Betsy Bates

TUCSON, ARIZ. — One woman in four suffers neuropathic injury to the levator ani with her first delivery, according to a novel study that used pre- and postpartum concentric needle electromyographic examinations to study muscle function.

Cesarean sections performed during labor were not protective in the study conducted by Dr. Alison C. Weidner and her associates at Duke University Medical Center and presented at the annual meeting of the Society of Gynecologic Surgeons.

Initial EMG studies were performed on 58 primiparous women during the early third trimester, providing baseline data on muscle function at four separate sites of the levator ani. A quantitative amplitude analysis provided data on muscle function at rest and during moderate and maximum voluntary contractions.

Information was collected on the subjects' labor and delivery patterns, and follow-up examinations were performed 6 weeks and 6 months post partum. The mean age of the subjects was 29 years, and their mean body mass index was 25 kg/m

Evidence of neuropathic injury was seen in 14 (24%) of 58 subjects at the 6-week examination and 17 (29%) of 58 at the 6-month examination, said Dr. Weidner, chief of the division of urogynecology at the Durham, N.C., institution. Some women who demonstrated neuropathic injury at 6 weeks were normal by 6 months, while a few who seemed normal at 6 weeks showed evidence of injury at 6 months.

Dr. Weidner said patterns of muscle recruitment in women who exhibited injury only at 6 months suggest that muscle atrophy takes time, and that the full extent of damage was not clear at the 6-week visit.

“My point is that all of the patients who had this pattern were actually suffering levator injury at the time of delivery,” although it could not be measured initially, she explained.

A close look at obstetric variables revealed findings that Dr. Weidner called “striking.”

For example, the 11 women who underwent a C-section during labor suffered injury rates equivalent to those seen in the 36 women who had spontaneous vaginal deliveries and nearly as high as the 8 who had operative vaginal deliveries.

Only the three women who had elective C-sections seemed to be spared significant levels of injury, with just one woman showing injury at one of the four levator ani sites measured at 6 months post partum.

That C-section was not protective in the context of labor surprised Dr. Weidner, since only 2 of those 11 patients progressed far enough in labor to push.

In addition, a shorter duration of epidural analgesia during labor and operative vaginal delivery were independently associated with a higher rate of injury in a logistic regression analysis.

TUCSON, ARIZ. — One woman in four suffers neuropathic injury to the levator ani with her first delivery, according to a novel study that used pre- and postpartum concentric needle electromyographic examinations to study muscle function.

Cesarean sections performed during labor were not protective in the study conducted by Dr. Alison C. Weidner and her associates at Duke University Medical Center and presented at the annual meeting of the Society of Gynecologic Surgeons.

Initial EMG studies were performed on 58 primiparous women during the early third trimester, providing baseline data on muscle function at four separate sites of the levator ani. A quantitative amplitude analysis provided data on muscle function at rest and during moderate and maximum voluntary contractions.

Information was collected on the subjects' labor and delivery patterns, and follow-up examinations were performed 6 weeks and 6 months post partum. The mean age of the subjects was 29 years, and their mean body mass index was 25 kg/m

Evidence of neuropathic injury was seen in 14 (24%) of 58 subjects at the 6-week examination and 17 (29%) of 58 at the 6-month examination, said Dr. Weidner, chief of the division of urogynecology at the Durham, N.C., institution. Some women who demonstrated neuropathic injury at 6 weeks were normal by 6 months, while a few who seemed normal at 6 weeks showed evidence of injury at 6 months.

Dr. Weidner said patterns of muscle recruitment in women who exhibited injury only at 6 months suggest that muscle atrophy takes time, and that the full extent of damage was not clear at the 6-week visit.

“My point is that all of the patients who had this pattern were actually suffering levator injury at the time of delivery,” although it could not be measured initially, she explained.

A close look at obstetric variables revealed findings that Dr. Weidner called “striking.”

For example, the 11 women who underwent a C-section during labor suffered injury rates equivalent to those seen in the 36 women who had spontaneous vaginal deliveries and nearly as high as the 8 who had operative vaginal deliveries.

Only the three women who had elective C-sections seemed to be spared significant levels of injury, with just one woman showing injury at one of the four levator ani sites measured at 6 months post partum.

That C-section was not protective in the context of labor surprised Dr. Weidner, since only 2 of those 11 patients progressed far enough in labor to push.

In addition, a shorter duration of epidural analgesia during labor and operative vaginal delivery were independently associated with a higher rate of injury in a logistic regression analysis.

TUCSON, ARIZ. — One woman in four suffers neuropathic injury to the levator ani with her first delivery, according to a novel study that used pre- and postpartum concentric needle electromyographic examinations to study muscle function.

Cesarean sections performed during labor were not protective in the study conducted by Dr. Alison C. Weidner and her associates at Duke University Medical Center and presented at the annual meeting of the Society of Gynecologic Surgeons.

Initial EMG studies were performed on 58 primiparous women during the early third trimester, providing baseline data on muscle function at four separate sites of the levator ani. A quantitative amplitude analysis provided data on muscle function at rest and during moderate and maximum voluntary contractions.

Information was collected on the subjects' labor and delivery patterns, and follow-up examinations were performed 6 weeks and 6 months post partum. The mean age of the subjects was 29 years, and their mean body mass index was 25 kg/m

Evidence of neuropathic injury was seen in 14 (24%) of 58 subjects at the 6-week examination and 17 (29%) of 58 at the 6-month examination, said Dr. Weidner, chief of the division of urogynecology at the Durham, N.C., institution. Some women who demonstrated neuropathic injury at 6 weeks were normal by 6 months, while a few who seemed normal at 6 weeks showed evidence of injury at 6 months.

Dr. Weidner said patterns of muscle recruitment in women who exhibited injury only at 6 months suggest that muscle atrophy takes time, and that the full extent of damage was not clear at the 6-week visit.

“My point is that all of the patients who had this pattern were actually suffering levator injury at the time of delivery,” although it could not be measured initially, she explained.

A close look at obstetric variables revealed findings that Dr. Weidner called “striking.”

For example, the 11 women who underwent a C-section during labor suffered injury rates equivalent to those seen in the 36 women who had spontaneous vaginal deliveries and nearly as high as the 8 who had operative vaginal deliveries.

Only the three women who had elective C-sections seemed to be spared significant levels of injury, with just one woman showing injury at one of the four levator ani sites measured at 6 months post partum.

That C-section was not protective in the context of labor surprised Dr. Weidner, since only 2 of those 11 patients progressed far enough in labor to push.

In addition, a shorter duration of epidural analgesia during labor and operative vaginal delivery were independently associated with a higher rate of injury in a logistic regression analysis.

SAN FRANCISCO — Colorectal cancer risk reduction has been found to be highly associated with the use of several over-the-counter and prescription drugs, as well as with exercise and consumption of vegetables, in a large ongoing chemoprevention study in Israel.

Low-dose aspirin and statins, for example, each appeared to be protective in the case-control Molecular Epidemiology of Colorectal Cancer (MECC) study.

Combined, the protective benefit of the two drugs appeared to be even more powerful, reducing by 60% the relative risk of colorectal cancer in healthy adults, said Dr. Gad Rennert, director of the CHS National Israeli Cancer Control Center in Haifa.

Case-control studies do not produce strong evidence of an association, as would be seen in a randomized, controlled trial, Dr. Rennert noted at a symposium sponsored by the American Society of Clinical Oncology. But large studies such as MECC can examine multiple potential contributors to cancer risk—factors that are common to many people in the population. Fairly good evidence of an association can be seen if there are sharp differences in factors such as lifestyle or prescribed drugs between controls and people diagnosed with cancer.

In the MECC study, there was a lower relative risk of colorectal cancer in people taking aspirin and other nonsteroidal anti-inflammatory drugs, statins, allopurinol, and thyroxine, compared with people who were not using such agents. Those interventions were associated with even greater reductions in relative risk in a high-risk group: carriers of the APC 11307K genetic mutation, which is linked to a twofold elevation in risk of colorectal cancer in Ashkenazi Jews. (See box.)

“We see strong associations with very narrow confidence intervals—pretty much the dream of an epidemiologist,” Dr. Rennert said. The largest risk reductions were seen among subjects who participated in sports, ate five or more vegetables a day, and took either a statin or an aspirin or NSAID daily. These subjects had a relative risk of colorectal cancer of 0.22—a reduction of nearly 80%, compared with people with none of these protective factors. In the high-risk group, the protective factors combined to confer an 84% reduction in risk.

Referring to colorectal cancer as “a highly preventable disease,” Dr. Rennert said the MECC findings might ultimately point to preventive strategies for healthy people and, especially, those at high risk for the disease. The MECC study is a collaboration between Dr. Stephen B. Gruber of the University of Michigan, Ann Arbor, and Dr. Rennert in Israel. The research is funded by the National Institutes of Health.

More than 6,000 subjects have been enrolled, with one control for each patient newly diagnosed with colorectal cancer. The study draws on clinical and pharmacy records, pathology reports, and biopsy studies, as well as thorough interviews covering lifestyle and nutrition issues.

Applying the findings to preventive efforts becomes tricky, since any intervention must be weighed against possible harm. “Side effects are extremely important when you're talking about healthy people,” he noted. In people with a high risk for colorectal cancer because of a personal or family history or genetic profile, the balance may tip more in favor of preventive intervention.

There is little hope of ever studying the preventive benefit of low-dose aspirin or statins in a randomized, placebo-controlled trial, Dr. Rennert said, because the drugs are so commonly used that it would be hard to enroll an unbiased sample and ensure that results were not contaminated.

But the “very strong evidence” in the MECC case-control study suggests that these agents, when used for other indications by a wide variety of people, may reduce colorectal cancer rates in the future.

“Time will say whether this is the case or not,” he said at the meeting, which was also sponsored by the American Gastroenterological Association, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

Low-dose aspirin and statins each appeared to be protective in the case-control study. DR. RENNERT

SAN FRANCISCO — Colorectal cancer risk reduction has been found to be highly associated with the use of several over-the-counter and prescription drugs, as well as with exercise and consumption of vegetables, in a large ongoing chemoprevention study in Israel.

Low-dose aspirin and statins, for example, each appeared to be protective in the case-control Molecular Epidemiology of Colorectal Cancer (MECC) study.

Combined, the protective benefit of the two drugs appeared to be even more powerful, reducing by 60% the relative risk of colorectal cancer in healthy adults, said Dr. Gad Rennert, director of the CHS National Israeli Cancer Control Center in Haifa.

Case-control studies do not produce strong evidence of an association, as would be seen in a randomized, controlled trial, Dr. Rennert noted at a symposium sponsored by the American Society of Clinical Oncology. But large studies such as MECC can examine multiple potential contributors to cancer risk—factors that are common to many people in the population. Fairly good evidence of an association can be seen if there are sharp differences in factors such as lifestyle or prescribed drugs between controls and people diagnosed with cancer.

In the MECC study, there was a lower relative risk of colorectal cancer in people taking aspirin and other nonsteroidal anti-inflammatory drugs, statins, allopurinol, and thyroxine, compared with people who were not using such agents. Those interventions were associated with even greater reductions in relative risk in a high-risk group: carriers of the APC 11307K genetic mutation, which is linked to a twofold elevation in risk of colorectal cancer in Ashkenazi Jews. (See box.)

“We see strong associations with very narrow confidence intervals—pretty much the dream of an epidemiologist,” Dr. Rennert said. The largest risk reductions were seen among subjects who participated in sports, ate five or more vegetables a day, and took either a statin or an aspirin or NSAID daily. These subjects had a relative risk of colorectal cancer of 0.22—a reduction of nearly 80%, compared with people with none of these protective factors. In the high-risk group, the protective factors combined to confer an 84% reduction in risk.

Referring to colorectal cancer as “a highly preventable disease,” Dr. Rennert said the MECC findings might ultimately point to preventive strategies for healthy people and, especially, those at high risk for the disease. The MECC study is a collaboration between Dr. Stephen B. Gruber of the University of Michigan, Ann Arbor, and Dr. Rennert in Israel. The research is funded by the National Institutes of Health.

More than 6,000 subjects have been enrolled, with one control for each patient newly diagnosed with colorectal cancer. The study draws on clinical and pharmacy records, pathology reports, and biopsy studies, as well as thorough interviews covering lifestyle and nutrition issues.

Applying the findings to preventive efforts becomes tricky, since any intervention must be weighed against possible harm. “Side effects are extremely important when you're talking about healthy people,” he noted. In people with a high risk for colorectal cancer because of a personal or family history or genetic profile, the balance may tip more in favor of preventive intervention.

There is little hope of ever studying the preventive benefit of low-dose aspirin or statins in a randomized, placebo-controlled trial, Dr. Rennert said, because the drugs are so commonly used that it would be hard to enroll an unbiased sample and ensure that results were not contaminated.

But the “very strong evidence” in the MECC case-control study suggests that these agents, when used for other indications by a wide variety of people, may reduce colorectal cancer rates in the future.

“Time will say whether this is the case or not,” he said at the meeting, which was also sponsored by the American Gastroenterological Association, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

Low-dose aspirin and statins each appeared to be protective in the case-control study. DR. RENNERT

SAN FRANCISCO — Colorectal cancer risk reduction has been found to be highly associated with the use of several over-the-counter and prescription drugs, as well as with exercise and consumption of vegetables, in a large ongoing chemoprevention study in Israel.

Low-dose aspirin and statins, for example, each appeared to be protective in the case-control Molecular Epidemiology of Colorectal Cancer (MECC) study.

Combined, the protective benefit of the two drugs appeared to be even more powerful, reducing by 60% the relative risk of colorectal cancer in healthy adults, said Dr. Gad Rennert, director of the CHS National Israeli Cancer Control Center in Haifa.

Case-control studies do not produce strong evidence of an association, as would be seen in a randomized, controlled trial, Dr. Rennert noted at a symposium sponsored by the American Society of Clinical Oncology. But large studies such as MECC can examine multiple potential contributors to cancer risk—factors that are common to many people in the population. Fairly good evidence of an association can be seen if there are sharp differences in factors such as lifestyle or prescribed drugs between controls and people diagnosed with cancer.

In the MECC study, there was a lower relative risk of colorectal cancer in people taking aspirin and other nonsteroidal anti-inflammatory drugs, statins, allopurinol, and thyroxine, compared with people who were not using such agents. Those interventions were associated with even greater reductions in relative risk in a high-risk group: carriers of the APC 11307K genetic mutation, which is linked to a twofold elevation in risk of colorectal cancer in Ashkenazi Jews. (See box.)

“We see strong associations with very narrow confidence intervals—pretty much the dream of an epidemiologist,” Dr. Rennert said. The largest risk reductions were seen among subjects who participated in sports, ate five or more vegetables a day, and took either a statin or an aspirin or NSAID daily. These subjects had a relative risk of colorectal cancer of 0.22—a reduction of nearly 80%, compared with people with none of these protective factors. In the high-risk group, the protective factors combined to confer an 84% reduction in risk.

Referring to colorectal cancer as “a highly preventable disease,” Dr. Rennert said the MECC findings might ultimately point to preventive strategies for healthy people and, especially, those at high risk for the disease. The MECC study is a collaboration between Dr. Stephen B. Gruber of the University of Michigan, Ann Arbor, and Dr. Rennert in Israel. The research is funded by the National Institutes of Health.

More than 6,000 subjects have been enrolled, with one control for each patient newly diagnosed with colorectal cancer. The study draws on clinical and pharmacy records, pathology reports, and biopsy studies, as well as thorough interviews covering lifestyle and nutrition issues.

Applying the findings to preventive efforts becomes tricky, since any intervention must be weighed against possible harm. “Side effects are extremely important when you're talking about healthy people,” he noted. In people with a high risk for colorectal cancer because of a personal or family history or genetic profile, the balance may tip more in favor of preventive intervention.

There is little hope of ever studying the preventive benefit of low-dose aspirin or statins in a randomized, placebo-controlled trial, Dr. Rennert said, because the drugs are so commonly used that it would be hard to enroll an unbiased sample and ensure that results were not contaminated.

But the “very strong evidence” in the MECC case-control study suggests that these agents, when used for other indications by a wide variety of people, may reduce colorectal cancer rates in the future.

“Time will say whether this is the case or not,” he said at the meeting, which was also sponsored by the American Gastroenterological Association, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

Low-dose aspirin and statins each appeared to be protective in the case-control study. DR. RENNERT

TUCSON, ARIZ. — Three studies presented at the annual meeting of the Society of Gynecologic Surgeons have begun to unravel the advantages and disadvantages of tension-free vaginal tape (TVT) and transobturator tape (TOT) procedures in patients with stress or mixed urinary incontinence.

The introduction of TVT sling procedures in the mid-1990s rapidly took hold worldwide as a simple, minimally invasive alternative to open or laparoscopic Burch colposuspension. They are now the most widely performed procedures in the United States for stress urinary incontinence.

The more recent entry into this arena of hammocklike procedures using TOT avoided the retropubic space and therefore offered a theoretical safety advantage over TVT procedures. Bladder perforation has been reported in as many as 6%–9% of TVT cases; bowel and vascular injuries are very rare but do occur, explained Dr. Matthew Barber of the Cleveland Clinic.

Few studies have directly compared the two approaches in terms of safety and efficacy, or to identify the best candidates for each procedure. The SGS meeting featured comparisons of the following:

▸ Perioperative complications and adverse events. Dr. Barber and associates reviewed safety in 205 patients who underwent a TOT and 213 who underwent a TVT procedure at the Cleveland Clinic between January 2003 and August 2005. Concurrent surgical procedures were performed in 72% of all subjects, but neither the number nor type of procedures differed between the two groups.

The most significant difference in perioperative complications was bladder injury, which occurred in 5.1% of women undergoing TVT and no patient undergoing TOT.

Voiding dysfunction was present in 8.9% of women following TVT surgery and 2.9% of women following TOT procedures. Anticholinergic medications were required beyond 6 weeks postsurgery in 14% of women in the TVT group and 6.3% of those in the TOT group.

Dr. Barber disclosed that he has received grant/research support from American Medical Systems and Eli Lilly, and two of his coinvestigators have served as consultants or received support from Gynecare, American Medical Systems, or Organogenesis, makers of products used in stress incontinence surgery.

▸ Efficacy in patients with borderline maximal urethral closure pressure. Dr. Jay-James Miller and associates at Northwestern University in Evanston, Ill., and Michigan State University in Flint noted that most TOT failures occur in patients with low maximal urethral closure pressures.

They therefore undertook a study of 14-week outcomes in 145 patients (85 who underwent TOT and 60 who underwent TVT), analyzing results based on a cutoff point of maximal urethral closure pressure of 42 cm H₂0 or less. With that threshold, the TOT procedure was six times more likely to fail in patients with a borderline maximal urethral closure pressure at baseline. Specifically, failure occurred in 7 of 37 patients meeting that definition who had TOT vs. 1 of 36 patients who had a TVT procedure.

Among all patients evaluated at 14 weeks, almost three times as many objective failures were seen with TOT: 8 of 77 vs. 2 of 58 with TVT.

Longer-term follow-up and a prospective randomized controlled trial would be helpful in determining whether this preliminary observation proves true, said Dr. Miller, a fellow at the Evanston Continence Center of Evanston Northwestern Healthcare. If so, routine preoperative evaluation of urethral function may be helpful during preoperative planning so that patients receive the most appropriate surgical procedure, said Dr. Miller.

Dr. Peter K. Sand, director of urogynecology at Evanston Northwestern Healthcare and an investigator on the study has been an advisor, investigator, and lecturer for American Medical Systems (AMS), which makes MONARC transobturator tape. AMS did not fund the study.

▸ Detrusor overactivity and urge incontinence following surgery. Dr. Sylvia M. Botros, also a fellow at Northwestern's Evanston Continence Center, presented a poster detailing postsurgical resolution rates of detrusor overactivity and subjective urge urinary incontinence (UUI) in 276 subjects with urodynamic stress or mixed urinary incontinence.

Patients underwent one of three procedures: TVT (n=99), SPARC (suprapubic arch sling, n=52), or TOT (N=125). Preoperatively, subjective UUI was reported by 66%, 61%, and 64%, and detrusor overactivity was present in 59%, 62%, and 66% of patients undergoing TVT, SPARC, or TOT.

“At 1 year, with follow-up ranging from 54% to 90% in the three groups, 85% Monarc [TOT] vs. 55% TVT vs. 60% SPARC subjectively had no UUI,” she said.

Patients in the TOT group had a very low rate of de novo UUI and were three times as likely to have resolution of presurgical UUI as those who underwent retropubic midurethral sling procedures.

“When adjusted for possible confounding factors, the Monarc significantly increased the chance of resolution of UUI over TVT (odds ratio 3.12) or SPARC (odds ratio 3.03) postoperatively.”

No differences were seen in detrusor overactivity resolution based on which procedure was performed.

Several of Dr. Botros's co-investigators disclosed consultant or investigator relationships with Boston Scientific or American Medical Systems, makers of TOT products.

Longer-term follow-up and a prospective, randomized controlled trial would be helpful. DR. MILLER

TUCSON, ARIZ. — Three studies presented at the annual meeting of the Society of Gynecologic Surgeons have begun to unravel the advantages and disadvantages of tension-free vaginal tape (TVT) and transobturator tape (TOT) procedures in patients with stress or mixed urinary incontinence.

The introduction of TVT sling procedures in the mid-1990s rapidly took hold worldwide as a simple, minimally invasive alternative to open or laparoscopic Burch colposuspension. They are now the most widely performed procedures in the United States for stress urinary incontinence.

The more recent entry into this arena of hammocklike procedures using TOT avoided the retropubic space and therefore offered a theoretical safety advantage over TVT procedures. Bladder perforation has been reported in as many as 6%–9% of TVT cases; bowel and vascular injuries are very rare but do occur, explained Dr. Matthew Barber of the Cleveland Clinic.

Few studies have directly compared the two approaches in terms of safety and efficacy, or to identify the best candidates for each procedure. The SGS meeting featured comparisons of the following:

▸ Perioperative complications and adverse events. Dr. Barber and associates reviewed safety in 205 patients who underwent a TOT and 213 who underwent a TVT procedure at the Cleveland Clinic between January 2003 and August 2005. Concurrent surgical procedures were performed in 72% of all subjects, but neither the number nor type of procedures differed between the two groups.

The most significant difference in perioperative complications was bladder injury, which occurred in 5.1% of women undergoing TVT and no patient undergoing TOT.

Voiding dysfunction was present in 8.9% of women following TVT surgery and 2.9% of women following TOT procedures. Anticholinergic medications were required beyond 6 weeks postsurgery in 14% of women in the TVT group and 6.3% of those in the TOT group.

Dr. Barber disclosed that he has received grant/research support from American Medical Systems and Eli Lilly, and two of his coinvestigators have served as consultants or received support from Gynecare, American Medical Systems, or Organogenesis, makers of products used in stress incontinence surgery.

▸ Efficacy in patients with borderline maximal urethral closure pressure. Dr. Jay-James Miller and associates at Northwestern University in Evanston, Ill., and Michigan State University in Flint noted that most TOT failures occur in patients with low maximal urethral closure pressures.

They therefore undertook a study of 14-week outcomes in 145 patients (85 who underwent TOT and 60 who underwent TVT), analyzing results based on a cutoff point of maximal urethral closure pressure of 42 cm H₂0 or less. With that threshold, the TOT procedure was six times more likely to fail in patients with a borderline maximal urethral closure pressure at baseline. Specifically, failure occurred in 7 of 37 patients meeting that definition who had TOT vs. 1 of 36 patients who had a TVT procedure.

Among all patients evaluated at 14 weeks, almost three times as many objective failures were seen with TOT: 8 of 77 vs. 2 of 58 with TVT.

Longer-term follow-up and a prospective randomized controlled trial would be helpful in determining whether this preliminary observation proves true, said Dr. Miller, a fellow at the Evanston Continence Center of Evanston Northwestern Healthcare. If so, routine preoperative evaluation of urethral function may be helpful during preoperative planning so that patients receive the most appropriate surgical procedure, said Dr. Miller.

Dr. Peter K. Sand, director of urogynecology at Evanston Northwestern Healthcare and an investigator on the study has been an advisor, investigator, and lecturer for American Medical Systems (AMS), which makes MONARC transobturator tape. AMS did not fund the study.

▸ Detrusor overactivity and urge incontinence following surgery. Dr. Sylvia M. Botros, also a fellow at Northwestern's Evanston Continence Center, presented a poster detailing postsurgical resolution rates of detrusor overactivity and subjective urge urinary incontinence (UUI) in 276 subjects with urodynamic stress or mixed urinary incontinence.

Patients underwent one of three procedures: TVT (n=99), SPARC (suprapubic arch sling, n=52), or TOT (N=125). Preoperatively, subjective UUI was reported by 66%, 61%, and 64%, and detrusor overactivity was present in 59%, 62%, and 66% of patients undergoing TVT, SPARC, or TOT.

“At 1 year, with follow-up ranging from 54% to 90% in the three groups, 85% Monarc [TOT] vs. 55% TVT vs. 60% SPARC subjectively had no UUI,” she said.

Patients in the TOT group had a very low rate of de novo UUI and were three times as likely to have resolution of presurgical UUI as those who underwent retropubic midurethral sling procedures.

“When adjusted for possible confounding factors, the Monarc significantly increased the chance of resolution of UUI over TVT (odds ratio 3.12) or SPARC (odds ratio 3.03) postoperatively.”

No differences were seen in detrusor overactivity resolution based on which procedure was performed.

Several of Dr. Botros's co-investigators disclosed consultant or investigator relationships with Boston Scientific or American Medical Systems, makers of TOT products.

Longer-term follow-up and a prospective, randomized controlled trial would be helpful. DR. MILLER

TUCSON, ARIZ. — Three studies presented at the annual meeting of the Society of Gynecologic Surgeons have begun to unravel the advantages and disadvantages of tension-free vaginal tape (TVT) and transobturator tape (TOT) procedures in patients with stress or mixed urinary incontinence.

The introduction of TVT sling procedures in the mid-1990s rapidly took hold worldwide as a simple, minimally invasive alternative to open or laparoscopic Burch colposuspension. They are now the most widely performed procedures in the United States for stress urinary incontinence.

The more recent entry into this arena of hammocklike procedures using TOT avoided the retropubic space and therefore offered a theoretical safety advantage over TVT procedures. Bladder perforation has been reported in as many as 6%–9% of TVT cases; bowel and vascular injuries are very rare but do occur, explained Dr. Matthew Barber of the Cleveland Clinic.

Few studies have directly compared the two approaches in terms of safety and efficacy, or to identify the best candidates for each procedure. The SGS meeting featured comparisons of the following:

▸ Perioperative complications and adverse events. Dr. Barber and associates reviewed safety in 205 patients who underwent a TOT and 213 who underwent a TVT procedure at the Cleveland Clinic between January 2003 and August 2005. Concurrent surgical procedures were performed in 72% of all subjects, but neither the number nor type of procedures differed between the two groups.

The most significant difference in perioperative complications was bladder injury, which occurred in 5.1% of women undergoing TVT and no patient undergoing TOT.

Voiding dysfunction was present in 8.9% of women following TVT surgery and 2.9% of women following TOT procedures. Anticholinergic medications were required beyond 6 weeks postsurgery in 14% of women in the TVT group and 6.3% of those in the TOT group.

Dr. Barber disclosed that he has received grant/research support from American Medical Systems and Eli Lilly, and two of his coinvestigators have served as consultants or received support from Gynecare, American Medical Systems, or Organogenesis, makers of products used in stress incontinence surgery.

▸ Efficacy in patients with borderline maximal urethral closure pressure. Dr. Jay-James Miller and associates at Northwestern University in Evanston, Ill., and Michigan State University in Flint noted that most TOT failures occur in patients with low maximal urethral closure pressures.

They therefore undertook a study of 14-week outcomes in 145 patients (85 who underwent TOT and 60 who underwent TVT), analyzing results based on a cutoff point of maximal urethral closure pressure of 42 cm H₂0 or less. With that threshold, the TOT procedure was six times more likely to fail in patients with a borderline maximal urethral closure pressure at baseline. Specifically, failure occurred in 7 of 37 patients meeting that definition who had TOT vs. 1 of 36 patients who had a TVT procedure.

Among all patients evaluated at 14 weeks, almost three times as many objective failures were seen with TOT: 8 of 77 vs. 2 of 58 with TVT.

Longer-term follow-up and a prospective randomized controlled trial would be helpful in determining whether this preliminary observation proves true, said Dr. Miller, a fellow at the Evanston Continence Center of Evanston Northwestern Healthcare. If so, routine preoperative evaluation of urethral function may be helpful during preoperative planning so that patients receive the most appropriate surgical procedure, said Dr. Miller.

Dr. Peter K. Sand, director of urogynecology at Evanston Northwestern Healthcare and an investigator on the study has been an advisor, investigator, and lecturer for American Medical Systems (AMS), which makes MONARC transobturator tape. AMS did not fund the study.

▸ Detrusor overactivity and urge incontinence following surgery. Dr. Sylvia M. Botros, also a fellow at Northwestern's Evanston Continence Center, presented a poster detailing postsurgical resolution rates of detrusor overactivity and subjective urge urinary incontinence (UUI) in 276 subjects with urodynamic stress or mixed urinary incontinence.

Patients underwent one of three procedures: TVT (n=99), SPARC (suprapubic arch sling, n=52), or TOT (N=125). Preoperatively, subjective UUI was reported by 66%, 61%, and 64%, and detrusor overactivity was present in 59%, 62%, and 66% of patients undergoing TVT, SPARC, or TOT.

“At 1 year, with follow-up ranging from 54% to 90% in the three groups, 85% Monarc [TOT] vs. 55% TVT vs. 60% SPARC subjectively had no UUI,” she said.

Patients in the TOT group had a very low rate of de novo UUI and were three times as likely to have resolution of presurgical UUI as those who underwent retropubic midurethral sling procedures.

“When adjusted for possible confounding factors, the Monarc significantly increased the chance of resolution of UUI over TVT (odds ratio 3.12) or SPARC (odds ratio 3.03) postoperatively.”

No differences were seen in detrusor overactivity resolution based on which procedure was performed.

Several of Dr. Botros's co-investigators disclosed consultant or investigator relationships with Boston Scientific or American Medical Systems, makers of TOT products.

Longer-term follow-up and a prospective, randomized controlled trial would be helpful. DR. MILLER

TUCSON, ARIZ. — A randomized crossover trial suggests that symptom relief and satisfaction can be obtained by either of two commonly used pessary types, but that patient selection and patience are both key to success.

The multicenter study enrolled 134 women ages 30–89 (mean age 61) with symptomatic pelvic organ prolapse. They were randomized to be fitted with one of two types of pessary and to wear it, if possible, for 3 months before being switched to the other pessary design for 3 months.

Subjects could discontinue the use of either pessary at any time.

Indeed, only 62 of 134 subjects stayed in the study long enough to complete satisfaction scores on both types of pessaries and of those, just 22 were highly satisfied with both.

“Some could not be fitted. Some didn't like pessaries. Some had had enough of pessaries after one trial.

“The message I got was that pessaries aren't really for everyone. They really are for a subset of patients,” said Dr. Geoffrey W. Cundiff, professor of obstetrics and gynecology at Johns Hopkins School of Medicine in Baltimore.

Surprisingly, younger women were far less likely than their older counterparts to complete the trial comparing a ring pessary with support and a gellhorn pessary, reported Dr. Cundiff at the annual meeting of the Society of Gynecologic Surgeons.

Satisfaction rates were similar for the two pessary types, but there was a clear difference in the types of patients who preferred each design.

The 36 women who reported high satisfaction with the ring pessary were older and had weaker pelvic floor muscles. They were more likely to be nonwhite and to be more parous than those who preferred the gellhorn pessary.

Meanwhile, the 39 women who strongly preferred the gellhorn pessary were more likely to have anterior wall prolapse and less likely to have had a hysterectomy or prior prolapse surgery.

Refusal to wear a pessary for 3 months was significantly more common among younger women (mean age 57, compared with 66) and nonwhite women. The nine subjects who wore the pessaries but were dissatisfied with both were more likely to be white, have a history of prior prolapse surgery, and have stage II prolapse.

A subanalysis of the data demonstrated that patients who wore either pessary for 3 months experienced a significant reduction in lower urinary tract symptoms, particularly obstructive symptoms.

Among 97 patients who completed the Pelvic Floor Distress Inventory, no differences were seen in symptomatic relief offered by the ring or gellhorn pessaries, reported Dr. Joseph I. Schaffer, chief of gynecology at the University of Texas Southwestern Medical Center in Dallas.

Scores on the Obstructive/Discomfort subscale declined from a mean 20.32 at baseline to 8.61. Irritative subscale scores declined from a baseline mean of 15.85 to 10, and Stress subscale scores declined from 15.55 at baseline to 12.24.

On another measure, the Urinary Distress Inventory, scores improved from a baseline mean of 51.31 to 31.45.

“This study challenges commonly held beliefs regarding pessaries,” said Dr. Cundiff, and audience members agreed.

One attendee, Dr. Marc Toglia of Philadelphia, admitted the results “challenge my belief system.”

Both physicians acknowledged their surprise that so many women would find the gellhorn pessary preferable to a ring pessary, particularly if they had anterior wall prolapse.

A formal discussant on the study, Dr. Deborah Myers of Brown University School of Medicine in Providence, R.I., took note of the fact that a third of the patients required refitting of a pessary.

“This is important information for patients and physicians,” she said. “Don't give up on the first try.”

'This study challenges commonly held beliefs regarding pessaries.' DR. CUNDIFF

TUCSON, ARIZ. — A randomized crossover trial suggests that symptom relief and satisfaction can be obtained by either of two commonly used pessary types, but that patient selection and patience are both key to success.

The multicenter study enrolled 134 women ages 30–89 (mean age 61) with symptomatic pelvic organ prolapse. They were randomized to be fitted with one of two types of pessary and to wear it, if possible, for 3 months before being switched to the other pessary design for 3 months.

Subjects could discontinue the use of either pessary at any time.

Indeed, only 62 of 134 subjects stayed in the study long enough to complete satisfaction scores on both types of pessaries and of those, just 22 were highly satisfied with both.

“Some could not be fitted. Some didn't like pessaries. Some had had enough of pessaries after one trial.

“The message I got was that pessaries aren't really for everyone. They really are for a subset of patients,” said Dr. Geoffrey W. Cundiff, professor of obstetrics and gynecology at Johns Hopkins School of Medicine in Baltimore.

Surprisingly, younger women were far less likely than their older counterparts to complete the trial comparing a ring pessary with support and a gellhorn pessary, reported Dr. Cundiff at the annual meeting of the Society of Gynecologic Surgeons.

Satisfaction rates were similar for the two pessary types, but there was a clear difference in the types of patients who preferred each design.

The 36 women who reported high satisfaction with the ring pessary were older and had weaker pelvic floor muscles. They were more likely to be nonwhite and to be more parous than those who preferred the gellhorn pessary.

Meanwhile, the 39 women who strongly preferred the gellhorn pessary were more likely to have anterior wall prolapse and less likely to have had a hysterectomy or prior prolapse surgery.

Refusal to wear a pessary for 3 months was significantly more common among younger women (mean age 57, compared with 66) and nonwhite women. The nine subjects who wore the pessaries but were dissatisfied with both were more likely to be white, have a history of prior prolapse surgery, and have stage II prolapse.

A subanalysis of the data demonstrated that patients who wore either pessary for 3 months experienced a significant reduction in lower urinary tract symptoms, particularly obstructive symptoms.

Among 97 patients who completed the Pelvic Floor Distress Inventory, no differences were seen in symptomatic relief offered by the ring or gellhorn pessaries, reported Dr. Joseph I. Schaffer, chief of gynecology at the University of Texas Southwestern Medical Center in Dallas.

Scores on the Obstructive/Discomfort subscale declined from a mean 20.32 at baseline to 8.61. Irritative subscale scores declined from a baseline mean of 15.85 to 10, and Stress subscale scores declined from 15.55 at baseline to 12.24.

On another measure, the Urinary Distress Inventory, scores improved from a baseline mean of 51.31 to 31.45.

“This study challenges commonly held beliefs regarding pessaries,” said Dr. Cundiff, and audience members agreed.

One attendee, Dr. Marc Toglia of Philadelphia, admitted the results “challenge my belief system.”

Both physicians acknowledged their surprise that so many women would find the gellhorn pessary preferable to a ring pessary, particularly if they had anterior wall prolapse.

A formal discussant on the study, Dr. Deborah Myers of Brown University School of Medicine in Providence, R.I., took note of the fact that a third of the patients required refitting of a pessary.

“This is important information for patients and physicians,” she said. “Don't give up on the first try.”

'This study challenges commonly held beliefs regarding pessaries.' DR. CUNDIFF

TUCSON, ARIZ. — A randomized crossover trial suggests that symptom relief and satisfaction can be obtained by either of two commonly used pessary types, but that patient selection and patience are both key to success.

The multicenter study enrolled 134 women ages 30–89 (mean age 61) with symptomatic pelvic organ prolapse. They were randomized to be fitted with one of two types of pessary and to wear it, if possible, for 3 months before being switched to the other pessary design for 3 months.

Subjects could discontinue the use of either pessary at any time.

Indeed, only 62 of 134 subjects stayed in the study long enough to complete satisfaction scores on both types of pessaries and of those, just 22 were highly satisfied with both.

“Some could not be fitted. Some didn't like pessaries. Some had had enough of pessaries after one trial.

“The message I got was that pessaries aren't really for everyone. They really are for a subset of patients,” said Dr. Geoffrey W. Cundiff, professor of obstetrics and gynecology at Johns Hopkins School of Medicine in Baltimore.

Surprisingly, younger women were far less likely than their older counterparts to complete the trial comparing a ring pessary with support and a gellhorn pessary, reported Dr. Cundiff at the annual meeting of the Society of Gynecologic Surgeons.

Satisfaction rates were similar for the two pessary types, but there was a clear difference in the types of patients who preferred each design.

The 36 women who reported high satisfaction with the ring pessary were older and had weaker pelvic floor muscles. They were more likely to be nonwhite and to be more parous than those who preferred the gellhorn pessary.

Meanwhile, the 39 women who strongly preferred the gellhorn pessary were more likely to have anterior wall prolapse and less likely to have had a hysterectomy or prior prolapse surgery.

Refusal to wear a pessary for 3 months was significantly more common among younger women (mean age 57, compared with 66) and nonwhite women. The nine subjects who wore the pessaries but were dissatisfied with both were more likely to be white, have a history of prior prolapse surgery, and have stage II prolapse.

A subanalysis of the data demonstrated that patients who wore either pessary for 3 months experienced a significant reduction in lower urinary tract symptoms, particularly obstructive symptoms.

Among 97 patients who completed the Pelvic Floor Distress Inventory, no differences were seen in symptomatic relief offered by the ring or gellhorn pessaries, reported Dr. Joseph I. Schaffer, chief of gynecology at the University of Texas Southwestern Medical Center in Dallas.

Scores on the Obstructive/Discomfort subscale declined from a mean 20.32 at baseline to 8.61. Irritative subscale scores declined from a baseline mean of 15.85 to 10, and Stress subscale scores declined from 15.55 at baseline to 12.24.

On another measure, the Urinary Distress Inventory, scores improved from a baseline mean of 51.31 to 31.45.

“This study challenges commonly held beliefs regarding pessaries,” said Dr. Cundiff, and audience members agreed.

One attendee, Dr. Marc Toglia of Philadelphia, admitted the results “challenge my belief system.”

Both physicians acknowledged their surprise that so many women would find the gellhorn pessary preferable to a ring pessary, particularly if they had anterior wall prolapse.

A formal discussant on the study, Dr. Deborah Myers of Brown University School of Medicine in Providence, R.I., took note of the fact that a third of the patients required refitting of a pessary.

“This is important information for patients and physicians,” she said. “Don't give up on the first try.”

'This study challenges commonly held beliefs regarding pessaries.' DR. CUNDIFF

TUCSON, ARIZ. — One woman in four suffers neuropathic injury to the levator ani with her first delivery, according to a novel study that used pre- and postpartum concentric needle electromyographic examinations to study muscle function.

Cesarean sections performed during labor were not protective in the study conducted by Dr. Alison C. Weidner and her associates at Duke University Medical Center and presented at the annual meeting of the Society of Gynecologic Surgeons.

Initial EMG studies were performed on 58 primiparous women in the early third trimester, providing baseline data on muscle function at four separate sites of the levator ani. A quantitative amplitude analysis provided data on muscle function at rest and during moderate and maximum voluntary contractions.

Information was collected on the subjects' labor and delivery patterns, and follow-up examinations were performed 6 weeks and 6 months post partum.

The mean age of the subjects was 29 years, and their mean body mass index was 25 kg/m

Evidence of neuropathic injury was seen in 14 (24%) of 58 subjects at the 6-week examination and 17 (29%) of 58 at the 6-month examination, said Dr. Weidner, chief of the division of urogynecology at the Durham, N.C., institution.

Some women who demonstrated neuropathic injury at 6 weeks were normal by 6 months, while a few who seemed normal at 6 weeks showed evidence of injury at 6 months.

Dr. Weidner said patterns of muscle recruitment in women who exhibited injury only at 6 months suggest that muscle atrophy takes time, and that the full extent of damage was not clear at the 6-week visit.

“My point is that all of the patients who had this pattern were actually suffering levator injury at the time of delivery,” although it could not be measured initially, she explained.

A close look at obstetric variables revealed findings that Dr. Weidner called “striking.”

For example, the 11 women who underwent a C-section during labor suffered injury rates equivalent to those seen in the 36 women who had spontaneous vaginal deliveries and nearly as high as the 8 who had operative vaginal deliveries.

Only the three women who had elective C-sections seemed to be spared significant levels of injury, with just one woman showing injury at one of the four levator ani sites measured at 6 months post partum.

That C-section was not protective in the context of labor surprised Dr. Weidner, since only 2 of those 11 patients progressed far enough in labor to push.

Another interesting finding was the role of a prolonged second stage of labor in women who received epidural anesthesia, which has historically been assumed to lead to greater injury to the pelvic floor. In fact, a shorter duration of epidural analgesia during labor and operative vaginal delivery were independently associated with a higher rate of injury in a logistic regression analysis.

A formal discussant of Dr. Weidner's paper, Dr. Michael Aronson of the University of Massachusetts, Worcester, said the study constituted “a very important contribution to the literature” that may shed light on potentially modifiable mechanisms of injury during labor and delivery.

TUCSON, ARIZ. — One woman in four suffers neuropathic injury to the levator ani with her first delivery, according to a novel study that used pre- and postpartum concentric needle electromyographic examinations to study muscle function.

Cesarean sections performed during labor were not protective in the study conducted by Dr. Alison C. Weidner and her associates at Duke University Medical Center and presented at the annual meeting of the Society of Gynecologic Surgeons.

Initial EMG studies were performed on 58 primiparous women in the early third trimester, providing baseline data on muscle function at four separate sites of the levator ani. A quantitative amplitude analysis provided data on muscle function at rest and during moderate and maximum voluntary contractions.

Information was collected on the subjects' labor and delivery patterns, and follow-up examinations were performed 6 weeks and 6 months post partum.

The mean age of the subjects was 29 years, and their mean body mass index was 25 kg/m

Evidence of neuropathic injury was seen in 14 (24%) of 58 subjects at the 6-week examination and 17 (29%) of 58 at the 6-month examination, said Dr. Weidner, chief of the division of urogynecology at the Durham, N.C., institution.

Some women who demonstrated neuropathic injury at 6 weeks were normal by 6 months, while a few who seemed normal at 6 weeks showed evidence of injury at 6 months.

Dr. Weidner said patterns of muscle recruitment in women who exhibited injury only at 6 months suggest that muscle atrophy takes time, and that the full extent of damage was not clear at the 6-week visit.

“My point is that all of the patients who had this pattern were actually suffering levator injury at the time of delivery,” although it could not be measured initially, she explained.

A close look at obstetric variables revealed findings that Dr. Weidner called “striking.”

For example, the 11 women who underwent a C-section during labor suffered injury rates equivalent to those seen in the 36 women who had spontaneous vaginal deliveries and nearly as high as the 8 who had operative vaginal deliveries.

Only the three women who had elective C-sections seemed to be spared significant levels of injury, with just one woman showing injury at one of the four levator ani sites measured at 6 months post partum.

That C-section was not protective in the context of labor surprised Dr. Weidner, since only 2 of those 11 patients progressed far enough in labor to push.

Another interesting finding was the role of a prolonged second stage of labor in women who received epidural anesthesia, which has historically been assumed to lead to greater injury to the pelvic floor. In fact, a shorter duration of epidural analgesia during labor and operative vaginal delivery were independently associated with a higher rate of injury in a logistic regression analysis.

A formal discussant of Dr. Weidner's paper, Dr. Michael Aronson of the University of Massachusetts, Worcester, said the study constituted “a very important contribution to the literature” that may shed light on potentially modifiable mechanisms of injury during labor and delivery.

TUCSON, ARIZ. — One woman in four suffers neuropathic injury to the levator ani with her first delivery, according to a novel study that used pre- and postpartum concentric needle electromyographic examinations to study muscle function.

Cesarean sections performed during labor were not protective in the study conducted by Dr. Alison C. Weidner and her associates at Duke University Medical Center and presented at the annual meeting of the Society of Gynecologic Surgeons.

Initial EMG studies were performed on 58 primiparous women in the early third trimester, providing baseline data on muscle function at four separate sites of the levator ani. A quantitative amplitude analysis provided data on muscle function at rest and during moderate and maximum voluntary contractions.

Information was collected on the subjects' labor and delivery patterns, and follow-up examinations were performed 6 weeks and 6 months post partum.

The mean age of the subjects was 29 years, and their mean body mass index was 25 kg/m

Evidence of neuropathic injury was seen in 14 (24%) of 58 subjects at the 6-week examination and 17 (29%) of 58 at the 6-month examination, said Dr. Weidner, chief of the division of urogynecology at the Durham, N.C., institution.

Some women who demonstrated neuropathic injury at 6 weeks were normal by 6 months, while a few who seemed normal at 6 weeks showed evidence of injury at 6 months.

Dr. Weidner said patterns of muscle recruitment in women who exhibited injury only at 6 months suggest that muscle atrophy takes time, and that the full extent of damage was not clear at the 6-week visit.

“My point is that all of the patients who had this pattern were actually suffering levator injury at the time of delivery,” although it could not be measured initially, she explained.

A close look at obstetric variables revealed findings that Dr. Weidner called “striking.”

For example, the 11 women who underwent a C-section during labor suffered injury rates equivalent to those seen in the 36 women who had spontaneous vaginal deliveries and nearly as high as the 8 who had operative vaginal deliveries.

Only the three women who had elective C-sections seemed to be spared significant levels of injury, with just one woman showing injury at one of the four levator ani sites measured at 6 months post partum.

That C-section was not protective in the context of labor surprised Dr. Weidner, since only 2 of those 11 patients progressed far enough in labor to push.

Another interesting finding was the role of a prolonged second stage of labor in women who received epidural anesthesia, which has historically been assumed to lead to greater injury to the pelvic floor. In fact, a shorter duration of epidural analgesia during labor and operative vaginal delivery were independently associated with a higher rate of injury in a logistic regression analysis.

A formal discussant of Dr. Weidner's paper, Dr. Michael Aronson of the University of Massachusetts, Worcester, said the study constituted “a very important contribution to the literature” that may shed light on potentially modifiable mechanisms of injury during labor and delivery.

TUCSON, ARIZ. — The rate of anal sphincter laceration during vaginal delivery has declined sharply in recent years, paralleling modifications in obstetric practice, a University of Southern California study revealed.

Anal sphincter laceration occurred in 11.2% of vaginal deliveries at the colossal Los Angeles County/USC Medical Center in 1996, compared with 7.9% in 2004, with about a 6% reduction in risk every year after 1996, reported Dr. Steven Minaglia at the annual meeting of the Society of Gynecologic Surgeons.

“Changes in obstetric practice, such as the increase in cesarean section and the decrease in operative delivery and episiotomy, may have contributed to the dramatic reduction in sphincter laceration,” Dr. Minaglia said.

During the time period studied, episiotomies declined from 9% to 8% of vaginal deliveries, vacuum deliveries from 5.1% to 2.9%, and forceps deliveries from 1.7% to 0%. “Of note, the C-section rate went from 18.2% to 32.3%,” he said.

The retrospective study assessed characteristics in 1,703 patients who had an anal sphincter laceration and 14,964 who did not have such an injury, for a total of 16,667 singleton vaginal deliveries at greater than 20 weeks of gestation. Younger age, lower parity, and higher birth weight all were associated with a higher likelihood of an anal sphincter laceration.

Other important risk factors independently associated with a laceration included vacuum delivery (odds ratio 3.19), forceps delivery (OR 2.79), episiotomy (OR 1.36), shoulder dystocia (OR 2.03), and gestational age (OR 1.03, about a 4% increased risk for each week of gestation).

Dr. Minaglia, of the division of female pelvic medicine and reconstructive surgery, encouraged a further minimization of modifiable risk factors such as episiotomy and operative delivery to minimize long-term harm associated with sphincter laceration.

A second study presented at the meeting found similar risk factors at the University of New Mexico Hospital in Albuquerque, where episiotomy and operative vaginal delivery rates are 5%–25% lower than national rates.

The case-control study matched 350 women who sustained a third- or fourth-degree anal sphincter laceration to 716 women matched by gestational age and chronologic time of delivery who did not have a laceration.

The risk of an anal sphincter laceration increased with vacuum extraction (OR 5.96), forceps extraction (OR 11.05), and episiotomy (OR 2.34,); as well as maternal age (OR 1.09 per year); and infant weight (OR 1.09 per 100 g).

As in the USC study, multiparity was protective, reported Dr. Alana Williams and associates in a poster presentation.

TUCSON, ARIZ. — The rate of anal sphincter laceration during vaginal delivery has declined sharply in recent years, paralleling modifications in obstetric practice, a University of Southern California study revealed.

Anal sphincter laceration occurred in 11.2% of vaginal deliveries at the colossal Los Angeles County/USC Medical Center in 1996, compared with 7.9% in 2004, with about a 6% reduction in risk every year after 1996, reported Dr. Steven Minaglia at the annual meeting of the Society of Gynecologic Surgeons.

“Changes in obstetric practice, such as the increase in cesarean section and the decrease in operative delivery and episiotomy, may have contributed to the dramatic reduction in sphincter laceration,” Dr. Minaglia said.

During the time period studied, episiotomies declined from 9% to 8% of vaginal deliveries, vacuum deliveries from 5.1% to 2.9%, and forceps deliveries from 1.7% to 0%. “Of note, the C-section rate went from 18.2% to 32.3%,” he said.

The retrospective study assessed characteristics in 1,703 patients who had an anal sphincter laceration and 14,964 who did not have such an injury, for a total of 16,667 singleton vaginal deliveries at greater than 20 weeks of gestation. Younger age, lower parity, and higher birth weight all were associated with a higher likelihood of an anal sphincter laceration.

Other important risk factors independently associated with a laceration included vacuum delivery (odds ratio 3.19), forceps delivery (OR 2.79), episiotomy (OR 1.36), shoulder dystocia (OR 2.03), and gestational age (OR 1.03, about a 4% increased risk for each week of gestation).

Dr. Minaglia, of the division of female pelvic medicine and reconstructive surgery, encouraged a further minimization of modifiable risk factors such as episiotomy and operative delivery to minimize long-term harm associated with sphincter laceration.

A second study presented at the meeting found similar risk factors at the University of New Mexico Hospital in Albuquerque, where episiotomy and operative vaginal delivery rates are 5%–25% lower than national rates.

The case-control study matched 350 women who sustained a third- or fourth-degree anal sphincter laceration to 716 women matched by gestational age and chronologic time of delivery who did not have a laceration.

The risk of an anal sphincter laceration increased with vacuum extraction (OR 5.96), forceps extraction (OR 11.05), and episiotomy (OR 2.34,); as well as maternal age (OR 1.09 per year); and infant weight (OR 1.09 per 100 g).

As in the USC study, multiparity was protective, reported Dr. Alana Williams and associates in a poster presentation.

TUCSON, ARIZ. — The rate of anal sphincter laceration during vaginal delivery has declined sharply in recent years, paralleling modifications in obstetric practice, a University of Southern California study revealed.

Anal sphincter laceration occurred in 11.2% of vaginal deliveries at the colossal Los Angeles County/USC Medical Center in 1996, compared with 7.9% in 2004, with about a 6% reduction in risk every year after 1996, reported Dr. Steven Minaglia at the annual meeting of the Society of Gynecologic Surgeons.

“Changes in obstetric practice, such as the increase in cesarean section and the decrease in operative delivery and episiotomy, may have contributed to the dramatic reduction in sphincter laceration,” Dr. Minaglia said.

During the time period studied, episiotomies declined from 9% to 8% of vaginal deliveries, vacuum deliveries from 5.1% to 2.9%, and forceps deliveries from 1.7% to 0%. “Of note, the C-section rate went from 18.2% to 32.3%,” he said.

The retrospective study assessed characteristics in 1,703 patients who had an anal sphincter laceration and 14,964 who did not have such an injury, for a total of 16,667 singleton vaginal deliveries at greater than 20 weeks of gestation. Younger age, lower parity, and higher birth weight all were associated with a higher likelihood of an anal sphincter laceration.

Other important risk factors independently associated with a laceration included vacuum delivery (odds ratio 3.19), forceps delivery (OR 2.79), episiotomy (OR 1.36), shoulder dystocia (OR 2.03), and gestational age (OR 1.03, about a 4% increased risk for each week of gestation).

Dr. Minaglia, of the division of female pelvic medicine and reconstructive surgery, encouraged a further minimization of modifiable risk factors such as episiotomy and operative delivery to minimize long-term harm associated with sphincter laceration.

A second study presented at the meeting found similar risk factors at the University of New Mexico Hospital in Albuquerque, where episiotomy and operative vaginal delivery rates are 5%–25% lower than national rates.

The case-control study matched 350 women who sustained a third- or fourth-degree anal sphincter laceration to 716 women matched by gestational age and chronologic time of delivery who did not have a laceration.

The risk of an anal sphincter laceration increased with vacuum extraction (OR 5.96), forceps extraction (OR 11.05), and episiotomy (OR 2.34,); as well as maternal age (OR 1.09 per year); and infant weight (OR 1.09 per 100 g).

As in the USC study, multiparity was protective, reported Dr. Alana Williams and associates in a poster presentation.

LOS CABOS, MEXICO — Jet-black dots that resemble marks from a ballpoint pen may be an easily overlooked sign of basal cell carcinoma, Dr. Jennifer L. Vesper said at the annual meeting of the Noah Worcester Dermatological Society.

Dr. Vesper first noticed the tiny black dots on a 51-year-old female patient's forehead in the vicinity of a suspicious lesion that turned out to be basal cell carcinoma (BCC).

Once she was attuned to looking for them, she began to notice the dots on other patients as well.

“I came to realize even a focus of black pigment, often showing up as a very dark black dot, may be the first sign of basal cell carcinoma,” she said.

Since that first patient in 1996, she has documented the dots as a presenting sign of BCC in 14 patients.

“I may or may not see erythema or pearliness upon stretching of the skin,” said Dr. Vesper, a dermatologist in private practice in Bradenton, Fla.

In one patient who presented with a typical BCC with focal black dots on the abdomen, Dr. Vesper noticed more small, ink-black, “slightly papular” dots on the patient's chest on otherwise normal-appearing skin. She and the patient agreed that if the abdominal lesion proved to be BCC, another biopsy would be taken of the chest.

The second biopsy confirmed BCC on the chest.

Dr. Vesper examined an 89-year-old patient with a history of three episodes of BCC and found several lesions dotted with pinpoints of black pigment. When she biopsied six of the lesions, two revealed pigmented BCC, and three showed superficial BCC. Three of the lesions had clear margins. The patient had no history of radiation or arsenic exposure. Histology of clinically uniform-appearing lesions may show various patterns, including pigmented keratinous microcysts, one dot of pigment in a central necrotic tumor nest, pigment in melanophages but not in tumor, or pigment within a tumor and melanophages. Differential diagnosis may include melanoma, compound nevi, angiokeratoma, solar elastosis, or even open comedones.

A biopsy is prudent unless a patient has many dotted lesions, of which some have proved to be BCC, in which case the patient may opt to just have them all removed.

In one case, the biopsy of a lesion with jet-black dots initially came back with a diagnosis of solar elastosis, but after a section, the diagnosis was revised to BCC.

Dr. Vesper reviewed a recent publication chronicling “pigmented speckling” as a distinguishing feature of BCC in 17 patients, 15 of whom had tumors on the head and neck (Dermatol. Surg. 2004;30:1553–5). Although these cases were more focused than cases she has seen, she said the report likely reflects her same observations.

LOS CABOS, MEXICO — Jet-black dots that resemble marks from a ballpoint pen may be an easily overlooked sign of basal cell carcinoma, Dr. Jennifer L. Vesper said at the annual meeting of the Noah Worcester Dermatological Society.

Dr. Vesper first noticed the tiny black dots on a 51-year-old female patient's forehead in the vicinity of a suspicious lesion that turned out to be basal cell carcinoma (BCC).

Once she was attuned to looking for them, she began to notice the dots on other patients as well.

“I came to realize even a focus of black pigment, often showing up as a very dark black dot, may be the first sign of basal cell carcinoma,” she said.

Since that first patient in 1996, she has documented the dots as a presenting sign of BCC in 14 patients.

“I may or may not see erythema or pearliness upon stretching of the skin,” said Dr. Vesper, a dermatologist in private practice in Bradenton, Fla.

In one patient who presented with a typical BCC with focal black dots on the abdomen, Dr. Vesper noticed more small, ink-black, “slightly papular” dots on the patient's chest on otherwise normal-appearing skin. She and the patient agreed that if the abdominal lesion proved to be BCC, another biopsy would be taken of the chest.

The second biopsy confirmed BCC on the chest.

Dr. Vesper examined an 89-year-old patient with a history of three episodes of BCC and found several lesions dotted with pinpoints of black pigment. When she biopsied six of the lesions, two revealed pigmented BCC, and three showed superficial BCC. Three of the lesions had clear margins. The patient had no history of radiation or arsenic exposure. Histology of clinically uniform-appearing lesions may show various patterns, including pigmented keratinous microcysts, one dot of pigment in a central necrotic tumor nest, pigment in melanophages but not in tumor, or pigment within a tumor and melanophages. Differential diagnosis may include melanoma, compound nevi, angiokeratoma, solar elastosis, or even open comedones.

A biopsy is prudent unless a patient has many dotted lesions, of which some have proved to be BCC, in which case the patient may opt to just have them all removed.

In one case, the biopsy of a lesion with jet-black dots initially came back with a diagnosis of solar elastosis, but after a section, the diagnosis was revised to BCC.

Dr. Vesper reviewed a recent publication chronicling “pigmented speckling” as a distinguishing feature of BCC in 17 patients, 15 of whom had tumors on the head and neck (Dermatol. Surg. 2004;30:1553–5). Although these cases were more focused than cases she has seen, she said the report likely reflects her same observations.

LOS CABOS, MEXICO — Jet-black dots that resemble marks from a ballpoint pen may be an easily overlooked sign of basal cell carcinoma, Dr. Jennifer L. Vesper said at the annual meeting of the Noah Worcester Dermatological Society.

Dr. Vesper first noticed the tiny black dots on a 51-year-old female patient's forehead in the vicinity of a suspicious lesion that turned out to be basal cell carcinoma (BCC).

Once she was attuned to looking for them, she began to notice the dots on other patients as well.

“I came to realize even a focus of black pigment, often showing up as a very dark black dot, may be the first sign of basal cell carcinoma,” she said.

Since that first patient in 1996, she has documented the dots as a presenting sign of BCC in 14 patients.

“I may or may not see erythema or pearliness upon stretching of the skin,” said Dr. Vesper, a dermatologist in private practice in Bradenton, Fla.

In one patient who presented with a typical BCC with focal black dots on the abdomen, Dr. Vesper noticed more small, ink-black, “slightly papular” dots on the patient's chest on otherwise normal-appearing skin. She and the patient agreed that if the abdominal lesion proved to be BCC, another biopsy would be taken of the chest.

The second biopsy confirmed BCC on the chest.

Dr. Vesper examined an 89-year-old patient with a history of three episodes of BCC and found several lesions dotted with pinpoints of black pigment. When she biopsied six of the lesions, two revealed pigmented BCC, and three showed superficial BCC. Three of the lesions had clear margins. The patient had no history of radiation or arsenic exposure. Histology of clinically uniform-appearing lesions may show various patterns, including pigmented keratinous microcysts, one dot of pigment in a central necrotic tumor nest, pigment in melanophages but not in tumor, or pigment within a tumor and melanophages. Differential diagnosis may include melanoma, compound nevi, angiokeratoma, solar elastosis, or even open comedones.

A biopsy is prudent unless a patient has many dotted lesions, of which some have proved to be BCC, in which case the patient may opt to just have them all removed.

In one case, the biopsy of a lesion with jet-black dots initially came back with a diagnosis of solar elastosis, but after a section, the diagnosis was revised to BCC.

Dr. Vesper reviewed a recent publication chronicling “pigmented speckling” as a distinguishing feature of BCC in 17 patients, 15 of whom had tumors on the head and neck (Dermatol. Surg. 2004;30:1553–5). Although these cases were more focused than cases she has seen, she said the report likely reflects her same observations.

VANCOUVER, B.C. – Graphomotor dysfunction–a disconnect between a child's thoughts and his or her ability to write them down–is becoming increasingly common in elementary school children, Dr. Melvin D. Levine said at a conference sponsored by the North Pacific Pediatric Society.

“We're seeing an epidemic of little boys with graphomotor dysfunction,” asserted Dr. Levine, who is the cofounder of All Kinds of Minds, an institute for the study of learning differences, and professor of pediatrics at the University of North Carolina, Chapel Hill.

Years ago, when Dr. Levine visited a school, he expected to find one or two children with graphomotor problems. But now the proportion of students who experience the dysfunction “may be as high as 25% of boys in some classes,” although girls can show it too, he said.

Some people believe video games may be driving the increase in graphomotor problems because they require visual feedback in a way that writing doesn't.

Although he isn't certain of the cause or why little boys seem overrepresented, Dr. Levine is sure of the need for pediatricians to recognize graphomotor problems within the context of a child's neurologic development and school performance and to intervene with school districts when necessary.

He explained that graphomotor function is not the same as fine motor function. “It requires totally different software,” said Dr. Levine. This difference explains why a child may have illegible handwriting despite being the best artist in the class.

Graphomotor skills required to write include previsualization (picturing a letter or number symbol before creating it); memory (recalling letter and number forms quickly and accurately); production (possessing the many motor skills required to form the letters and numbers on the page with one's fingers); and feedback (knowing where the pencil is during writing without actually having to look at it).

Watching a child write and looking at his or her writing can be helpful in identifying areas of difficulty. A child who holds a pen with a death grip, perhaps at an awkward angle, may be trying to compensate for graphomotor production deficits.

A bright and verbal child who fails writing assignments may have an “output” problem with graphomotor memory. The ideas are flowing in his or her mind faster than they can be put onto paper in an orderly way.

“When you talk, you don't have to punctuate, capitalize, and spell,” said Dr. Levine.

Many steps can be taken to help children with graphomotor dysfunction, but solutions begin with a careful diagnosis and a “demystifying” of the problem.

For these children, “writing can be so humiliating … that their natural response is defiant refusal,” said Dr. Levine.

Once the children know which elements of the writing task are causing them problems, they can work around these problems, rely on their writing strengths, and recapture their self-esteem. But for school success, accommodation also makes sense.

A child who has tremendous difficulty with cursive writing should be allowed to print forever, he said.

Likewise, a child who does better with the flow of cursive writing should be able to use that method.

Smooth-flowing writing implements may help. Ballpoint pens are not recommended because they do not create enough friction on the page to provide feedback to the child with graphomotor difficulties. Many children with graphomotor problems do much better keyboarding, and they should be allowed to take notes on a laptop computer in class.

Tape recorders can be substituted for note-taking.

Dr. Levine opposes timed exercises or tests for most children, but especially for those with graphomotor problems.

“At the very least, let's not hurt anyone with public humiliation,” he said.

For these children, 'Writing can be so humiliating … that their natural response is defiant refusal.' DR. LEVINE

VANCOUVER, B.C. – Graphomotor dysfunction–a disconnect between a child's thoughts and his or her ability to write them down–is becoming increasingly common in elementary school children, Dr. Melvin D. Levine said at a conference sponsored by the North Pacific Pediatric Society.

“We're seeing an epidemic of little boys with graphomotor dysfunction,” asserted Dr. Levine, who is the cofounder of All Kinds of Minds, an institute for the study of learning differences, and professor of pediatrics at the University of North Carolina, Chapel Hill.

Years ago, when Dr. Levine visited a school, he expected to find one or two children with graphomotor problems. But now the proportion of students who experience the dysfunction “may be as high as 25% of boys in some classes,” although girls can show it too, he said.

Some people believe video games may be driving the increase in graphomotor problems because they require visual feedback in a way that writing doesn't.

Although he isn't certain of the cause or why little boys seem overrepresented, Dr. Levine is sure of the need for pediatricians to recognize graphomotor problems within the context of a child's neurologic development and school performance and to intervene with school districts when necessary.

He explained that graphomotor function is not the same as fine motor function. “It requires totally different software,” said Dr. Levine. This difference explains why a child may have illegible handwriting despite being the best artist in the class.

Graphomotor skills required to write include previsualization (picturing a letter or number symbol before creating it); memory (recalling letter and number forms quickly and accurately); production (possessing the many motor skills required to form the letters and numbers on the page with one's fingers); and feedback (knowing where the pencil is during writing without actually having to look at it).

Watching a child write and looking at his or her writing can be helpful in identifying areas of difficulty. A child who holds a pen with a death grip, perhaps at an awkward angle, may be trying to compensate for graphomotor production deficits.

A bright and verbal child who fails writing assignments may have an “output” problem with graphomotor memory. The ideas are flowing in his or her mind faster than they can be put onto paper in an orderly way.

“When you talk, you don't have to punctuate, capitalize, and spell,” said Dr. Levine.

Many steps can be taken to help children with graphomotor dysfunction, but solutions begin with a careful diagnosis and a “demystifying” of the problem.

For these children, “writing can be so humiliating … that their natural response is defiant refusal,” said Dr. Levine.

Once the children know which elements of the writing task are causing them problems, they can work around these problems, rely on their writing strengths, and recapture their self-esteem. But for school success, accommodation also makes sense.

A child who has tremendous difficulty with cursive writing should be allowed to print forever, he said.

Likewise, a child who does better with the flow of cursive writing should be able to use that method.

Smooth-flowing writing implements may help. Ballpoint pens are not recommended because they do not create enough friction on the page to provide feedback to the child with graphomotor difficulties. Many children with graphomotor problems do much better keyboarding, and they should be allowed to take notes on a laptop computer in class.

Tape recorders can be substituted for note-taking.

Dr. Levine opposes timed exercises or tests for most children, but especially for those with graphomotor problems.

“At the very least, let's not hurt anyone with public humiliation,” he said.

For these children, 'Writing can be so humiliating … that their natural response is defiant refusal.' DR. LEVINE

VANCOUVER, B.C. – Graphomotor dysfunction–a disconnect between a child's thoughts and his or her ability to write them down–is becoming increasingly common in elementary school children, Dr. Melvin D. Levine said at a conference sponsored by the North Pacific Pediatric Society.

“We're seeing an epidemic of little boys with graphomotor dysfunction,” asserted Dr. Levine, who is the cofounder of All Kinds of Minds, an institute for the study of learning differences, and professor of pediatrics at the University of North Carolina, Chapel Hill.

Years ago, when Dr. Levine visited a school, he expected to find one or two children with graphomotor problems. But now the proportion of students who experience the dysfunction “may be as high as 25% of boys in some classes,” although girls can show it too, he said.

Some people believe video games may be driving the increase in graphomotor problems because they require visual feedback in a way that writing doesn't.

Although he isn't certain of the cause or why little boys seem overrepresented, Dr. Levine is sure of the need for pediatricians to recognize graphomotor problems within the context of a child's neurologic development and school performance and to intervene with school districts when necessary.

He explained that graphomotor function is not the same as fine motor function. “It requires totally different software,” said Dr. Levine. This difference explains why a child may have illegible handwriting despite being the best artist in the class.

Graphomotor skills required to write include previsualization (picturing a letter or number symbol before creating it); memory (recalling letter and number forms quickly and accurately); production (possessing the many motor skills required to form the letters and numbers on the page with one's fingers); and feedback (knowing where the pencil is during writing without actually having to look at it).

Watching a child write and looking at his or her writing can be helpful in identifying areas of difficulty. A child who holds a pen with a death grip, perhaps at an awkward angle, may be trying to compensate for graphomotor production deficits.

A bright and verbal child who fails writing assignments may have an “output” problem with graphomotor memory. The ideas are flowing in his or her mind faster than they can be put onto paper in an orderly way.

“When you talk, you don't have to punctuate, capitalize, and spell,” said Dr. Levine.

Many steps can be taken to help children with graphomotor dysfunction, but solutions begin with a careful diagnosis and a “demystifying” of the problem.

For these children, “writing can be so humiliating … that their natural response is defiant refusal,” said Dr. Levine.

Once the children know which elements of the writing task are causing them problems, they can work around these problems, rely on their writing strengths, and recapture their self-esteem. But for school success, accommodation also makes sense.

A child who has tremendous difficulty with cursive writing should be allowed to print forever, he said.

Likewise, a child who does better with the flow of cursive writing should be able to use that method.

Smooth-flowing writing implements may help. Ballpoint pens are not recommended because they do not create enough friction on the page to provide feedback to the child with graphomotor difficulties. Many children with graphomotor problems do much better keyboarding, and they should be allowed to take notes on a laptop computer in class.

Tape recorders can be substituted for note-taking.

Dr. Levine opposes timed exercises or tests for most children, but especially for those with graphomotor problems.

“At the very least, let's not hurt anyone with public humiliation,” he said.

For these children, 'Writing can be so humiliating … that their natural response is defiant refusal.' DR. LEVINE

SAN FRANCISCO — Trimodality therapy outperformed surgery alone in the treatment of stage I-III esophageal cancer in a prospective, randomized study presented at a symposium sponsored by the American Society of Clinical Oncology.

Patients who received chemoradiation followed by surgery had a median survival of 4.5 years, compared with 1.8 years for those who received surgery alone in the multi-institution Cancer and Leukemia Group B (CALGB)-9781 study.

Five years after diagnosis, 39% of 30 patients in the trimodality group were alive, compared with 16% of 26 patients in the surgery-alone group.

However, the study conducted by 12 institutions in the U.S. Gastrointestinal Intergroup accrued just 56 patients, hundreds short of the original planned cohort, leaving some experts still unsure of the best therapeutic strategy to recommend.

Because so few patients could be found who would agree to be randomized to surgery alone, CALGB-9781 was “very underpowered” to make sweeping conclusions or to clarify ambiguity left in the wake of a host of small studies with conflicting results, said Dr. Bruce D. Minsky of Memorial Sloan-Kettering Cancer Center in New York City.

He said he thinks trimodality therapy probably confers about a 5%–10% survival advantage over other alternatives, “but we would need a large trial to show that.”

Dr. Mark Krasna, head of the division of thoracic surgery at the University of Maryland, Baltimore, countered that, despite its small numbers, the CALGB-9781 study was powered to show small differences between the trimodality and surgery-alone arms.

After 6 years of follow-up, the differences were not small. “The results are so stark that I think the conclusions will be vindicated,” he said during a press conference preceding the presentation of the study findings.

“What's extremely exciting is that in a study that included surgery after combination therapy, we were actually able to assess … pathological response, no visible viable tumors or significant response,” Dr. Krasna said at the meeting, which was also sponsored by the American Gastroenterological Association, the American Society for Therapeutic Radiation and Oncology, and the Society of Surgical Oncology.

Complete or partial pathological response to chemoradiation was seen in 24 of 30 trimodality patients. No viable tumor cells were seen at surgery in 12.

The study population reflected the demographic population associated with adenocarcinoma of the esophagus. There were 42 patients with that diagnosis, compared with just 14 with squamous cell carcinoma. Males predominated, with 51 enrolled, compared with 5 females. There were 48 whites and 8 blacks.

The trial randomized trimodality patients to receive 5-fluorouracil and cisplatin and 50.4 Gy of radiation over 5 weeks. They underwent surgery 3–8 weeks later.

Patients in the surgery arm underwent surgery shortly after their diagnosis.

Complications were frequent in both study arms, including grade 3 hematologic toxicities in more than half of all patients and GI toxicity in 40%. Surgical complications also occurred, as expected. “This is a very big surgery, considered one of the largest operations we do,” said Dr. Krasna.

In the surgery-alone arm, 14 patients suffered complications and 2 died post surgery. There were no surgery-related deaths in the trimodality arm, but 17 patients suffered complications, including 2 who developed leaks between the esophagus and stomach.

Esophagectomy with lymph node dissection is associated with a 3%–10% mortality rate, so the surgical results were not surprising, Dr. Krasna said.

The mean postoperative stay was 10–12 days, “which is actually quite reasonable,” he added.

“The important message we can take from this trial is that there is actually a curative possibility for esophageal cancer patients,” said Dr. Krasna. “Hopefully, chemotherapy and radiation followed by surgery will make a difference.”

Esophageal cancer results in 12,000 deaths a year in the United States, and adenocarcinoma of the esophagus is rising for reasons that are not fully understood.

SAN FRANCISCO — Trimodality therapy outperformed surgery alone in the treatment of stage I-III esophageal cancer in a prospective, randomized study presented at a symposium sponsored by the American Society of Clinical Oncology.

Patients who received chemoradiation followed by surgery had a median survival of 4.5 years, compared with 1.8 years for those who received surgery alone in the multi-institution Cancer and Leukemia Group B (CALGB)-9781 study.

Five years after diagnosis, 39% of 30 patients in the trimodality group were alive, compared with 16% of 26 patients in the surgery-alone group.

However, the study conducted by 12 institutions in the U.S. Gastrointestinal Intergroup accrued just 56 patients, hundreds short of the original planned cohort, leaving some experts still unsure of the best therapeutic strategy to recommend.

Because so few patients could be found who would agree to be randomized to surgery alone, CALGB-9781 was “very underpowered” to make sweeping conclusions or to clarify ambiguity left in the wake of a host of small studies with conflicting results, said Dr. Bruce D. Minsky of Memorial Sloan-Kettering Cancer Center in New York City.

He said he thinks trimodality therapy probably confers about a 5%–10% survival advantage over other alternatives, “but we would need a large trial to show that.”

Dr. Mark Krasna, head of the division of thoracic surgery at the University of Maryland, Baltimore, countered that, despite its small numbers, the CALGB-9781 study was powered to show small differences between the trimodality and surgery-alone arms.

After 6 years of follow-up, the differences were not small. “The results are so stark that I think the conclusions will be vindicated,” he said during a press conference preceding the presentation of the study findings.

“What's extremely exciting is that in a study that included surgery after combination therapy, we were actually able to assess … pathological response, no visible viable tumors or significant response,” Dr. Krasna said at the meeting, which was also sponsored by the American Gastroenterological Association, the American Society for Therapeutic Radiation and Oncology, and the Society of Surgical Oncology.

Complete or partial pathological response to chemoradiation was seen in 24 of 30 trimodality patients. No viable tumor cells were seen at surgery in 12.

The study population reflected the demographic population associated with adenocarcinoma of the esophagus. There were 42 patients with that diagnosis, compared with just 14 with squamous cell carcinoma. Males predominated, with 51 enrolled, compared with 5 females. There were 48 whites and 8 blacks.

The trial randomized trimodality patients to receive 5-fluorouracil and cisplatin and 50.4 Gy of radiation over 5 weeks. They underwent surgery 3–8 weeks later.

Patients in the surgery arm underwent surgery shortly after their diagnosis.

Complications were frequent in both study arms, including grade 3 hematologic toxicities in more than half of all patients and GI toxicity in 40%. Surgical complications also occurred, as expected. “This is a very big surgery, considered one of the largest operations we do,” said Dr. Krasna.

In the surgery-alone arm, 14 patients suffered complications and 2 died post surgery. There were no surgery-related deaths in the trimodality arm, but 17 patients suffered complications, including 2 who developed leaks between the esophagus and stomach.

Esophagectomy with lymph node dissection is associated with a 3%–10% mortality rate, so the surgical results were not surprising, Dr. Krasna said.

The mean postoperative stay was 10–12 days, “which is actually quite reasonable,” he added.

“The important message we can take from this trial is that there is actually a curative possibility for esophageal cancer patients,” said Dr. Krasna. “Hopefully, chemotherapy and radiation followed by surgery will make a difference.”

Esophageal cancer results in 12,000 deaths a year in the United States, and adenocarcinoma of the esophagus is rising for reasons that are not fully understood.

SAN FRANCISCO — Trimodality therapy outperformed surgery alone in the treatment of stage I-III esophageal cancer in a prospective, randomized study presented at a symposium sponsored by the American Society of Clinical Oncology.

Patients who received chemoradiation followed by surgery had a median survival of 4.5 years, compared with 1.8 years for those who received surgery alone in the multi-institution Cancer and Leukemia Group B (CALGB)-9781 study.

Five years after diagnosis, 39% of 30 patients in the trimodality group were alive, compared with 16% of 26 patients in the surgery-alone group.

However, the study conducted by 12 institutions in the U.S. Gastrointestinal Intergroup accrued just 56 patients, hundreds short of the original planned cohort, leaving some experts still unsure of the best therapeutic strategy to recommend.

Because so few patients could be found who would agree to be randomized to surgery alone, CALGB-9781 was “very underpowered” to make sweeping conclusions or to clarify ambiguity left in the wake of a host of small studies with conflicting results, said Dr. Bruce D. Minsky of Memorial Sloan-Kettering Cancer Center in New York City.

He said he thinks trimodality therapy probably confers about a 5%–10% survival advantage over other alternatives, “but we would need a large trial to show that.”

Dr. Mark Krasna, head of the division of thoracic surgery at the University of Maryland, Baltimore, countered that, despite its small numbers, the CALGB-9781 study was powered to show small differences between the trimodality and surgery-alone arms.

After 6 years of follow-up, the differences were not small. “The results are so stark that I think the conclusions will be vindicated,” he said during a press conference preceding the presentation of the study findings.

“What's extremely exciting is that in a study that included surgery after combination therapy, we were actually able to assess … pathological response, no visible viable tumors or significant response,” Dr. Krasna said at the meeting, which was also sponsored by the American Gastroenterological Association, the American Society for Therapeutic Radiation and Oncology, and the Society of Surgical Oncology.

Complete or partial pathological response to chemoradiation was seen in 24 of 30 trimodality patients. No viable tumor cells were seen at surgery in 12.

The study population reflected the demographic population associated with adenocarcinoma of the esophagus. There were 42 patients with that diagnosis, compared with just 14 with squamous cell carcinoma. Males predominated, with 51 enrolled, compared with 5 females. There were 48 whites and 8 blacks.

The trial randomized trimodality patients to receive 5-fluorouracil and cisplatin and 50.4 Gy of radiation over 5 weeks. They underwent surgery 3–8 weeks later.

Patients in the surgery arm underwent surgery shortly after their diagnosis.

Complications were frequent in both study arms, including grade 3 hematologic toxicities in more than half of all patients and GI toxicity in 40%. Surgical complications also occurred, as expected. “This is a very big surgery, considered one of the largest operations we do,” said Dr. Krasna.

In the surgery-alone arm, 14 patients suffered complications and 2 died post surgery. There were no surgery-related deaths in the trimodality arm, but 17 patients suffered complications, including 2 who developed leaks between the esophagus and stomach.

Esophagectomy with lymph node dissection is associated with a 3%–10% mortality rate, so the surgical results were not surprising, Dr. Krasna said.

The mean postoperative stay was 10–12 days, “which is actually quite reasonable,” he added.

“The important message we can take from this trial is that there is actually a curative possibility for esophageal cancer patients,” said Dr. Krasna. “Hopefully, chemotherapy and radiation followed by surgery will make a difference.”

Esophageal cancer results in 12,000 deaths a year in the United States, and adenocarcinoma of the esophagus is rising for reasons that are not fully understood.

SAN FRANCISCO — The odds of surviving cancer improve with time, making prognosis a moving target for any individual patient, researchers noted at a symposium sponsored by the American Society of Clinical Oncology.

The concept of “conditional survival” drove investigators to begin formulating survival odds for patients who live beyond 1 year after a diagnosis with gastric or gallbladder adenocarcinoma.

They are working on conditional survival paradigms for other cancers as well.

Patients often ask, “Doc, what's my chance of survival now that I've survived a year?” recounted Dr. Samuel J. Wang of the department of radiation oncology at the University of Texas Health Science Center at San Antonio. “Clinicians are left making their best guess or estimate, based on 5− or 10-year survival data from the time of diagnosis,” he said. “It might be that a patient is ahead of the curve by having beaten the odds at 1 year.”

Dr. Wang and associates therefore used the Surveillance, Epidemiology, and End Results (SEER) database to compare survival of gastric cancer from the time of diagnosis to survival of patients who had already lived with the disease for 5 years.

Survival probability improved markedly over time for patients with any stage of the disease, they found. For example, the 5-year observed, conditional survival was 46% at the time of diagnosis for a patient with localized disease, but improved to 65% after 5 years. Patients whose cancer had spread to regional lymph nodes had a 27% chance of 5-year survival at diagnosis, but a 62% chance of survival after living 5 years.

Improvement in conditional survival was greatest for patients with distant disease and for those under age 65, Dr. Wang said.

Patients with distant disease had a 5-year observed conditional survival of 2% at the time of diagnosis, compared with 53% at 5 years post diagnosis. Conditional survival for patients under age 65 increased from 19% to 76% at 5 years.

A second study examined year-by-year conditional survival of gallbladder adenocarcinoma.

Led by Clifton D. Fuller, a medical student in the department of radiation oncology at the University of Texas Health Science Center at San Antonio, the team found “dismal 5-year survival at diagnosis,” but improving odds for patients who lived between 1 and 4 years, when conditional survival began to plateau. (See box.)

“Although the disease-free survival outcomes for patients with gallbladder adenocarcinoma remain low, for those patients surviving even 1 year post diagnosis, conditional survival estimates increase rapidly,” the authors reported in their poster presentation at the meeting, which also was sponsored by the American Gastroenterological Association, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

Conditional survival calculations can offer some encouragement to cancer patients and can help clinicians decide how aggressively they should work up survivors as the years pass after a cancer diagnosis, Dr. Wang said in an interview at the meeting.

Moreover, these calculations “offer answers to very practical questions patients always have,” he added.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — The odds of surviving cancer improve with time, making prognosis a moving target for any individual patient, researchers noted at a symposium sponsored by the American Society of Clinical Oncology.

The concept of “conditional survival” drove investigators to begin formulating survival odds for patients who live beyond 1 year after a diagnosis with gastric or gallbladder adenocarcinoma.

They are working on conditional survival paradigms for other cancers as well.

Patients often ask, “Doc, what's my chance of survival now that I've survived a year?” recounted Dr. Samuel J. Wang of the department of radiation oncology at the University of Texas Health Science Center at San Antonio. “Clinicians are left making their best guess or estimate, based on 5− or 10-year survival data from the time of diagnosis,” he said. “It might be that a patient is ahead of the curve by having beaten the odds at 1 year.”

Dr. Wang and associates therefore used the Surveillance, Epidemiology, and End Results (SEER) database to compare survival of gastric cancer from the time of diagnosis to survival of patients who had already lived with the disease for 5 years.

Survival probability improved markedly over time for patients with any stage of the disease, they found. For example, the 5-year observed, conditional survival was 46% at the time of diagnosis for a patient with localized disease, but improved to 65% after 5 years. Patients whose cancer had spread to regional lymph nodes had a 27% chance of 5-year survival at diagnosis, but a 62% chance of survival after living 5 years.

Improvement in conditional survival was greatest for patients with distant disease and for those under age 65, Dr. Wang said.

Patients with distant disease had a 5-year observed conditional survival of 2% at the time of diagnosis, compared with 53% at 5 years post diagnosis. Conditional survival for patients under age 65 increased from 19% to 76% at 5 years.

A second study examined year-by-year conditional survival of gallbladder adenocarcinoma.

Led by Clifton D. Fuller, a medical student in the department of radiation oncology at the University of Texas Health Science Center at San Antonio, the team found “dismal 5-year survival at diagnosis,” but improving odds for patients who lived between 1 and 4 years, when conditional survival began to plateau. (See box.)

“Although the disease-free survival outcomes for patients with gallbladder adenocarcinoma remain low, for those patients surviving even 1 year post diagnosis, conditional survival estimates increase rapidly,” the authors reported in their poster presentation at the meeting, which also was sponsored by the American Gastroenterological Association, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

Conditional survival calculations can offer some encouragement to cancer patients and can help clinicians decide how aggressively they should work up survivors as the years pass after a cancer diagnosis, Dr. Wang said in an interview at the meeting.

Moreover, these calculations “offer answers to very practical questions patients always have,” he added.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — The odds of surviving cancer improve with time, making prognosis a moving target for any individual patient, researchers noted at a symposium sponsored by the American Society of Clinical Oncology.

The concept of “conditional survival” drove investigators to begin formulating survival odds for patients who live beyond 1 year after a diagnosis with gastric or gallbladder adenocarcinoma.

They are working on conditional survival paradigms for other cancers as well.

Patients often ask, “Doc, what's my chance of survival now that I've survived a year?” recounted Dr. Samuel J. Wang of the department of radiation oncology at the University of Texas Health Science Center at San Antonio. “Clinicians are left making their best guess or estimate, based on 5− or 10-year survival data from the time of diagnosis,” he said. “It might be that a patient is ahead of the curve by having beaten the odds at 1 year.”

Dr. Wang and associates therefore used the Surveillance, Epidemiology, and End Results (SEER) database to compare survival of gastric cancer from the time of diagnosis to survival of patients who had already lived with the disease for 5 years.

Survival probability improved markedly over time for patients with any stage of the disease, they found. For example, the 5-year observed, conditional survival was 46% at the time of diagnosis for a patient with localized disease, but improved to 65% after 5 years. Patients whose cancer had spread to regional lymph nodes had a 27% chance of 5-year survival at diagnosis, but a 62% chance of survival after living 5 years.

Improvement in conditional survival was greatest for patients with distant disease and for those under age 65, Dr. Wang said.

Patients with distant disease had a 5-year observed conditional survival of 2% at the time of diagnosis, compared with 53% at 5 years post diagnosis. Conditional survival for patients under age 65 increased from 19% to 76% at 5 years.

A second study examined year-by-year conditional survival of gallbladder adenocarcinoma.

Led by Clifton D. Fuller, a medical student in the department of radiation oncology at the University of Texas Health Science Center at San Antonio, the team found “dismal 5-year survival at diagnosis,” but improving odds for patients who lived between 1 and 4 years, when conditional survival began to plateau. (See box.)

“Although the disease-free survival outcomes for patients with gallbladder adenocarcinoma remain low, for those patients surviving even 1 year post diagnosis, conditional survival estimates increase rapidly,” the authors reported in their poster presentation at the meeting, which also was sponsored by the American Gastroenterological Association, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

Conditional survival calculations can offer some encouragement to cancer patients and can help clinicians decide how aggressively they should work up survivors as the years pass after a cancer diagnosis, Dr. Wang said in an interview at the meeting.

Moreover, these calculations “offer answers to very practical questions patients always have,” he added.

ELSEVIER GLOBAL MEDICAL NEWS