NCT06482697

Safety and Efficacy of Different Procedures of Colpocleisis: a Randomized Controlled Trial

To Compare the Clinical Efficacy and Complications of Total Colpocleisis and Partial Colpocleisis in the Treatment of Pelvic Organ Orolapse

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Lan Zhu · Academic / Other
• Sex: Female
• Age: 70 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Background: Pelvic organ prolapse (POP) is one of the most common benign gynecological diseases among middle-aged and elderly women, which severely affects the quality of life of patients. Colpocleisis for the treatment of POP has a high success rate and low incidence of complications. The classic colpocleisis is divided into total colpocleisis and partial colpocleisis (LeFort). However, there are no long-term follow-up large-scale randomized trials to compare the clinical efficacy, complications between the two surgical methods. This study aims to compare the incidence of surgical complications, objective surgical success rate, subjective satisfaction rate, pelvic floor symptom improvement rate, and regret rate in patients with pelvic organ prolapse treated by total colpocleisis and LeFort. Methods: This trial is a prospective, multicenter, randomized, non-blinded non-inferiority trial, comparing the application of hysterectomy with total colpocleisis and LeFort in symptomatic pelvic organ prolapse patients with no need for vaginal sexual life, and aged ≥70 years. The primary outcome measure is the incidence of surgical complications, including perioperative and postoperative complications within 3 months, as well as the incidence of severe complications. Secondary outcomes include the objective surgical success rate, subjective satisfaction rate, pelvic floor symptom improvement rate, and regret rate at 3 months, 1 year, and 2 years post-surgery. This study is a non-inferiority study, based on the literature reports that the incidence of complications for colpocleisis and LeFort with hysterectomy are 11.4% and 7.0%, respectively, with a non-inferiority boundary value of 5%, α=0.025 (one-sided), β=0.2, and a ratio of 1:1 between the two groups. The sample size is calculated to be n=296, considering a 10% dropout rate, a total of 330 patients need to be included. Discussion: This is a randomized multicenter clinical trial that will provide evidence to demonstrate the differences in complications and efficacy between colpocleisis and LeFort with hysterectomy.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	total colpocleisis	Total colpocleisis refers to the process where, during the dissection of the anterior and posterior vaginal walls to remove the vaginal mucosa, no holes are left. When suturing, the anterior and posterior vaginal walls are completely interrupted with mattress sutures, and no holes are left on either side or at the top of the vagina.
PROCEDURE	partial colpocleisis (LeFort)	LeFort involves the removal of a rectangular piece of mucosa from the anterior and posterior walls of the vagina, leaving a strip of mucosa 2 to 3 cm wide on each side of the vagina. The dissection is carried out close to the vaginal mucosa while preserving the vaginal bladder fascia as much as possible, creating channels on both sides of the vagina.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2024-07-01
• Last updated: 2024-07-01