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

摘要

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.