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

Peking University

Status: Active, not recruiting

Conditions: Pelvic Organ Prolapse (POP)

Treatments: Procedure: laparoscopic lateral suspension; Procedure: Transvaginal sacrospinous ligament fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT06903988

2024PHB374-002

Details and patient eligibility

About

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

Enrollment: 86 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

laparoscopic lateral suspension

Experimental group

Treatment:

Procedure: laparoscopic lateral suspension

transvaginal sacrospinous ligament fixation

Active Comparator group

Treatment:

Procedure: Transvaginal sacrospinous ligament fixation