Post-hysterectomy Vaginal Cuff Prolapse Repair

Not Applicable

Recruiting

• Conditions: Vaginal Cuff Complications

• Registration Number: NCT07174921
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

This study is a randomized controlled trial comparing two minimally invasive surgeries-laparoscopic lateral suspension and laparoscopic sacrocolporopexy-for women who develop vaginal cuff prolapse after hysterectomy. Vaginal cuff prolapse occurs when the top of the vagina loses support after the uterus is removed, which can cause discomfort, bulging, or urinary and bowel problems.

The goal of this study is to determine which surgical approach is safer, more effective, and improves quality of life for patients. Women enrolled in the trial will be randomly assigned to one of the two surgeries, and outcomes such as prolapse recurrence, complications, recovery time, and patient satisfaction will be carefully monitored.

By comparing these two techniques, this study aims to provide clear guidance for surgeons and patients to make informed decisions about the best surgical treatment for post-hysterectomy vaginal cuff prolapse.

Detailed Description

This study is a randomized controlled trial (RCT) designed to compare the outcomes of two minimally invasive surgical techniques-laparoscopic lateral suspension and laparoscopic sacrocolpopexy-for the treatment of vaginal cuff prolapse following hysterectomy. Vaginal cuff prolapse occurs when the top of the vagina loses its normal support after the uterus has been removed, leading to symptoms such as a sensation of vaginal bulging, pelvic pressure, urinary or bowel dysfunction, and discomfort during daily activities or sexual intercourse.

Eligible participants are women who have previously undergone hysterectomy and are experiencing symptomatic vaginal cuff prolapse. Participants will be randomly assigned to undergo either laparoscopic lateral suspension or laparoscopic sacrocolpopexy. Both procedures are performed using minimally invasive laparoscopic techniques, which typically result in smaller incisions, less pain, and faster recovery compared to traditional open surgery.

The study will assess multiple clinical and patient-reported outcomes, including:

Anatomical success: Prevention of prolapse recurrence at follow-up visits.

Functional outcomes: Improvement in urinary, bowel, and sexual function.

Complications: Intraoperative and postoperative adverse events.

Recovery metrics: Length of hospital stay, return to daily activities, and postoperative pain.

Patient satisfaction: Quality of life and overall satisfaction with the procedure.

By conducting this study, researchers aim to provide evidence-based guidance on which surgical approach offers better long-term outcomes, fewer complications, and higher patient satisfaction. The results of this trial may help clinicians make informed decisions and improve the care of women with post-hysterectomy vaginal cuff prolapse.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-13
• Last Update Submitted: 2025-09-13
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-09-30
• Primary Completion: 2026-09-30
• Study Completion: 2026-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Women aged ≥18 years.

History of hysterectomy (any approach: abdominal, vaginal, or laparoscopic).

Symptomatic vaginal cuff prolapse (POP-Q stage ≥ II).

Able to provide written informed consent.

Willing and able to comply with study procedures and follow-up visits.

Exclusion Criteria

Prior sacrocolpopexy or lateral suspension surgery.

Active pelvic infection or untreated malignancy.

Severe cardiopulmonary or systemic disease that contraindicates laparoscopic surgery.

Known allergy to mesh materials used in the procedures.

Inability to complete patient-reported questionnaires due to cognitive or language barriers.

Concurrent pelvic organ prolapse requiring additional surgical repair beyond vaginal cuff suspension.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anatomical Success (Point C of POP-Q System)	12 months post-surgery	Vaginal cuff support measured objectively using POP-Q system, focusing on point C (position of the vaginal apex relative to the hymen). Success is defined as point C remaining above the hymen at follow-up by a blinded examiner.

Secondary Outcome Measures

Name	Time	Method
Operative Time	During surgery	Total duration of the surgery measured in minutes from incision to closure.
Postoperative Hospital Stay	From the day of surgery through hospital discharge (an expected average of 2 days)	Length of hospital stay in days from surgery to discharge.
Postoperative Complications	Up to 12 months post-surgery	Includes mesh exposure, infection, bleeding, urinary or bowel injury, and reoperation.
Pelvic Floor Distress Inventory (PFDI-20)	Preoperative and 12 months post-surgery	Patient-reported measure of prolapse, urinary, and bowel symptoms.; The PFDI-20 consists of 3 subscales: Pelvic Organ Prolapse Distress Inventory (POPDI-6); Colorectal-Anal Distress Inventory (CRADI-8); Urinary Distress Inventory (UDI-6) Each subscale is scored 0-100, and the total score is the sum of the three subscales (0-300).; 0 = no pelvic floor-related distress at all.; 300 = the maximum possible distress, meaning the respondent endorsed the highest level of bother on all 20 items.
Pelvic Floor Impact Questionnaire (PFIQ-7)	Preoperative and 12 months post-surgery	Patient-reported measure of the impact of pelvic floor disorders on daily activities, relationships, and quality of life.; The PFIQ-7 includes 3 subscales: Urinary Impact Questionnaire (UIQ-7); Colorectal-Anal Impact Questionnaire (CRAIQ-7); Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7); Each subscale contains items scored 0-3 ("not at all" to "quite a bit"), then converted to a 0-100 scale.; The three subscales are summed for a total score ranging from 0 to 300.; 0 = no impact on quality of life.; 300 = maximum impact across all domains (urinary, colorectal-anal, and prolapse).; Higher scores indicate worse quality-of-life impairment due to pelvic floor disorders.
Patient Global Impression (PGI) Scale	Preoperative and 12 months post-surgery	Patient-reported scale evaluating overall improvement or satisfaction with surgery, typically rated from 1 ("very much improved") to 7 ("very much worse").

Trial Locations

Locations (1)

Basaksehir Cam and Sakura City Hospital; Istanbul, Istanbul, Turkey (Türkiye)