced pancreatic cancers. For this study, Dr. Martin and his colleagues maintained an approved, prospective soft-tissue ablation registry for patients (n = 200; median age, 62 years) with locally advanced pancreatic cancer treated in participating centers from 2010 to 2014.

Participating patients received chemotherapy, radiation, or both as initial treatment according to the protocol of individual institutions. At 4-6 weeks after completing initial treatment, patients were assessed using a triple-phase CT scan and tumor markers. Those who showed no metastatic disease and whose tumors were stable were considered for IRE. Patients were generally well nourished and without multiple comorbidities.

The IRE procedure was performed with (n = 50) or without (n = 150) conventional tumor resection, depending on surgeon judgment. Complete tumor ablation occurred in all 50 patients who received resection and marginal IRE and in 148 of 150 who received IRE alone. Of the patients who had surgery, 20 experienced a total of 49 complications; of those who had IRE alone, 54 had a total of 100 complications. The overall grade of complications was 2, and mean length of stay was 6 days.

The disease progressed in 29% of the 200 patients, with a median overall survival of 28.3 months for those who had resection and IRE and 23.2 months for those receiving IRE alone. Patients receiving standard care survived a median of 13 months (P = .01).

IRE had a reasonable level of safety and demonstrated excellent local control of tumor growth, noted discussant Dr. Jeffrey Drebin, chair of the department of surgery at Penn Medicine, Philadelphia. He asked, however, whether the study would have benefited from an intention-to-treat analysis, since not all patients with locally advanced disease will be candidates for optimized chemotherapy.

Dr. Martin noted that, as better neoadjuvant treatments have come along, “we are taking far more patients to the operating room … because we are rewarded by being able to resect their tumors.”

He called for “cautious optimism” regarding the role of IRE. The next step should include validation of the study results in the United States, first through a single-arm study and then in a randomized controlled trial comparing IRE to radiation therapy. Full assessment of efficacy also will hinge on identifying appropriate imaging techniques for precise documentation of tumor response.

An attitude of “persistent nihilism” in treating pancreatic cancer can pose a barrier to the willingness of patients and providers to try multimodality, aggressive treatment, he said. “Precise management of locally advanced pancreatic cancer with trimodality treatment can lead to improvement.”

Dr. Martin reported compensation from Angiodynamics. The other authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – A surgical technique for ablating pancreatic tumors improved overall survival for individuals with locally advanced pancreatic cancer when combined with optimized chemotherapy and radiation therapy.

Pancreatic cancer is the fourth-leading cause of cancer death in the United States. It often is not detected until disease is advanced, with a 5-year survival rate of less than 6%. Further, the pancreas has tight anatomic association with such major vessels as the superior mesenteric artery and the celiac trunk, meaning that the primary tumor of advanced pancreatic cancer is difficult to resect with conventional surgical techniques.

Irreversible electroporation (IRE) is an Food and Drug Administration–approved surgical technique that delivers multiple targeted high-voltage charges of short duration – 70-90 microseconds – to tumor tissue. Cell death occurs slowly by apoptosis over 6-8 weeks, thus avoiding a large inflammatory response and allowing macrophages to help clear cell debris, Dr. Robert Martin of the University of Louisville (Ky.) said at the annual meeting of the American Surgical Association.

Previous work by Dr. Martin and others showed IRE to be safe for appropriately selected patients with locally advanced pancreatic cancers. For this study, Dr. Martin and his colleagues maintained an approved, prospective soft-tissue ablation registry for patients (n = 200; median age, 62 years) with locally advanced pancreatic cancer treated in participating centers from 2010 to 2014.

Participating patients received chemotherapy, radiation, or both as initial treatment according to the protocol of individual institutions. At 4-6 weeks after completing initial treatment, patients were assessed using a triple-phase CT scan and tumor markers. Those who showed no metastatic disease and whose tumors were stable were considered for IRE. Patients were generally well nourished and without multiple comorbidities.

The IRE procedure was performed with (n = 50) or without (n = 150) conventional tumor resection, depending on surgeon judgment. Complete tumor ablation occurred in all 50 patients who received resection and marginal IRE and in 148 of 150 who received IRE alone. Of the patients who had surgery, 20 experienced a total of 49 complications; of those who had IRE alone, 54 had a total of 100 complications. The overall grade of complications was 2, and mean length of stay was 6 days.

The disease progressed in 29% of the 200 patients, with a median overall survival of 28.3 months for those who had resection and IRE and 23.2 months for those receiving IRE alone. Patients receiving standard care survived a median of 13 months (P = .01).

IRE had a reasonable level of safety and demonstrated excellent local control of tumor growth, noted discussant Dr. Jeffrey Drebin, chair of the department of surgery at Penn Medicine, Philadelphia. He asked, however, whether the study would have benefited from an intention-to-treat analysis, since not all patients with locally advanced disease will be candidates for optimized chemotherapy.

Dr. Martin noted that, as better neoadjuvant treatments have come along, “we are taking far more patients to the operating room … because we are rewarded by being able to resect their tumors.”

He called for “cautious optimism” regarding the role of IRE. The next step should include validation of the study results in the United States, first through a single-arm study and then in a randomized controlled trial comparing IRE to radiation therapy. Full assessment of efficacy also will hinge on identifying appropriate imaging techniques for precise documentation of tumor response.

An attitude of “persistent nihilism” in treating pancreatic cancer can pose a barrier to the willingness of patients and providers to try multimodality, aggressive treatment, he said. “Precise management of locally advanced pancreatic cancer with trimodality treatment can lead to improvement.”

Dr. Martin reported compensation from Angiodynamics. The other authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – A surgical technique for ablating pancreatic tumors improved overall survival for individuals with locally advanced pancreatic cancer when combined with optimized chemotherapy and radiation therapy.

Pancreatic cancer is the fourth-leading cause of cancer death in the United States. It often is not detected until disease is advanced, with a 5-year survival rate of less than 6%. Further, the pancreas has tight anatomic association with such major vessels as the superior mesenteric artery and the celiac trunk, meaning that the primary tumor of advanced pancreatic cancer is difficult to resect with conventional surgical techniques.

Irreversible electroporation (IRE) is an Food and Drug Administration–approved surgical technique that delivers multiple targeted high-voltage charges of short duration – 70-90 microseconds – to tumor tissue. Cell death occurs slowly by apoptosis over 6-8 weeks, thus avoiding a large inflammatory response and allowing macrophages to help clear cell debris, Dr. Robert Martin of the University of Louisville (Ky.) said at the annual meeting of the American Surgical Association.

Previous work by Dr. Martin and others showed IRE to be safe for appropriately selected patients with locally advanced pancreatic cancers. For this study, Dr. Martin and his colleagues maintained an approved, prospective soft-tissue ablation registry for patients (n = 200; median age, 62 years) with locally advanced pancreatic cancer treated in participating centers from 2010 to 2014.

Participating patients received chemotherapy, radiation, or both as initial treatment according to the protocol of individual institutions. At 4-6 weeks after completing initial treatment, patients were assessed using a triple-phase CT scan and tumor markers. Those who showed no metastatic disease and whose tumors were stable were considered for IRE. Patients were generally well nourished and without multiple comorbidities.

The IRE procedure was performed with (n = 50) or without (n = 150) conventional tumor resection, depending on surgeon judgment. Complete tumor ablation occurred in all 50 patients who received resection and marginal IRE and in 148 of 150 who received IRE alone. Of the patients who had surgery, 20 experienced a total of 49 complications; of those who had IRE alone, 54 had a total of 100 complications. The overall grade of complications was 2, and mean length of stay was 6 days.

The disease progressed in 29% of the 200 patients, with a median overall survival of 28.3 months for those who had resection and IRE and 23.2 months for those receiving IRE alone. Patients receiving standard care survived a median of 13 months (P = .01).

IRE had a reasonable level of safety and demonstrated excellent local control of tumor growth, noted discussant Dr. Jeffrey Drebin, chair of the department of surgery at Penn Medicine, Philadelphia. He asked, however, whether the study would have benefited from an intention-to-treat analysis, since not all patients with locally advanced disease will be candidates for optimized chemotherapy.

Dr. Martin noted that, as better neoadjuvant treatments have come along, “we are taking far more patients to the operating room … because we are rewarded by being able to resect their tumors.”

He called for “cautious optimism” regarding the role of IRE. The next step should include validation of the study results in the United States, first through a single-arm study and then in a randomized controlled trial comparing IRE to radiation therapy. Full assessment of efficacy also will hinge on identifying appropriate imaging techniques for precise documentation of tumor response.

An attitude of “persistent nihilism” in treating pancreatic cancer can pose a barrier to the willingness of patients and providers to try multimodality, aggressive treatment, he said. “Precise management of locally advanced pancreatic cancer with trimodality treatment can lead to improvement.”

Dr. Martin reported compensation from Angiodynamics. The other authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Though blood products have unique, lifesaving qualities, they are often in limited supply, and fresh red blood cells have a short shelf life. Frozen red blood cells can stabilize and extend the supply provided by fresh products, and were found safe and effective when used in trauma patients.

“Frozen red blood cells can be stored in massive quantities and represent a flexible blood supply that can be used interchangeably with fresh blood,” Dr. Martin Schreiber, professor of surgery at Oregon Health & Science University, Portland, said at the American Surgical Association’s annual meeting. Frozen red blood cells have a favorable biochemical profile when compared to fresh red blood cells, added Dr. Schreiber.

Of the 14 million units of blood transfused annually, 10%-15% are used for trauma patients. Fresh refrigerated red blood cells must be used within 42 days, meaning that $80 million worth of red blood cells (RBCs) are wasted every year because they can’t be used before expiration. Further, there are seasonally increased needs for red blood cells and seasonal troughs in donation patterns. Particularly for those with rare blood types or in case of natural disasters or civil emergencies, blood supply issues can create a critical missing link in the chain of trauma and surgery care, he said.

Cryopreserved red blood cells (CRBCs) offer the potential for a more predictable and secure blood supply. However, concerns about the safety and efficacy of routine use of CRBCs have persisted, although cryopreservation has been in use since the 1950s, when it was pioneered by the U.S. military. Military use of frozen blood red blood cells occurred through the Vietnam War and continues into the present day in conflict arenas. The American Red Cross also maintains frozen red blood cells as part of its rare donor registry program, as does the New York Blood Center for its rare phenotype program.

Red blood cells are frozen to –80 degrees Celsius within 6 days after donation, and may be kept frozen for up to 10 years. Glycerol is used to protect the cells during freezing and must be washed from the cells on thawing. The thawing process takes about 90 minutes; the blood may then be refrigerated and must be used within 14 days of thawing.

In a multisite prospective, randomized, double blind study conducted at five level-I trauma centers in the United States, Dr. Schreiber and his colleagues compared the safety and efficacy of new RBCs (14 days old or younger) and old RBCs (older than 14 days) to CRBCs for stable adult trauma patients requiring transfusion. Patients were included if they had an injury severity score of greater than 4, were considered stable, and if transfusion was an anticipated component of their care. Excluded were pregnant trauma patients and those requiring emergent or massive transfusion.

Patients, whose demographics and hospital length of stay were similar among groups, were randomized by the blood bank to receive young RBCs (n = 82), old RBCs (n = 86), or CRBCs (n = 86). The researchers used near infrared spectroscopy (NIRS) to measure tissue oxygenation as one of two primary outcome measures; the second primary outcome measure was clinical outcomes, including acute renal failure, infection, pulmonary complications, pulmonary embolus or deep venous clots, and death.

Secondary outcome measures assessed how the three types of blood products affected blood biochemistry. Among the measures included were measurement of blood proteins, including hemoglobin and C-reactive protein; inflammatory cytokines, including interleukins, tumor necrosis factor–alpha, and granulocyte-macrophage colony stimulating factor (GM-CSF); and coagulation measures, including PT, PTT, D-dimer, and fibrinogen. There were no significant differences among the three treatment groups in tissue oxygenation from baseline to 3 hours after transfusion, and all clinical outcomes were similar among groups as well.

Overall, CRBCs exhibited “a superior biochemical profile,” according to Dr. Schreiber: Those receiving CRBCs had significantly lower levels of interleukins 2 and 4, as well as lower levels of GM-CSF, another cytokine associated with systemic inflammation. Coagulation and hemoglobin measures were similar among groups.

This study had a relatively small sample size and was not powered for equivalence, noted Dr. Schreiber, nor did it assess the long-term effects of receiving CRBCs. Also, the study examined only stable trauma patients who received an average of two units of RBCs, though trauma patients have received massive amounts of CRBCs in battlefront situations and further studies will include massively transfused patients.

Even so, the “quality of this study and the completeness of the biochemistry are truly noteworthy,” said discussant Dr. Ronald Maier of the University of Washington, Seattle.

With the caveats Dr. Schreiber noted about the study’s limitations, this study affirms that CRBCs are a flexible way to augment the existing blood supply, and may be thought of as a safe and interchangeable equivalent to fresh RBCs. A storage cache of CRBCs would help ensure adequate blood supplies in austere conditions, for rural locations, and in disaster scenarios, he said.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Though blood products have unique, lifesaving qualities, they are often in limited supply, and fresh red blood cells have a short shelf life. Frozen red blood cells can stabilize and extend the supply provided by fresh products, and were found safe and effective when used in trauma patients.

“Frozen red blood cells can be stored in massive quantities and represent a flexible blood supply that can be used interchangeably with fresh blood,” Dr. Martin Schreiber, professor of surgery at Oregon Health & Science University, Portland, said at the American Surgical Association’s annual meeting. Frozen red blood cells have a favorable biochemical profile when compared to fresh red blood cells, added Dr. Schreiber.

Of the 14 million units of blood transfused annually, 10%-15% are used for trauma patients. Fresh refrigerated red blood cells must be used within 42 days, meaning that $80 million worth of red blood cells (RBCs) are wasted every year because they can’t be used before expiration. Further, there are seasonally increased needs for red blood cells and seasonal troughs in donation patterns. Particularly for those with rare blood types or in case of natural disasters or civil emergencies, blood supply issues can create a critical missing link in the chain of trauma and surgery care, he said.

Cryopreserved red blood cells (CRBCs) offer the potential for a more predictable and secure blood supply. However, concerns about the safety and efficacy of routine use of CRBCs have persisted, although cryopreservation has been in use since the 1950s, when it was pioneered by the U.S. military. Military use of frozen blood red blood cells occurred through the Vietnam War and continues into the present day in conflict arenas. The American Red Cross also maintains frozen red blood cells as part of its rare donor registry program, as does the New York Blood Center for its rare phenotype program.

Red blood cells are frozen to –80 degrees Celsius within 6 days after donation, and may be kept frozen for up to 10 years. Glycerol is used to protect the cells during freezing and must be washed from the cells on thawing. The thawing process takes about 90 minutes; the blood may then be refrigerated and must be used within 14 days of thawing.

In a multisite prospective, randomized, double blind study conducted at five level-I trauma centers in the United States, Dr. Schreiber and his colleagues compared the safety and efficacy of new RBCs (14 days old or younger) and old RBCs (older than 14 days) to CRBCs for stable adult trauma patients requiring transfusion. Patients were included if they had an injury severity score of greater than 4, were considered stable, and if transfusion was an anticipated component of their care. Excluded were pregnant trauma patients and those requiring emergent or massive transfusion.

Patients, whose demographics and hospital length of stay were similar among groups, were randomized by the blood bank to receive young RBCs (n = 82), old RBCs (n = 86), or CRBCs (n = 86). The researchers used near infrared spectroscopy (NIRS) to measure tissue oxygenation as one of two primary outcome measures; the second primary outcome measure was clinical outcomes, including acute renal failure, infection, pulmonary complications, pulmonary embolus or deep venous clots, and death.

Secondary outcome measures assessed how the three types of blood products affected blood biochemistry. Among the measures included were measurement of blood proteins, including hemoglobin and C-reactive protein; inflammatory cytokines, including interleukins, tumor necrosis factor–alpha, and granulocyte-macrophage colony stimulating factor (GM-CSF); and coagulation measures, including PT, PTT, D-dimer, and fibrinogen. There were no significant differences among the three treatment groups in tissue oxygenation from baseline to 3 hours after transfusion, and all clinical outcomes were similar among groups as well.

Overall, CRBCs exhibited “a superior biochemical profile,” according to Dr. Schreiber: Those receiving CRBCs had significantly lower levels of interleukins 2 and 4, as well as lower levels of GM-CSF, another cytokine associated with systemic inflammation. Coagulation and hemoglobin measures were similar among groups.

This study had a relatively small sample size and was not powered for equivalence, noted Dr. Schreiber, nor did it assess the long-term effects of receiving CRBCs. Also, the study examined only stable trauma patients who received an average of two units of RBCs, though trauma patients have received massive amounts of CRBCs in battlefront situations and further studies will include massively transfused patients.

Even so, the “quality of this study and the completeness of the biochemistry are truly noteworthy,” said discussant Dr. Ronald Maier of the University of Washington, Seattle.

With the caveats Dr. Schreiber noted about the study’s limitations, this study affirms that CRBCs are a flexible way to augment the existing blood supply, and may be thought of as a safe and interchangeable equivalent to fresh RBCs. A storage cache of CRBCs would help ensure adequate blood supplies in austere conditions, for rural locations, and in disaster scenarios, he said.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Though blood products have unique, lifesaving qualities, they are often in limited supply, and fresh red blood cells have a short shelf life. Frozen red blood cells can stabilize and extend the supply provided by fresh products, and were found safe and effective when used in trauma patients.

“Frozen red blood cells can be stored in massive quantities and represent a flexible blood supply that can be used interchangeably with fresh blood,” Dr. Martin Schreiber, professor of surgery at Oregon Health & Science University, Portland, said at the American Surgical Association’s annual meeting. Frozen red blood cells have a favorable biochemical profile when compared to fresh red blood cells, added Dr. Schreiber.

Of the 14 million units of blood transfused annually, 10%-15% are used for trauma patients. Fresh refrigerated red blood cells must be used within 42 days, meaning that $80 million worth of red blood cells (RBCs) are wasted every year because they can’t be used before expiration. Further, there are seasonally increased needs for red blood cells and seasonal troughs in donation patterns. Particularly for those with rare blood types or in case of natural disasters or civil emergencies, blood supply issues can create a critical missing link in the chain of trauma and surgery care, he said.

Cryopreserved red blood cells (CRBCs) offer the potential for a more predictable and secure blood supply. However, concerns about the safety and efficacy of routine use of CRBCs have persisted, although cryopreservation has been in use since the 1950s, when it was pioneered by the U.S. military. Military use of frozen blood red blood cells occurred through the Vietnam War and continues into the present day in conflict arenas. The American Red Cross also maintains frozen red blood cells as part of its rare donor registry program, as does the New York Blood Center for its rare phenotype program.

Red blood cells are frozen to –80 degrees Celsius within 6 days after donation, and may be kept frozen for up to 10 years. Glycerol is used to protect the cells during freezing and must be washed from the cells on thawing. The thawing process takes about 90 minutes; the blood may then be refrigerated and must be used within 14 days of thawing.

In a multisite prospective, randomized, double blind study conducted at five level-I trauma centers in the United States, Dr. Schreiber and his colleagues compared the safety and efficacy of new RBCs (14 days old or younger) and old RBCs (older than 14 days) to CRBCs for stable adult trauma patients requiring transfusion. Patients were included if they had an injury severity score of greater than 4, were considered stable, and if transfusion was an anticipated component of their care. Excluded were pregnant trauma patients and those requiring emergent or massive transfusion.

Patients, whose demographics and hospital length of stay were similar among groups, were randomized by the blood bank to receive young RBCs (n = 82), old RBCs (n = 86), or CRBCs (n = 86). The researchers used near infrared spectroscopy (NIRS) to measure tissue oxygenation as one of two primary outcome measures; the second primary outcome measure was clinical outcomes, including acute renal failure, infection, pulmonary complications, pulmonary embolus or deep venous clots, and death.

Secondary outcome measures assessed how the three types of blood products affected blood biochemistry. Among the measures included were measurement of blood proteins, including hemoglobin and C-reactive protein; inflammatory cytokines, including interleukins, tumor necrosis factor–alpha, and granulocyte-macrophage colony stimulating factor (GM-CSF); and coagulation measures, including PT, PTT, D-dimer, and fibrinogen. There were no significant differences among the three treatment groups in tissue oxygenation from baseline to 3 hours after transfusion, and all clinical outcomes were similar among groups as well.

Overall, CRBCs exhibited “a superior biochemical profile,” according to Dr. Schreiber: Those receiving CRBCs had significantly lower levels of interleukins 2 and 4, as well as lower levels of GM-CSF, another cytokine associated with systemic inflammation. Coagulation and hemoglobin measures were similar among groups.

This study had a relatively small sample size and was not powered for equivalence, noted Dr. Schreiber, nor did it assess the long-term effects of receiving CRBCs. Also, the study examined only stable trauma patients who received an average of two units of RBCs, though trauma patients have received massive amounts of CRBCs in battlefront situations and further studies will include massively transfused patients.

Even so, the “quality of this study and the completeness of the biochemistry are truly noteworthy,” said discussant Dr. Ronald Maier of the University of Washington, Seattle.

With the caveats Dr. Schreiber noted about the study’s limitations, this study affirms that CRBCs are a flexible way to augment the existing blood supply, and may be thought of as a safe and interchangeable equivalent to fresh RBCs. A storage cache of CRBCs would help ensure adequate blood supplies in austere conditions, for rural locations, and in disaster scenarios, he said.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.