A Prospective Randomized Trial Comparing Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy

This is a randomized single-blind, non-inferiorty trial. Abdominal sacrocolpopexy is considered the gold standard for vault prolapse, and has demonstrated superior anatomic outcomes compared to transvaginal suspension procedures. Sacrocolpopexy involves suspension of the vagina to the anterior longitudinal ligament of the sacrum at the level of S1 using a bridging graft which can be made of biologic or synthetic materials. The graft is sutured to the anterior as well as the posterior vagina and then attached to the anterior longitudinal ligament of the sacrum. ). Both the Restorelle® Smartmesh (Coloplast, Inc., Minneapolis, MN, USA) and the Vertessa® lite mesh (Caldera Medical. Inc., Agoura Hills, CA, USA) are ultra-light macroporous polypropylene mesh grafts that are intended for pelvic floor reconstruction, both types of grafts are used to perform sacrocolpopexy. Currently no prospective data exists on the Vertessa® lite mesh for sacrocolpopexy. It is used by many surgeons, but there are no data showing that it is as efficacious in treating prolapse and avoiding mesh erosion in those patients undergoing sacrocolpopexy. Therefore, the primary objective of the proposed study is to compare outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh at the time of laparoscopic and robotic-assisted laparoscopic sacrocolpopexy.

Study subjects will be recruited from patients that present to the Center for Urogynecology & Pelvic Reconstructive Surgery in the Department of Obstetrics and Gynecology at the Cleveland Clinic Main campus, Hillcrest Hospital and Fairview Hospital, and their surgeries will be performed at either one of these sites. All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The subjects will then we randomized to either Restorelle® or Vertessa® Y sacrocolpopexy according to a computer-generated randomization schedule with random block sizes with the use of the SAS statistical software package (SAS Institute, Cary, NC). All patients will be blinded to their assignment.

All subjects will be seen at a preoperative visit, then again at 6, 12 and 24 months postoperatively. During each visit. a vaginal exam and a complete Pelvic Organ Prolapse Quantification (POP-Q) exam will be performed. In addition, patients will be asked to complete the Pelvic Floor Distress Inventory (PFDI-20), Incontinence Severity Index (ISI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) questionnaires at the preoperative visit as well as the 6, 12, and 24 month postoperative visits.

Laparoscopic sacrocolpopexy will be performed using four ports: an umbilical port for the laparoscope, two ports (either 5 or 10/12 mm) in the bilateral lower quadrants, and one 5-mm port placed at the level of the umbilicus, lateral to the rectus muscle on either side for retraction. The robotic-assisted hysterectomy will be performed using the da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) using five ports: a 12mm umbilical port for the laparoscopic, two 8 mm robotic ports placed 2cm inferior and 9-10cm lateral to the umbilicus bilaterally, an 8mm robotic port placed in the left axillary line at the level of the umbilicus, and a 8mm or 10/12mm accessory port either in the right upper quadrant approximately 3cm distal from the costal margin, or in the right lower quadrant, 2cm above and medial to the anterior superior iliac spine.

If a supracervical hysterectomy is to be performed, it will be done in a standard fashion. A uterine manipulator will be placed inside of the uterus. The round ligaments will be transected using cautery. The fallopian tubes and ovaries will be left in situ or removed at the time of hysterectomy depending upon the preoperative decision made between the surgeon and patient. The uterine arteries and cardinal ligaments will be cauterized laparoscopically. The uterus will be amputated at the level of the internal cervical os and the endocervical canal will be cauterized.