High uterosacral ligament suspension by transvaginal natural orifice transluminal endoscopic surgery or laparoendoscopic surgery for uterine prolapse: a protocol for a non-inferiority randomized controlled trial

Abstract

Abstract Introduction: Uterine prolapse is a prevalent health condition that significantly impairs the daily activities and quality of life of women. High uterosacral ligament suspension (HULS) through conventional laparoscopy (cLap) is a frequently employed surgical procedure for treating uterine prolapse. In recent years, gynecological surgeons have increasingly considered transvaginal natural orifice transluminal endoscopic surgery (vNOTES) due to its favorable outcomes, including enhanced cosmetic appearance and expedited postoperative recovery. However, there is a lack of studies comparing the techniques of vNOTES-HULS and cLap-HULS. Therefore, this trial aims to compare the efficacy and safety of vNOTES-HULS and cLap-HULS for the treatment of uterine prolapse at stage 2 or higher, providing valuable insights for surgical decision-making. Methods A two-arm, single-center, non-inferiority randomized controlled trial (RCT) will be conducted to evaluate whether the vNOTES-HULS procedure is non-inferior to the cLap-HULS procedure in the repair of uterine prolapse. The study aims to recruit a total of 116 patients diagnosed with stage 2 or above uterine prolapse from Meizhou People's Hospital. These patients will be randomly allocated to either the vNOTES-HULS or cLap-HULS intervention. The primary objective of the study is to determine the rate of successful uterine prolapse treatment during the 1-year follow-up evaluation. Secondary outcomes include perioperative parameters, complications, costs, postoperative recovery, and quality of life assessed at 1-month, 1-year, and 5-year intervals. Discussion This study aims to compare the effectiveness of vNOTES-HULS and cLap-HULS in the treatment of stage II or higher uterine prolapse based on the Pelvic Organ Prolapse Quantification classification. Trial registration: The study protocol received approval from the Research Ethics Committee of the Meizhou People’s Hospital (No. 2022-C-23) on October 3, 2022. It was registered into the Chinese Clinical Trials Registry on September 6, 2022 (no. ChiCTR2200063408). This study is currently in progress.