Colon and Rectal

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

Operating room time, body mass index, and the surgeon performing the procedure were the top three factors affecting readmission rates, transfusion rates, and surgical site infections after colorectal surgery in a single-center prospective study of more than 3,000 patients.

Many previous studies have addressed risk factors and surgical outcomes, but "little is known about the relative contribution of various risk factors to specific outcomes," said Elena Manilich, Ph.D., of the Cleveland Clinic. She presented the findings at the annual meeting of the American Society of Colon and Rectal Surgeons.

She and her colleagues analyzed outcomes from 3,552 patients who underwent colorectal surgery. Their average age at the time of surgery was 51 years, and approximately half were women. Cancer was the most common indication for surgery (16%).

Overall, the length of surgery was significantly associated with increased complication rates, Dr. Manilich said. In particular, the adjusted odds ratios for procedures lasting more than 200 minutes vs. those lasting less than 200 minutes were 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Surgeons who performed fewer than 20 procedures were significant predictors of surgical site infections, abscesses, reoperation, and anastomotic leaks in their patients, Dr. Manilich said.

Increased patient body mass index was independently associated with wound infection, surgical site infection, and portal and deep vein thrombosis, she added.

In addition, a patient age older than 75 years was independently associated with transfusion and reoperation.

The outcomes that were most influenced by complications were hospital readmission, transfusion, surgical site infection, wound infections, and abscesses. Complications were defined as outcomes that occurred prior to hospital discharge or within 30 days of the initial surgery.

The findings were limited by the use of data from a single hospital and by the inability to adjust for patient histories (such as prior abdominal procedures) that might have affected the outcomes, Dr. Manilich said. But the study is unique in its use of a logistic regression analysis to identify which variables predict which outcomes, she added.

"An understanding of these results may be useful to colorectal surgeons who are making an effort to understand and improve their surgical outcomes," she said.

Dr. Manilich had no financial conflicts to disclose.

Operating room time, body mass index, and the surgeon performing the procedure were the top three factors affecting readmission rates, transfusion rates, and surgical site infections after colorectal surgery in a single-center prospective study of more than 3,000 patients.

Many previous studies have addressed risk factors and surgical outcomes, but "little is known about the relative contribution of various risk factors to specific outcomes," said Elena Manilich, Ph.D., of the Cleveland Clinic. She presented the findings at the annual meeting of the American Society of Colon and Rectal Surgeons.

She and her colleagues analyzed outcomes from 3,552 patients who underwent colorectal surgery. Their average age at the time of surgery was 51 years, and approximately half were women. Cancer was the most common indication for surgery (16%).

Overall, the length of surgery was significantly associated with increased complication rates, Dr. Manilich said. In particular, the adjusted odds ratios for procedures lasting more than 200 minutes vs. those lasting less than 200 minutes were 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Surgeons who performed fewer than 20 procedures were significant predictors of surgical site infections, abscesses, reoperation, and anastomotic leaks in their patients, Dr. Manilich said.

Increased patient body mass index was independently associated with wound infection, surgical site infection, and portal and deep vein thrombosis, she added.

In addition, a patient age older than 75 years was independently associated with transfusion and reoperation.

The outcomes that were most influenced by complications were hospital readmission, transfusion, surgical site infection, wound infections, and abscesses. Complications were defined as outcomes that occurred prior to hospital discharge or within 30 days of the initial surgery.

The findings were limited by the use of data from a single hospital and by the inability to adjust for patient histories (such as prior abdominal procedures) that might have affected the outcomes, Dr. Manilich said. But the study is unique in its use of a logistic regression analysis to identify which variables predict which outcomes, she added.

"An understanding of these results may be useful to colorectal surgeons who are making an effort to understand and improve their surgical outcomes," she said.

Dr. Manilich had no financial conflicts to disclose.

Operating room time, body mass index, and the surgeon performing the procedure were the top three factors affecting readmission rates, transfusion rates, and surgical site infections after colorectal surgery in a single-center prospective study of more than 3,000 patients.

Many previous studies have addressed risk factors and surgical outcomes, but "little is known about the relative contribution of various risk factors to specific outcomes," said Elena Manilich, Ph.D., of the Cleveland Clinic. She presented the findings at the annual meeting of the American Society of Colon and Rectal Surgeons.

She and her colleagues analyzed outcomes from 3,552 patients who underwent colorectal surgery. Their average age at the time of surgery was 51 years, and approximately half were women. Cancer was the most common indication for surgery (16%).

Overall, the length of surgery was significantly associated with increased complication rates, Dr. Manilich said. In particular, the adjusted odds ratios for procedures lasting more than 200 minutes vs. those lasting less than 200 minutes were 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Surgeons who performed fewer than 20 procedures were significant predictors of surgical site infections, abscesses, reoperation, and anastomotic leaks in their patients, Dr. Manilich said.

Increased patient body mass index was independently associated with wound infection, surgical site infection, and portal and deep vein thrombosis, she added.

In addition, a patient age older than 75 years was independently associated with transfusion and reoperation.

The outcomes that were most influenced by complications were hospital readmission, transfusion, surgical site infection, wound infections, and abscesses. Complications were defined as outcomes that occurred prior to hospital discharge or within 30 days of the initial surgery.

The findings were limited by the use of data from a single hospital and by the inability to adjust for patient histories (such as prior abdominal procedures) that might have affected the outcomes, Dr. Manilich said. But the study is unique in its use of a logistic regression analysis to identify which variables predict which outcomes, she added.

"An understanding of these results may be useful to colorectal surgeons who are making an effort to understand and improve their surgical outcomes," she said.

Dr. Manilich had no financial conflicts to disclose.

SAN DIEGO – Changing the acid content of the gastrointestinal tract may reduce the risk of developing pouchitis following ileal pouch anal anastomosis, based on a review of 85 patients at one U.S. center.

After patients underwent ileal pouch anal anastomosis (IPAA) for ulcerative colitis, those who did not develop pouchitis used a proton pump inhibitor (PPI) or histamine₂ (H₂) blocker on a daily basis significantly more often than did patients who developed pouchitis during follow-up, Dr. Lisa S. Poritz said at the annual Digestive Disease Week.

Patients who did not develop pouchitis also regularly used an antacid significantly more often than did those with pouchitis during follow-up, but "occasional" use of a PPI or H₂ blocker showed no statistically significant association with reduced pouchitis incidence, said Dr. Poritz, a colon and rectal surgeon at Pennsylvania State University, Hershey.

Pouchitis is the most common complication of IPAA, occurring in about half of these patients, and chronic pouchitis develops in 5%-19% of them, Dr. Poritz said. Pouchitis produces urgency, bloody bowel movements, and abdominal pain.

IPAA patients who require chronic antibiotic treatment for pouchitis are the subgroup with the best chance to benefit from daily treatment to stop or neutralize acid secretion, a strategy that would "hopefully get them off chronic antibiotics," she said.

The study reviewed ulcerative colitis patients from the Penn State Familial IBD Registry who had undergone IPAA and had at least 2 subsequent years of follow-up. In all, 45 patients developed no pouchitis, and 40 had pouchitis. The registry data showed no demographic or clinical differences between the two subgroups.

The researchers limited their analysis of acid treatment associations to the subgroup of patients for whom data were available. In all, 15 of 30 patients who had no pouchitis following IPAA and 5 of 35 who developed pouchitis received daily treatment with a PPI or H₂ blocker, a statistically significant difference. And 12 of 21 patients with no pouchitis took an antacid more than once a week, compared with 3 of 25 patients who developed pouchitis, also a statistically significant difference.

The analysis showed very similar usage rates among the pouchitis and no-pouchitis subgroups for a variety of other agents that could potentially influence this complication, including probiotics, NSAIDs, fiber supplements, antidiarrheal drugs, and immunosuppressive drugs.

The treatment effects of a PPI or H₂ blocker on the incidence of pouchitis may be mediated by changes in fecal flora, but clear evidence for the mechanism of action will require further study, she said.

Dr. Poritz said that she had no disclosures.

SAN DIEGO – Changing the acid content of the gastrointestinal tract may reduce the risk of developing pouchitis following ileal pouch anal anastomosis, based on a review of 85 patients at one U.S. center.

After patients underwent ileal pouch anal anastomosis (IPAA) for ulcerative colitis, those who did not develop pouchitis used a proton pump inhibitor (PPI) or histamine₂ (H₂) blocker on a daily basis significantly more often than did patients who developed pouchitis during follow-up, Dr. Lisa S. Poritz said at the annual Digestive Disease Week.

Patients who did not develop pouchitis also regularly used an antacid significantly more often than did those with pouchitis during follow-up, but "occasional" use of a PPI or H₂ blocker showed no statistically significant association with reduced pouchitis incidence, said Dr. Poritz, a colon and rectal surgeon at Pennsylvania State University, Hershey.

Pouchitis is the most common complication of IPAA, occurring in about half of these patients, and chronic pouchitis develops in 5%-19% of them, Dr. Poritz said. Pouchitis produces urgency, bloody bowel movements, and abdominal pain.

IPAA patients who require chronic antibiotic treatment for pouchitis are the subgroup with the best chance to benefit from daily treatment to stop or neutralize acid secretion, a strategy that would "hopefully get them off chronic antibiotics," she said.

The study reviewed ulcerative colitis patients from the Penn State Familial IBD Registry who had undergone IPAA and had at least 2 subsequent years of follow-up. In all, 45 patients developed no pouchitis, and 40 had pouchitis. The registry data showed no demographic or clinical differences between the two subgroups.

The researchers limited their analysis of acid treatment associations to the subgroup of patients for whom data were available. In all, 15 of 30 patients who had no pouchitis following IPAA and 5 of 35 who developed pouchitis received daily treatment with a PPI or H₂ blocker, a statistically significant difference. And 12 of 21 patients with no pouchitis took an antacid more than once a week, compared with 3 of 25 patients who developed pouchitis, also a statistically significant difference.

The analysis showed very similar usage rates among the pouchitis and no-pouchitis subgroups for a variety of other agents that could potentially influence this complication, including probiotics, NSAIDs, fiber supplements, antidiarrheal drugs, and immunosuppressive drugs.

The treatment effects of a PPI or H₂ blocker on the incidence of pouchitis may be mediated by changes in fecal flora, but clear evidence for the mechanism of action will require further study, she said.

Dr. Poritz said that she had no disclosures.

SAN DIEGO – Changing the acid content of the gastrointestinal tract may reduce the risk of developing pouchitis following ileal pouch anal anastomosis, based on a review of 85 patients at one U.S. center.

After patients underwent ileal pouch anal anastomosis (IPAA) for ulcerative colitis, those who did not develop pouchitis used a proton pump inhibitor (PPI) or histamine₂ (H₂) blocker on a daily basis significantly more often than did patients who developed pouchitis during follow-up, Dr. Lisa S. Poritz said at the annual Digestive Disease Week.

Patients who did not develop pouchitis also regularly used an antacid significantly more often than did those with pouchitis during follow-up, but "occasional" use of a PPI or H₂ blocker showed no statistically significant association with reduced pouchitis incidence, said Dr. Poritz, a colon and rectal surgeon at Pennsylvania State University, Hershey.

Pouchitis is the most common complication of IPAA, occurring in about half of these patients, and chronic pouchitis develops in 5%-19% of them, Dr. Poritz said. Pouchitis produces urgency, bloody bowel movements, and abdominal pain.

IPAA patients who require chronic antibiotic treatment for pouchitis are the subgroup with the best chance to benefit from daily treatment to stop or neutralize acid secretion, a strategy that would "hopefully get them off chronic antibiotics," she said.

The study reviewed ulcerative colitis patients from the Penn State Familial IBD Registry who had undergone IPAA and had at least 2 subsequent years of follow-up. In all, 45 patients developed no pouchitis, and 40 had pouchitis. The registry data showed no demographic or clinical differences between the two subgroups.

The researchers limited their analysis of acid treatment associations to the subgroup of patients for whom data were available. In all, 15 of 30 patients who had no pouchitis following IPAA and 5 of 35 who developed pouchitis received daily treatment with a PPI or H₂ blocker, a statistically significant difference. And 12 of 21 patients with no pouchitis took an antacid more than once a week, compared with 3 of 25 patients who developed pouchitis, also a statistically significant difference.

The analysis showed very similar usage rates among the pouchitis and no-pouchitis subgroups for a variety of other agents that could potentially influence this complication, including probiotics, NSAIDs, fiber supplements, antidiarrheal drugs, and immunosuppressive drugs.

The treatment effects of a PPI or H₂ blocker on the incidence of pouchitis may be mediated by changes in fecal flora, but clear evidence for the mechanism of action will require further study, she said.

Dr. Poritz said that she had no disclosures.

ORLANDO – Patients who undergo surgical resection with narrow distal margins for ultra low rectal cancers can have local control of disease and overall survival comparable to those in patients with wider resection margins, investigators reported at a symposium of the Society of Surgical Oncology.

Dr. Wim P. Ceelen and coauthors reviewed 109 patients who underwent neoadjuvant chemoradiation and surgery for rectal cancers 5 cm or less from the anal verge from 1998 to 2010. Overall survival and local control were found to be the same in a comparison of patients with distal resection margins 1 cm wide or less and those with margins greater than 1 cm.

"Close but free distal margins after neoadjuvant radiation and sphincter-saving surgery do not compromise local or systemic control," said Dr. Ceelen, a surgical oncologist at University Hospital in Ghent, Belgium.

Neoadjuvant chemoradiation has made sphincter-sparing procedures available to more patients, but the surgical results often leave distal margins that some surgeons find too close for comfort, because they fall short of the so-called "1-cm rule" holding that margins should be a minimum of 1 cm from the tumor.

"There is some controversy about the oncological safety of having very close margins, i.e., less than 1 cm," Dr. Ceelen said.

To see whether margins matter, he and colleagues reviewed records in a prospective database on the 109 patients with ultra-low rectal cancers (median pretreatment distance of 3 cm from the anal verge). All patients underwent neoadjuvant chemoradiation with 5-fluorouracil and 45 Gy radiation delivered in 25 fractions, followed by sphincter-saving surgery with R0 (cancer-free) resections. In all, 59% of the patients were clinically node positive.

Surgeries included intersphincteric resection and coloanal anastomosis in 38 patients, and stapled anastamosis in 71. The large majority of patients (98) had protective loop ileostomies.

Surgical specimens showed tumors were stage 0 (pathologic complete response to chemoradiation) in 16%, stage 1 (T1-T2) in 30%, stage II (T3-T4) in 21%, and stage III (node-positive) in 19%. The median distal resection margin was 10 mm.

At a median follow-up of 33 months, 5 patients (4.6%) had a local recurrence. Two of these patients had had surgical margins of 1 cm or less, and 3 had margin greater than 1 cm. Of the 30 patients (27.5%) who had a systemic recurrence, 12 had resections with margins of 1 cm or less, and 18 had margins greater than 1 cm. Neither difference was statistically significant.

Overall 5-year survival was 70%, and again there was no significant difference in survival by margin size.

Dr. Ceelen noted that the results echo those of a recently published systematic review (Ann. Surg. Oncol. 2012;19: 801-8).

The study was internally funded. Dr. Ceelen had no disclosures.

ORLANDO – Patients who undergo surgical resection with narrow distal margins for ultra low rectal cancers can have local control of disease and overall survival comparable to those in patients with wider resection margins, investigators reported at a symposium of the Society of Surgical Oncology.

Dr. Wim P. Ceelen and coauthors reviewed 109 patients who underwent neoadjuvant chemoradiation and surgery for rectal cancers 5 cm or less from the anal verge from 1998 to 2010. Overall survival and local control were found to be the same in a comparison of patients with distal resection margins 1 cm wide or less and those with margins greater than 1 cm.

"Close but free distal margins after neoadjuvant radiation and sphincter-saving surgery do not compromise local or systemic control," said Dr. Ceelen, a surgical oncologist at University Hospital in Ghent, Belgium.

Neoadjuvant chemoradiation has made sphincter-sparing procedures available to more patients, but the surgical results often leave distal margins that some surgeons find too close for comfort, because they fall short of the so-called "1-cm rule" holding that margins should be a minimum of 1 cm from the tumor.

"There is some controversy about the oncological safety of having very close margins, i.e., less than 1 cm," Dr. Ceelen said.

To see whether margins matter, he and colleagues reviewed records in a prospective database on the 109 patients with ultra-low rectal cancers (median pretreatment distance of 3 cm from the anal verge). All patients underwent neoadjuvant chemoradiation with 5-fluorouracil and 45 Gy radiation delivered in 25 fractions, followed by sphincter-saving surgery with R0 (cancer-free) resections. In all, 59% of the patients were clinically node positive.

Surgeries included intersphincteric resection and coloanal anastomosis in 38 patients, and stapled anastamosis in 71. The large majority of patients (98) had protective loop ileostomies.

Surgical specimens showed tumors were stage 0 (pathologic complete response to chemoradiation) in 16%, stage 1 (T1-T2) in 30%, stage II (T3-T4) in 21%, and stage III (node-positive) in 19%. The median distal resection margin was 10 mm.

At a median follow-up of 33 months, 5 patients (4.6%) had a local recurrence. Two of these patients had had surgical margins of 1 cm or less, and 3 had margin greater than 1 cm. Of the 30 patients (27.5%) who had a systemic recurrence, 12 had resections with margins of 1 cm or less, and 18 had margins greater than 1 cm. Neither difference was statistically significant.

Overall 5-year survival was 70%, and again there was no significant difference in survival by margin size.

Dr. Ceelen noted that the results echo those of a recently published systematic review (Ann. Surg. Oncol. 2012;19: 801-8).

The study was internally funded. Dr. Ceelen had no disclosures.

ORLANDO – Patients who undergo surgical resection with narrow distal margins for ultra low rectal cancers can have local control of disease and overall survival comparable to those in patients with wider resection margins, investigators reported at a symposium of the Society of Surgical Oncology.

Dr. Wim P. Ceelen and coauthors reviewed 109 patients who underwent neoadjuvant chemoradiation and surgery for rectal cancers 5 cm or less from the anal verge from 1998 to 2010. Overall survival and local control were found to be the same in a comparison of patients with distal resection margins 1 cm wide or less and those with margins greater than 1 cm.

"Close but free distal margins after neoadjuvant radiation and sphincter-saving surgery do not compromise local or systemic control," said Dr. Ceelen, a surgical oncologist at University Hospital in Ghent, Belgium.

Neoadjuvant chemoradiation has made sphincter-sparing procedures available to more patients, but the surgical results often leave distal margins that some surgeons find too close for comfort, because they fall short of the so-called "1-cm rule" holding that margins should be a minimum of 1 cm from the tumor.

"There is some controversy about the oncological safety of having very close margins, i.e., less than 1 cm," Dr. Ceelen said.

To see whether margins matter, he and colleagues reviewed records in a prospective database on the 109 patients with ultra-low rectal cancers (median pretreatment distance of 3 cm from the anal verge). All patients underwent neoadjuvant chemoradiation with 5-fluorouracil and 45 Gy radiation delivered in 25 fractions, followed by sphincter-saving surgery with R0 (cancer-free) resections. In all, 59% of the patients were clinically node positive.

Surgeries included intersphincteric resection and coloanal anastomosis in 38 patients, and stapled anastamosis in 71. The large majority of patients (98) had protective loop ileostomies.

Surgical specimens showed tumors were stage 0 (pathologic complete response to chemoradiation) in 16%, stage 1 (T1-T2) in 30%, stage II (T3-T4) in 21%, and stage III (node-positive) in 19%. The median distal resection margin was 10 mm.

At a median follow-up of 33 months, 5 patients (4.6%) had a local recurrence. Two of these patients had had surgical margins of 1 cm or less, and 3 had margin greater than 1 cm. Of the 30 patients (27.5%) who had a systemic recurrence, 12 had resections with margins of 1 cm or less, and 18 had margins greater than 1 cm. Neither difference was statistically significant.

Overall 5-year survival was 70%, and again there was no significant difference in survival by margin size.

Dr. Ceelen noted that the results echo those of a recently published systematic review (Ann. Surg. Oncol. 2012;19: 801-8).

The study was internally funded. Dr. Ceelen had no disclosures.

MADISON, WIS. – Laparoscopic resection of hepatic colorectal cancer offered short-term benefits over open resection and equivalent cancer control in a propensity matched cohort study of 173 patients.

"The oncologic outcomes are really not affected at all by the performance of the minimally invasive procedure," lead author Robert Cannon said at the annual meeting of the Central Surgical Association.

He reported on 35 patients who underwent laparoscopic resection and 138 patients undergoing open resection during the same time period. To minimize selection bias, the two groups were matched on the basis of age, size and number of lesions, whether major hepatectomy (three or more segments) or synchronous colectomy was performed, and the Fong score.

The laparoscopic group had significantly less mean blood loss than did the open group (202 mL vs. 392 mL; P less than .001), fewer complications (23% vs. 48%; P = .007), and shorter length of stay (4.8 days vs. 7.8 days; P less than .001), said Dr. Cannon of the department of surgery as the University of Louisville (Ky.).

The ability to achieve microscopically negative margins was significantly higher in the laparoscopic group, at 97%, compared with 81% in the open group (P = .02). Mortality at 90 days was similar at 0% vs. 0.7%, respectively (P = 1.0).

At 1, 3, and 5 years, median disease-free survival rates were similar at 79.3%, 37% , and 15.4%, respectively, in the laparoscopic group vs. 78.4%, 35.4% and 21.6%, respectively, in the open group (P = .715). Likewise, median overall survival rates were similar at 97%, 62.6%, and 36% vs. 95.4%, 60.3%, and 36.6% (P = .911), he said.

Dr. Cannon pointed out that the benefits of laparoscopy were observed in "appropriately selected patients," and suggested that the procedure is ideal for patients with left lateral lesions and for those who are obese.

"A thick abdominal wall doesn’t really hurt you as much when you’re going through a scope as it does when you have to make an incision that goes through all that subcutaneous fat," he said. "Also, with the shorter hospitalization, we think [laparoscopy] minimizes recovery and duration of chemotherapy in selected patients."

The higher positive-margin rate in the open group suggests that some selection bias remains in the analysis, and supports the idea that some patients – notably those with portal vein embolization, extensive disease, or tumors close to major vessels – will always be candidates for open surgery, said invited discussant Dr. Sharon Weber, professor and vice chair of general surgery at the University of Wisconsin, Madison.

Dr. Weber asked whether it’s truly possible to compare the open and laparoscopic groups statistically, or whether one can only say that outcomes tend to be better for those patients who are candidates for laparoscopic resection.

"I agree that the two groups will probably never be strictly comparable," Dr. Cannon replied. "There’s always going to be a role for open operations, especially for the lesions you mentioned [and] for those who may require biliary reconstruction or resection, or [who] have centrally located tumors such as at the base of segment four and five." He added that the purpose of doing matched studies like this one is to show that, for a patient who could go either way, perhaps the laparoscopic procedure offers benefits.

Dr. Weber also questioned how the investigators chose the factors that went into their propensity scoring, observing that some would consider factors such as neoadjuvant therapy, bilateral disease, and underlying liver fibrosis and cirrhosis equally relevant. In addition, recent work from the Netherlands suggests that the clinical risk score has become less relevant for patients with colorectal-level metastases in the era of contemporary neoadjuvant chemotherapy (Ann. Surg. Oncol. 2011;18:2757-63).

Dr. Cannon said that the availability of data influenced what factors were selected, to a large extent. The two groups had a median of one tumor, a median Charlson Comorbidity Index score of 4, and a median Fong score of 2. Their average age was 62 years. The mean tumor sizes were 4.3 cm in the open group and 4.2 cm in the laparoscopic group; positive nodes were present in 64% and 57%, respectively, and mean carcinoembryonic antigen levels at hepatectomy were 91.6 and 52, respectively.

Left lateral segmentectomy was performed in 28.6% of the laparoscopic group and in 6.5% of the open group (P less than .001), whereas wedge/bisegmentectomy was significantly more common in the open group at 34.8% vs. 14.3% in the laparoscopic group (P = .019). Rates of major hepatectomy were similar at 55.8% in the open group and 54.3% in the laparoscopic group (P = .872).

The investigators did not control for the individual year when surgery was performed, choosing instead to limit the analysis to cases performed from 2004 on, when it could be reasonably assumed that adjuvant therapy would be comparable, Dr. Cannon said.

When asked whether a financial analysis of the two procedures had been performed because of the greater expense associated with laparoscopic instruments, Dr. Cannon replied that cost data will be presented at the upcoming Society of Surgical Oncology Annual Cancer Symposium.

Dr. Cannon and Dr. Weber reported no conflicts of interest.*

*Correction, 3/8/2012: This story was updated to reflect the fact that Dr. Cannon has no conflicts of interest. The conflicts that were initially attributed to Dr. Cannon were incorrectly reported by the meeting organizers.  

MADISON, WIS. – Laparoscopic resection of hepatic colorectal cancer offered short-term benefits over open resection and equivalent cancer control in a propensity matched cohort study of 173 patients.

"The oncologic outcomes are really not affected at all by the performance of the minimally invasive procedure," lead author Robert Cannon said at the annual meeting of the Central Surgical Association.

He reported on 35 patients who underwent laparoscopic resection and 138 patients undergoing open resection during the same time period. To minimize selection bias, the two groups were matched on the basis of age, size and number of lesions, whether major hepatectomy (three or more segments) or synchronous colectomy was performed, and the Fong score.

The laparoscopic group had significantly less mean blood loss than did the open group (202 mL vs. 392 mL; P less than .001), fewer complications (23% vs. 48%; P = .007), and shorter length of stay (4.8 days vs. 7.8 days; P less than .001), said Dr. Cannon of the department of surgery as the University of Louisville (Ky.).

The ability to achieve microscopically negative margins was significantly higher in the laparoscopic group, at 97%, compared with 81% in the open group (P = .02). Mortality at 90 days was similar at 0% vs. 0.7%, respectively (P = 1.0).

At 1, 3, and 5 years, median disease-free survival rates were similar at 79.3%, 37% , and 15.4%, respectively, in the laparoscopic group vs. 78.4%, 35.4% and 21.6%, respectively, in the open group (P = .715). Likewise, median overall survival rates were similar at 97%, 62.6%, and 36% vs. 95.4%, 60.3%, and 36.6% (P = .911), he said.

Dr. Cannon pointed out that the benefits of laparoscopy were observed in "appropriately selected patients," and suggested that the procedure is ideal for patients with left lateral lesions and for those who are obese.

"A thick abdominal wall doesn’t really hurt you as much when you’re going through a scope as it does when you have to make an incision that goes through all that subcutaneous fat," he said. "Also, with the shorter hospitalization, we think [laparoscopy] minimizes recovery and duration of chemotherapy in selected patients."

The higher positive-margin rate in the open group suggests that some selection bias remains in the analysis, and supports the idea that some patients – notably those with portal vein embolization, extensive disease, or tumors close to major vessels – will always be candidates for open surgery, said invited discussant Dr. Sharon Weber, professor and vice chair of general surgery at the University of Wisconsin, Madison.

Dr. Weber asked whether it’s truly possible to compare the open and laparoscopic groups statistically, or whether one can only say that outcomes tend to be better for those patients who are candidates for laparoscopic resection.

"I agree that the two groups will probably never be strictly comparable," Dr. Cannon replied. "There’s always going to be a role for open operations, especially for the lesions you mentioned [and] for those who may require biliary reconstruction or resection, or [who] have centrally located tumors such as at the base of segment four and five." He added that the purpose of doing matched studies like this one is to show that, for a patient who could go either way, perhaps the laparoscopic procedure offers benefits.

Dr. Weber also questioned how the investigators chose the factors that went into their propensity scoring, observing that some would consider factors such as neoadjuvant therapy, bilateral disease, and underlying liver fibrosis and cirrhosis equally relevant. In addition, recent work from the Netherlands suggests that the clinical risk score has become less relevant for patients with colorectal-level metastases in the era of contemporary neoadjuvant chemotherapy (Ann. Surg. Oncol. 2011;18:2757-63).

Dr. Cannon said that the availability of data influenced what factors were selected, to a large extent. The two groups had a median of one tumor, a median Charlson Comorbidity Index score of 4, and a median Fong score of 2. Their average age was 62 years. The mean tumor sizes were 4.3 cm in the open group and 4.2 cm in the laparoscopic group; positive nodes were present in 64% and 57%, respectively, and mean carcinoembryonic antigen levels at hepatectomy were 91.6 and 52, respectively.

Left lateral segmentectomy was performed in 28.6% of the laparoscopic group and in 6.5% of the open group (P less than .001), whereas wedge/bisegmentectomy was significantly more common in the open group at 34.8% vs. 14.3% in the laparoscopic group (P = .019). Rates of major hepatectomy were similar at 55.8% in the open group and 54.3% in the laparoscopic group (P = .872).

The investigators did not control for the individual year when surgery was performed, choosing instead to limit the analysis to cases performed from 2004 on, when it could be reasonably assumed that adjuvant therapy would be comparable, Dr. Cannon said.

When asked whether a financial analysis of the two procedures had been performed because of the greater expense associated with laparoscopic instruments, Dr. Cannon replied that cost data will be presented at the upcoming Society of Surgical Oncology Annual Cancer Symposium.

Dr. Cannon and Dr. Weber reported no conflicts of interest.*

*Correction, 3/8/2012: This story was updated to reflect the fact that Dr. Cannon has no conflicts of interest. The conflicts that were initially attributed to Dr. Cannon were incorrectly reported by the meeting organizers.  

MADISON, WIS. – Laparoscopic resection of hepatic colorectal cancer offered short-term benefits over open resection and equivalent cancer control in a propensity matched cohort study of 173 patients.

"The oncologic outcomes are really not affected at all by the performance of the minimally invasive procedure," lead author Robert Cannon said at the annual meeting of the Central Surgical Association.

He reported on 35 patients who underwent laparoscopic resection and 138 patients undergoing open resection during the same time period. To minimize selection bias, the two groups were matched on the basis of age, size and number of lesions, whether major hepatectomy (three or more segments) or synchronous colectomy was performed, and the Fong score.

The laparoscopic group had significantly less mean blood loss than did the open group (202 mL vs. 392 mL; P less than .001), fewer complications (23% vs. 48%; P = .007), and shorter length of stay (4.8 days vs. 7.8 days; P less than .001), said Dr. Cannon of the department of surgery as the University of Louisville (Ky.).

The ability to achieve microscopically negative margins was significantly higher in the laparoscopic group, at 97%, compared with 81% in the open group (P = .02). Mortality at 90 days was similar at 0% vs. 0.7%, respectively (P = 1.0).

At 1, 3, and 5 years, median disease-free survival rates were similar at 79.3%, 37% , and 15.4%, respectively, in the laparoscopic group vs. 78.4%, 35.4% and 21.6%, respectively, in the open group (P = .715). Likewise, median overall survival rates were similar at 97%, 62.6%, and 36% vs. 95.4%, 60.3%, and 36.6% (P = .911), he said.

Dr. Cannon pointed out that the benefits of laparoscopy were observed in "appropriately selected patients," and suggested that the procedure is ideal for patients with left lateral lesions and for those who are obese.

"A thick abdominal wall doesn’t really hurt you as much when you’re going through a scope as it does when you have to make an incision that goes through all that subcutaneous fat," he said. "Also, with the shorter hospitalization, we think [laparoscopy] minimizes recovery and duration of chemotherapy in selected patients."

The higher positive-margin rate in the open group suggests that some selection bias remains in the analysis, and supports the idea that some patients – notably those with portal vein embolization, extensive disease, or tumors close to major vessels – will always be candidates for open surgery, said invited discussant Dr. Sharon Weber, professor and vice chair of general surgery at the University of Wisconsin, Madison.

Dr. Weber asked whether it’s truly possible to compare the open and laparoscopic groups statistically, or whether one can only say that outcomes tend to be better for those patients who are candidates for laparoscopic resection.

"I agree that the two groups will probably never be strictly comparable," Dr. Cannon replied. "There’s always going to be a role for open operations, especially for the lesions you mentioned [and] for those who may require biliary reconstruction or resection, or [who] have centrally located tumors such as at the base of segment four and five." He added that the purpose of doing matched studies like this one is to show that, for a patient who could go either way, perhaps the laparoscopic procedure offers benefits.

Dr. Weber also questioned how the investigators chose the factors that went into their propensity scoring, observing that some would consider factors such as neoadjuvant therapy, bilateral disease, and underlying liver fibrosis and cirrhosis equally relevant. In addition, recent work from the Netherlands suggests that the clinical risk score has become less relevant for patients with colorectal-level metastases in the era of contemporary neoadjuvant chemotherapy (Ann. Surg. Oncol. 2011;18:2757-63).

Dr. Cannon said that the availability of data influenced what factors were selected, to a large extent. The two groups had a median of one tumor, a median Charlson Comorbidity Index score of 4, and a median Fong score of 2. Their average age was 62 years. The mean tumor sizes were 4.3 cm in the open group and 4.2 cm in the laparoscopic group; positive nodes were present in 64% and 57%, respectively, and mean carcinoembryonic antigen levels at hepatectomy were 91.6 and 52, respectively.

Left lateral segmentectomy was performed in 28.6% of the laparoscopic group and in 6.5% of the open group (P less than .001), whereas wedge/bisegmentectomy was significantly more common in the open group at 34.8% vs. 14.3% in the laparoscopic group (P = .019). Rates of major hepatectomy were similar at 55.8% in the open group and 54.3% in the laparoscopic group (P = .872).

The investigators did not control for the individual year when surgery was performed, choosing instead to limit the analysis to cases performed from 2004 on, when it could be reasonably assumed that adjuvant therapy would be comparable, Dr. Cannon said.

When asked whether a financial analysis of the two procedures had been performed because of the greater expense associated with laparoscopic instruments, Dr. Cannon replied that cost data will be presented at the upcoming Society of Surgical Oncology Annual Cancer Symposium.

Dr. Cannon and Dr. Weber reported no conflicts of interest.*

*Correction, 3/8/2012: This story was updated to reflect the fact that Dr. Cannon has no conflicts of interest. The conflicts that were initially attributed to Dr. Cannon were incorrectly reported by the meeting organizers.  

HOT SPRINGS, VA – Using risk adjustment alone to compare surgical site infection rates among hospitals may not be valid, judging by a retrospective analysis of data on colorectal procedures.

An examination of data submitted on 336,190 cases by 237 hospitals participating in the National Surgical Quality Improvement Project (NSQIP) in 2009 revealed that a patient’s underlying disease state is an important contributor to the risk of surgical site infection, said Dr. Robert Cima.

Dr. Cima and his colleagues at the Mayo Clinic Rochester, Minn., identified 24,673 colorectal procedures, using CPT codes. Of those procedures, 6,324 patients had colon cancer, 2,061 had benign neoplasm, 2,859 had rectal cancer, 4,821 had diverticular disease, 764 had ulcerative colitis, 862 had regional enteritis (Crohn’s disease), and 6,982 had other conditions, which included perforation, volvulus, intestinal obstruction, rectal prolapse, fistula, vascular insufficiency and unspecified neoplasms.

"Comparisons between hospitals could be misleading if they don’t include case mix," Dr. Cima said.

They specifically analyzed colorectal procedures because they are associated with the largest rate of surgical site infections (SSI; 5%-30%) and those infections led to a longer length of stay, higher costs, and higher mortality.

To get a baseline rate of SSIs for comparison purposes, the authors queried the data set to determine which procedure had the lowest rate. Benign neoplasms had the lowest overall rate, and because they were not caused by underlying disorders or malignancies, that rate was chosen as the reference, Dr. Cima said at the annual meeting of the Southern Surgical Association.

The authors conducted a regression analysis using the same factors used in the NSQIP risk adjustment: age, body mass index, American Society of Anesthesiology classification, wound classification, and relative value units (RVU) used, which are a surrogate for CPT codes. Odds ratios for SSIs were then calculated for each procedure.

Overall, 13.5% of patients developed an SSI. Rectal cancer patients had the highest overall odds ratio at 1.9, followed by Crohn’s disease, at 1.7. Rectal cancer patients also had the highest risk of superficial incisional SSI at 1.6; diverticular disease patients had a 1.6-fold higher risk than did those with benign neoplasms.

The patients at highest risk for deep incisional infections were those with ulcerative colitis (OR, 2.4), followed by rectal cancer (2.1). Both of those conditions also put patients at higher risk for organ/space infections (OR, 2.2 and 2.1).

The difference in infection rates by underlying disease led the researchers to question whether case mix might have an effect on the infection rates at individual institutions. Looking at the Mayo Clinic’s profile, compared with all NSQIP facilities’ case mix, they found that there was a higher percentage of patients with the higher-risk conditions: rectal cancer, regional enteritis, and ulcerative colitis.

The NSQIP data include a disease diagnosis, but it does not factor that into risk-adjusted figures, which will soon be publicly reported, noted Dr. Cima. Comparisons between hospitals could be misleading if they don’t include case mix, he said. And, there are implications for quality improvement, said Dr. Cima.

"If we had just looked at the overall surgical site infection rate and tried to design studies or processes to just reduce it without consideration of case mix, we would not be able to really determine whether or not we can drive it down," he said.

"This is a provocative and important study," said Dr. Danny Jacobs, chairman of the department of surgery at Duke University, Durham, N.C., in commenting on the paper. And, he said, it raises questions about whether the risk-adjustment system being used by NSQIP is adequate.

Dr. Susan Galandiuk, a professor of surgery at the University of Louisville (Ky.), questioned whether infection rates weren’t also influenced by the duration of surgery and whether patients were given appropriate antibiotic prophylaxis.

Dr. Cima said that while many studies have shown that infections rise as the length of surgery increases, it was not clear whether that was a factor in his study.

He agreed with Dr. Jacobs that the paper raised questions. The data do "go to the very heart of using data sets to drive quality improvement," he said.

HOT SPRINGS, VA – Using risk adjustment alone to compare surgical site infection rates among hospitals may not be valid, judging by a retrospective analysis of data on colorectal procedures.

An examination of data submitted on 336,190 cases by 237 hospitals participating in the National Surgical Quality Improvement Project (NSQIP) in 2009 revealed that a patient’s underlying disease state is an important contributor to the risk of surgical site infection, said Dr. Robert Cima.

Dr. Cima and his colleagues at the Mayo Clinic Rochester, Minn., identified 24,673 colorectal procedures, using CPT codes. Of those procedures, 6,324 patients had colon cancer, 2,061 had benign neoplasm, 2,859 had rectal cancer, 4,821 had diverticular disease, 764 had ulcerative colitis, 862 had regional enteritis (Crohn’s disease), and 6,982 had other conditions, which included perforation, volvulus, intestinal obstruction, rectal prolapse, fistula, vascular insufficiency and unspecified neoplasms.

"Comparisons between hospitals could be misleading if they don’t include case mix," Dr. Cima said.

They specifically analyzed colorectal procedures because they are associated with the largest rate of surgical site infections (SSI; 5%-30%) and those infections led to a longer length of stay, higher costs, and higher mortality.

To get a baseline rate of SSIs for comparison purposes, the authors queried the data set to determine which procedure had the lowest rate. Benign neoplasms had the lowest overall rate, and because they were not caused by underlying disorders or malignancies, that rate was chosen as the reference, Dr. Cima said at the annual meeting of the Southern Surgical Association.

The authors conducted a regression analysis using the same factors used in the NSQIP risk adjustment: age, body mass index, American Society of Anesthesiology classification, wound classification, and relative value units (RVU) used, which are a surrogate for CPT codes. Odds ratios for SSIs were then calculated for each procedure.

Overall, 13.5% of patients developed an SSI. Rectal cancer patients had the highest overall odds ratio at 1.9, followed by Crohn’s disease, at 1.7. Rectal cancer patients also had the highest risk of superficial incisional SSI at 1.6; diverticular disease patients had a 1.6-fold higher risk than did those with benign neoplasms.

The patients at highest risk for deep incisional infections were those with ulcerative colitis (OR, 2.4), followed by rectal cancer (2.1). Both of those conditions also put patients at higher risk for organ/space infections (OR, 2.2 and 2.1).

The difference in infection rates by underlying disease led the researchers to question whether case mix might have an effect on the infection rates at individual institutions. Looking at the Mayo Clinic’s profile, compared with all NSQIP facilities’ case mix, they found that there was a higher percentage of patients with the higher-risk conditions: rectal cancer, regional enteritis, and ulcerative colitis.

The NSQIP data include a disease diagnosis, but it does not factor that into risk-adjusted figures, which will soon be publicly reported, noted Dr. Cima. Comparisons between hospitals could be misleading if they don’t include case mix, he said. And, there are implications for quality improvement, said Dr. Cima.

"If we had just looked at the overall surgical site infection rate and tried to design studies or processes to just reduce it without consideration of case mix, we would not be able to really determine whether or not we can drive it down," he said.

"This is a provocative and important study," said Dr. Danny Jacobs, chairman of the department of surgery at Duke University, Durham, N.C., in commenting on the paper. And, he said, it raises questions about whether the risk-adjustment system being used by NSQIP is adequate.

Dr. Susan Galandiuk, a professor of surgery at the University of Louisville (Ky.), questioned whether infection rates weren’t also influenced by the duration of surgery and whether patients were given appropriate antibiotic prophylaxis.

Dr. Cima said that while many studies have shown that infections rise as the length of surgery increases, it was not clear whether that was a factor in his study.

He agreed with Dr. Jacobs that the paper raised questions. The data do "go to the very heart of using data sets to drive quality improvement," he said.

HOT SPRINGS, VA – Using risk adjustment alone to compare surgical site infection rates among hospitals may not be valid, judging by a retrospective analysis of data on colorectal procedures.

An examination of data submitted on 336,190 cases by 237 hospitals participating in the National Surgical Quality Improvement Project (NSQIP) in 2009 revealed that a patient’s underlying disease state is an important contributor to the risk of surgical site infection, said Dr. Robert Cima.

Dr. Cima and his colleagues at the Mayo Clinic Rochester, Minn., identified 24,673 colorectal procedures, using CPT codes. Of those procedures, 6,324 patients had colon cancer, 2,061 had benign neoplasm, 2,859 had rectal cancer, 4,821 had diverticular disease, 764 had ulcerative colitis, 862 had regional enteritis (Crohn’s disease), and 6,982 had other conditions, which included perforation, volvulus, intestinal obstruction, rectal prolapse, fistula, vascular insufficiency and unspecified neoplasms.

"Comparisons between hospitals could be misleading if they don’t include case mix," Dr. Cima said.

They specifically analyzed colorectal procedures because they are associated with the largest rate of surgical site infections (SSI; 5%-30%) and those infections led to a longer length of stay, higher costs, and higher mortality.

To get a baseline rate of SSIs for comparison purposes, the authors queried the data set to determine which procedure had the lowest rate. Benign neoplasms had the lowest overall rate, and because they were not caused by underlying disorders or malignancies, that rate was chosen as the reference, Dr. Cima said at the annual meeting of the Southern Surgical Association.

The authors conducted a regression analysis using the same factors used in the NSQIP risk adjustment: age, body mass index, American Society of Anesthesiology classification, wound classification, and relative value units (RVU) used, which are a surrogate for CPT codes. Odds ratios for SSIs were then calculated for each procedure.

Overall, 13.5% of patients developed an SSI. Rectal cancer patients had the highest overall odds ratio at 1.9, followed by Crohn’s disease, at 1.7. Rectal cancer patients also had the highest risk of superficial incisional SSI at 1.6; diverticular disease patients had a 1.6-fold higher risk than did those with benign neoplasms.

The patients at highest risk for deep incisional infections were those with ulcerative colitis (OR, 2.4), followed by rectal cancer (2.1). Both of those conditions also put patients at higher risk for organ/space infections (OR, 2.2 and 2.1).

The difference in infection rates by underlying disease led the researchers to question whether case mix might have an effect on the infection rates at individual institutions. Looking at the Mayo Clinic’s profile, compared with all NSQIP facilities’ case mix, they found that there was a higher percentage of patients with the higher-risk conditions: rectal cancer, regional enteritis, and ulcerative colitis.

The NSQIP data include a disease diagnosis, but it does not factor that into risk-adjusted figures, which will soon be publicly reported, noted Dr. Cima. Comparisons between hospitals could be misleading if they don’t include case mix, he said. And, there are implications for quality improvement, said Dr. Cima.

"If we had just looked at the overall surgical site infection rate and tried to design studies or processes to just reduce it without consideration of case mix, we would not be able to really determine whether or not we can drive it down," he said.

"This is a provocative and important study," said Dr. Danny Jacobs, chairman of the department of surgery at Duke University, Durham, N.C., in commenting on the paper. And, he said, it raises questions about whether the risk-adjustment system being used by NSQIP is adequate.

Dr. Susan Galandiuk, a professor of surgery at the University of Louisville (Ky.), questioned whether infection rates weren’t also influenced by the duration of surgery and whether patients were given appropriate antibiotic prophylaxis.

Dr. Cima said that while many studies have shown that infections rise as the length of surgery increases, it was not clear whether that was a factor in his study.

He agreed with Dr. Jacobs that the paper raised questions. The data do "go to the very heart of using data sets to drive quality improvement," he said.

HOT SPRINGS, VA. – A shorter length of stay appears to be associated with a higher risk of readmission after colectomy, but only in patients who are older and have more preoperative comorbidities and perioperative complications, results of a large database review demonstrate.

Dr. Timothy Pawlik and his colleagues from Johns Hopkins Hospital, Baltimore, conducted a retrospective study of the Surveillance, Epidemiology, and End Results (SEER) database of 149,622 Medicare patients with a primary diagnosis of colorectal cancer who underwent colectomy from 1986 to 2005. The goal was to determine trends in readmission rates during the first 30 days.

"How do we begin to remedy the demonization of legitimate readmissions either politically, medically, or both?"

Increasingly, payers – especially Medicare – are penalizing hospitals for failing to prevent readmissions, which cost about $40 billion annually. Moreover, up to three-quarters of readmissions may be avoidable. In the meantime, many hospitals are fast-tracking patients for discharge after colorectal surgery.

In the SEER data, the mean age was 75 years in the 1986-1990 period and 77 years in the later period of 2001-2005. Patients were sicker in the later time period, with 63% having a Charlson comorbidity score of 3 or greater, compared with only 53% in the earlier time frame.

Most patients (38%) had a right colectomy; 23% had a sigmoid procedure, 13% had a rectal procedure, and 11% had a left colectomy. Forty-six percent of patients had lymph node metastasis, and 17% had an emergent procedure.

Morbidity for the entire study period was 37%; most complications were gastrointestinal or related to bleeding or postoperative infection. Again, there was a significant difference between the earlier and the later time frames. Perioperative morbidity was 27% in the 1986-1990 time frame, vs. 40% in 2001-2005. Mortality, at 4%, remained stable over time.

The mean length of stay decreased from 14 to 10 days from the early time to the later time period. And, over time, the percentage of patients discharged to home decreased, while discharges to skilled nursing facilities increased.

Overall, there were 17,000 readmissions, for a rate of 11%. Readmissions also increased, from 10% early on to 14% in 2001-2005. During that later time frame, patients had a 46% increased risk of readmission. Almost half of the readmissions occurred within the first 7 days after surgery, primarily for complications, dehydration, or infection. The mortality rate associated with readmission was 8%.

Multivariate analysis showed that the factors most likely to impact readmission were multiple comorbidities or a history of any perioperative complication, said Dr. Pawlik. Early discharge alone was not associated with a higher risk of readmission.

The study shows that "ongoing initiatives to reduce risk of readmissions and the associated costs, morbidity, and mortality are needed," said Dr. Pawlik.

It also "provides data that we all know to be true: namely, that the patients we are operating on have more comorbidities and that length of stay increases the rate of readmissions," said Dr. Susan Galandiuk, the discussant at the meeting. However, payers have been using length of stay and readmissions as quality surrogates, said Dr. Galandiuk, professor of surgery at the University of Louisville, Ky.

Not readmitting an elderly patient with many comorbidities and complications "would be a quality of care issue, and not the other way around," she added. The problem now is, "How do we begin to remedy the demonization of legitimate readmissions either politically, medically, or both?" asked Dr. Galandiuk.

Dr. Pawlik agreed that readmissions should not necessarily be held to be all bad. "Blaming readmissions on length of stay is a gross oversimplification of what’s going on," he added. Surgeons are clearly operating on older and sicker patients, and are doing more complicated operations that may result in a higher rate of morbidity – all this "in a culture of being asked to send people home earlier," he said.

"Our data clearly show that early discharge is feasible in some patients, but it needs to be used judiciously, especially in an older population," said Dr. Pawlik.

Dr. Pawlik and Dr. Galandiuk reported no conflicts.

HOT SPRINGS, VA. – A shorter length of stay appears to be associated with a higher risk of readmission after colectomy, but only in patients who are older and have more preoperative comorbidities and perioperative complications, results of a large database review demonstrate.

Dr. Timothy Pawlik and his colleagues from Johns Hopkins Hospital, Baltimore, conducted a retrospective study of the Surveillance, Epidemiology, and End Results (SEER) database of 149,622 Medicare patients with a primary diagnosis of colorectal cancer who underwent colectomy from 1986 to 2005. The goal was to determine trends in readmission rates during the first 30 days.

"How do we begin to remedy the demonization of legitimate readmissions either politically, medically, or both?"

Increasingly, payers – especially Medicare – are penalizing hospitals for failing to prevent readmissions, which cost about $40 billion annually. Moreover, up to three-quarters of readmissions may be avoidable. In the meantime, many hospitals are fast-tracking patients for discharge after colorectal surgery.

In the SEER data, the mean age was 75 years in the 1986-1990 period and 77 years in the later period of 2001-2005. Patients were sicker in the later time period, with 63% having a Charlson comorbidity score of 3 or greater, compared with only 53% in the earlier time frame.

Most patients (38%) had a right colectomy; 23% had a sigmoid procedure, 13% had a rectal procedure, and 11% had a left colectomy. Forty-six percent of patients had lymph node metastasis, and 17% had an emergent procedure.

Morbidity for the entire study period was 37%; most complications were gastrointestinal or related to bleeding or postoperative infection. Again, there was a significant difference between the earlier and the later time frames. Perioperative morbidity was 27% in the 1986-1990 time frame, vs. 40% in 2001-2005. Mortality, at 4%, remained stable over time.

The mean length of stay decreased from 14 to 10 days from the early time to the later time period. And, over time, the percentage of patients discharged to home decreased, while discharges to skilled nursing facilities increased.

Overall, there were 17,000 readmissions, for a rate of 11%. Readmissions also increased, from 10% early on to 14% in 2001-2005. During that later time frame, patients had a 46% increased risk of readmission. Almost half of the readmissions occurred within the first 7 days after surgery, primarily for complications, dehydration, or infection. The mortality rate associated with readmission was 8%.

Multivariate analysis showed that the factors most likely to impact readmission were multiple comorbidities or a history of any perioperative complication, said Dr. Pawlik. Early discharge alone was not associated with a higher risk of readmission.

The study shows that "ongoing initiatives to reduce risk of readmissions and the associated costs, morbidity, and mortality are needed," said Dr. Pawlik.

It also "provides data that we all know to be true: namely, that the patients we are operating on have more comorbidities and that length of stay increases the rate of readmissions," said Dr. Susan Galandiuk, the discussant at the meeting. However, payers have been using length of stay and readmissions as quality surrogates, said Dr. Galandiuk, professor of surgery at the University of Louisville, Ky.

Not readmitting an elderly patient with many comorbidities and complications "would be a quality of care issue, and not the other way around," she added. The problem now is, "How do we begin to remedy the demonization of legitimate readmissions either politically, medically, or both?" asked Dr. Galandiuk.

Dr. Pawlik agreed that readmissions should not necessarily be held to be all bad. "Blaming readmissions on length of stay is a gross oversimplification of what’s going on," he added. Surgeons are clearly operating on older and sicker patients, and are doing more complicated operations that may result in a higher rate of morbidity – all this "in a culture of being asked to send people home earlier," he said.

"Our data clearly show that early discharge is feasible in some patients, but it needs to be used judiciously, especially in an older population," said Dr. Pawlik.

Dr. Pawlik and Dr. Galandiuk reported no conflicts.

HOT SPRINGS, VA. – A shorter length of stay appears to be associated with a higher risk of readmission after colectomy, but only in patients who are older and have more preoperative comorbidities and perioperative complications, results of a large database review demonstrate.

Dr. Timothy Pawlik and his colleagues from Johns Hopkins Hospital, Baltimore, conducted a retrospective study of the Surveillance, Epidemiology, and End Results (SEER) database of 149,622 Medicare patients with a primary diagnosis of colorectal cancer who underwent colectomy from 1986 to 2005. The goal was to determine trends in readmission rates during the first 30 days.

"How do we begin to remedy the demonization of legitimate readmissions either politically, medically, or both?"

Increasingly, payers – especially Medicare – are penalizing hospitals for failing to prevent readmissions, which cost about $40 billion annually. Moreover, up to three-quarters of readmissions may be avoidable. In the meantime, many hospitals are fast-tracking patients for discharge after colorectal surgery.

In the SEER data, the mean age was 75 years in the 1986-1990 period and 77 years in the later period of 2001-2005. Patients were sicker in the later time period, with 63% having a Charlson comorbidity score of 3 or greater, compared with only 53% in the earlier time frame.

Most patients (38%) had a right colectomy; 23% had a sigmoid procedure, 13% had a rectal procedure, and 11% had a left colectomy. Forty-six percent of patients had lymph node metastasis, and 17% had an emergent procedure.

Morbidity for the entire study period was 37%; most complications were gastrointestinal or related to bleeding or postoperative infection. Again, there was a significant difference between the earlier and the later time frames. Perioperative morbidity was 27% in the 1986-1990 time frame, vs. 40% in 2001-2005. Mortality, at 4%, remained stable over time.

The mean length of stay decreased from 14 to 10 days from the early time to the later time period. And, over time, the percentage of patients discharged to home decreased, while discharges to skilled nursing facilities increased.

Overall, there were 17,000 readmissions, for a rate of 11%. Readmissions also increased, from 10% early on to 14% in 2001-2005. During that later time frame, patients had a 46% increased risk of readmission. Almost half of the readmissions occurred within the first 7 days after surgery, primarily for complications, dehydration, or infection. The mortality rate associated with readmission was 8%.

Multivariate analysis showed that the factors most likely to impact readmission were multiple comorbidities or a history of any perioperative complication, said Dr. Pawlik. Early discharge alone was not associated with a higher risk of readmission.

The study shows that "ongoing initiatives to reduce risk of readmissions and the associated costs, morbidity, and mortality are needed," said Dr. Pawlik.

It also "provides data that we all know to be true: namely, that the patients we are operating on have more comorbidities and that length of stay increases the rate of readmissions," said Dr. Susan Galandiuk, the discussant at the meeting. However, payers have been using length of stay and readmissions as quality surrogates, said Dr. Galandiuk, professor of surgery at the University of Louisville, Ky.

Not readmitting an elderly patient with many comorbidities and complications "would be a quality of care issue, and not the other way around," she added. The problem now is, "How do we begin to remedy the demonization of legitimate readmissions either politically, medically, or both?" asked Dr. Galandiuk.

Dr. Pawlik agreed that readmissions should not necessarily be held to be all bad. "Blaming readmissions on length of stay is a gross oversimplification of what’s going on," he added. Surgeons are clearly operating on older and sicker patients, and are doing more complicated operations that may result in a higher rate of morbidity – all this "in a culture of being asked to send people home earlier," he said.

"Our data clearly show that early discharge is feasible in some patients, but it needs to be used judiciously, especially in an older population," said Dr. Pawlik.

Dr. Pawlik and Dr. Galandiuk reported no conflicts.

SAN FRANCISCO – A majority of patients who are rehospitalized after surgery have a postoperative complication, most commonly after colectomy, lower extremity bypass, or carotid endarterectomy.

Reducing postoperative complications could reduce costs associated with readmissions by millions of dollars per year, a retrospective study of data on 90,932 patients from 214 hospitals suggests.

Investigators linked records from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) and the Medicare Provider Analysis and Review files for patients aged 65 years or older who underwent surgery in 2005-2008.

Within 30 days of surgery, 13% of patients were readmitted. A postoperative complication listed in the ACS-NSQIP registry was seen in 53% of readmitted patients compared with 16% of patients who did not need readmission, Dr. Elise H. Lawson and her associates reported at the annual clinical congress of the American College of Surgeons.

The study looked at 20 postoperative complications, including surgical site infections, wound disruption, pneumonia, unplanned intubation, pulmonary embolism, progressive renal insufficiency, acute renal failure, urinary tract infection, stroke, coma, cardiac arrest requiring CPR, myocardial infarction, bleeding requiring transfusion, deep venous thrombosis, sepsis or septic shock, being on a ventilator for more than 48 hours, and an unplanned return to the OR, among others.

Colectomy was associated with the greatest number of readmissions, followed by lower extremity bypass and carotid endarterectomy. After colectomy, 27% of patients developed a complication, and 13.4% of all colectomy patients were readmitted within 30 days.

Readmission rates after colectomy were 28% for patients who developed postoperative complications and 8% for patients without complications, said Dr. Lawson of the University of California, Los Angeles. She won the College’s 2011 Excellence in Research Award for her study.

Hypothetically, if postoperative complications could be prevented after colectomy, the risk-adjusted probability of readmission within 30 days would be 8%, she said. The study adjusted for the effects of many other factors that influenced the risk of having a postoperative complication, including age, sex, body mass index, functional status, emergency procedures, smoking, renal failure, and diabetes.

Not only did patients with complications have more readmissions, but those readmissions were more expensive. The cost for readmission after colectomy was $13,400 for patients with a complication and $7,500 for those without complications.

It’s unrealistic to think that a hospital could prevent all postoperative complications, Dr. Lawson said. Reducing complications after colectomy by even 10% (to 24%) would lower the overall postcolectomy readmission rate from 13.4% to 12.8%, the investigators estimated. For the 108,820 colectomies performed each year in Medicare beneficiaries aged 65 years or older, a 10% reduction in postoperative complications would reduce costs from readmissions alone by $9.3 million per year, she said.

Reducing complications after colectomy by 30% (to 19%) would lower the postcolectomy readmission rate to 11.7% and save an estimated $28 million per year in readmission costs. Halving the postcolectomy complication rate (to 13.5%) would reduce the readmission rate to 10.6% and save an estimated $46 million per year in readmission costs.

Previous data suggest that 13% of surgical patients and 16% of medical patients are readmitted after discharge from hospitalization, accounting for an estimated $17 billion in Medicare costs. Medicare plans to reduce payments for readmissions starting in 2013.

The reasons that patients are readmitted are not well understood, which was one motivation for the study, Dr. Lawson said. Unplanned readmissions that are related to the initial surgery may be due to postoperative complications or exacerbations of a preoperative comorbidity. Unplanned readmissions also may be for reasons unrelated to the initial surgery, such as for trauma or falls. In other cases, readmission may be planned for chemotherapy or elective procedures. The study excluded patients who died before discharge or who were not discharged from the primary hospitalization.

Dr. Lawson said she has no relevant conflicts of interest.

SAN FRANCISCO – A majority of patients who are rehospitalized after surgery have a postoperative complication, most commonly after colectomy, lower extremity bypass, or carotid endarterectomy.

Reducing postoperative complications could reduce costs associated with readmissions by millions of dollars per year, a retrospective study of data on 90,932 patients from 214 hospitals suggests.

Investigators linked records from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) and the Medicare Provider Analysis and Review files for patients aged 65 years or older who underwent surgery in 2005-2008.

Within 30 days of surgery, 13% of patients were readmitted. A postoperative complication listed in the ACS-NSQIP registry was seen in 53% of readmitted patients compared with 16% of patients who did not need readmission, Dr. Elise H. Lawson and her associates reported at the annual clinical congress of the American College of Surgeons.

The study looked at 20 postoperative complications, including surgical site infections, wound disruption, pneumonia, unplanned intubation, pulmonary embolism, progressive renal insufficiency, acute renal failure, urinary tract infection, stroke, coma, cardiac arrest requiring CPR, myocardial infarction, bleeding requiring transfusion, deep venous thrombosis, sepsis or septic shock, being on a ventilator for more than 48 hours, and an unplanned return to the OR, among others.

Colectomy was associated with the greatest number of readmissions, followed by lower extremity bypass and carotid endarterectomy. After colectomy, 27% of patients developed a complication, and 13.4% of all colectomy patients were readmitted within 30 days.

Readmission rates after colectomy were 28% for patients who developed postoperative complications and 8% for patients without complications, said Dr. Lawson of the University of California, Los Angeles. She won the College’s 2011 Excellence in Research Award for her study.

Hypothetically, if postoperative complications could be prevented after colectomy, the risk-adjusted probability of readmission within 30 days would be 8%, she said. The study adjusted for the effects of many other factors that influenced the risk of having a postoperative complication, including age, sex, body mass index, functional status, emergency procedures, smoking, renal failure, and diabetes.

Not only did patients with complications have more readmissions, but those readmissions were more expensive. The cost for readmission after colectomy was $13,400 for patients with a complication and $7,500 for those without complications.

It’s unrealistic to think that a hospital could prevent all postoperative complications, Dr. Lawson said. Reducing complications after colectomy by even 10% (to 24%) would lower the overall postcolectomy readmission rate from 13.4% to 12.8%, the investigators estimated. For the 108,820 colectomies performed each year in Medicare beneficiaries aged 65 years or older, a 10% reduction in postoperative complications would reduce costs from readmissions alone by $9.3 million per year, she said.

Reducing complications after colectomy by 30% (to 19%) would lower the postcolectomy readmission rate to 11.7% and save an estimated $28 million per year in readmission costs. Halving the postcolectomy complication rate (to 13.5%) would reduce the readmission rate to 10.6% and save an estimated $46 million per year in readmission costs.

Previous data suggest that 13% of surgical patients and 16% of medical patients are readmitted after discharge from hospitalization, accounting for an estimated $17 billion in Medicare costs. Medicare plans to reduce payments for readmissions starting in 2013.

The reasons that patients are readmitted are not well understood, which was one motivation for the study, Dr. Lawson said. Unplanned readmissions that are related to the initial surgery may be due to postoperative complications or exacerbations of a preoperative comorbidity. Unplanned readmissions also may be for reasons unrelated to the initial surgery, such as for trauma or falls. In other cases, readmission may be planned for chemotherapy or elective procedures. The study excluded patients who died before discharge or who were not discharged from the primary hospitalization.

Dr. Lawson said she has no relevant conflicts of interest.

SAN FRANCISCO – A majority of patients who are rehospitalized after surgery have a postoperative complication, most commonly after colectomy, lower extremity bypass, or carotid endarterectomy.

Reducing postoperative complications could reduce costs associated with readmissions by millions of dollars per year, a retrospective study of data on 90,932 patients from 214 hospitals suggests.

Investigators linked records from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) and the Medicare Provider Analysis and Review files for patients aged 65 years or older who underwent surgery in 2005-2008.

Within 30 days of surgery, 13% of patients were readmitted. A postoperative complication listed in the ACS-NSQIP registry was seen in 53% of readmitted patients compared with 16% of patients who did not need readmission, Dr. Elise H. Lawson and her associates reported at the annual clinical congress of the American College of Surgeons.

The study looked at 20 postoperative complications, including surgical site infections, wound disruption, pneumonia, unplanned intubation, pulmonary embolism, progressive renal insufficiency, acute renal failure, urinary tract infection, stroke, coma, cardiac arrest requiring CPR, myocardial infarction, bleeding requiring transfusion, deep venous thrombosis, sepsis or septic shock, being on a ventilator for more than 48 hours, and an unplanned return to the OR, among others.

Colectomy was associated with the greatest number of readmissions, followed by lower extremity bypass and carotid endarterectomy. After colectomy, 27% of patients developed a complication, and 13.4% of all colectomy patients were readmitted within 30 days.

Readmission rates after colectomy were 28% for patients who developed postoperative complications and 8% for patients without complications, said Dr. Lawson of the University of California, Los Angeles. She won the College’s 2011 Excellence in Research Award for her study.

Hypothetically, if postoperative complications could be prevented after colectomy, the risk-adjusted probability of readmission within 30 days would be 8%, she said. The study adjusted for the effects of many other factors that influenced the risk of having a postoperative complication, including age, sex, body mass index, functional status, emergency procedures, smoking, renal failure, and diabetes.

Not only did patients with complications have more readmissions, but those readmissions were more expensive. The cost for readmission after colectomy was $13,400 for patients with a complication and $7,500 for those without complications.

It’s unrealistic to think that a hospital could prevent all postoperative complications, Dr. Lawson said. Reducing complications after colectomy by even 10% (to 24%) would lower the overall postcolectomy readmission rate from 13.4% to 12.8%, the investigators estimated. For the 108,820 colectomies performed each year in Medicare beneficiaries aged 65 years or older, a 10% reduction in postoperative complications would reduce costs from readmissions alone by $9.3 million per year, she said.

Reducing complications after colectomy by 30% (to 19%) would lower the postcolectomy readmission rate to 11.7% and save an estimated $28 million per year in readmission costs. Halving the postcolectomy complication rate (to 13.5%) would reduce the readmission rate to 10.6% and save an estimated $46 million per year in readmission costs.

Previous data suggest that 13% of surgical patients and 16% of medical patients are readmitted after discharge from hospitalization, accounting for an estimated $17 billion in Medicare costs. Medicare plans to reduce payments for readmissions starting in 2013.

The reasons that patients are readmitted are not well understood, which was one motivation for the study, Dr. Lawson said. Unplanned readmissions that are related to the initial surgery may be due to postoperative complications or exacerbations of a preoperative comorbidity. Unplanned readmissions also may be for reasons unrelated to the initial surgery, such as for trauma or falls. In other cases, readmission may be planned for chemotherapy or elective procedures. The study excluded patients who died before discharge or who were not discharged from the primary hospitalization.

Dr. Lawson said she has no relevant conflicts of interest.

STOCKHOLM – Laparoscopic surgery offers the same radical resection for noninvasive rectal cancer as does open surgery, according to short-term outcomes of the randomized, noninferiority phase III COLOR II trial.

The circumferential resection margin, described as the most important parameter for rectal cancer surgery, was 1.3 cm after laparoscopic and open surgery (P = .16). The distal margin was similar at 3.6 cm (P = .68).

The proximal margin was 17.0 cm in the laparoscopic group and 19.0 cm in the open group. The difference was statistically significant (P less than .001), but "clinically, totally irrelevant since a 17-cm margin is wide enough for a safe tumor resection," lead author Dr. H. Jaap Bonjer said at the European Multidisciplinary Cancer Congress.

COLOR II (Colorectal Cancer Laparoscopic or Open Resection) sought to answer whether laparoscopic total mesorectal excision is as oncologically safe as open surgery is. Removing the entire mesorectum, or fatty tissue around the rectum, is important because the radial spread of rectal cancer is more prominent than is longitudinal spread, explained Dr. Bonjer of the surgery department at Vrije University Medical Centre, Amsterdam.

Researchers at 30 centers in eight countries, including Canada, randomized 1,103 patients with a single rectal carcinoma within 15 cm of the anal verge, staged T1, T2, or T3 with a margin to the endopelvic fascia greater than 2 mm, to laparoscopic or open surgery. The analysis included 699 patients in the laparoscopic arm and 345 in the open surgery arm.

The technically demanding nature of laparoscopic surgery resulted in a longer operating time than with open surgery (median 240 minutes vs. 188 minutes, P less than .001), but blood loss was cut in half (median 200 mL vs. 400 mL, P less than .001), Dr. Bonjer said.

The number of lymph nodes harvested was similar at 13 in the laparoscopic group and 14 in the open group.

The overall positive resection margin rate, defined as less than 2 mm, was 9% in the laparoscopic group and 10% in the open group (P = .078), Dr. Bonjer said at the joint congress of the European Cancer Organization, the European Society for Medical Oncology, and the European Society for Radiotherapy and Oncology.

Subgroup analyses showed similar positive resection margin rates in the upper rectum (10% vs. 9%, P = .92) and middle rectum (9% vs. 3%, P = .073), but a significantly better rate in the lower rectum after laparoscopic surgery at 9% vs. 21% after open surgery (P = .013).

The laparoscopic group also had improved postoperative recovery compared with the open group including a shorter time to first bowel movement (2.9 days vs. 3.7 days, P = .001), time to intake of 1 liter of fluid (2.6 days vs. 2.8 days P = .006) and hospital stay (11.9 days vs. 12.1 days, P = .037), he said.

Anastomotic leakage occurred in 7% of patients after laparoscopic surgery and 6% after open surgery (P = .63). One-third of patients had a diverting ileostomy.

Mortality rates within 28 days after surgery did not differ between the laparoscopic and open groups (1.1% vs. 1.7%, P = .41), nor did morbidity (39.5% vs. 36.5%, P = .28), Dr. Bonjer said.

Dr. Peter Naredi, invited discussant and president of the European Society of Surgical Oncology, said COLOR II was very well performed, and that the large number of laparoscopic patients "will make a huge impact on the results of how good laparoscopic surgery is versus open surgery" when added to the current database.

He highlighted a meta-analysis published this spring of six randomized trials enrolling 1,033 patients that showed no difference between the two techniques with regard to number of lymph nodes harvested, involvement of the circumferential resection margin, 3-year-overall survival, and disease-free survival (Int. J. Colorectal. Dis. 2011;26:415-21).

Dr. Naredi, chair of surgery at Umeå (Sweden) University, expressed concern, however, about the 21% positive resection margin rates in the lower rectum for the open group, and said this would likely convert into differences in local recurrence between the two groups. He also stressed the importance of standardization when evaluating multimodal treatments, and pointed out that preoperative radiotherapy was used in 72% of the lower rectal cancer patients treated with laparoscopy and only 63% treated with open surgery.

Ethicon EndoSurgery supported the trial. No individual disclosures were presented.

STOCKHOLM – Laparoscopic surgery offers the same radical resection for noninvasive rectal cancer as does open surgery, according to short-term outcomes of the randomized, noninferiority phase III COLOR II trial.

The circumferential resection margin, described as the most important parameter for rectal cancer surgery, was 1.3 cm after laparoscopic and open surgery (P = .16). The distal margin was similar at 3.6 cm (P = .68).

The proximal margin was 17.0 cm in the laparoscopic group and 19.0 cm in the open group. The difference was statistically significant (P less than .001), but "clinically, totally irrelevant since a 17-cm margin is wide enough for a safe tumor resection," lead author Dr. H. Jaap Bonjer said at the European Multidisciplinary Cancer Congress.

COLOR II (Colorectal Cancer Laparoscopic or Open Resection) sought to answer whether laparoscopic total mesorectal excision is as oncologically safe as open surgery is. Removing the entire mesorectum, or fatty tissue around the rectum, is important because the radial spread of rectal cancer is more prominent than is longitudinal spread, explained Dr. Bonjer of the surgery department at Vrije University Medical Centre, Amsterdam.

Researchers at 30 centers in eight countries, including Canada, randomized 1,103 patients with a single rectal carcinoma within 15 cm of the anal verge, staged T1, T2, or T3 with a margin to the endopelvic fascia greater than 2 mm, to laparoscopic or open surgery. The analysis included 699 patients in the laparoscopic arm and 345 in the open surgery arm.

The technically demanding nature of laparoscopic surgery resulted in a longer operating time than with open surgery (median 240 minutes vs. 188 minutes, P less than .001), but blood loss was cut in half (median 200 mL vs. 400 mL, P less than .001), Dr. Bonjer said.

The number of lymph nodes harvested was similar at 13 in the laparoscopic group and 14 in the open group.

The overall positive resection margin rate, defined as less than 2 mm, was 9% in the laparoscopic group and 10% in the open group (P = .078), Dr. Bonjer said at the joint congress of the European Cancer Organization, the European Society for Medical Oncology, and the European Society for Radiotherapy and Oncology.

Subgroup analyses showed similar positive resection margin rates in the upper rectum (10% vs. 9%, P = .92) and middle rectum (9% vs. 3%, P = .073), but a significantly better rate in the lower rectum after laparoscopic surgery at 9% vs. 21% after open surgery (P = .013).

The laparoscopic group also had improved postoperative recovery compared with the open group including a shorter time to first bowel movement (2.9 days vs. 3.7 days, P = .001), time to intake of 1 liter of fluid (2.6 days vs. 2.8 days P = .006) and hospital stay (11.9 days vs. 12.1 days, P = .037), he said.

Anastomotic leakage occurred in 7% of patients after laparoscopic surgery and 6% after open surgery (P = .63). One-third of patients had a diverting ileostomy.

Mortality rates within 28 days after surgery did not differ between the laparoscopic and open groups (1.1% vs. 1.7%, P = .41), nor did morbidity (39.5% vs. 36.5%, P = .28), Dr. Bonjer said.

Dr. Peter Naredi, invited discussant and president of the European Society of Surgical Oncology, said COLOR II was very well performed, and that the large number of laparoscopic patients "will make a huge impact on the results of how good laparoscopic surgery is versus open surgery" when added to the current database.

He highlighted a meta-analysis published this spring of six randomized trials enrolling 1,033 patients that showed no difference between the two techniques with regard to number of lymph nodes harvested, involvement of the circumferential resection margin, 3-year-overall survival, and disease-free survival (Int. J. Colorectal. Dis. 2011;26:415-21).

Dr. Naredi, chair of surgery at Umeå (Sweden) University, expressed concern, however, about the 21% positive resection margin rates in the lower rectum for the open group, and said this would likely convert into differences in local recurrence between the two groups. He also stressed the importance of standardization when evaluating multimodal treatments, and pointed out that preoperative radiotherapy was used in 72% of the lower rectal cancer patients treated with laparoscopy and only 63% treated with open surgery.

Ethicon EndoSurgery supported the trial. No individual disclosures were presented.

STOCKHOLM – Laparoscopic surgery offers the same radical resection for noninvasive rectal cancer as does open surgery, according to short-term outcomes of the randomized, noninferiority phase III COLOR II trial.

The circumferential resection margin, described as the most important parameter for rectal cancer surgery, was 1.3 cm after laparoscopic and open surgery (P = .16). The distal margin was similar at 3.6 cm (P = .68).

The proximal margin was 17.0 cm in the laparoscopic group and 19.0 cm in the open group. The difference was statistically significant (P less than .001), but "clinically, totally irrelevant since a 17-cm margin is wide enough for a safe tumor resection," lead author Dr. H. Jaap Bonjer said at the European Multidisciplinary Cancer Congress.

COLOR II (Colorectal Cancer Laparoscopic or Open Resection) sought to answer whether laparoscopic total mesorectal excision is as oncologically safe as open surgery is. Removing the entire mesorectum, or fatty tissue around the rectum, is important because the radial spread of rectal cancer is more prominent than is longitudinal spread, explained Dr. Bonjer of the surgery department at Vrije University Medical Centre, Amsterdam.

Researchers at 30 centers in eight countries, including Canada, randomized 1,103 patients with a single rectal carcinoma within 15 cm of the anal verge, staged T1, T2, or T3 with a margin to the endopelvic fascia greater than 2 mm, to laparoscopic or open surgery. The analysis included 699 patients in the laparoscopic arm and 345 in the open surgery arm.

The technically demanding nature of laparoscopic surgery resulted in a longer operating time than with open surgery (median 240 minutes vs. 188 minutes, P less than .001), but blood loss was cut in half (median 200 mL vs. 400 mL, P less than .001), Dr. Bonjer said.

The number of lymph nodes harvested was similar at 13 in the laparoscopic group and 14 in the open group.

The overall positive resection margin rate, defined as less than 2 mm, was 9% in the laparoscopic group and 10% in the open group (P = .078), Dr. Bonjer said at the joint congress of the European Cancer Organization, the European Society for Medical Oncology, and the European Society for Radiotherapy and Oncology.

Subgroup analyses showed similar positive resection margin rates in the upper rectum (10% vs. 9%, P = .92) and middle rectum (9% vs. 3%, P = .073), but a significantly better rate in the lower rectum after laparoscopic surgery at 9% vs. 21% after open surgery (P = .013).

The laparoscopic group also had improved postoperative recovery compared with the open group including a shorter time to first bowel movement (2.9 days vs. 3.7 days, P = .001), time to intake of 1 liter of fluid (2.6 days vs. 2.8 days P = .006) and hospital stay (11.9 days vs. 12.1 days, P = .037), he said.

Anastomotic leakage occurred in 7% of patients after laparoscopic surgery and 6% after open surgery (P = .63). One-third of patients had a diverting ileostomy.

Mortality rates within 28 days after surgery did not differ between the laparoscopic and open groups (1.1% vs. 1.7%, P = .41), nor did morbidity (39.5% vs. 36.5%, P = .28), Dr. Bonjer said.

Dr. Peter Naredi, invited discussant and president of the European Society of Surgical Oncology, said COLOR II was very well performed, and that the large number of laparoscopic patients "will make a huge impact on the results of how good laparoscopic surgery is versus open surgery" when added to the current database.

He highlighted a meta-analysis published this spring of six randomized trials enrolling 1,033 patients that showed no difference between the two techniques with regard to number of lymph nodes harvested, involvement of the circumferential resection margin, 3-year-overall survival, and disease-free survival (Int. J. Colorectal. Dis. 2011;26:415-21).

Dr. Naredi, chair of surgery at Umeå (Sweden) University, expressed concern, however, about the 21% positive resection margin rates in the lower rectum for the open group, and said this would likely convert into differences in local recurrence between the two groups. He also stressed the importance of standardization when evaluating multimodal treatments, and pointed out that preoperative radiotherapy was used in 72% of the lower rectal cancer patients treated with laparoscopy and only 63% treated with open surgery.

Ethicon EndoSurgery supported the trial. No individual disclosures were presented.