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vNOTES Pelvic Reconstruction and Presacral–Uterosacral Ligament Compound Suspension with Vaginal Wall Repair for Treatment of Multisite Pelvic Organ Prolapse: A Randomized Controlled Trial
Importance: Pelvic floor reconstruction surgery remains the mainstay for patients with multisite moderate-to-severe pelvic organ prolapse (POP). Classical surgeries like uterosacral ligament suspension (USLS) and sacrospinous ligament fixation (SSLF) have high recurrence rates. In this study, we investigated the therapeutic efficacy of two new surgical procedures: transvaginal natural orifice transluminal endoscopic surgery for pelvic reconstruction (vNOTES-PRC) and presacral–uterosacral ligament compound suspension (vNOTES-PULS) with anterior and posterior vaginal wall repair.
Objective: To compare the surgical outcomes of vNOTES-PRC, vNOTES-PULS and SSLF with anterior and posterior vaginal wall repair for the treatment of multisite moderate-to-severe POP.DESIGN, SETTING, AND PARTICIPANTSA Single-center, nonblinded prospective randomized controlled trail was conducted at the Obstetrics and Gynecology Hospital of Fudan University in China. One hundred and fifty Patients undergoing initial surgery for POP were recruited from March 2021 to March 2022.
Interventions: Participants were randomly assigned to undergo vNOTES-PRC (n=50), vNOTES-PULS (n=50), or SSLF (n=50).
Main Outcomes and Measures: The primary outcome was a composite outcome of success, defined as absence of POP beyond the hymen, absence of troublesome bulging symptoms, and absence of prolapse retreatment (pessary or surgery) in any compartment within 2 years after surgery. Secondary outcomes included anatomic and patient-reported outcomes, perioperative parameters, and surgery-related complications.
Results: A total of 138 patients were included in the 2-year postoperative follow-up study among 145 enrolled patients. vNOTE-PRC group had an overall surgical success rate of 95.7%, higher than the vNOTES-PULS group (80.4%) and the SSLF group (74.5%), and no significant differences in the success rates were found between the vNOTES-PULS and SSLF groups. The main perioperative outcomes and complications among the three groups showed no significant differences.
Conclusions: vNOTES-PRC is superior to vNOTES-PULS and SSLF for the treatment of multisite moderate-to-severe POP based on the composite surgical success outcome of 2-year follow-up. vNOTES-PULS is more suitable for patients with predominantly apical prolapse.
Funding: This work was supported by the Shanghai Committee of Science and Technology, China (Grant No. 20Y11907300 & 21Y11906700).
Declaration of Interest: None reported.
Ethical Approval: The study was approved by the Ethics Committee of Obstetrics and Gynecology Hospital of Fudan University (file number 2020-186). All participants provided informed written consent prior to inclusion and randomization.
Peng, Jing and Wang, Xiaojuan and Li, Junwei and Zhang, Jie and Lu, Zhiying and Hu, Changdong and Hua, Keqin and Chen, Yisong, vNOTES Pelvic Reconstruction and Presacral–Uterosacral Ligament Compound Suspension with Vaginal Wall Repair for Treatment of Multisite Pelvic Organ Prolapse: A Randomized Controlled Trial. Available at SSRN: https://ssrn.com/abstract=5034332 or http://dx.doi.org/10.2139/ssrn.5034332
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