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

NCT ID: NCT06903988

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-05
• Study Completion Date: 2026-08-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

laparoscopic lateral suspension

Group Type: EXPERIMENTAL

laparoscopic lateral suspension

Intervention Type: PROCEDURE

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.

transvaginal sacrospinous ligament fixation

Group Type: ACTIVE_COMPARATOR

Transvaginal sacrospinous ligament fixation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years;

2. According to the POP-Q classification, patients who meet any of the following conditions: a. Patients with anterior wall prolapse of stage III or higher; b. Patients with apical prolapse of stage III or higher;

3. Patients who refuse conservative treatment or have ineffective conservative treatment and request surgical treatment for prolapse;

4. Patients who voluntarily participate in this study, sign the informed consent form, and are able to attend follow-up visits on time;

5. Patients who have received education at the primary school level or above;

6. Patients who are able to visit the hospital for examinations;

7. Patients who are deemed fit to undergo surgery according to preoperative anesthesia assessment.

Exclusion Criteria

1. Patients who have previously undergone surgery for pelvic organ prolapse (POP);

2. Patients with a history of anti-incontinence surgery or who are planned to undergo mid-urethral sling surgery for anti-incontinence during the current operation;

3. Patients who, after evaluation by the surgeon, have other conditions that affect eligibility for inclusion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Shiyan

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, , China

Countries

China

Other Identifiers

2024PHB374-002

Identifier Type: -

Identifier Source: org_study_id