Jane Salodof MacNeil

SANTA FE, N.M. — Although the complication rate for hysteroscopic myomectomy is relatively low, physicians must guard against uterine perforation and hyponatremia during the procedure, Stephen M. Cohen, M.D., advised at a conference on gynecologic surgery sponsored by Omnia Education.

All but the smallest fibroids should be removed in an operating room, according to Dr. Cohen, chief of the division of gynecology and director of women's minimal access surgery at Albany (N.Y.) Medical College. In cases in which a large vascular fibroid is detected, Dr. Cohen also recommended allowing time to shrink it with a GnRH agonist before attempting removal.

He noted that patients should be forewarned that a second operative procedure might be necessary to remove the entire fibroid.

Uterine perforation—usually during cervical dilation—is the most common complication of operative hysteroscopic, occurring in 1%–10% of cases, according to Dr. Cohen. Patients with Asherman's syndrome and cervical stenosis are most at risk.

He advised physicians to prevent perforation by withdrawing the resectoscope as soon as advancing it becomes difficult.

“Back out, redilate, and make it go easy. Don't keep pushing ahead if you can't see where you're going,” he said.

The hyponatremia risk stems from the pumping of low-viscosity fluids containing sorbitol, mannitol, or glycine to distend the uterus during the procedure. Younger women are at greater risk for permanent brain damage and death from severe sodium depletion, according to Dr. Cohen.

He cited the theoretical effects of estrogen's possible interference with sodium balance, the decreased effect of vasopressin in the reduction of cerebral edema, and the smaller intracranial space in young women.

Dr. Cohen said intrauterine pressure ideally should be kept to a mean arterial pressure of 75 mm Hg. This may not be adequate in some patients, however, so he occasionally starts as high as 120 mm Hg and titrates down until he sees the uterus beginning to collapse.

Physicians need to have a system for keeping meticulous track of the intake and output of fluids, noted Dr. Cohen. Some patients absorb more fluid than do others, he said, and the amount can increase substantially during a long procedure.

If the imbalance reaches 1,000 mL, he recommended giving intravenous Lasix (furosemide). If the amount reaches 1,500 mL, the operation should be stopped immediately, he said.

“When they absorb 1,500 mL, that's done—case over. … It's better to go back a second time for a fibroid than to be reporting a death,” Dr. Cohen said, advising that extreme cases of fluid overload may need to be treated in the intensive care unit.

If the patient is under general anesthesia, Dr. Cohen advised watching for decreased oxygen saturation and dilated pupils as the first signs of hyponatremia. Should the plasma sodium level fall below 120 mEq/L, he recommended infusion of a 3% saline solution monitored in the ICU.

Under local anesthesia, symptoms of mild hyponatremia (130–135 mEq/L) include apprehension, disorientation, irritability, twitching, nausea, vomiting, and shortness of breath. As sodium levels drop, the list grows to include pulmonary edema, moist skin, polyuria, hypotension, bradycardia, cyanosis, mental changes, encephalopathy, chronic heart failure, lethargy, confusion, twitching, and convulsion.

With sodium less than 115 mEq/L, the patient faces brain stem herniation, respiratory arrest, coma, and death, he said.

SANTA FE, N.M. — Although the complication rate for hysteroscopic myomectomy is relatively low, physicians must guard against uterine perforation and hyponatremia during the procedure, Stephen M. Cohen, M.D., advised at a conference on gynecologic surgery sponsored by Omnia Education.

All but the smallest fibroids should be removed in an operating room, according to Dr. Cohen, chief of the division of gynecology and director of women's minimal access surgery at Albany (N.Y.) Medical College. In cases in which a large vascular fibroid is detected, Dr. Cohen also recommended allowing time to shrink it with a GnRH agonist before attempting removal.

He noted that patients should be forewarned that a second operative procedure might be necessary to remove the entire fibroid.

Uterine perforation—usually during cervical dilation—is the most common complication of operative hysteroscopic, occurring in 1%–10% of cases, according to Dr. Cohen. Patients with Asherman's syndrome and cervical stenosis are most at risk.

He advised physicians to prevent perforation by withdrawing the resectoscope as soon as advancing it becomes difficult.

“Back out, redilate, and make it go easy. Don't keep pushing ahead if you can't see where you're going,” he said.

The hyponatremia risk stems from the pumping of low-viscosity fluids containing sorbitol, mannitol, or glycine to distend the uterus during the procedure. Younger women are at greater risk for permanent brain damage and death from severe sodium depletion, according to Dr. Cohen.

He cited the theoretical effects of estrogen's possible interference with sodium balance, the decreased effect of vasopressin in the reduction of cerebral edema, and the smaller intracranial space in young women.

Dr. Cohen said intrauterine pressure ideally should be kept to a mean arterial pressure of 75 mm Hg. This may not be adequate in some patients, however, so he occasionally starts as high as 120 mm Hg and titrates down until he sees the uterus beginning to collapse.

Physicians need to have a system for keeping meticulous track of the intake and output of fluids, noted Dr. Cohen. Some patients absorb more fluid than do others, he said, and the amount can increase substantially during a long procedure.

If the imbalance reaches 1,000 mL, he recommended giving intravenous Lasix (furosemide). If the amount reaches 1,500 mL, the operation should be stopped immediately, he said.

“When they absorb 1,500 mL, that's done—case over. … It's better to go back a second time for a fibroid than to be reporting a death,” Dr. Cohen said, advising that extreme cases of fluid overload may need to be treated in the intensive care unit.

If the patient is under general anesthesia, Dr. Cohen advised watching for decreased oxygen saturation and dilated pupils as the first signs of hyponatremia. Should the plasma sodium level fall below 120 mEq/L, he recommended infusion of a 3% saline solution monitored in the ICU.

Under local anesthesia, symptoms of mild hyponatremia (130–135 mEq/L) include apprehension, disorientation, irritability, twitching, nausea, vomiting, and shortness of breath. As sodium levels drop, the list grows to include pulmonary edema, moist skin, polyuria, hypotension, bradycardia, cyanosis, mental changes, encephalopathy, chronic heart failure, lethargy, confusion, twitching, and convulsion.

With sodium less than 115 mEq/L, the patient faces brain stem herniation, respiratory arrest, coma, and death, he said.

SANTA FE, N.M. — Although the complication rate for hysteroscopic myomectomy is relatively low, physicians must guard against uterine perforation and hyponatremia during the procedure, Stephen M. Cohen, M.D., advised at a conference on gynecologic surgery sponsored by Omnia Education.

All but the smallest fibroids should be removed in an operating room, according to Dr. Cohen, chief of the division of gynecology and director of women's minimal access surgery at Albany (N.Y.) Medical College. In cases in which a large vascular fibroid is detected, Dr. Cohen also recommended allowing time to shrink it with a GnRH agonist before attempting removal.

He noted that patients should be forewarned that a second operative procedure might be necessary to remove the entire fibroid.

Uterine perforation—usually during cervical dilation—is the most common complication of operative hysteroscopic, occurring in 1%–10% of cases, according to Dr. Cohen. Patients with Asherman's syndrome and cervical stenosis are most at risk.

He advised physicians to prevent perforation by withdrawing the resectoscope as soon as advancing it becomes difficult.

“Back out, redilate, and make it go easy. Don't keep pushing ahead if you can't see where you're going,” he said.

The hyponatremia risk stems from the pumping of low-viscosity fluids containing sorbitol, mannitol, or glycine to distend the uterus during the procedure. Younger women are at greater risk for permanent brain damage and death from severe sodium depletion, according to Dr. Cohen.

He cited the theoretical effects of estrogen's possible interference with sodium balance, the decreased effect of vasopressin in the reduction of cerebral edema, and the smaller intracranial space in young women.

Dr. Cohen said intrauterine pressure ideally should be kept to a mean arterial pressure of 75 mm Hg. This may not be adequate in some patients, however, so he occasionally starts as high as 120 mm Hg and titrates down until he sees the uterus beginning to collapse.

Physicians need to have a system for keeping meticulous track of the intake and output of fluids, noted Dr. Cohen. Some patients absorb more fluid than do others, he said, and the amount can increase substantially during a long procedure.

If the imbalance reaches 1,000 mL, he recommended giving intravenous Lasix (furosemide). If the amount reaches 1,500 mL, the operation should be stopped immediately, he said.

“When they absorb 1,500 mL, that's done—case over. … It's better to go back a second time for a fibroid than to be reporting a death,” Dr. Cohen said, advising that extreme cases of fluid overload may need to be treated in the intensive care unit.

If the patient is under general anesthesia, Dr. Cohen advised watching for decreased oxygen saturation and dilated pupils as the first signs of hyponatremia. Should the plasma sodium level fall below 120 mEq/L, he recommended infusion of a 3% saline solution monitored in the ICU.

Under local anesthesia, symptoms of mild hyponatremia (130–135 mEq/L) include apprehension, disorientation, irritability, twitching, nausea, vomiting, and shortness of breath. As sodium levels drop, the list grows to include pulmonary edema, moist skin, polyuria, hypotension, bradycardia, cyanosis, mental changes, encephalopathy, chronic heart failure, lethargy, confusion, twitching, and convulsion.

With sodium less than 115 mEq/L, the patient faces brain stem herniation, respiratory arrest, coma, and death, he said.

NEW ORLEANS — Preliminary results from the phase II/III trial of an implantable miniature telescope suggest the experimental prosthetic device can enhance the vision of end-stage advanced macular degeneration and Stargardt's disease patients for whom no effective treatments currently exist.

Of 202 patients who wore the telescope for 6 months, 89% were able to improve their distance or near vision by at least two lines in the reading of an eye chart, according to investigator Jeffrey S. Heier, M.D., a vitreoretinal specialist at Ophthalmic Consultants of Boston and Tufts University, Boston. About half had a three-line improvement, he said.

Not all patients could tolerate the lens, however. Investigator Paul R. Lichter, M.D., director of the University of Michigan Kellogg Eye Center, reported that 11 of the first 217 implantations had to be aborted and that two telescopes were removed because of device failures.

The two researchers presented similar data from the ongoing trial at the annual meeting of the American Academy of Ophthalmology. The researchers were consultants to VisionCare Ophthalmic Technologies of Saratoga, Calif., which was cofounded by the telescope's inventors, Isaac Lipshitz, M.D., and Yossi Gross.

The implantable miniature telescope is said to give patients a wider visual field than external telescopes currently in use for advanced macular degeneration (AMD). Eye movement and visual appearance are also described as more natural.

Surgeons at 28 centers implanted the telescopes in one eye in each of 218 patients. Participants had to have a cataract in their study eye to be eligible for the trial. Their average age was 76, and they entered with best-corrected distance vision between 20/80 and 20/800.

Dr. Lichter noted that the telescope is not an intraocular lens. It required a 10- to 12-mm incision and was inserted with posterior pressure to avoid corneal touch. He described the surgery as three times as difficult as a cataract operation, with surgical success dependent on the surgeon's developing mastery of the technique.

“Experience counts. There was higher cell loss in the first three cases,” Dr. Lichter said, referring to the one study end point with notably poor results. Mean endothelial cell loss was 22% at 6 months, whereas the study goal had been less than 17% at 2 years.

In the 11 eyes where implantation was aborted, Dr. Lichter reported eight capsular tears (half of which occurred during extraction), two suprachoroidal hemorrhages, and one suspected suprachoroidal hemorrhage.

Common complications were elevated intraocular pressure and corneal edema during the first month of follow-up. Less than 5% of patients had adverse events, according to the analysis, and no postoperative retinal complications were reported. Only 2% of patients lost two or more lines of vision 6 months after implantation.

Dr. Lichter and Dr. Heier each stressed that the telescope will not help everyone with advanced AMD. Patients must be committed to learning how to use the telescope, they said, citing six visual rehabilitation sessions scheduled in addition to postoperative visits.

“It is important that patient selection be very, very careful,” Dr. Lichter said. “Patients have to understand this is not a cure, and optimal outcome requires fairly intense visual rehabilitation.”

A panel of experts responded positively to Dr. Heier's presentation. They expressed concerns about safety but applauded the possibility of a new treatment for AMD.

Cynthia A. Toth, M.D., of Duke University Eye Center in Durham, N.C., said VisionCare's data were difficult to assess because the statistical analysis only included patients who wore the telescope for 6 months.

VisionCare has announced plans to file a U.S. Food and Drug Administration premarket approval application for the telescope in the first half of 2005.

NEW ORLEANS — Preliminary results from the phase II/III trial of an implantable miniature telescope suggest the experimental prosthetic device can enhance the vision of end-stage advanced macular degeneration and Stargardt's disease patients for whom no effective treatments currently exist.

Of 202 patients who wore the telescope for 6 months, 89% were able to improve their distance or near vision by at least two lines in the reading of an eye chart, according to investigator Jeffrey S. Heier, M.D., a vitreoretinal specialist at Ophthalmic Consultants of Boston and Tufts University, Boston. About half had a three-line improvement, he said.

Not all patients could tolerate the lens, however. Investigator Paul R. Lichter, M.D., director of the University of Michigan Kellogg Eye Center, reported that 11 of the first 217 implantations had to be aborted and that two telescopes were removed because of device failures.

The two researchers presented similar data from the ongoing trial at the annual meeting of the American Academy of Ophthalmology. The researchers were consultants to VisionCare Ophthalmic Technologies of Saratoga, Calif., which was cofounded by the telescope's inventors, Isaac Lipshitz, M.D., and Yossi Gross.

The implantable miniature telescope is said to give patients a wider visual field than external telescopes currently in use for advanced macular degeneration (AMD). Eye movement and visual appearance are also described as more natural.

Surgeons at 28 centers implanted the telescopes in one eye in each of 218 patients. Participants had to have a cataract in their study eye to be eligible for the trial. Their average age was 76, and they entered with best-corrected distance vision between 20/80 and 20/800.

Dr. Lichter noted that the telescope is not an intraocular lens. It required a 10- to 12-mm incision and was inserted with posterior pressure to avoid corneal touch. He described the surgery as three times as difficult as a cataract operation, with surgical success dependent on the surgeon's developing mastery of the technique.

“Experience counts. There was higher cell loss in the first three cases,” Dr. Lichter said, referring to the one study end point with notably poor results. Mean endothelial cell loss was 22% at 6 months, whereas the study goal had been less than 17% at 2 years.

In the 11 eyes where implantation was aborted, Dr. Lichter reported eight capsular tears (half of which occurred during extraction), two suprachoroidal hemorrhages, and one suspected suprachoroidal hemorrhage.

Common complications were elevated intraocular pressure and corneal edema during the first month of follow-up. Less than 5% of patients had adverse events, according to the analysis, and no postoperative retinal complications were reported. Only 2% of patients lost two or more lines of vision 6 months after implantation.

Dr. Lichter and Dr. Heier each stressed that the telescope will not help everyone with advanced AMD. Patients must be committed to learning how to use the telescope, they said, citing six visual rehabilitation sessions scheduled in addition to postoperative visits.

“It is important that patient selection be very, very careful,” Dr. Lichter said. “Patients have to understand this is not a cure, and optimal outcome requires fairly intense visual rehabilitation.”

A panel of experts responded positively to Dr. Heier's presentation. They expressed concerns about safety but applauded the possibility of a new treatment for AMD.

Cynthia A. Toth, M.D., of Duke University Eye Center in Durham, N.C., said VisionCare's data were difficult to assess because the statistical analysis only included patients who wore the telescope for 6 months.

VisionCare has announced plans to file a U.S. Food and Drug Administration premarket approval application for the telescope in the first half of 2005.

NEW ORLEANS — Preliminary results from the phase II/III trial of an implantable miniature telescope suggest the experimental prosthetic device can enhance the vision of end-stage advanced macular degeneration and Stargardt's disease patients for whom no effective treatments currently exist.

Of 202 patients who wore the telescope for 6 months, 89% were able to improve their distance or near vision by at least two lines in the reading of an eye chart, according to investigator Jeffrey S. Heier, M.D., a vitreoretinal specialist at Ophthalmic Consultants of Boston and Tufts University, Boston. About half had a three-line improvement, he said.

Not all patients could tolerate the lens, however. Investigator Paul R. Lichter, M.D., director of the University of Michigan Kellogg Eye Center, reported that 11 of the first 217 implantations had to be aborted and that two telescopes were removed because of device failures.

The two researchers presented similar data from the ongoing trial at the annual meeting of the American Academy of Ophthalmology. The researchers were consultants to VisionCare Ophthalmic Technologies of Saratoga, Calif., which was cofounded by the telescope's inventors, Isaac Lipshitz, M.D., and Yossi Gross.

The implantable miniature telescope is said to give patients a wider visual field than external telescopes currently in use for advanced macular degeneration (AMD). Eye movement and visual appearance are also described as more natural.

Surgeons at 28 centers implanted the telescopes in one eye in each of 218 patients. Participants had to have a cataract in their study eye to be eligible for the trial. Their average age was 76, and they entered with best-corrected distance vision between 20/80 and 20/800.

Dr. Lichter noted that the telescope is not an intraocular lens. It required a 10- to 12-mm incision and was inserted with posterior pressure to avoid corneal touch. He described the surgery as three times as difficult as a cataract operation, with surgical success dependent on the surgeon's developing mastery of the technique.

“Experience counts. There was higher cell loss in the first three cases,” Dr. Lichter said, referring to the one study end point with notably poor results. Mean endothelial cell loss was 22% at 6 months, whereas the study goal had been less than 17% at 2 years.

In the 11 eyes where implantation was aborted, Dr. Lichter reported eight capsular tears (half of which occurred during extraction), two suprachoroidal hemorrhages, and one suspected suprachoroidal hemorrhage.

Common complications were elevated intraocular pressure and corneal edema during the first month of follow-up. Less than 5% of patients had adverse events, according to the analysis, and no postoperative retinal complications were reported. Only 2% of patients lost two or more lines of vision 6 months after implantation.

Dr. Lichter and Dr. Heier each stressed that the telescope will not help everyone with advanced AMD. Patients must be committed to learning how to use the telescope, they said, citing six visual rehabilitation sessions scheduled in addition to postoperative visits.

“It is important that patient selection be very, very careful,” Dr. Lichter said. “Patients have to understand this is not a cure, and optimal outcome requires fairly intense visual rehabilitation.”

A panel of experts responded positively to Dr. Heier's presentation. They expressed concerns about safety but applauded the possibility of a new treatment for AMD.

Cynthia A. Toth, M.D., of Duke University Eye Center in Durham, N.C., said VisionCare's data were difficult to assess because the statistical analysis only included patients who wore the telescope for 6 months.

VisionCare has announced plans to file a U.S. Food and Drug Administration premarket approval application for the telescope in the first half of 2005.

LAS VEGAS — Results from a study of nearly 6,000 people in the 1998 Scottish Health Survey suggest that patients who say they are “fit and fat” do not have a good excuse for not losing weight, Catherine Hankey, Ph.D., reported at the annual meeting of the North American Association for the Study of Obesity.

Overweight and obese people who exercised did have lower levels of cardiovascular risk factors for coronary heart disease than couch potatoes of comparable excess weight, said Dr. Hankey of the University of Glasgow (Scotland).

Compared with people of normal weight, however, the fit and fat were still worse off. Cholesterol, hypertension, systolic blood pressure, and other indicators showed greater risk when body mass index (BMI) measured 25 kg/m2 or above.

Physicians need to make sure these patients know the health risks of being overweight, Dr. Hankey said. “The most important thing to tackle is the weight,” she said at the meeting, cosponsored by the American Diabetes Association.

LAS VEGAS — Results from a study of nearly 6,000 people in the 1998 Scottish Health Survey suggest that patients who say they are “fit and fat” do not have a good excuse for not losing weight, Catherine Hankey, Ph.D., reported at the annual meeting of the North American Association for the Study of Obesity.

Overweight and obese people who exercised did have lower levels of cardiovascular risk factors for coronary heart disease than couch potatoes of comparable excess weight, said Dr. Hankey of the University of Glasgow (Scotland).

Compared with people of normal weight, however, the fit and fat were still worse off. Cholesterol, hypertension, systolic blood pressure, and other indicators showed greater risk when body mass index (BMI) measured 25 kg/m2 or above.

Physicians need to make sure these patients know the health risks of being overweight, Dr. Hankey said. “The most important thing to tackle is the weight,” she said at the meeting, cosponsored by the American Diabetes Association.

LAS VEGAS — Results from a study of nearly 6,000 people in the 1998 Scottish Health Survey suggest that patients who say they are “fit and fat” do not have a good excuse for not losing weight, Catherine Hankey, Ph.D., reported at the annual meeting of the North American Association for the Study of Obesity.

Overweight and obese people who exercised did have lower levels of cardiovascular risk factors for coronary heart disease than couch potatoes of comparable excess weight, said Dr. Hankey of the University of Glasgow (Scotland).

Compared with people of normal weight, however, the fit and fat were still worse off. Cholesterol, hypertension, systolic blood pressure, and other indicators showed greater risk when body mass index (BMI) measured 25 kg/m2 or above.

Physicians need to make sure these patients know the health risks of being overweight, Dr. Hankey said. “The most important thing to tackle is the weight,” she said at the meeting, cosponsored by the American Diabetes Association.

SANTE FE, N.M. — Many physicians need to unlearn what they were taught about rectoceles, according to Marvin H. Terry Grody, M.D., of Robert Wood Johnson Medical School at Camden (N.J.).

Tears in the connective tissue of the rectovaginal septum cause these defects—neither attenuation nor deterioration is responsible, he said at a conference on gynecologic surgery sponsored by Omnia Education.

“We've all been trained in the traditional method that searches around for scraps of tissue to bring together in the hopes that we can eliminate the rectocele. That's what we all have been doing for 200 years, and it's wrong,” Dr. Grody said.

Some medical school professors still describe tears as uncommon, holding to the historic explanation of rectoceles as starting with the stretching of tissue in vaginal delivery, according to Dr. Grody. Usually childbirth does play an instigating role. He credited A. Cullen Richardson, M.D., with conclusively demonstrating over the last 2 decades of the 20th century that rectoceles most often stem from trauma caused by the descending vertex in vaginal delivery.

“How come we didn't know about this before?” Dr. Grody asked rhetorically. “Well, we never bothered looking for them because we assumed attrition—deterioration—caused the defects. We didn't think tears.”

Transverse tears—“either detachment from below adjacent to the perineal body or separation at the top in juxtaposition to the fibrous uterosacral extensions in the area of the cul-de-sac”—are the most frequent cause of rectoceles, he said. U-shaped tears at the bottom or top of the posterior pelvic compartment are also common.

Lesions shaped like a hockey stick may also be seen. These combine a longitudinal tear and a transverse tear. Less common, Dr. Grody said, is a double defect in which the Denonvilliers' fascia is torn in the perineal area and adjacent to the vault. Even stellate tears might have to be puzzled together.

Physicians should not assume the tear responsible for a rectocele will have a common shape. “It doesn't make a difference what statistics tell you in percentages of occurrence,” he said. “That patient is one hundred percent of one, and she will have a lesion that is peculiar to her. Simply go find it, and put it together.”

As outlined by Dr. Grody, the procedure is easier than the “traditional archaic repair.” The physician places a finger in the rectum to find the defect and search for torn edges. “I guarantee you in 19 out of 20 cases you are going to find them—either up above or down below or on the side,” he said.

Once the torn edges are located, he recommended sewing them together with interrupted monofilament sutures. “You cannot sterilize the vagina, and monofilament sutures resist infection far better than do braided or polyfilament sutures, very simply because bacteria cannot hide in monofilament sutures,” he said.

After the breaks are repaired, the physician should place a finger in the rectum again.

“Where it could come well forward [before] because there was no resistance, you now cannot do it,” Dr. Grody said. “The rectovaginal septum is restored to its natural configuration, and you can't poke your finger through it.”

SANTE FE, N.M. — Many physicians need to unlearn what they were taught about rectoceles, according to Marvin H. Terry Grody, M.D., of Robert Wood Johnson Medical School at Camden (N.J.).

Tears in the connective tissue of the rectovaginal septum cause these defects—neither attenuation nor deterioration is responsible, he said at a conference on gynecologic surgery sponsored by Omnia Education.

“We've all been trained in the traditional method that searches around for scraps of tissue to bring together in the hopes that we can eliminate the rectocele. That's what we all have been doing for 200 years, and it's wrong,” Dr. Grody said.

Some medical school professors still describe tears as uncommon, holding to the historic explanation of rectoceles as starting with the stretching of tissue in vaginal delivery, according to Dr. Grody. Usually childbirth does play an instigating role. He credited A. Cullen Richardson, M.D., with conclusively demonstrating over the last 2 decades of the 20th century that rectoceles most often stem from trauma caused by the descending vertex in vaginal delivery.

“How come we didn't know about this before?” Dr. Grody asked rhetorically. “Well, we never bothered looking for them because we assumed attrition—deterioration—caused the defects. We didn't think tears.”

Transverse tears—“either detachment from below adjacent to the perineal body or separation at the top in juxtaposition to the fibrous uterosacral extensions in the area of the cul-de-sac”—are the most frequent cause of rectoceles, he said. U-shaped tears at the bottom or top of the posterior pelvic compartment are also common.

Lesions shaped like a hockey stick may also be seen. These combine a longitudinal tear and a transverse tear. Less common, Dr. Grody said, is a double defect in which the Denonvilliers' fascia is torn in the perineal area and adjacent to the vault. Even stellate tears might have to be puzzled together.

Physicians should not assume the tear responsible for a rectocele will have a common shape. “It doesn't make a difference what statistics tell you in percentages of occurrence,” he said. “That patient is one hundred percent of one, and she will have a lesion that is peculiar to her. Simply go find it, and put it together.”

As outlined by Dr. Grody, the procedure is easier than the “traditional archaic repair.” The physician places a finger in the rectum to find the defect and search for torn edges. “I guarantee you in 19 out of 20 cases you are going to find them—either up above or down below or on the side,” he said.

Once the torn edges are located, he recommended sewing them together with interrupted monofilament sutures. “You cannot sterilize the vagina, and monofilament sutures resist infection far better than do braided or polyfilament sutures, very simply because bacteria cannot hide in monofilament sutures,” he said.

After the breaks are repaired, the physician should place a finger in the rectum again.

“Where it could come well forward [before] because there was no resistance, you now cannot do it,” Dr. Grody said. “The rectovaginal septum is restored to its natural configuration, and you can't poke your finger through it.”

SANTE FE, N.M. — Many physicians need to unlearn what they were taught about rectoceles, according to Marvin H. Terry Grody, M.D., of Robert Wood Johnson Medical School at Camden (N.J.).

Tears in the connective tissue of the rectovaginal septum cause these defects—neither attenuation nor deterioration is responsible, he said at a conference on gynecologic surgery sponsored by Omnia Education.

“We've all been trained in the traditional method that searches around for scraps of tissue to bring together in the hopes that we can eliminate the rectocele. That's what we all have been doing for 200 years, and it's wrong,” Dr. Grody said.

Some medical school professors still describe tears as uncommon, holding to the historic explanation of rectoceles as starting with the stretching of tissue in vaginal delivery, according to Dr. Grody. Usually childbirth does play an instigating role. He credited A. Cullen Richardson, M.D., with conclusively demonstrating over the last 2 decades of the 20th century that rectoceles most often stem from trauma caused by the descending vertex in vaginal delivery.

“How come we didn't know about this before?” Dr. Grody asked rhetorically. “Well, we never bothered looking for them because we assumed attrition—deterioration—caused the defects. We didn't think tears.”

Transverse tears—“either detachment from below adjacent to the perineal body or separation at the top in juxtaposition to the fibrous uterosacral extensions in the area of the cul-de-sac”—are the most frequent cause of rectoceles, he said. U-shaped tears at the bottom or top of the posterior pelvic compartment are also common.

Lesions shaped like a hockey stick may also be seen. These combine a longitudinal tear and a transverse tear. Less common, Dr. Grody said, is a double defect in which the Denonvilliers' fascia is torn in the perineal area and adjacent to the vault. Even stellate tears might have to be puzzled together.

Physicians should not assume the tear responsible for a rectocele will have a common shape. “It doesn't make a difference what statistics tell you in percentages of occurrence,” he said. “That patient is one hundred percent of one, and she will have a lesion that is peculiar to her. Simply go find it, and put it together.”

As outlined by Dr. Grody, the procedure is easier than the “traditional archaic repair.” The physician places a finger in the rectum to find the defect and search for torn edges. “I guarantee you in 19 out of 20 cases you are going to find them—either up above or down below or on the side,” he said.

Once the torn edges are located, he recommended sewing them together with interrupted monofilament sutures. “You cannot sterilize the vagina, and monofilament sutures resist infection far better than do braided or polyfilament sutures, very simply because bacteria cannot hide in monofilament sutures,” he said.

After the breaks are repaired, the physician should place a finger in the rectum again.

“Where it could come well forward [before] because there was no resistance, you now cannot do it,” Dr. Grody said. “The rectovaginal septum is restored to its natural configuration, and you can't poke your finger through it.”

LAS VEGAS — Sibutramine (Meridia) enabled obese adolescents to shed weight and improve obesity-related risk factors in a 12-month, randomized, double-blind, placebo-controlled trial.

The proportion of teenagers who lost at least 5% of body mass index (BMI) was more than three times greater in the sibutramine group compared with the control group—62% vs. 18%, Robert I. Berkowitz, M.D., reported at the annual meeting of North American Association for the Study of Obesity. When BMI loss of 10% or more was tallied, the sibutramine advantage was 39% vs. 6% of the patients.

Along with declines in glucose, insulin, and triglyceride levels, sibutramine helped the teenagers improve their psychological and emotional well-being and their school and social functioning, said Dr. Berkowitz, psychiatrist-in-chief at Children's Hospital of Philadelphia's behavioral health center.

“The improvements were significantly greater in the sibutramine group than in the placebo group,” he said.

Few long-term studies have addressed adolescent obesity. Mainly they have looked at behavioral changes in diet and exercise. “Most report a loss of only 1–4 kg, with participants still overweight at the end of the study,” Dr. Berkowitz said.

Sibutramine is not approved for patients under age 16.

The trial enrolled 498 patients aged 12 to 16 years (mean age 13.6 years), who had a BMI two units above the 95th percentile for their ages. Two-thirds of the patients were female.

“These were very overweight teenagers,” Dr. Berkowitz noted, reporting that the population had a mean BMI of 36 kg/m

All the patients started the trial on 10 mg of sibutramine or placebo in the morning. If they had lost less than 10% of body weight at 6 months, the dose was increased to 15 mg. The regimen also included behavioral programs for all of the participants.

The patients on sibutramine reduced their BMI by 8.2% on average, with a mean absolute reduction of 2.9 kg/m

Changes in risk factors were more significant, Dr. Berkowitz reported at the meeting, which was cosponsored by the American Diabetes Association. The sibutramine arm had a 5.9% reduction in triglyceride, vs. a 9% elevation in the teenagers on placebo. HDL cholesterol increased 7% with sibutramine but stayed the same with placebo. Insulin levels went down 10.8% in the sibutramine arm, but rose 30.2% in the control group.

Systolic blood pressure and pulse rates were similar in the two groups, as were the rates of most adverse events (headaches and flu being the most frequent). Tachycardia was significantly greater with sibutramine: 13% vs. 6%.

Three-fourths of 368 teenagers on sibutramine completed the study, but less than two-thirds of 130 in the placebo group continued to the end, perhaps because of dissatisfaction with the amount of weight loss. Only 5% of the sibutramine arm and 6% of the control group withdrew because of adverse events.

Pending Food and Drug Administration review of data from the study, Dr. Berkowitz said physicians might consider using sibutramine off label in obese teenagers with serious medical problems. He cautioned, however, that physicians should be very careful to use it as indicated in the labeling for adults.

Dr. Berkowitz received grant support from and is a consultant to and advisory board member of Abbott Laboratories, which markets sibutramine.

LAS VEGAS — Sibutramine (Meridia) enabled obese adolescents to shed weight and improve obesity-related risk factors in a 12-month, randomized, double-blind, placebo-controlled trial.

The proportion of teenagers who lost at least 5% of body mass index (BMI) was more than three times greater in the sibutramine group compared with the control group—62% vs. 18%, Robert I. Berkowitz, M.D., reported at the annual meeting of North American Association for the Study of Obesity. When BMI loss of 10% or more was tallied, the sibutramine advantage was 39% vs. 6% of the patients.

Along with declines in glucose, insulin, and triglyceride levels, sibutramine helped the teenagers improve their psychological and emotional well-being and their school and social functioning, said Dr. Berkowitz, psychiatrist-in-chief at Children's Hospital of Philadelphia's behavioral health center.

“The improvements were significantly greater in the sibutramine group than in the placebo group,” he said.

Few long-term studies have addressed adolescent obesity. Mainly they have looked at behavioral changes in diet and exercise. “Most report a loss of only 1–4 kg, with participants still overweight at the end of the study,” Dr. Berkowitz said.

Sibutramine is not approved for patients under age 16.

The trial enrolled 498 patients aged 12 to 16 years (mean age 13.6 years), who had a BMI two units above the 95th percentile for their ages. Two-thirds of the patients were female.

“These were very overweight teenagers,” Dr. Berkowitz noted, reporting that the population had a mean BMI of 36 kg/m

All the patients started the trial on 10 mg of sibutramine or placebo in the morning. If they had lost less than 10% of body weight at 6 months, the dose was increased to 15 mg. The regimen also included behavioral programs for all of the participants.

The patients on sibutramine reduced their BMI by 8.2% on average, with a mean absolute reduction of 2.9 kg/m

Changes in risk factors were more significant, Dr. Berkowitz reported at the meeting, which was cosponsored by the American Diabetes Association. The sibutramine arm had a 5.9% reduction in triglyceride, vs. a 9% elevation in the teenagers on placebo. HDL cholesterol increased 7% with sibutramine but stayed the same with placebo. Insulin levels went down 10.8% in the sibutramine arm, but rose 30.2% in the control group.

Systolic blood pressure and pulse rates were similar in the two groups, as were the rates of most adverse events (headaches and flu being the most frequent). Tachycardia was significantly greater with sibutramine: 13% vs. 6%.

Three-fourths of 368 teenagers on sibutramine completed the study, but less than two-thirds of 130 in the placebo group continued to the end, perhaps because of dissatisfaction with the amount of weight loss. Only 5% of the sibutramine arm and 6% of the control group withdrew because of adverse events.

Pending Food and Drug Administration review of data from the study, Dr. Berkowitz said physicians might consider using sibutramine off label in obese teenagers with serious medical problems. He cautioned, however, that physicians should be very careful to use it as indicated in the labeling for adults.

Dr. Berkowitz received grant support from and is a consultant to and advisory board member of Abbott Laboratories, which markets sibutramine.

LAS VEGAS — Sibutramine (Meridia) enabled obese adolescents to shed weight and improve obesity-related risk factors in a 12-month, randomized, double-blind, placebo-controlled trial.

The proportion of teenagers who lost at least 5% of body mass index (BMI) was more than three times greater in the sibutramine group compared with the control group—62% vs. 18%, Robert I. Berkowitz, M.D., reported at the annual meeting of North American Association for the Study of Obesity. When BMI loss of 10% or more was tallied, the sibutramine advantage was 39% vs. 6% of the patients.

Along with declines in glucose, insulin, and triglyceride levels, sibutramine helped the teenagers improve their psychological and emotional well-being and their school and social functioning, said Dr. Berkowitz, psychiatrist-in-chief at Children's Hospital of Philadelphia's behavioral health center.

“The improvements were significantly greater in the sibutramine group than in the placebo group,” he said.

Few long-term studies have addressed adolescent obesity. Mainly they have looked at behavioral changes in diet and exercise. “Most report a loss of only 1–4 kg, with participants still overweight at the end of the study,” Dr. Berkowitz said.

Sibutramine is not approved for patients under age 16.

The trial enrolled 498 patients aged 12 to 16 years (mean age 13.6 years), who had a BMI two units above the 95th percentile for their ages. Two-thirds of the patients were female.

“These were very overweight teenagers,” Dr. Berkowitz noted, reporting that the population had a mean BMI of 36 kg/m

All the patients started the trial on 10 mg of sibutramine or placebo in the morning. If they had lost less than 10% of body weight at 6 months, the dose was increased to 15 mg. The regimen also included behavioral programs for all of the participants.

The patients on sibutramine reduced their BMI by 8.2% on average, with a mean absolute reduction of 2.9 kg/m

Changes in risk factors were more significant, Dr. Berkowitz reported at the meeting, which was cosponsored by the American Diabetes Association. The sibutramine arm had a 5.9% reduction in triglyceride, vs. a 9% elevation in the teenagers on placebo. HDL cholesterol increased 7% with sibutramine but stayed the same with placebo. Insulin levels went down 10.8% in the sibutramine arm, but rose 30.2% in the control group.

Systolic blood pressure and pulse rates were similar in the two groups, as were the rates of most adverse events (headaches and flu being the most frequent). Tachycardia was significantly greater with sibutramine: 13% vs. 6%.

Three-fourths of 368 teenagers on sibutramine completed the study, but less than two-thirds of 130 in the placebo group continued to the end, perhaps because of dissatisfaction with the amount of weight loss. Only 5% of the sibutramine arm and 6% of the control group withdrew because of adverse events.

Pending Food and Drug Administration review of data from the study, Dr. Berkowitz said physicians might consider using sibutramine off label in obese teenagers with serious medical problems. He cautioned, however, that physicians should be very careful to use it as indicated in the labeling for adults.

Dr. Berkowitz received grant support from and is a consultant to and advisory board member of Abbott Laboratories, which markets sibutramine.

LAS VEGAS — Laparoscopic gastric band bypass produced significantly better outcomes for weight loss, health, and quality of life without sacrificing safety in a randomized, controlled trial comparing surgery with medical treatment for mild to moderate obesity.

At 2 years of follow-up, surgical patients had lost more excess weight (68%) than patients given individualized medical care (17%), Paul E. O'Brien, M.D., reported at the annual meeting of the North American Association for the Study of Obesity.

The trial included 80 patients, mean age 41 years, of whom 40 were randomized to surgery and 40 to medical care. At the outset, 38% of each group had metabolic syndrome. At 2 years' follow-up, all surgical patients except one were free of metabolic syndrome, whereas 24% of the medical patients still met criteria for the constellation of disorders.

Medical and surgical patients alike lost 45% of their excess weight in the first 6 months of the study. Over time, however, the medical patients began to gain weight, while the surgical patients continued to lose; they were still shedding pounds at the end of 2 years.

Despite the disparity in results, Dr. O'Brien characterized the medical group's average loss of 17% of their excess weight over 2 years as “still quite a reasonable outcome for this group of patients.”

The surgical patients reported better quality-of-life outcomes on the SF-36 questionnaire. They showed significant improvement in all eight subscales, whereas the medical patients did so in only three: physical functioning, vitality, and mental health.

The medical treatment was primarily a very-low-calorie diet, with counseling, exercise, and a behavioral therapy program. Although orlistat (Xenical) was prescribed, Dr. O'Brien minimized its role, characterizing compliance as “touchy.”

“We feel it's time that health administrators, insurers, physicians, and surgeons recognize the effectiveness of bariatric surgery for this most common and most lethal of our health problems,” said Dr. O'Brien, a surgeon at Monash University in Victoria, Australia, where the study was conducted.

The investigators found no difference in adverse events between the medical and surgical patients. Eight medical patients could not tolerate orlistat or another medication prescribed as part of their regimen, Dr. O'Brien said.

No major surgical complications occurred, but one surgical patient had a transient port infection, and four had to have their bands adjusted because of posterior prolapse. Four medical patients and one surgical patient underwent cholecystectomy for acute cholecystitis.

Participants had to agree to accept randomization before entering the trial; Dr. O'Brien said none were allowed to choose between medical and surgical care. Nonetheless, one man in the surgical group backed out on the eve of surgery, and five medical patients withdrew during the study.

In each case, Dr. O'Brien said the patient's last clinical measures were carried forward in the intent-to-treat analysis presented at the meeting, which was cosponsored by the American Diabetes Association.

None of the patients met U.S. National Institutes of Health criteria for gastric bypass surgery, which specify that the surgery can be considered in motivated patients with severe obesity (body mass index greater than 40 kg/m

A randomized trial would not have been ethical had the patients been more obese, Dr. O'Brien pointed out.

“Ethically, I couldn't look someone in the eye with a BMI of 36 and say medical therapy might just work as well as surgery,” he said, “whereas 30–35 is a gray zone in our thinking.”

In an interview, Dr. O'Brien predicted that the laparoscopic gastric band procedure would be standard for patients with mild to moderate obesity in 5–10 years. First, he said, advocates must balance the costs of surgery against the costs of continuing to treat diabetes and the other conditions that make up metabolic syndrome.

The investigators did not build an economic analysis into this trial, but Dr. O'Brien said they have begun doing such studies. “It frightens administrators to think everybody is going to need to have surgery,” he said. “I think that might be cost effective, though.”

LAS VEGAS — Laparoscopic gastric band bypass produced significantly better outcomes for weight loss, health, and quality of life without sacrificing safety in a randomized, controlled trial comparing surgery with medical treatment for mild to moderate obesity.

At 2 years of follow-up, surgical patients had lost more excess weight (68%) than patients given individualized medical care (17%), Paul E. O'Brien, M.D., reported at the annual meeting of the North American Association for the Study of Obesity.

The trial included 80 patients, mean age 41 years, of whom 40 were randomized to surgery and 40 to medical care. At the outset, 38% of each group had metabolic syndrome. At 2 years' follow-up, all surgical patients except one were free of metabolic syndrome, whereas 24% of the medical patients still met criteria for the constellation of disorders.

Medical and surgical patients alike lost 45% of their excess weight in the first 6 months of the study. Over time, however, the medical patients began to gain weight, while the surgical patients continued to lose; they were still shedding pounds at the end of 2 years.

Despite the disparity in results, Dr. O'Brien characterized the medical group's average loss of 17% of their excess weight over 2 years as “still quite a reasonable outcome for this group of patients.”

The surgical patients reported better quality-of-life outcomes on the SF-36 questionnaire. They showed significant improvement in all eight subscales, whereas the medical patients did so in only three: physical functioning, vitality, and mental health.

The medical treatment was primarily a very-low-calorie diet, with counseling, exercise, and a behavioral therapy program. Although orlistat (Xenical) was prescribed, Dr. O'Brien minimized its role, characterizing compliance as “touchy.”

“We feel it's time that health administrators, insurers, physicians, and surgeons recognize the effectiveness of bariatric surgery for this most common and most lethal of our health problems,” said Dr. O'Brien, a surgeon at Monash University in Victoria, Australia, where the study was conducted.

The investigators found no difference in adverse events between the medical and surgical patients. Eight medical patients could not tolerate orlistat or another medication prescribed as part of their regimen, Dr. O'Brien said.

No major surgical complications occurred, but one surgical patient had a transient port infection, and four had to have their bands adjusted because of posterior prolapse. Four medical patients and one surgical patient underwent cholecystectomy for acute cholecystitis.

Participants had to agree to accept randomization before entering the trial; Dr. O'Brien said none were allowed to choose between medical and surgical care. Nonetheless, one man in the surgical group backed out on the eve of surgery, and five medical patients withdrew during the study.

In each case, Dr. O'Brien said the patient's last clinical measures were carried forward in the intent-to-treat analysis presented at the meeting, which was cosponsored by the American Diabetes Association.

None of the patients met U.S. National Institutes of Health criteria for gastric bypass surgery, which specify that the surgery can be considered in motivated patients with severe obesity (body mass index greater than 40 kg/m

A randomized trial would not have been ethical had the patients been more obese, Dr. O'Brien pointed out.

“Ethically, I couldn't look someone in the eye with a BMI of 36 and say medical therapy might just work as well as surgery,” he said, “whereas 30–35 is a gray zone in our thinking.”

In an interview, Dr. O'Brien predicted that the laparoscopic gastric band procedure would be standard for patients with mild to moderate obesity in 5–10 years. First, he said, advocates must balance the costs of surgery against the costs of continuing to treat diabetes and the other conditions that make up metabolic syndrome.

The investigators did not build an economic analysis into this trial, but Dr. O'Brien said they have begun doing such studies. “It frightens administrators to think everybody is going to need to have surgery,” he said. “I think that might be cost effective, though.”

LAS VEGAS — Laparoscopic gastric band bypass produced significantly better outcomes for weight loss, health, and quality of life without sacrificing safety in a randomized, controlled trial comparing surgery with medical treatment for mild to moderate obesity.

At 2 years of follow-up, surgical patients had lost more excess weight (68%) than patients given individualized medical care (17%), Paul E. O'Brien, M.D., reported at the annual meeting of the North American Association for the Study of Obesity.

The trial included 80 patients, mean age 41 years, of whom 40 were randomized to surgery and 40 to medical care. At the outset, 38% of each group had metabolic syndrome. At 2 years' follow-up, all surgical patients except one were free of metabolic syndrome, whereas 24% of the medical patients still met criteria for the constellation of disorders.

Medical and surgical patients alike lost 45% of their excess weight in the first 6 months of the study. Over time, however, the medical patients began to gain weight, while the surgical patients continued to lose; they were still shedding pounds at the end of 2 years.

Despite the disparity in results, Dr. O'Brien characterized the medical group's average loss of 17% of their excess weight over 2 years as “still quite a reasonable outcome for this group of patients.”

The surgical patients reported better quality-of-life outcomes on the SF-36 questionnaire. They showed significant improvement in all eight subscales, whereas the medical patients did so in only three: physical functioning, vitality, and mental health.

The medical treatment was primarily a very-low-calorie diet, with counseling, exercise, and a behavioral therapy program. Although orlistat (Xenical) was prescribed, Dr. O'Brien minimized its role, characterizing compliance as “touchy.”

“We feel it's time that health administrators, insurers, physicians, and surgeons recognize the effectiveness of bariatric surgery for this most common and most lethal of our health problems,” said Dr. O'Brien, a surgeon at Monash University in Victoria, Australia, where the study was conducted.

The investigators found no difference in adverse events between the medical and surgical patients. Eight medical patients could not tolerate orlistat or another medication prescribed as part of their regimen, Dr. O'Brien said.

No major surgical complications occurred, but one surgical patient had a transient port infection, and four had to have their bands adjusted because of posterior prolapse. Four medical patients and one surgical patient underwent cholecystectomy for acute cholecystitis.

Participants had to agree to accept randomization before entering the trial; Dr. O'Brien said none were allowed to choose between medical and surgical care. Nonetheless, one man in the surgical group backed out on the eve of surgery, and five medical patients withdrew during the study.

In each case, Dr. O'Brien said the patient's last clinical measures were carried forward in the intent-to-treat analysis presented at the meeting, which was cosponsored by the American Diabetes Association.

None of the patients met U.S. National Institutes of Health criteria for gastric bypass surgery, which specify that the surgery can be considered in motivated patients with severe obesity (body mass index greater than 40 kg/m

A randomized trial would not have been ethical had the patients been more obese, Dr. O'Brien pointed out.

“Ethically, I couldn't look someone in the eye with a BMI of 36 and say medical therapy might just work as well as surgery,” he said, “whereas 30–35 is a gray zone in our thinking.”

In an interview, Dr. O'Brien predicted that the laparoscopic gastric band procedure would be standard for patients with mild to moderate obesity in 5–10 years. First, he said, advocates must balance the costs of surgery against the costs of continuing to treat diabetes and the other conditions that make up metabolic syndrome.

The investigators did not build an economic analysis into this trial, but Dr. O'Brien said they have begun doing such studies. “It frightens administrators to think everybody is going to need to have surgery,” he said. “I think that might be cost effective, though.”

LAS VEGAS — Laparoscopic gastric band bypass produced significantly better outcomes for weight loss, health, and quality of life without sacrificing safety in a randomized, controlled trial comparing surgery with medical treatment for mild to moderate obesity.

At 2 years of follow-up, surgical patients had lost more excess weight (68%) than patients given individualized medical care (17%), Paul E. O'Brien, M.D., reported at the annual meeting of the North American Association for the Study of Obesity.

The trial included 80 patients, mean age 41 years, of whom 40 were randomized to surgery and 40 to medical care. At the outset, 38% of each group had metabolic syndrome. At 2 years' follow-up, all surgical patients but one were free of metabolic syndrome, while 24% of the medical patients still met criteria for the constellation of disorders.

Medical and surgical patients alike lost 45% of their excess weight in the first 6 months of the study. Over time, however, the medical patients began to gain weight, while the surgical patients continued to lose throughout the 2-years of follow-up.

Despite the disparity in results, Dr. O'Brien characterized the medical group's average loss of 17% of their excess weight over 2 years as “still quite a reasonable outcome for this group of patients.”

The surgical patients reported better quality-of-life outcomes on the SF-36 questionnaire. They showed significant improvement in all eight subscales, whereas the medical patients did so in three: physical functioning, vitality, and mental health.

The medical treatment was primarily a very-low-calorie diet, with counseling, exercise, and a behavioral therapy program. Although orlistat (Xenical) was prescribed, Dr. O'Brien minimized its role, characterizing compliance as “touchy.”

“We feel it's time that health administrators, insurers, physicians, and surgeons recognize the effectiveness of bariatric surgery for this most common and most lethal of our health problems,” said Dr. O'Brien, a surgeon at Monash University in Victoria, Australia, where the study was conducted.

The investigators found no difference in adverse events between the medical and surgical patients. Eight medical patients could not tolerate orlistat or another medication prescribed as part of their regimen, Dr. O'Brien said.

No major surgical complications occurred, but one surgical patient had a transient port infection, and four had to have their bands adjusted because of posterior prolapse. Four medical patients and one surgical patient underwent cholecystectomy for acute cholecystitis.

Participants had to agree to accept randomization before entering the trial; Dr. O'Brien said that none were allowed to choose between medical and surgical care. One man in the surgical group backed out on the eve of surgery, and five medical patients withdrew during the study.

In each case, Dr. O'Brien said the patient's last clinical measures were carried forward in the intent-to-treat analysis presented at the meeting, cosponsored by the American Diabetes Association.

None of the patients met National Institutes of Health criteria for gastric bypass surgery, which specify that the surgery can be considered in motivated patients with severe obesity (body mass index [BMI] greater than 40 kg/m2) or in patients with less severe obesity (BMI greater than 35 kg/m2) who have high-risk comorbid conditions. The average BMI of the study patients was 33 kg/m2, with a range of 30 to 35 kg/m2.

A randomized trial would not have been ethical had the patients been more obese, Dr. O'Brien said. “Ethically, I couldn't look someone in the eye with a BMI of 36 and say medical therapy might just work as well as surgery,” he said, “whereas 30 to 35 is a gray zone in our thinking.”

In an interview, Dr. O'Brien predicted that the laparoscopic gastric band procedure would be standard for patients with mild to moderate obesity in 5-10 years. First, he said, advocates must balance the costs of surgery against the costs of continuing to treat diabetes and the other conditions of metabolic syndrome.

LAS VEGAS — Laparoscopic gastric band bypass produced significantly better outcomes for weight loss, health, and quality of life without sacrificing safety in a randomized, controlled trial comparing surgery with medical treatment for mild to moderate obesity.

At 2 years of follow-up, surgical patients had lost more excess weight (68%) than patients given individualized medical care (17%), Paul E. O'Brien, M.D., reported at the annual meeting of the North American Association for the Study of Obesity.

The trial included 80 patients, mean age 41 years, of whom 40 were randomized to surgery and 40 to medical care. At the outset, 38% of each group had metabolic syndrome. At 2 years' follow-up, all surgical patients but one were free of metabolic syndrome, while 24% of the medical patients still met criteria for the constellation of disorders.

Medical and surgical patients alike lost 45% of their excess weight in the first 6 months of the study. Over time, however, the medical patients began to gain weight, while the surgical patients continued to lose throughout the 2-years of follow-up.

Despite the disparity in results, Dr. O'Brien characterized the medical group's average loss of 17% of their excess weight over 2 years as “still quite a reasonable outcome for this group of patients.”

The surgical patients reported better quality-of-life outcomes on the SF-36 questionnaire. They showed significant improvement in all eight subscales, whereas the medical patients did so in three: physical functioning, vitality, and mental health.

The medical treatment was primarily a very-low-calorie diet, with counseling, exercise, and a behavioral therapy program. Although orlistat (Xenical) was prescribed, Dr. O'Brien minimized its role, characterizing compliance as “touchy.”

“We feel it's time that health administrators, insurers, physicians, and surgeons recognize the effectiveness of bariatric surgery for this most common and most lethal of our health problems,” said Dr. O'Brien, a surgeon at Monash University in Victoria, Australia, where the study was conducted.

The investigators found no difference in adverse events between the medical and surgical patients. Eight medical patients could not tolerate orlistat or another medication prescribed as part of their regimen, Dr. O'Brien said.

No major surgical complications occurred, but one surgical patient had a transient port infection, and four had to have their bands adjusted because of posterior prolapse. Four medical patients and one surgical patient underwent cholecystectomy for acute cholecystitis.

Participants had to agree to accept randomization before entering the trial; Dr. O'Brien said that none were allowed to choose between medical and surgical care. One man in the surgical group backed out on the eve of surgery, and five medical patients withdrew during the study.

In each case, Dr. O'Brien said the patient's last clinical measures were carried forward in the intent-to-treat analysis presented at the meeting, cosponsored by the American Diabetes Association.

None of the patients met National Institutes of Health criteria for gastric bypass surgery, which specify that the surgery can be considered in motivated patients with severe obesity (body mass index [BMI] greater than 40 kg/m2) or in patients with less severe obesity (BMI greater than 35 kg/m2) who have high-risk comorbid conditions. The average BMI of the study patients was 33 kg/m2, with a range of 30 to 35 kg/m2.

A randomized trial would not have been ethical had the patients been more obese, Dr. O'Brien said. “Ethically, I couldn't look someone in the eye with a BMI of 36 and say medical therapy might just work as well as surgery,” he said, “whereas 30 to 35 is a gray zone in our thinking.”

In an interview, Dr. O'Brien predicted that the laparoscopic gastric band procedure would be standard for patients with mild to moderate obesity in 5-10 years. First, he said, advocates must balance the costs of surgery against the costs of continuing to treat diabetes and the other conditions of metabolic syndrome.

LAS VEGAS — Laparoscopic gastric band bypass produced significantly better outcomes for weight loss, health, and quality of life without sacrificing safety in a randomized, controlled trial comparing surgery with medical treatment for mild to moderate obesity.

At 2 years of follow-up, surgical patients had lost more excess weight (68%) than patients given individualized medical care (17%), Paul E. O'Brien, M.D., reported at the annual meeting of the North American Association for the Study of Obesity.

The trial included 80 patients, mean age 41 years, of whom 40 were randomized to surgery and 40 to medical care. At the outset, 38% of each group had metabolic syndrome. At 2 years' follow-up, all surgical patients but one were free of metabolic syndrome, while 24% of the medical patients still met criteria for the constellation of disorders.

Medical and surgical patients alike lost 45% of their excess weight in the first 6 months of the study. Over time, however, the medical patients began to gain weight, while the surgical patients continued to lose throughout the 2-years of follow-up.

Despite the disparity in results, Dr. O'Brien characterized the medical group's average loss of 17% of their excess weight over 2 years as “still quite a reasonable outcome for this group of patients.”

The surgical patients reported better quality-of-life outcomes on the SF-36 questionnaire. They showed significant improvement in all eight subscales, whereas the medical patients did so in three: physical functioning, vitality, and mental health.

The medical treatment was primarily a very-low-calorie diet, with counseling, exercise, and a behavioral therapy program. Although orlistat (Xenical) was prescribed, Dr. O'Brien minimized its role, characterizing compliance as “touchy.”

“We feel it's time that health administrators, insurers, physicians, and surgeons recognize the effectiveness of bariatric surgery for this most common and most lethal of our health problems,” said Dr. O'Brien, a surgeon at Monash University in Victoria, Australia, where the study was conducted.

The investigators found no difference in adverse events between the medical and surgical patients. Eight medical patients could not tolerate orlistat or another medication prescribed as part of their regimen, Dr. O'Brien said.

No major surgical complications occurred, but one surgical patient had a transient port infection, and four had to have their bands adjusted because of posterior prolapse. Four medical patients and one surgical patient underwent cholecystectomy for acute cholecystitis.

Participants had to agree to accept randomization before entering the trial; Dr. O'Brien said that none were allowed to choose between medical and surgical care. One man in the surgical group backed out on the eve of surgery, and five medical patients withdrew during the study.

In each case, Dr. O'Brien said the patient's last clinical measures were carried forward in the intent-to-treat analysis presented at the meeting, cosponsored by the American Diabetes Association.

None of the patients met National Institutes of Health criteria for gastric bypass surgery, which specify that the surgery can be considered in motivated patients with severe obesity (body mass index [BMI] greater than 40 kg/m2) or in patients with less severe obesity (BMI greater than 35 kg/m2) who have high-risk comorbid conditions. The average BMI of the study patients was 33 kg/m2, with a range of 30 to 35 kg/m2.

A randomized trial would not have been ethical had the patients been more obese, Dr. O'Brien said. “Ethically, I couldn't look someone in the eye with a BMI of 36 and say medical therapy might just work as well as surgery,” he said, “whereas 30 to 35 is a gray zone in our thinking.”

In an interview, Dr. O'Brien predicted that the laparoscopic gastric band procedure would be standard for patients with mild to moderate obesity in 5-10 years. First, he said, advocates must balance the costs of surgery against the costs of continuing to treat diabetes and the other conditions of metabolic syndrome.

SANTA FE, N.M. — No treatment option for endometriosis is likely to provide permanent relief from pelvic pain, and patients should be warned accordingly before undergoing surgery for the condition, Stephen M. Cohen, M.D., advised.

“When we are going to do surgery on a patient who has this disease, we have to tell her, 'This is a chronic disease. I am there to make you feel better but not to cure you,'” he suggested at a conference on gynecologic surgery sponsored by Omnia Education.

“If they expect a cure, you will be the 14th doctor on the hit parade that the patient has gone to and been dissatisfied with,” warned Dr. Cohen, chief of the division of gynecology and director of women's minimal access surgery at Albany (N.Y.) Medical College.

Pain will recur in about a third of patients within 2 years of surgery. Pain and stage are unrelated, however, and the causes of endometriosis are unclear. “Stage I hurts as much as stage IV,” he said, reporting that the least pain is associated with black lesions, the worst with red lesions.

When a patient complains of pelvic pain, Dr. Cohen said that empiric therapy—“treating without looking”—is an option. A thorough work-up is essential, however, to rule out all other possible causes, including fibromyalgia and depression.

“In point of fact, you will be right in diagnosing endometriosis 75% of the time without putting the laparoscope in,” he said. “If you include infertility and pain, you will be right 85% of the time.”

The preferred medical treatment of endometriosis is leuprolide, but surgery can help some patients, according to Dr. Cohen. Conservative treatment with excision, ablation, or both can be undertaken when patients undergo diagnostic laparoscopy. The choice would depend on the surgeon's preference and experience.

Dr. Cohen cited mixed data on the effectiveness of adhesion excision. In his experience, he said, it helps patients who can point to the exact spot where the pain originates. “The ones that have diffuse adhesions don't seem to get better very often for any extended period of time,” he said. “Many patients that have adhesions never have pain.”

Presacral neurectomy is another option that might be helpful, Dr. Cohen said, but only for patients with pure midline pain or dysmenorrhea. Because as many as 9 out of 10 patients are likely to become constipated after this surgery, he recommended using it selectively.

He argued against laparoscopic uterosacral nerve ablation (LUNA), citing two studies that reported it had no effect on pelvic pain (Fertil. Steril. 1997;68:1070-4; Fertil. Steril. 1997;68:393-401). In one randomized controlled study of LUNA, significant differences favored the patients who had laser vaporization of endometriosis without LUNA.

Whatever surgery is done, Dr. Cohen said it should be conservative and should be followed immediately by treatment with a GnRH agonist. “If you do treat these patients with some form of [postoperative] medical therapy—progesterone, Danazol, Lupron—you won't reduce the recurrence of pain, but you will lengthen the time before recurrence takes place,” he said, citing a study showing dramatic differences over 2 years, compared with patients who had excision or ablation without postoperative medical therapy (Obstet. Gynecol. 2003;102:397-408).

SANTA FE, N.M. — No treatment option for endometriosis is likely to provide permanent relief from pelvic pain, and patients should be warned accordingly before undergoing surgery for the condition, Stephen M. Cohen, M.D., advised.

“When we are going to do surgery on a patient who has this disease, we have to tell her, 'This is a chronic disease. I am there to make you feel better but not to cure you,'” he suggested at a conference on gynecologic surgery sponsored by Omnia Education.

“If they expect a cure, you will be the 14th doctor on the hit parade that the patient has gone to and been dissatisfied with,” warned Dr. Cohen, chief of the division of gynecology and director of women's minimal access surgery at Albany (N.Y.) Medical College.

Pain will recur in about a third of patients within 2 years of surgery. Pain and stage are unrelated, however, and the causes of endometriosis are unclear. “Stage I hurts as much as stage IV,” he said, reporting that the least pain is associated with black lesions, the worst with red lesions.

When a patient complains of pelvic pain, Dr. Cohen said that empiric therapy—“treating without looking”—is an option. A thorough work-up is essential, however, to rule out all other possible causes, including fibromyalgia and depression.

“In point of fact, you will be right in diagnosing endometriosis 75% of the time without putting the laparoscope in,” he said. “If you include infertility and pain, you will be right 85% of the time.”

The preferred medical treatment of endometriosis is leuprolide, but surgery can help some patients, according to Dr. Cohen. Conservative treatment with excision, ablation, or both can be undertaken when patients undergo diagnostic laparoscopy. The choice would depend on the surgeon's preference and experience.

Dr. Cohen cited mixed data on the effectiveness of adhesion excision. In his experience, he said, it helps patients who can point to the exact spot where the pain originates. “The ones that have diffuse adhesions don't seem to get better very often for any extended period of time,” he said. “Many patients that have adhesions never have pain.”

Presacral neurectomy is another option that might be helpful, Dr. Cohen said, but only for patients with pure midline pain or dysmenorrhea. Because as many as 9 out of 10 patients are likely to become constipated after this surgery, he recommended using it selectively.

He argued against laparoscopic uterosacral nerve ablation (LUNA), citing two studies that reported it had no effect on pelvic pain (Fertil. Steril. 1997;68:1070-4; Fertil. Steril. 1997;68:393-401). In one randomized controlled study of LUNA, significant differences favored the patients who had laser vaporization of endometriosis without LUNA.

Whatever surgery is done, Dr. Cohen said it should be conservative and should be followed immediately by treatment with a GnRH agonist. “If you do treat these patients with some form of [postoperative] medical therapy—progesterone, Danazol, Lupron—you won't reduce the recurrence of pain, but you will lengthen the time before recurrence takes place,” he said, citing a study showing dramatic differences over 2 years, compared with patients who had excision or ablation without postoperative medical therapy (Obstet. Gynecol. 2003;102:397-408).

SANTA FE, N.M. — No treatment option for endometriosis is likely to provide permanent relief from pelvic pain, and patients should be warned accordingly before undergoing surgery for the condition, Stephen M. Cohen, M.D., advised.

“When we are going to do surgery on a patient who has this disease, we have to tell her, 'This is a chronic disease. I am there to make you feel better but not to cure you,'” he suggested at a conference on gynecologic surgery sponsored by Omnia Education.

“If they expect a cure, you will be the 14th doctor on the hit parade that the patient has gone to and been dissatisfied with,” warned Dr. Cohen, chief of the division of gynecology and director of women's minimal access surgery at Albany (N.Y.) Medical College.

Pain will recur in about a third of patients within 2 years of surgery. Pain and stage are unrelated, however, and the causes of endometriosis are unclear. “Stage I hurts as much as stage IV,” he said, reporting that the least pain is associated with black lesions, the worst with red lesions.

When a patient complains of pelvic pain, Dr. Cohen said that empiric therapy—“treating without looking”—is an option. A thorough work-up is essential, however, to rule out all other possible causes, including fibromyalgia and depression.

“In point of fact, you will be right in diagnosing endometriosis 75% of the time without putting the laparoscope in,” he said. “If you include infertility and pain, you will be right 85% of the time.”

The preferred medical treatment of endometriosis is leuprolide, but surgery can help some patients, according to Dr. Cohen. Conservative treatment with excision, ablation, or both can be undertaken when patients undergo diagnostic laparoscopy. The choice would depend on the surgeon's preference and experience.

Dr. Cohen cited mixed data on the effectiveness of adhesion excision. In his experience, he said, it helps patients who can point to the exact spot where the pain originates. “The ones that have diffuse adhesions don't seem to get better very often for any extended period of time,” he said. “Many patients that have adhesions never have pain.”

Presacral neurectomy is another option that might be helpful, Dr. Cohen said, but only for patients with pure midline pain or dysmenorrhea. Because as many as 9 out of 10 patients are likely to become constipated after this surgery, he recommended using it selectively.

He argued against laparoscopic uterosacral nerve ablation (LUNA), citing two studies that reported it had no effect on pelvic pain (Fertil. Steril. 1997;68:1070-4; Fertil. Steril. 1997;68:393-401). In one randomized controlled study of LUNA, significant differences favored the patients who had laser vaporization of endometriosis without LUNA.

Whatever surgery is done, Dr. Cohen said it should be conservative and should be followed immediately by treatment with a GnRH agonist. “If you do treat these patients with some form of [postoperative] medical therapy—progesterone, Danazol, Lupron—you won't reduce the recurrence of pain, but you will lengthen the time before recurrence takes place,” he said, citing a study showing dramatic differences over 2 years, compared with patients who had excision or ablation without postoperative medical therapy (Obstet. Gynecol. 2003;102:397-408).

LAS VEGAS — Adding a weight-loss medication to cognitive-behavioral therapy for binge eating disorder produced a higher remission rate and greater weight loss than cognitive-behavioral therapy alone in a randomized, double-blind, placebo-controlled trial.

More than a third (36%) of 25 obese binge eaters had a 5% weight loss with the combination of cognitive-behavioral therapy (CBT) and orlistat (Xenical), Carlos M. Grilo, Ph.D., reported at the annual meeting of North American Association for the Study of Obesity.

Fewer patients in the control group met the 5% standard for weight loss: only 8%, compared with the 36% of patients on combined therapy. The control group of 25 patients received CBT and a placebo.

Remission was achieved by nearly two-thirds (64%) of the combination therapy group during the 12-week study, and 52% were still in remission 3 months after the end of treatment, according to Dr. Grilo, director of the eating disorder program in the department of psychiatry at Yale University, New Haven.

In the control group, only 36% achieved remission, which was defined as no binge eating for at least 28 consecutive days.

The dosage of orlistat used in the combined therapy group was 120 mg, three times a day.

The average weight loss of 4·4 kg in the combined therapy group was small, but it was encouraging because helping binge eaters to achieve any degree of weight loss has been a major challenge. “This may appear modest, but with this patient group, it is a promising first step,” Dr. Grilo said at the meeting, which was cosponsored by the American Diabetes Association. The control group lost less weight on average—only 1·9 kg.

The Eating Disorder Examination interview was used to assess outcomes. After patients finished the program, they were encouraged to stay on a three-meal, three-snack-a-day regimen.

The trial enrolled 50 consecutive obese patients, mean age 47, who met strict criteria for binge eating. Predominantly white and female, the population averaged 13·5 binge-eating episodes per month and had an average body mass index of 36 kg/m2. Sixty percent had at least one additional psychiatric disorder, the most common of which was major depression.

“The severity of our patients is similar to most CBT trials and greater than most medication trials,” Dr. Grilo said. In both arms of the study, he noted, 78% of patients completed the treatment.

CBT was the same for both groups, and it consisted primarily of guided self-help with six individual meetings.

CBT has been the best-established treatment for binge eating to date, but it has produced modest results, according to Dr. Grilo.

“The cognitive-behavioral therapy guided self-help was given by specialists—doctoral-level research clinicians with experience in CBT as well as obesity and eating disorders,” Dr. Grilo said. “It's unknown whether similar outcomes would be seen with generalists.”

The approach needs to be extended to other patient groups, especially diabetic binge eaters who were excluded from the study, he said. Longer follow-up, as well as replication of the trial, is also needed.

LAS VEGAS — Adding a weight-loss medication to cognitive-behavioral therapy for binge eating disorder produced a higher remission rate and greater weight loss than cognitive-behavioral therapy alone in a randomized, double-blind, placebo-controlled trial.

More than a third (36%) of 25 obese binge eaters had a 5% weight loss with the combination of cognitive-behavioral therapy (CBT) and orlistat (Xenical), Carlos M. Grilo, Ph.D., reported at the annual meeting of North American Association for the Study of Obesity.

Fewer patients in the control group met the 5% standard for weight loss: only 8%, compared with the 36% of patients on combined therapy. The control group of 25 patients received CBT and a placebo.

Remission was achieved by nearly two-thirds (64%) of the combination therapy group during the 12-week study, and 52% were still in remission 3 months after the end of treatment, according to Dr. Grilo, director of the eating disorder program in the department of psychiatry at Yale University, New Haven.

In the control group, only 36% achieved remission, which was defined as no binge eating for at least 28 consecutive days.

The dosage of orlistat used in the combined therapy group was 120 mg, three times a day.

The average weight loss of 4·4 kg in the combined therapy group was small, but it was encouraging because helping binge eaters to achieve any degree of weight loss has been a major challenge. “This may appear modest, but with this patient group, it is a promising first step,” Dr. Grilo said at the meeting, which was cosponsored by the American Diabetes Association. The control group lost less weight on average—only 1·9 kg.

The Eating Disorder Examination interview was used to assess outcomes. After patients finished the program, they were encouraged to stay on a three-meal, three-snack-a-day regimen.

The trial enrolled 50 consecutive obese patients, mean age 47, who met strict criteria for binge eating. Predominantly white and female, the population averaged 13·5 binge-eating episodes per month and had an average body mass index of 36 kg/m2. Sixty percent had at least one additional psychiatric disorder, the most common of which was major depression.

“The severity of our patients is similar to most CBT trials and greater than most medication trials,” Dr. Grilo said. In both arms of the study, he noted, 78% of patients completed the treatment.

CBT was the same for both groups, and it consisted primarily of guided self-help with six individual meetings.

CBT has been the best-established treatment for binge eating to date, but it has produced modest results, according to Dr. Grilo.

“The cognitive-behavioral therapy guided self-help was given by specialists—doctoral-level research clinicians with experience in CBT as well as obesity and eating disorders,” Dr. Grilo said. “It's unknown whether similar outcomes would be seen with generalists.”

The approach needs to be extended to other patient groups, especially diabetic binge eaters who were excluded from the study, he said. Longer follow-up, as well as replication of the trial, is also needed.

LAS VEGAS — Adding a weight-loss medication to cognitive-behavioral therapy for binge eating disorder produced a higher remission rate and greater weight loss than cognitive-behavioral therapy alone in a randomized, double-blind, placebo-controlled trial.

More than a third (36%) of 25 obese binge eaters had a 5% weight loss with the combination of cognitive-behavioral therapy (CBT) and orlistat (Xenical), Carlos M. Grilo, Ph.D., reported at the annual meeting of North American Association for the Study of Obesity.

Fewer patients in the control group met the 5% standard for weight loss: only 8%, compared with the 36% of patients on combined therapy. The control group of 25 patients received CBT and a placebo.

Remission was achieved by nearly two-thirds (64%) of the combination therapy group during the 12-week study, and 52% were still in remission 3 months after the end of treatment, according to Dr. Grilo, director of the eating disorder program in the department of psychiatry at Yale University, New Haven.

In the control group, only 36% achieved remission, which was defined as no binge eating for at least 28 consecutive days.

The dosage of orlistat used in the combined therapy group was 120 mg, three times a day.

The average weight loss of 4·4 kg in the combined therapy group was small, but it was encouraging because helping binge eaters to achieve any degree of weight loss has been a major challenge. “This may appear modest, but with this patient group, it is a promising first step,” Dr. Grilo said at the meeting, which was cosponsored by the American Diabetes Association. The control group lost less weight on average—only 1·9 kg.

The Eating Disorder Examination interview was used to assess outcomes. After patients finished the program, they were encouraged to stay on a three-meal, three-snack-a-day regimen.

The trial enrolled 50 consecutive obese patients, mean age 47, who met strict criteria for binge eating. Predominantly white and female, the population averaged 13·5 binge-eating episodes per month and had an average body mass index of 36 kg/m2. Sixty percent had at least one additional psychiatric disorder, the most common of which was major depression.

“The severity of our patients is similar to most CBT trials and greater than most medication trials,” Dr. Grilo said. In both arms of the study, he noted, 78% of patients completed the treatment.

CBT was the same for both groups, and it consisted primarily of guided self-help with six individual meetings.

CBT has been the best-established treatment for binge eating to date, but it has produced modest results, according to Dr. Grilo.

“The cognitive-behavioral therapy guided self-help was given by specialists—doctoral-level research clinicians with experience in CBT as well as obesity and eating disorders,” Dr. Grilo said. “It's unknown whether similar outcomes would be seen with generalists.”

The approach needs to be extended to other patient groups, especially diabetic binge eaters who were excluded from the study, he said. Longer follow-up, as well as replication of the trial, is also needed.