Large study: Robotic prolapse repair safe, durable

A robot-assisted abdominal approach to pelvic organ prolapse repair has a favorable safety profile and is associated with durable anatomic outcomes, findings of a retrospective chart review indicate.

Royal Oak, MI-A robot-assisted abdominal approach to pelvic organ prolapse repair has a favorable safety profile and is associated with durable anatomic outcomes, findings of a retrospective chart review indicate.

Commentary: Robotics finding a role in prolapse repair

Women underwent the procedure at a large teaching institution, Beaumont Hospital in Royal Oak, MI.

The series included 197 consecutive women operated on between 2007 and 2014 by surgeons with fellowship training in female pelvic medicine and reconstructive surgery. With the exception of six women (3%) who had a hysteropexy and one woman (0.5%) who had enterocele repair, all of the other procedures were sacrocolpopexy. Follow-up for the cohort averaged almost 14 months; 187 women had documented exams at 1 month and 123 women had follow-up beyond 6 months.

Analyses of the extracted data showed most operative and postoperative complications were minor. The rate of anatomic failure, defined by presence of grade 2 or 3 prolapse on follow-up, was about 24%, and when considering only women followed longer than 6 months, the mesh exposure rate was 9.8%, reported first author Michael Ehlert, MD, at the AUA annual meeting in New Orleans.

Next: “We believe this study comprises the largest series on robotic prolapse repair."

“We believe this study comprises the largest series on robotic prolapse repair and that it provides better insight than previous reports about the complications, especially in terms of the nuances of an abdominal approach,” said Dr. Ehlert, formerly a female pelvic medicine and reconstructive surgery fellow at Beaumont Hospital who is now in practice in Minneapolis.

“The anatomic outcome in our cohort is similar to that reported during long-term follow-up in the NIH-sponsored study of open abdominal sacrocolpopexy [JAMA 2013; 309:2016-24]. Our mesh exposure rate is similar as well, underscoring that this problem is not avoided with an abdominal approach. While we found that the complications associated with the procedure were minor overall, the rates were higher than in previous reports, and we attribute that to our careful chart review.”

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The demographic characteristics of the Beaumont Hospital cohort were similar to those of women included in previous studies from other institutions and in large open trials of colpopexy. About 20% of women had a history of prolapse repair, 20% had undergone prior stress urinary incontinence (SUI) surgery, just over half had prior hysterectomy, and 57% had another form of abdominal surgery previously.

Concomitant procedures included SUI surgery in about half of the women and hysterectomy in women who did not have a hysteropexy and prior hysterectomy. Average OR time was about 3.5 hours when hysterectomy was not done and 80 minutes longer when it was. Dr. Ehlert noted the OR time was similar to that reported in previous robotic series, and the majority of women were discharged on the first postoperative day.

NEXT: 13 intraoperative complications observed

13 intraoperative complications observed

Intraoperatively, there were 13 complications, including four cases each of cystotomy and vaginotomy that were repaired primarily, two conversions to an open procedure, two aborted procedures, and one case where the ureter was sutured by the gynecology team.

The only pre-op or operative difference noted in women with an intraoperative complication was a slightly, but significantly higher estimated blood loss.

The Clavien-Dindo system was used to classify complications. There were 18 early complications (within 30 days), of which 16 were Clavien I or II (UTI, constipation). The two Clavien IIIb complications requiring a return to the OR involved a woman with a port site hernia on post-op day 2 and the patient with a suture in the ureter, which was easily removed endoscopically.

There were 36 late complications, three-fourths of which were Clavien I. Of the 12 mesh exposures, five were managed surgically, while the majority were either observed or treated with topical estrogen. Average time to mesh excision was 9 months.

Anatomic outcomes were analyzed among the 187 women who had at least 4 weeks follow-up. At last follow-up, the prolapsed grade was 0 in 100 women (53.5%), grade 1 in 47 women (25.1%), grade 2 in 26 women (13.9%), and grade 3 in 14 women (7.5%). The grade 3 cases were equally divided between anterior and posterior prolapse.

“We had no cases of recurrent apical prolapse, and the majority of anterior and posterior compartments were not symptomatic requiring surgery,” Dr. Ehlert said.

Nine of the 14 women with a grade 3 prolapse underwent surgery for their recurrence at a mean of 9.5 months.

A number of clinical and operative variables were analyzed for their possible association with recurrence, including age, body mass index, hysterectomy, and prior prolapse repair, but none was found to be an independent predictor.