Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07174921

Post-hysterectomy Vaginal Cuff Prolapse Repair

Led by Kanuni Sultan Suleyman Training and Research Hospital · Updated on 2025-09-16

50

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Post-hysterectomy Vaginal Cuff Prolapse Repair

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 65;18 years
  • History of hysterectomy by any approach (abdominal, vaginal, or laparoscopic)
  • Symptomatic vaginal cuff prolapse with POP-Q stage 65; II
  • Able to provide written informed consent
  • Willing and able to follow study procedures and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Previous sacrocolpopexy or lateral suspension surgery
  • Active pelvic infection or untreated malignancy
  • Severe heart, lung, or systemic disease that prevents laparoscopic surgery
  • Known allergy to mesh materials used in the procedures
  • Unable to complete patient questionnaires due to cognitive or language difficulties
  • Additional pelvic organ prolapse requiring more surgery beyond vaginal cuff suspension

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Basaksehir Cam and Sakura City Hospital

Istanbul, Istanbul, Turkey (Türkiye), 34494

Actively Recruiting

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Research Team

O

Ozan Karadeniz, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Post-hysterectomy Vaginal Cuff Prolapse Repair | DecenTrialz