NCT06903988

Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse

A Randomized Controlled Study on the Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, non-blinded, non-inferiority randomized controlled trial, planning to recruit 86 patients with Stage III or higher pelvic organ prolapse who are unresponsive to conservative treatment and are requesting surgical treatment. Patients who meet the inclusion and exclusion criteria will be randomly assigned to the transvaginal sacrospinous ligament fixation group and the laparoscopic lateral suspension group in a 1:1 ratio. Follow-ups will be conducted at 1 month, 3 months, 6 months, and 1 year after surgery for the enrolled patients. The primary outcome measure is the difference in surgical success rate between the two groups of patients at 1 year after surgery. We hypothesize that the surgical success rate of laparoscopic lateral suspension is not inferior to that of transvaginal sacrospinous ligament fixation

Conditions

• Pelvic Organ Prolapse (POP)

Interventions

Type	Name	Description
PROCEDURE	laparoscopic lateral suspension	Laparoscopic lateral suspension: Place a 1/2 T4 mesh in the vesicovaginal space. The two lateral slings are passed out from the outer upper side of the bilateral anterior superior iliac spine, and the prolapsed organs are suspended to the abdominal wall.
PROCEDURE	Transvaginal sacrospinous ligament fixation	Transvaginal sacrospinous ligament fixation: Dissect the rectovaginal space to expose the right sacrospinous ligament, and fix the cervix or vaginal cuff to the right sacrospinous ligament.

Timeline

• Start date: 2025-04-05
• Primary completion: 2026-08-30
• Completion: 2026-08-31
• First posted: 2025-04-01
• Last updated: 2026-02-02

Locations

1 site across 1 country: China