Urology

NEW ORLEANS – Long-term active surveillance seems to be a safe and effective way to avoid overtreatment in men with low- and very low-risk prostate cancer, while still offering a very good chance of catching progressive disease.

According to new data presented at the annual meeting of the American Urological Association, less than 3% of men developed metastatic disease or died from prostate cancer over 15 years of follow-up. The men’s risk of progression dramatically declined over time, decreasing by 30% after each annual, unchanged biopsy.

The findings should reassure both physicians and patients, all of whom want to balance the potential side effects of prostate cancer treatment with the risk of progressive disease, said Dr. Stacy Loeb of New York University, New York.

“Physicians in the U.S. have been slow to adopt the practice of active surveillance, which is much more common in other parts of the world,” said Dr. Loeb, who moderated the press briefing where the data were unveiled. She has worked with Swedish researchers, who determined that 84% of men with very low-risk cancers and 66% of those with low-risk cancers are being managed this way. “The question we have to ask is why we have been so slow to adopt this. Hopefully, studies like these, showing so many men free of disease even at 15 years, will encourage greater acceptance in this country.”

The briefing highlighted several studies on active surveillance; two of these were performed on the Johns Hopkins Active Surveillance Program cohort, which has enrolled about 1,300 men since 1995. Most (71%) have very low-risk cancer; the remainder have low-risk cancer.

The Hopkins protocol calls for a clinical exam and prostate specific antigen (PSA) test twice a year, annual prostate biopsy, and imaging every either year, said Dr. Jeffrey Tosoian, a urology resident at the university.

Triggers for treatment include a change in biopsy or patient decision. Changes in PSA and clinical exam alone don’t trigger treatment, but may prompt a stepped-up monitoring schedule or additional diagnostic studies.

The Hopkins cohort is a fairly typical prostate cancer group. The patients’ mean age at diagnosis is about 66 years, and their mean PSA level is 5.2 ng/mL. Mean follow-up time is now 5 years, but Dr. Tosoian also presented 10- and 15-year data.

At 5 years, 36% of the group had converted to some form of treatment. By 10 and 15 years, conversion had occurred in 50% and 56%, respectively. Not surprisingly, the rate of death from any cause increased as patients aged, from 4% by year 5, to 7% and 31% by years 10 and 15.

But the rate of prostate cancer-specific death was very low throughout the study period: 0.15% at year 5 and 1% at years 10 and 15. Over the entire 15 years, less than 1% of the men died from prostate cancer or developed metastatic disease.

These findings were somewhat more positive than those recently reported by a team at Sunnybrook University, Toronto (J. Clin. Oncol. 2015;33:272-7). That surveillance protocol is less stringent than the one at Hopkins, Dr. Tosoian said, with biopsies every 3-5 years, based on clinical findings and PSA levels.

In that cohort of 819 patients with a median follow-up of 6 years, 3% developed metastatic disease by 15 years and 1.5% died from it, but the men were nine times more likely to die from some other cause than their cancer.

“Certainly, our more intensive monitoring at Hopkins was associated with more treatment, but also with lower death and metastatic rates,” Dr. Tosoian said. “So there are still trade-offs in balancing overtreatment, but the real risk of cancer mortality is quite small.”

However, the question of how long must watchful waiting continue remains. Understandably, most men don’t want to commit to years and years of annual prostate biopsies, said Dr. Ridwan Alam, also of Johns Hopkins.

Dr. Alam presented 15-year data on 808 men who were completely compliant with the program (J. Urology 2015;193:1950-5). Restricting the cohort in this way gives a much more accurate prediction; he said up to 18% of men without disease progression will drop out of active surveillance because they find the process onerous, especially the biopsies.

For the first 2 years of follow-up, the rate of disease reclassification was nearly 0% in both low- and very low-risk groups. “But after that, there was a pretty big gap developing between the two, with the low-risk group doing worse,” Dr. Alam said. By 10 years, 60% of the very low-risk group still had no disease progression; that number remained stable throughout the remainder of the study period. Among low-risk men, however, 60% did have a disease stage reclassification by 7 years; by 10 years, nearly 80% had progressed.

Despite that, the overall risk of reclassification declined sharply over time, decreasing by 30% after every stable biopsy. “If a patient reached 7-9 years without a reclassification, his risk of disease by 15 years was virtually 0,” Dr. Alam said. “This may help reassure men and their doctors about the risks of surveillance, and also reduce the dropout rate by giving them a sense of security – a sense that we really can trust the data and make good decisions based on it.”

Neither Dr. Tosoian nor Dr. Alam had any financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

NEW ORLEANS – Long-term active surveillance seems to be a safe and effective way to avoid overtreatment in men with low- and very low-risk prostate cancer, while still offering a very good chance of catching progressive disease.

According to new data presented at the annual meeting of the American Urological Association, less than 3% of men developed metastatic disease or died from prostate cancer over 15 years of follow-up. The men’s risk of progression dramatically declined over time, decreasing by 30% after each annual, unchanged biopsy.

The findings should reassure both physicians and patients, all of whom want to balance the potential side effects of prostate cancer treatment with the risk of progressive disease, said Dr. Stacy Loeb of New York University, New York.

“Physicians in the U.S. have been slow to adopt the practice of active surveillance, which is much more common in other parts of the world,” said Dr. Loeb, who moderated the press briefing where the data were unveiled. She has worked with Swedish researchers, who determined that 84% of men with very low-risk cancers and 66% of those with low-risk cancers are being managed this way. “The question we have to ask is why we have been so slow to adopt this. Hopefully, studies like these, showing so many men free of disease even at 15 years, will encourage greater acceptance in this country.”

The briefing highlighted several studies on active surveillance; two of these were performed on the Johns Hopkins Active Surveillance Program cohort, which has enrolled about 1,300 men since 1995. Most (71%) have very low-risk cancer; the remainder have low-risk cancer.

The Hopkins protocol calls for a clinical exam and prostate specific antigen (PSA) test twice a year, annual prostate biopsy, and imaging every either year, said Dr. Jeffrey Tosoian, a urology resident at the university.

Triggers for treatment include a change in biopsy or patient decision. Changes in PSA and clinical exam alone don’t trigger treatment, but may prompt a stepped-up monitoring schedule or additional diagnostic studies.

The Hopkins cohort is a fairly typical prostate cancer group. The patients’ mean age at diagnosis is about 66 years, and their mean PSA level is 5.2 ng/mL. Mean follow-up time is now 5 years, but Dr. Tosoian also presented 10- and 15-year data.

At 5 years, 36% of the group had converted to some form of treatment. By 10 and 15 years, conversion had occurred in 50% and 56%, respectively. Not surprisingly, the rate of death from any cause increased as patients aged, from 4% by year 5, to 7% and 31% by years 10 and 15.

But the rate of prostate cancer-specific death was very low throughout the study period: 0.15% at year 5 and 1% at years 10 and 15. Over the entire 15 years, less than 1% of the men died from prostate cancer or developed metastatic disease.

These findings were somewhat more positive than those recently reported by a team at Sunnybrook University, Toronto (J. Clin. Oncol. 2015;33:272-7). That surveillance protocol is less stringent than the one at Hopkins, Dr. Tosoian said, with biopsies every 3-5 years, based on clinical findings and PSA levels.

In that cohort of 819 patients with a median follow-up of 6 years, 3% developed metastatic disease by 15 years and 1.5% died from it, but the men were nine times more likely to die from some other cause than their cancer.

“Certainly, our more intensive monitoring at Hopkins was associated with more treatment, but also with lower death and metastatic rates,” Dr. Tosoian said. “So there are still trade-offs in balancing overtreatment, but the real risk of cancer mortality is quite small.”

However, the question of how long must watchful waiting continue remains. Understandably, most men don’t want to commit to years and years of annual prostate biopsies, said Dr. Ridwan Alam, also of Johns Hopkins.

Dr. Alam presented 15-year data on 808 men who were completely compliant with the program (J. Urology 2015;193:1950-5). Restricting the cohort in this way gives a much more accurate prediction; he said up to 18% of men without disease progression will drop out of active surveillance because they find the process onerous, especially the biopsies.

For the first 2 years of follow-up, the rate of disease reclassification was nearly 0% in both low- and very low-risk groups. “But after that, there was a pretty big gap developing between the two, with the low-risk group doing worse,” Dr. Alam said. By 10 years, 60% of the very low-risk group still had no disease progression; that number remained stable throughout the remainder of the study period. Among low-risk men, however, 60% did have a disease stage reclassification by 7 years; by 10 years, nearly 80% had progressed.

Despite that, the overall risk of reclassification declined sharply over time, decreasing by 30% after every stable biopsy. “If a patient reached 7-9 years without a reclassification, his risk of disease by 15 years was virtually 0,” Dr. Alam said. “This may help reassure men and their doctors about the risks of surveillance, and also reduce the dropout rate by giving them a sense of security – a sense that we really can trust the data and make good decisions based on it.”

Neither Dr. Tosoian nor Dr. Alam had any financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

NEW ORLEANS – Long-term active surveillance seems to be a safe and effective way to avoid overtreatment in men with low- and very low-risk prostate cancer, while still offering a very good chance of catching progressive disease.

According to new data presented at the annual meeting of the American Urological Association, less than 3% of men developed metastatic disease or died from prostate cancer over 15 years of follow-up. The men’s risk of progression dramatically declined over time, decreasing by 30% after each annual, unchanged biopsy.

The findings should reassure both physicians and patients, all of whom want to balance the potential side effects of prostate cancer treatment with the risk of progressive disease, said Dr. Stacy Loeb of New York University, New York.

“Physicians in the U.S. have been slow to adopt the practice of active surveillance, which is much more common in other parts of the world,” said Dr. Loeb, who moderated the press briefing where the data were unveiled. She has worked with Swedish researchers, who determined that 84% of men with very low-risk cancers and 66% of those with low-risk cancers are being managed this way. “The question we have to ask is why we have been so slow to adopt this. Hopefully, studies like these, showing so many men free of disease even at 15 years, will encourage greater acceptance in this country.”

The briefing highlighted several studies on active surveillance; two of these were performed on the Johns Hopkins Active Surveillance Program cohort, which has enrolled about 1,300 men since 1995. Most (71%) have very low-risk cancer; the remainder have low-risk cancer.

The Hopkins protocol calls for a clinical exam and prostate specific antigen (PSA) test twice a year, annual prostate biopsy, and imaging every either year, said Dr. Jeffrey Tosoian, a urology resident at the university.

Triggers for treatment include a change in biopsy or patient decision. Changes in PSA and clinical exam alone don’t trigger treatment, but may prompt a stepped-up monitoring schedule or additional diagnostic studies.

The Hopkins cohort is a fairly typical prostate cancer group. The patients’ mean age at diagnosis is about 66 years, and their mean PSA level is 5.2 ng/mL. Mean follow-up time is now 5 years, but Dr. Tosoian also presented 10- and 15-year data.

At 5 years, 36% of the group had converted to some form of treatment. By 10 and 15 years, conversion had occurred in 50% and 56%, respectively. Not surprisingly, the rate of death from any cause increased as patients aged, from 4% by year 5, to 7% and 31% by years 10 and 15.

But the rate of prostate cancer-specific death was very low throughout the study period: 0.15% at year 5 and 1% at years 10 and 15. Over the entire 15 years, less than 1% of the men died from prostate cancer or developed metastatic disease.

These findings were somewhat more positive than those recently reported by a team at Sunnybrook University, Toronto (J. Clin. Oncol. 2015;33:272-7). That surveillance protocol is less stringent than the one at Hopkins, Dr. Tosoian said, with biopsies every 3-5 years, based on clinical findings and PSA levels.

In that cohort of 819 patients with a median follow-up of 6 years, 3% developed metastatic disease by 15 years and 1.5% died from it, but the men were nine times more likely to die from some other cause than their cancer.

“Certainly, our more intensive monitoring at Hopkins was associated with more treatment, but also with lower death and metastatic rates,” Dr. Tosoian said. “So there are still trade-offs in balancing overtreatment, but the real risk of cancer mortality is quite small.”

However, the question of how long must watchful waiting continue remains. Understandably, most men don’t want to commit to years and years of annual prostate biopsies, said Dr. Ridwan Alam, also of Johns Hopkins.

Dr. Alam presented 15-year data on 808 men who were completely compliant with the program (J. Urology 2015;193:1950-5). Restricting the cohort in this way gives a much more accurate prediction; he said up to 18% of men without disease progression will drop out of active surveillance because they find the process onerous, especially the biopsies.

For the first 2 years of follow-up, the rate of disease reclassification was nearly 0% in both low- and very low-risk groups. “But after that, there was a pretty big gap developing between the two, with the low-risk group doing worse,” Dr. Alam said. By 10 years, 60% of the very low-risk group still had no disease progression; that number remained stable throughout the remainder of the study period. Among low-risk men, however, 60% did have a disease stage reclassification by 7 years; by 10 years, nearly 80% had progressed.

Despite that, the overall risk of reclassification declined sharply over time, decreasing by 30% after every stable biopsy. “If a patient reached 7-9 years without a reclassification, his risk of disease by 15 years was virtually 0,” Dr. Alam said. “This may help reassure men and their doctors about the risks of surveillance, and also reduce the dropout rate by giving them a sense of security – a sense that we really can trust the data and make good decisions based on it.”

Neither Dr. Tosoian nor Dr. Alam had any financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

A combination of a cephalosporin and a beta-lactamase inhibitor in an intravenous formulation has been approved for treating complicated intra-abdominal infections and complicated urinary tract infections in adults, the Food and Drug Administration announced on Dec. 19.

The cephalosporin is ceftolozane and the beta-lactamase inhibitor is tazobactam; it will be marketed as Zerbaxa by Cubist Pharmaceuticals.

This is the fourth antibacterial drug product approved by the FDA in 2014 and, like the other three, it was designated as a Qualified Infectious Disease Product (QIDP) and was given priority review, according to the FDA statement. Zerbaxa was granted a QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act of the FDA Safety and Innovation Act, “because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,” the statement said.

As part of the QIDP program, the manufacturer has also been granted an extra 5 years of “exclusivity” – exclusive marketing rights – by the FDA.

Ceftolozane-tazobactam was approved for treating complicated intra-abdominal infections in combination with metronidazole; approval for this indication was based on a study of 979 adults, randomized to the combination or to meropenem.

Approval for complicated urinary tract infections, including pyelonephritis, was based on a study of 1,068 adults, randomized to treatment with ceftolozane-tazobactam or levofloxacin.

The prescribing information includes a warning about decreased efficacy in patients with renal impairment (a baseline creatinine clearance of 30-50 mL/min or less, and the recommendation to monitor creatinine clearance “at least daily in patients with changing renal function,” and to adjust dose accordingly. Nausea, diarrhea, headache, and fever were the most common adverse events in studies, according to the FDA statement.

The other antibacterials approved by the FDA in 2014 were approved for treating acute bacterial skin and skin structure infections caused by certain susceptible bacteria. They were dalbavancin (Dalvance), approved in May; tedizolid (Sivextro), approved in June; and oritavancin (Orbactiv), approved in August.

Serious adverse events associated with Zerbaxa should be reported to the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

emechcatie@frontlinemedcom.com

A combination of a cephalosporin and a beta-lactamase inhibitor in an intravenous formulation has been approved for treating complicated intra-abdominal infections and complicated urinary tract infections in adults, the Food and Drug Administration announced on Dec. 19.

The cephalosporin is ceftolozane and the beta-lactamase inhibitor is tazobactam; it will be marketed as Zerbaxa by Cubist Pharmaceuticals.

This is the fourth antibacterial drug product approved by the FDA in 2014 and, like the other three, it was designated as a Qualified Infectious Disease Product (QIDP) and was given priority review, according to the FDA statement. Zerbaxa was granted a QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act of the FDA Safety and Innovation Act, “because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,” the statement said.

As part of the QIDP program, the manufacturer has also been granted an extra 5 years of “exclusivity” – exclusive marketing rights – by the FDA.

Ceftolozane-tazobactam was approved for treating complicated intra-abdominal infections in combination with metronidazole; approval for this indication was based on a study of 979 adults, randomized to the combination or to meropenem.

Approval for complicated urinary tract infections, including pyelonephritis, was based on a study of 1,068 adults, randomized to treatment with ceftolozane-tazobactam or levofloxacin.

The prescribing information includes a warning about decreased efficacy in patients with renal impairment (a baseline creatinine clearance of 30-50 mL/min or less, and the recommendation to monitor creatinine clearance “at least daily in patients with changing renal function,” and to adjust dose accordingly. Nausea, diarrhea, headache, and fever were the most common adverse events in studies, according to the FDA statement.

The other antibacterials approved by the FDA in 2014 were approved for treating acute bacterial skin and skin structure infections caused by certain susceptible bacteria. They were dalbavancin (Dalvance), approved in May; tedizolid (Sivextro), approved in June; and oritavancin (Orbactiv), approved in August.

Serious adverse events associated with Zerbaxa should be reported to the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

emechcatie@frontlinemedcom.com

A combination of a cephalosporin and a beta-lactamase inhibitor in an intravenous formulation has been approved for treating complicated intra-abdominal infections and complicated urinary tract infections in adults, the Food and Drug Administration announced on Dec. 19.

The cephalosporin is ceftolozane and the beta-lactamase inhibitor is tazobactam; it will be marketed as Zerbaxa by Cubist Pharmaceuticals.

This is the fourth antibacterial drug product approved by the FDA in 2014 and, like the other three, it was designated as a Qualified Infectious Disease Product (QIDP) and was given priority review, according to the FDA statement. Zerbaxa was granted a QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act of the FDA Safety and Innovation Act, “because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,” the statement said.

As part of the QIDP program, the manufacturer has also been granted an extra 5 years of “exclusivity” – exclusive marketing rights – by the FDA.

Ceftolozane-tazobactam was approved for treating complicated intra-abdominal infections in combination with metronidazole; approval for this indication was based on a study of 979 adults, randomized to the combination or to meropenem.

Approval for complicated urinary tract infections, including pyelonephritis, was based on a study of 1,068 adults, randomized to treatment with ceftolozane-tazobactam or levofloxacin.

The prescribing information includes a warning about decreased efficacy in patients with renal impairment (a baseline creatinine clearance of 30-50 mL/min or less, and the recommendation to monitor creatinine clearance “at least daily in patients with changing renal function,” and to adjust dose accordingly. Nausea, diarrhea, headache, and fever were the most common adverse events in studies, according to the FDA statement.

The other antibacterials approved by the FDA in 2014 were approved for treating acute bacterial skin and skin structure infections caused by certain susceptible bacteria. They were dalbavancin (Dalvance), approved in May; tedizolid (Sivextro), approved in June; and oritavancin (Orbactiv), approved in August.

Serious adverse events associated with Zerbaxa should be reported to the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

emechcatie@frontlinemedcom.com

Active surveillance appears to be safe through 15 years of follow-up for men who have low-risk prostate cancer, according to a report published online Dec. 15 in the Journal of Clinical Oncology.

In extended follow-up of a prospective cohort study begun in 1995, 993 men (current median age, 68 years; range, 41-89 years) with low-risk prostate cancer were assessed. Active surveillance consisted of PSA testing every 3 months for the first 2 years after diagnosis and then every 6 months thereafter, with repeat biopsy at 1 year and then every 3-4 years until the age of 80. These study participants were offered radical intervention only if the disease showed signs of progression, said Dr. Laurence Klotz of Sunnybrook Health Sciences Centre, University of Toronto, and his associates.

A total of 149 patients died, 819 were alive, and 25 were lost to follow-up. Only 15 men (1.5%) died from prostate cancer, and an additional 13 men with confirmed metastases either are alive (9 patients) or died from other causes (4 patients). Overall, the risk of dying from another cause was nearly 10 times greater than that for dying from prostate cancer (HR, 9.2). Even among men younger than 70, who had lower competing risks of death from other causes than older men, the risk of death from another cause was almost six times greater than that for death from prostate cancer (HR, 5.8), the investigators said (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200/JCO.2014.55.1192]).

The rate of patients who developed PSA failure during follow-up was 2.8% at 5 years and 10.2% at 10 years after diagnosis. These outcomes are consistent with those in low-risk patients managed with initial definitive intervention such as radiotherapy and surgery, Dr. Klotz and his associates added.

This study was supported by the Prostate Cancer Research Foundation of Canada. Dr. Klotz and his associates reported having no financial conflicts of interest.

Active surveillance appears to be safe through 15 years of follow-up for men who have low-risk prostate cancer, according to a report published online Dec. 15 in the Journal of Clinical Oncology.

In extended follow-up of a prospective cohort study begun in 1995, 993 men (current median age, 68 years; range, 41-89 years) with low-risk prostate cancer were assessed. Active surveillance consisted of PSA testing every 3 months for the first 2 years after diagnosis and then every 6 months thereafter, with repeat biopsy at 1 year and then every 3-4 years until the age of 80. These study participants were offered radical intervention only if the disease showed signs of progression, said Dr. Laurence Klotz of Sunnybrook Health Sciences Centre, University of Toronto, and his associates.

A total of 149 patients died, 819 were alive, and 25 were lost to follow-up. Only 15 men (1.5%) died from prostate cancer, and an additional 13 men with confirmed metastases either are alive (9 patients) or died from other causes (4 patients). Overall, the risk of dying from another cause was nearly 10 times greater than that for dying from prostate cancer (HR, 9.2). Even among men younger than 70, who had lower competing risks of death from other causes than older men, the risk of death from another cause was almost six times greater than that for death from prostate cancer (HR, 5.8), the investigators said (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200/JCO.2014.55.1192]).

The rate of patients who developed PSA failure during follow-up was 2.8% at 5 years and 10.2% at 10 years after diagnosis. These outcomes are consistent with those in low-risk patients managed with initial definitive intervention such as radiotherapy and surgery, Dr. Klotz and his associates added.

This study was supported by the Prostate Cancer Research Foundation of Canada. Dr. Klotz and his associates reported having no financial conflicts of interest.

Active surveillance appears to be safe through 15 years of follow-up for men who have low-risk prostate cancer, according to a report published online Dec. 15 in the Journal of Clinical Oncology.

In extended follow-up of a prospective cohort study begun in 1995, 993 men (current median age, 68 years; range, 41-89 years) with low-risk prostate cancer were assessed. Active surveillance consisted of PSA testing every 3 months for the first 2 years after diagnosis and then every 6 months thereafter, with repeat biopsy at 1 year and then every 3-4 years until the age of 80. These study participants were offered radical intervention only if the disease showed signs of progression, said Dr. Laurence Klotz of Sunnybrook Health Sciences Centre, University of Toronto, and his associates.

A total of 149 patients died, 819 were alive, and 25 were lost to follow-up. Only 15 men (1.5%) died from prostate cancer, and an additional 13 men with confirmed metastases either are alive (9 patients) or died from other causes (4 patients). Overall, the risk of dying from another cause was nearly 10 times greater than that for dying from prostate cancer (HR, 9.2). Even among men younger than 70, who had lower competing risks of death from other causes than older men, the risk of death from another cause was almost six times greater than that for death from prostate cancer (HR, 5.8), the investigators said (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200/JCO.2014.55.1192]).

The rate of patients who developed PSA failure during follow-up was 2.8% at 5 years and 10.2% at 10 years after diagnosis. These outcomes are consistent with those in low-risk patients managed with initial definitive intervention such as radiotherapy and surgery, Dr. Klotz and his associates added.

This study was supported by the Prostate Cancer Research Foundation of Canada. Dr. Klotz and his associates reported having no financial conflicts of interest.

LAS VEGAS – Laparoscopic splenectomy for hematologic malignancies involving the spleen is an effective surgical strategy, although the operator must expect a higher rate of conversion to laparotomy than when laparoscopic splenectomy is performed for benign hematologic diseases, Dr. Roberta Gelmini said at the annual Minimally Invasive Surgery Week.

The rate of postoperative complications, including wound infection, abdominal abscess, hemiperitoneum, and splenic vein thrombosis, is low and similar to that associated with laparoscopic splenectomy for benign hematologic diseases. The one exception is the complication of pleural effusion, which is seven- to eightfold more frequent following laparoscopic splenectomy for malignancies, probably reflecting affected patients’ larger spleen size and higher conversion rate, observed Dr. Gelmini, professor of surgery at the University of Modena and Reggio Emilia (Italy).

She presented a retrospective analysis of a series of 126 consecutive elective laparoscopic splenectomies performed in adults. Fifty-five were performed for malignant diseases, 71 for benign hematologic conditions. The two groups were well matched except that the patients with benign hematologic diseases were younger and thinner, with a mean age of 39 and a body mass index of 24.4 kg/m², as compared with 55 years and 25.9 kg/m² in patients undergoing laparoscopic splenectomy for hematologic malignancies.

The No. 1 indication for splenectomy in patients with benign disease was idiopathic thrombocytopenic purpura, accounting for 61% of cases. In patients with malignancies, non-Hodgkin’s lymphoma was the indication for splenectomy in two-thirds of cases.

As part of their preoperative work-up, all patients underwent ultrasound to establish spleen size and vessel diameter. Bipolar splenic length was significantly greater in the group with malignancies: a mean of 17 cm, compared with 13.4 cm in patients with benign disease.

With regard to key intraoperative findings, the mean 148-minute operative time in patients with malignancies was 22 minutes longer than in patients with benign disease. The conversion rate was 18.2% in patients with malignancies, compared with 5.6% when laparoscopic splenectomy was undertaken for benign disease. But the incidence of intraoperative blood loss greater than 500 mL was similar in the two groups, as was the transfusion rate, Dr. Gelmini reported at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

Four patients underwent conversion to laparotomy or mini-laparotomy for malignancies because of a difficult splenic hilum dissection.

Pleural effusion occurred in 7% of patients operated upon for benign disease, compared with 56% of those with hematologic malignancies. Otherwise the complication rates in the two groups were similar.

Time to refeeding was similar in the two patient groups. Mean postoperative length of hospital stay was 5.3 days in patients who underwent laparoscopic splenectomy for benign disease and similar at 5.8 days for those with malignancies.

“Our data suggest that the nature of the disease does not significantly influence the postoperative outcome,” the surgeon observed.

She added that the results of her series were quite similar to those in an earlier report by surgeons at the University of Genoa (Italy) in terms of conversion rate and complications in 38 patients who underwent laparoscopic splenectomy for benign hematologic diseases and 25 with hematologic malignancies (Tumori 2004;90:229-32).

Dr. Gelmini reported having no financial conflicts regarding her presentation.

bjancin@frontlinemedcom

LAS VEGAS – Laparoscopic splenectomy for hematologic malignancies involving the spleen is an effective surgical strategy, although the operator must expect a higher rate of conversion to laparotomy than when laparoscopic splenectomy is performed for benign hematologic diseases, Dr. Roberta Gelmini said at the annual Minimally Invasive Surgery Week.

The rate of postoperative complications, including wound infection, abdominal abscess, hemiperitoneum, and splenic vein thrombosis, is low and similar to that associated with laparoscopic splenectomy for benign hematologic diseases. The one exception is the complication of pleural effusion, which is seven- to eightfold more frequent following laparoscopic splenectomy for malignancies, probably reflecting affected patients’ larger spleen size and higher conversion rate, observed Dr. Gelmini, professor of surgery at the University of Modena and Reggio Emilia (Italy).

She presented a retrospective analysis of a series of 126 consecutive elective laparoscopic splenectomies performed in adults. Fifty-five were performed for malignant diseases, 71 for benign hematologic conditions. The two groups were well matched except that the patients with benign hematologic diseases were younger and thinner, with a mean age of 39 and a body mass index of 24.4 kg/m², as compared with 55 years and 25.9 kg/m² in patients undergoing laparoscopic splenectomy for hematologic malignancies.

The No. 1 indication for splenectomy in patients with benign disease was idiopathic thrombocytopenic purpura, accounting for 61% of cases. In patients with malignancies, non-Hodgkin’s lymphoma was the indication for splenectomy in two-thirds of cases.

As part of their preoperative work-up, all patients underwent ultrasound to establish spleen size and vessel diameter. Bipolar splenic length was significantly greater in the group with malignancies: a mean of 17 cm, compared with 13.4 cm in patients with benign disease.

With regard to key intraoperative findings, the mean 148-minute operative time in patients with malignancies was 22 minutes longer than in patients with benign disease. The conversion rate was 18.2% in patients with malignancies, compared with 5.6% when laparoscopic splenectomy was undertaken for benign disease. But the incidence of intraoperative blood loss greater than 500 mL was similar in the two groups, as was the transfusion rate, Dr. Gelmini reported at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

Four patients underwent conversion to laparotomy or mini-laparotomy for malignancies because of a difficult splenic hilum dissection.

Pleural effusion occurred in 7% of patients operated upon for benign disease, compared with 56% of those with hematologic malignancies. Otherwise the complication rates in the two groups were similar.

Time to refeeding was similar in the two patient groups. Mean postoperative length of hospital stay was 5.3 days in patients who underwent laparoscopic splenectomy for benign disease and similar at 5.8 days for those with malignancies.

“Our data suggest that the nature of the disease does not significantly influence the postoperative outcome,” the surgeon observed.

She added that the results of her series were quite similar to those in an earlier report by surgeons at the University of Genoa (Italy) in terms of conversion rate and complications in 38 patients who underwent laparoscopic splenectomy for benign hematologic diseases and 25 with hematologic malignancies (Tumori 2004;90:229-32).

Dr. Gelmini reported having no financial conflicts regarding her presentation.

bjancin@frontlinemedcom

LAS VEGAS – Laparoscopic splenectomy for hematologic malignancies involving the spleen is an effective surgical strategy, although the operator must expect a higher rate of conversion to laparotomy than when laparoscopic splenectomy is performed for benign hematologic diseases, Dr. Roberta Gelmini said at the annual Minimally Invasive Surgery Week.

The rate of postoperative complications, including wound infection, abdominal abscess, hemiperitoneum, and splenic vein thrombosis, is low and similar to that associated with laparoscopic splenectomy for benign hematologic diseases. The one exception is the complication of pleural effusion, which is seven- to eightfold more frequent following laparoscopic splenectomy for malignancies, probably reflecting affected patients’ larger spleen size and higher conversion rate, observed Dr. Gelmini, professor of surgery at the University of Modena and Reggio Emilia (Italy).

She presented a retrospective analysis of a series of 126 consecutive elective laparoscopic splenectomies performed in adults. Fifty-five were performed for malignant diseases, 71 for benign hematologic conditions. The two groups were well matched except that the patients with benign hematologic diseases were younger and thinner, with a mean age of 39 and a body mass index of 24.4 kg/m², as compared with 55 years and 25.9 kg/m² in patients undergoing laparoscopic splenectomy for hematologic malignancies.

The No. 1 indication for splenectomy in patients with benign disease was idiopathic thrombocytopenic purpura, accounting for 61% of cases. In patients with malignancies, non-Hodgkin’s lymphoma was the indication for splenectomy in two-thirds of cases.

As part of their preoperative work-up, all patients underwent ultrasound to establish spleen size and vessel diameter. Bipolar splenic length was significantly greater in the group with malignancies: a mean of 17 cm, compared with 13.4 cm in patients with benign disease.

With regard to key intraoperative findings, the mean 148-minute operative time in patients with malignancies was 22 minutes longer than in patients with benign disease. The conversion rate was 18.2% in patients with malignancies, compared with 5.6% when laparoscopic splenectomy was undertaken for benign disease. But the incidence of intraoperative blood loss greater than 500 mL was similar in the two groups, as was the transfusion rate, Dr. Gelmini reported at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.

Four patients underwent conversion to laparotomy or mini-laparotomy for malignancies because of a difficult splenic hilum dissection.

Pleural effusion occurred in 7% of patients operated upon for benign disease, compared with 56% of those with hematologic malignancies. Otherwise the complication rates in the two groups were similar.

Time to refeeding was similar in the two patient groups. Mean postoperative length of hospital stay was 5.3 days in patients who underwent laparoscopic splenectomy for benign disease and similar at 5.8 days for those with malignancies.

“Our data suggest that the nature of the disease does not significantly influence the postoperative outcome,” the surgeon observed.

She added that the results of her series were quite similar to those in an earlier report by surgeons at the University of Genoa (Italy) in terms of conversion rate and complications in 38 patients who underwent laparoscopic splenectomy for benign hematologic diseases and 25 with hematologic malignancies (Tumori 2004;90:229-32).

Dr. Gelmini reported having no financial conflicts regarding her presentation.

bjancin@frontlinemedcom

Ultrasonography is known to be less sensitive than computed tomography for diagnosing kidney stones. But the initial use of ultrasonography, followed by CT imaging if indicated, results in less cumulative radiation exposure for patients without increasing the risk of adverse clinical outcomes or missed diagnoses, according to findings published online Sept 18 in the New England Journal of Medicine (doi:10.1056/NEJMoa1404446).

The multicenter study, led by Dr. Rebecca Smith-Bindman of the University of California, San Francisco, and colleagues, randomized 2,759 patients presenting in hospital emergency departments with symptoms of nephrolithiasis to receive initial ultrasonography performed by an emergency physician (n = 908); ultrasonography performed by a radiologist (n = 893), or abdominal CT (n = 958), with all further diagnostic and management decisions left up to the physician.

©decade3d/thinkstockphotos.com

High-risk diagnoses with complications within 30 days of initial imaging occurred infrequently across the groups (0.4% for all three, n = 11), with no significant differences seen among the groups (P = .30). Within 6 months, serious adverse advents occurred in 12.4% of patients assigned initial ED ultrasonography, 10.8% in those assigned radiology ultrasonography, and 11.2% of those assigned to CT (P = .50) with no significant differences in pain scores, return emergency department visits, or hospitalizations. Cumulative radiation exposure at 6 months, however, was significantly higher for the CT arm than for the two ultrasonography arms (P < .001).

Dr. Smith-Bindman and colleagues emphasized in their analysis that their results do not imply that patients with suspected nephrolithiasis should undergo only ultrasound imaging, “but rather that ultrasonography should be used as the initial diagnostic imaging test, with further imaging studies performed at the discretion of the physician on the basis of clinical judgment.” Patients with nephrolithiasis often undergo repeat imaging over time, the researchers observed, and “replacing initial CT with ultrasonography for this often-recurring disease reduced overall radiation exposure.”

Dr. Smith-Bindman and colleagues noted as a limitation of their study the fact that treatment assignment could not be blinded. The study was funded by the Agency for Healthcare Research and Quality; none of its authors declared financial conflicts of interest.

Ultrasonography is known to be less sensitive than computed tomography for diagnosing kidney stones. But the initial use of ultrasonography, followed by CT imaging if indicated, results in less cumulative radiation exposure for patients without increasing the risk of adverse clinical outcomes or missed diagnoses, according to findings published online Sept 18 in the New England Journal of Medicine (doi:10.1056/NEJMoa1404446).

The multicenter study, led by Dr. Rebecca Smith-Bindman of the University of California, San Francisco, and colleagues, randomized 2,759 patients presenting in hospital emergency departments with symptoms of nephrolithiasis to receive initial ultrasonography performed by an emergency physician (n = 908); ultrasonography performed by a radiologist (n = 893), or abdominal CT (n = 958), with all further diagnostic and management decisions left up to the physician.

©decade3d/thinkstockphotos.com

High-risk diagnoses with complications within 30 days of initial imaging occurred infrequently across the groups (0.4% for all three, n = 11), with no significant differences seen among the groups (P = .30). Within 6 months, serious adverse advents occurred in 12.4% of patients assigned initial ED ultrasonography, 10.8% in those assigned radiology ultrasonography, and 11.2% of those assigned to CT (P = .50) with no significant differences in pain scores, return emergency department visits, or hospitalizations. Cumulative radiation exposure at 6 months, however, was significantly higher for the CT arm than for the two ultrasonography arms (P < .001).

Dr. Smith-Bindman and colleagues emphasized in their analysis that their results do not imply that patients with suspected nephrolithiasis should undergo only ultrasound imaging, “but rather that ultrasonography should be used as the initial diagnostic imaging test, with further imaging studies performed at the discretion of the physician on the basis of clinical judgment.” Patients with nephrolithiasis often undergo repeat imaging over time, the researchers observed, and “replacing initial CT with ultrasonography for this often-recurring disease reduced overall radiation exposure.”

Dr. Smith-Bindman and colleagues noted as a limitation of their study the fact that treatment assignment could not be blinded. The study was funded by the Agency for Healthcare Research and Quality; none of its authors declared financial conflicts of interest.

Ultrasonography is known to be less sensitive than computed tomography for diagnosing kidney stones. But the initial use of ultrasonography, followed by CT imaging if indicated, results in less cumulative radiation exposure for patients without increasing the risk of adverse clinical outcomes or missed diagnoses, according to findings published online Sept 18 in the New England Journal of Medicine (doi:10.1056/NEJMoa1404446).

The multicenter study, led by Dr. Rebecca Smith-Bindman of the University of California, San Francisco, and colleagues, randomized 2,759 patients presenting in hospital emergency departments with symptoms of nephrolithiasis to receive initial ultrasonography performed by an emergency physician (n = 908); ultrasonography performed by a radiologist (n = 893), or abdominal CT (n = 958), with all further diagnostic and management decisions left up to the physician.

©decade3d/thinkstockphotos.com

High-risk diagnoses with complications within 30 days of initial imaging occurred infrequently across the groups (0.4% for all three, n = 11), with no significant differences seen among the groups (P = .30). Within 6 months, serious adverse advents occurred in 12.4% of patients assigned initial ED ultrasonography, 10.8% in those assigned radiology ultrasonography, and 11.2% of those assigned to CT (P = .50) with no significant differences in pain scores, return emergency department visits, or hospitalizations. Cumulative radiation exposure at 6 months, however, was significantly higher for the CT arm than for the two ultrasonography arms (P < .001).

Dr. Smith-Bindman and colleagues emphasized in their analysis that their results do not imply that patients with suspected nephrolithiasis should undergo only ultrasound imaging, “but rather that ultrasonography should be used as the initial diagnostic imaging test, with further imaging studies performed at the discretion of the physician on the basis of clinical judgment.” Patients with nephrolithiasis often undergo repeat imaging over time, the researchers observed, and “replacing initial CT with ultrasonography for this often-recurring disease reduced overall radiation exposure.”

Dr. Smith-Bindman and colleagues noted as a limitation of their study the fact that treatment assignment could not be blinded. The study was funded by the Agency for Healthcare Research and Quality; none of its authors declared financial conflicts of interest.

ORLANDO – Prostate-specific antigen density, total number of biopsies, and later year of diagnosis were significantly associated with disease progression in men under active surveillance for low-risk prostate cancer.

Of 808 study subjects, 554 met strict criteria for active surveillance based on the following criteria: stage less than cT3, prostate-specific antigen (PSA) level less than 10 ng/mL, Gleason score of 6 or less, less than a third of biopsies positive, and less than 50% single-core positive; 254 patients did not meet these strict criteria.

At 5 years after diagnosis, prostate cancer–specific survival was 100%, overall survival was 98%, metastasis-free survival was greater than 99%, and treatment-free survival was 60% Dr. Christopher J. Welty reported at the annual meeting of the American Urological Association.

On multivariate analysis, factors associated with disease progression were PSA density (hazard ratio, 2.06 for 0.1-0.15, and 2.83 for values exceeding 0.15), total number of biopsies (hazard ratio, 0.76), and later year of diagnosis (hazard ratio, 1.16), said Dr. Welty of the University of California, San Francisco. PSA density is based on PSA value per unit volume of prostate.

Study subjects were enrolled in active surveillance at UCSF between 1990 and 2012 and had a mean age of 62 years. Active surveillance consisted of quarterly PSA testing with risk-adapted use of serial prostate biopsy and reimaging. Participants underwent a median of three repeat biopsies during a median of 57 months.

"Of the clinical parameters tested, the likelihood of biopsy progression during active surveillance was most strongly associated with PSA density at diagnosis; the association was modified by prostate size," he said. A stronger association was seen in men with smaller prostates (less than 30 cc), and as expected, patients with larger prostates tended to have lower PSA density than the general cohort, which is a limitation of the study.

This study was supported in part by the U.S. Department of Defense Prostate Cancer Research Program. Dr. Welty reported having no disclosures.

ORLANDO – Prostate-specific antigen density, total number of biopsies, and later year of diagnosis were significantly associated with disease progression in men under active surveillance for low-risk prostate cancer.

Of 808 study subjects, 554 met strict criteria for active surveillance based on the following criteria: stage less than cT3, prostate-specific antigen (PSA) level less than 10 ng/mL, Gleason score of 6 or less, less than a third of biopsies positive, and less than 50% single-core positive; 254 patients did not meet these strict criteria.

At 5 years after diagnosis, prostate cancer–specific survival was 100%, overall survival was 98%, metastasis-free survival was greater than 99%, and treatment-free survival was 60% Dr. Christopher J. Welty reported at the annual meeting of the American Urological Association.

On multivariate analysis, factors associated with disease progression were PSA density (hazard ratio, 2.06 for 0.1-0.15, and 2.83 for values exceeding 0.15), total number of biopsies (hazard ratio, 0.76), and later year of diagnosis (hazard ratio, 1.16), said Dr. Welty of the University of California, San Francisco. PSA density is based on PSA value per unit volume of prostate.

Study subjects were enrolled in active surveillance at UCSF between 1990 and 2012 and had a mean age of 62 years. Active surveillance consisted of quarterly PSA testing with risk-adapted use of serial prostate biopsy and reimaging. Participants underwent a median of three repeat biopsies during a median of 57 months.

"Of the clinical parameters tested, the likelihood of biopsy progression during active surveillance was most strongly associated with PSA density at diagnosis; the association was modified by prostate size," he said. A stronger association was seen in men with smaller prostates (less than 30 cc), and as expected, patients with larger prostates tended to have lower PSA density than the general cohort, which is a limitation of the study.

This study was supported in part by the U.S. Department of Defense Prostate Cancer Research Program. Dr. Welty reported having no disclosures.

ORLANDO – Prostate-specific antigen density, total number of biopsies, and later year of diagnosis were significantly associated with disease progression in men under active surveillance for low-risk prostate cancer.

Of 808 study subjects, 554 met strict criteria for active surveillance based on the following criteria: stage less than cT3, prostate-specific antigen (PSA) level less than 10 ng/mL, Gleason score of 6 or less, less than a third of biopsies positive, and less than 50% single-core positive; 254 patients did not meet these strict criteria.

At 5 years after diagnosis, prostate cancer–specific survival was 100%, overall survival was 98%, metastasis-free survival was greater than 99%, and treatment-free survival was 60% Dr. Christopher J. Welty reported at the annual meeting of the American Urological Association.

On multivariate analysis, factors associated with disease progression were PSA density (hazard ratio, 2.06 for 0.1-0.15, and 2.83 for values exceeding 0.15), total number of biopsies (hazard ratio, 0.76), and later year of diagnosis (hazard ratio, 1.16), said Dr. Welty of the University of California, San Francisco. PSA density is based on PSA value per unit volume of prostate.

Study subjects were enrolled in active surveillance at UCSF between 1990 and 2012 and had a mean age of 62 years. Active surveillance consisted of quarterly PSA testing with risk-adapted use of serial prostate biopsy and reimaging. Participants underwent a median of three repeat biopsies during a median of 57 months.

"Of the clinical parameters tested, the likelihood of biopsy progression during active surveillance was most strongly associated with PSA density at diagnosis; the association was modified by prostate size," he said. A stronger association was seen in men with smaller prostates (less than 30 cc), and as expected, patients with larger prostates tended to have lower PSA density than the general cohort, which is a limitation of the study.

This study was supported in part by the U.S. Department of Defense Prostate Cancer Research Program. Dr. Welty reported having no disclosures.

Compared with open radical cystectomy, robot-assisted laparoscopic radical cystectomy did not reduce the number or severity of complications among patients with bladder cancer enrolled in a single-center randomized clinical trial, according to a letter to the editor in the New England Journal of Medicine.

Retrospective studies have suggested that the robot-assisted laparoscopic approach reduces the complication rate and shortens the length of hospitalization in patients with bladder cancer, many of whom are older, are smokers, and have coexisting conditions. This trial was designed to compare that approach against open radical cystectomy, with both procedures using extracorporeal urinary diversion, in 118 patients who had stage Ta-3N0-3M0 bladder cancer, said Dr. Bernard H. Bochner and his associates at Memorial Sloan Kettering Cancer Center, New York.

Courtesy Wikimedia Commons/Nimur/Creative Commons

The primary outcome – the rate of complications of grade 2-5 within 90 days of surgery—was 62% (37 of 60 patients) with robot-assisted laparoscopic surgery, which was not significantly different from the 66% rate (38 of 58 patients) with open surgery. Similarly, the rates of high-grade complications were not significantly different (22% vs 21%), and the mean length of hospitalization was identical (8 days) in both groups. The amount of intraoperative blood loss was smaller with the robot-assisted surgery (mean difference, 159 cc), but the duration of surgery was shorter with open surgery (mean difference, 127 minutes).

"Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation," Dr. Bochner and his associates said (N. Engl. J. Med. 2014;371:389-90).

This work was supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer. Dr. Bochner and his associates reported no financial conflicts of interest.

Compared with open radical cystectomy, robot-assisted laparoscopic radical cystectomy did not reduce the number or severity of complications among patients with bladder cancer enrolled in a single-center randomized clinical trial, according to a letter to the editor in the New England Journal of Medicine.

Retrospective studies have suggested that the robot-assisted laparoscopic approach reduces the complication rate and shortens the length of hospitalization in patients with bladder cancer, many of whom are older, are smokers, and have coexisting conditions. This trial was designed to compare that approach against open radical cystectomy, with both procedures using extracorporeal urinary diversion, in 118 patients who had stage Ta-3N0-3M0 bladder cancer, said Dr. Bernard H. Bochner and his associates at Memorial Sloan Kettering Cancer Center, New York.

Courtesy Wikimedia Commons/Nimur/Creative Commons

The primary outcome – the rate of complications of grade 2-5 within 90 days of surgery—was 62% (37 of 60 patients) with robot-assisted laparoscopic surgery, which was not significantly different from the 66% rate (38 of 58 patients) with open surgery. Similarly, the rates of high-grade complications were not significantly different (22% vs 21%), and the mean length of hospitalization was identical (8 days) in both groups. The amount of intraoperative blood loss was smaller with the robot-assisted surgery (mean difference, 159 cc), but the duration of surgery was shorter with open surgery (mean difference, 127 minutes).

"Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation," Dr. Bochner and his associates said (N. Engl. J. Med. 2014;371:389-90).

This work was supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer. Dr. Bochner and his associates reported no financial conflicts of interest.

Compared with open radical cystectomy, robot-assisted laparoscopic radical cystectomy did not reduce the number or severity of complications among patients with bladder cancer enrolled in a single-center randomized clinical trial, according to a letter to the editor in the New England Journal of Medicine.

Retrospective studies have suggested that the robot-assisted laparoscopic approach reduces the complication rate and shortens the length of hospitalization in patients with bladder cancer, many of whom are older, are smokers, and have coexisting conditions. This trial was designed to compare that approach against open radical cystectomy, with both procedures using extracorporeal urinary diversion, in 118 patients who had stage Ta-3N0-3M0 bladder cancer, said Dr. Bernard H. Bochner and his associates at Memorial Sloan Kettering Cancer Center, New York.

Courtesy Wikimedia Commons/Nimur/Creative Commons

The primary outcome – the rate of complications of grade 2-5 within 90 days of surgery—was 62% (37 of 60 patients) with robot-assisted laparoscopic surgery, which was not significantly different from the 66% rate (38 of 58 patients) with open surgery. Similarly, the rates of high-grade complications were not significantly different (22% vs 21%), and the mean length of hospitalization was identical (8 days) in both groups. The amount of intraoperative blood loss was smaller with the robot-assisted surgery (mean difference, 159 cc), but the duration of surgery was shorter with open surgery (mean difference, 127 minutes).

"Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation," Dr. Bochner and his associates said (N. Engl. J. Med. 2014;371:389-90).

This work was supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer. Dr. Bochner and his associates reported no financial conflicts of interest.

WASHINGTON – Bowel preparation for vaginal reconstructive surgery does not affect postoperative bowel function and bowel symptoms one way or the other, according to a secondary analysis of a single-blind randomized trial examining various effects of mechanical bowel preparation.

In a primary analysis published earlier this year, investigators found no benefit to mechanical bowel preparation with regard to the operative field quality. They also found that patients who were randomized not to receive bowel preparation were more satisfied and had fewer abdominal symptoms than those who received the intervention – a clear-liquid diet and enemas (Obstet. Gynecol. 2014;123:232-8).

The new analysis, reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, looked more closely at postoperative bowel habits after vaginal reconstructive surgery.

"As surgical intervention for pelvic organ prolapse increases, so does our need for knowledge of [best] perioperative management practices," said Dr. Alicia C. Ballard of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, where the study was conducted.

"Concerns about painful defecation and GI symptoms such as nausea and vomiting are significant concerns for women undergoing surgery," she said.

Women may be predisposed to postsurgical constipation as a result of preoperative bowel preparation (including diet), the lasting effects of anesthesia, the use of narcotics, and the surgery itself. Prior research has shown, moreover, that constipation and incomplete bowel evacuation are not uncommon preoperatively in women with pelvic organ prolapse, she noted.

The study randomized 150 women scheduled to undergo vaginal prolapse surgery with, at a minimum, a planned apical suspension and posterior compartment repair. Surgeries included other prolapse and incontinence procedures.

Women randomized to the bowel preparation group were instructed to have a clear-liquid diet and to self-administer two saline enemas in the late afternoon of the day before surgery.

Those who were randomized to receive no intervention were allowed to have a regular diet. Women in both groups were instructed to eat nothing after midnight on the day of surgery.

All study participants were instructed to complete a bowel diary for 7 days preoperatively and 14 days postoperatively. Those who completed the preoperative diary and 10 of 14 days of the postoperative diary were included in the analysis.

Of the 150 women randomized at the preoperative visit in a 1:1 fashion, 5 withdrew from the study or had surgery canceled, and 121 completed the bowel diary.

The mean time to first bowel movement after surgery was similar in the two groups: 3.3 days in the bowel prep group and 3.2 days in the control group. The groups were also similar with regard to pain, fecal urgency, and stool transit times on the day of the first postoperative bowel movement. The use of antiemetics postoperatively was similar as well (48% and 55% in the bowel prep and no-prep groups, respectively.)

Most of the 121 women – across both groups – used at least one laxative postoperatively, mainly osmotic laxatives. Women who had not received bowel preparation were more likely, however, to report daily fiber use.

"Bowel preparation ... doesn’t appear to affect the return of bowel function and other bowel symptoms postoperatively," Dr. Ballard said. Moreover, "the lack of bowel preparation doesn’t seem to impact painful defecation symptoms, and most women use some type of laxative."

The study’s exclusion criteria included colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, and symptoms of colonic inertia (fewer than three bowel movements per week). The decision to exclude patients with significant preoperative constipation was made in order to "decrease the risk of bowel dysfunction and was important for our primary outcomes," Dr. Ballard explained. "But there actually were not that many women excluded."

Dr. Ballard reported that she had no disclosures. Two of her five coinvestigators reported various relationships with St. Jude Medical and Pelvalon.

WASHINGTON – Bowel preparation for vaginal reconstructive surgery does not affect postoperative bowel function and bowel symptoms one way or the other, according to a secondary analysis of a single-blind randomized trial examining various effects of mechanical bowel preparation.

In a primary analysis published earlier this year, investigators found no benefit to mechanical bowel preparation with regard to the operative field quality. They also found that patients who were randomized not to receive bowel preparation were more satisfied and had fewer abdominal symptoms than those who received the intervention – a clear-liquid diet and enemas (Obstet. Gynecol. 2014;123:232-8).

The new analysis, reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, looked more closely at postoperative bowel habits after vaginal reconstructive surgery.

"As surgical intervention for pelvic organ prolapse increases, so does our need for knowledge of [best] perioperative management practices," said Dr. Alicia C. Ballard of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, where the study was conducted.

"Concerns about painful defecation and GI symptoms such as nausea and vomiting are significant concerns for women undergoing surgery," she said.

Women may be predisposed to postsurgical constipation as a result of preoperative bowel preparation (including diet), the lasting effects of anesthesia, the use of narcotics, and the surgery itself. Prior research has shown, moreover, that constipation and incomplete bowel evacuation are not uncommon preoperatively in women with pelvic organ prolapse, she noted.

The study randomized 150 women scheduled to undergo vaginal prolapse surgery with, at a minimum, a planned apical suspension and posterior compartment repair. Surgeries included other prolapse and incontinence procedures.

Women randomized to the bowel preparation group were instructed to have a clear-liquid diet and to self-administer two saline enemas in the late afternoon of the day before surgery.

Those who were randomized to receive no intervention were allowed to have a regular diet. Women in both groups were instructed to eat nothing after midnight on the day of surgery.

All study participants were instructed to complete a bowel diary for 7 days preoperatively and 14 days postoperatively. Those who completed the preoperative diary and 10 of 14 days of the postoperative diary were included in the analysis.

Of the 150 women randomized at the preoperative visit in a 1:1 fashion, 5 withdrew from the study or had surgery canceled, and 121 completed the bowel diary.

The mean time to first bowel movement after surgery was similar in the two groups: 3.3 days in the bowel prep group and 3.2 days in the control group. The groups were also similar with regard to pain, fecal urgency, and stool transit times on the day of the first postoperative bowel movement. The use of antiemetics postoperatively was similar as well (48% and 55% in the bowel prep and no-prep groups, respectively.)

Most of the 121 women – across both groups – used at least one laxative postoperatively, mainly osmotic laxatives. Women who had not received bowel preparation were more likely, however, to report daily fiber use.

"Bowel preparation ... doesn’t appear to affect the return of bowel function and other bowel symptoms postoperatively," Dr. Ballard said. Moreover, "the lack of bowel preparation doesn’t seem to impact painful defecation symptoms, and most women use some type of laxative."

The study’s exclusion criteria included colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, and symptoms of colonic inertia (fewer than three bowel movements per week). The decision to exclude patients with significant preoperative constipation was made in order to "decrease the risk of bowel dysfunction and was important for our primary outcomes," Dr. Ballard explained. "But there actually were not that many women excluded."

Dr. Ballard reported that she had no disclosures. Two of her five coinvestigators reported various relationships with St. Jude Medical and Pelvalon.

WASHINGTON – Bowel preparation for vaginal reconstructive surgery does not affect postoperative bowel function and bowel symptoms one way or the other, according to a secondary analysis of a single-blind randomized trial examining various effects of mechanical bowel preparation.

In a primary analysis published earlier this year, investigators found no benefit to mechanical bowel preparation with regard to the operative field quality. They also found that patients who were randomized not to receive bowel preparation were more satisfied and had fewer abdominal symptoms than those who received the intervention – a clear-liquid diet and enemas (Obstet. Gynecol. 2014;123:232-8).

The new analysis, reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, looked more closely at postoperative bowel habits after vaginal reconstructive surgery.

"As surgical intervention for pelvic organ prolapse increases, so does our need for knowledge of [best] perioperative management practices," said Dr. Alicia C. Ballard of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, where the study was conducted.

"Concerns about painful defecation and GI symptoms such as nausea and vomiting are significant concerns for women undergoing surgery," she said.

Women may be predisposed to postsurgical constipation as a result of preoperative bowel preparation (including diet), the lasting effects of anesthesia, the use of narcotics, and the surgery itself. Prior research has shown, moreover, that constipation and incomplete bowel evacuation are not uncommon preoperatively in women with pelvic organ prolapse, she noted.

The study randomized 150 women scheduled to undergo vaginal prolapse surgery with, at a minimum, a planned apical suspension and posterior compartment repair. Surgeries included other prolapse and incontinence procedures.

Women randomized to the bowel preparation group were instructed to have a clear-liquid diet and to self-administer two saline enemas in the late afternoon of the day before surgery.

Those who were randomized to receive no intervention were allowed to have a regular diet. Women in both groups were instructed to eat nothing after midnight on the day of surgery.

All study participants were instructed to complete a bowel diary for 7 days preoperatively and 14 days postoperatively. Those who completed the preoperative diary and 10 of 14 days of the postoperative diary were included in the analysis.

Of the 150 women randomized at the preoperative visit in a 1:1 fashion, 5 withdrew from the study or had surgery canceled, and 121 completed the bowel diary.

The mean time to first bowel movement after surgery was similar in the two groups: 3.3 days in the bowel prep group and 3.2 days in the control group. The groups were also similar with regard to pain, fecal urgency, and stool transit times on the day of the first postoperative bowel movement. The use of antiemetics postoperatively was similar as well (48% and 55% in the bowel prep and no-prep groups, respectively.)

Most of the 121 women – across both groups – used at least one laxative postoperatively, mainly osmotic laxatives. Women who had not received bowel preparation were more likely, however, to report daily fiber use.

"Bowel preparation ... doesn’t appear to affect the return of bowel function and other bowel symptoms postoperatively," Dr. Ballard said. Moreover, "the lack of bowel preparation doesn’t seem to impact painful defecation symptoms, and most women use some type of laxative."

The study’s exclusion criteria included colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, and symptoms of colonic inertia (fewer than three bowel movements per week). The decision to exclude patients with significant preoperative constipation was made in order to "decrease the risk of bowel dysfunction and was important for our primary outcomes," Dr. Ballard explained. "But there actually were not that many women excluded."

Dr. Ballard reported that she had no disclosures. Two of her five coinvestigators reported various relationships with St. Jude Medical and Pelvalon.