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A Prospective Randomized Trial Comparing Restorelle Y Mesh and Flat Mesh for Laparoscopic and Robotic-Assisted Laparoscopic Sacrocolpopexy

Ferrando, Cecile A., MD, MPH; Paraiso, Marie Fidela R., MD

Female Pelvic Medicine & Reconstructive Surgery: March/April 2019 - Volume 25 - Issue 2 - p 83–87
doi: 10.1097/SPV.0000000000000655
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Objective The primary objective of this study was to compare case and mesh placement times between Restorelle Y mesh and flat mesh. The secondary objective was to compare subjective and objective outcomes between the 2 mesh configurations.

Methods This is a randomized trial of women undergoing laparoscopic (LSC) or robotic (RSC) sacrocolpopexy for posthysterectomy vaginal prolapse. Subjects were predetermined to undergo either an LSC or RSC and randomized to Y mesh or flat mesh. Case and mesh placement times were defined as incision time to time of closure and time from mesh introduced into the abdomen to placement of the last sacral stitch, respectively. All subjects underwent Pelvic Organ Prolapse Quantification System examination and completed the 20-item Pelvic Floor Disability Index preoperatively, at 6, 12, and 24 months.

Results Sixty-two patients were enrolled, and 59 patients were implanted with mesh: 30 with Y mesh (17 LSC, 13 RSC) and 29 with flat mesh (18 LSC, 11 RSC). There were no differences in patient characteristics between mesh groups. Mean case and mesh placement times for all subjects were 204.4 ± 48 and 46.1 ± 13.5 minutes, respectively, with no differences between the groups. At 6 months, 20-item Pelvic Floor Disability Index scores improved significantly for all subjects with no differences by mesh type. Three subjects (5.5%) reported vaginal bulge symptoms, and no subjects were retreated for prolapse or were found to have recurrent prolapse on examination. There were also no mesh erosions.

Conclusions Case and mesh placement times do not differ in patients undergoing LSC or RSC with either Restorelle Y mesh or flat mesh. At 6 months, subjective and objective successes were 94% and 100%, respectively.

From the Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women’s Health Institute, Cleveland Clinic, Cleveland, OH.

Correspondence: Cecile A. Ferrando, MD, MPH, 9500 Euclid Ave, A81, Cleveland, OH 44195. E-mail: cecile.a.ferrando@gmail.com.

An unrestricted research grant was obtained to perform this study from Coloplast, Inc (Minneapolis, MN). Funds were used to provide salary support to the research nurses who enrolled, consented, and followed subjects and the subjects who were given compensation for follow-up visits.

This article was presented at PFD Week 2018 at the American Urogynecologic Society’s Annual Scientific Meeting; Chicago, IL; October 9 to 13, 2018.

Both authors receive authorship royalties from UpToDate, Inc.

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