Repairing vaginal cuff prolapse after hysterectomy
Official title: Laparoscopic Lateral Suspension Versus Laparoscopic Sacrocolpopexy for Post-Hysterectomy Vaginal Cuff Prolapse: A Randomized Controlled Trial
Run by Kanuni Sultan Suleyman Training and Research Hospital · NCT07174921 · Data updated 2026-11-12
This trial will try two minimally invasive surgeries—laparoscopic lateral suspension and laparoscopic sacrocolpopexy—for women with symptomatic vaginal cuff prolapse after hysterectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Kanuni Sultan Suleyman Training and Research Hospital Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | October 15, 2026 |
| Registry record updated | September 16, 2025 |
| Trial ID | NCT07174921 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older who have had a hysterectomy, have symptomatic vaginal cuff prolapse (POP-Q stage II or greater), can consent, and can follow the study schedule are ideal candidates.
✕Probably not a fit
Women with prior sacrocolpopexy or lateral suspension, active pelvic infection or untreated malignancy, severe contraindicating comorbidity, mesh allergy, or who need additional pelvic repairs are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial assigns eligible women with symptomatic vaginal cuff prolapse after hysterectomy to either laparoscopic lateral suspension or laparoscopic sacrocolpopexy. Both procedures are performed laparoscopically and outcomes will be tracked for anatomical recurrence, complications, recovery metrics, and patient-reported quality of life. Surgeons will follow standardized perioperative protocols and patients will attend scheduled follow-up visits to measure function, pain, and satisfaction. The goal is a head-to-head comparison to guide surgical decision making.
Why it matters
Potential benefit: If successful, the trial could identify which laparoscopic approach leads to fewer recurrences, fewer complications, and better recovery and quality of life for patients.
How similar studies have gone: Laparoscopic sacrocolpopexy is an established effective technique while lateral suspension has promising but less extensive comparative data, and direct randomized comparisons between these two approaches remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Basaksehir Cam and Sakura City Hospital
Istanbul, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Ozan Karadeniz, MD
- Email: dr.ozankrdnz@gmail.com
- Phone: +905333663003
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.