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

NCT06903988 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-02-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-05
Primary Completion
2026-08-30
Completion
2026-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06903988 on ClinicalTrials.gov