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RECRUITING
NCT07895953

Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

Summary

Uterine fibroids are the most common benign tumors in women of reproductive age and are a major indication for hysterectomy. This retrospective, single-center observational study aims to identify factors associated with the success or failure of vaginal natural orifice transluminal endoscopic surgery (v-NOTES) hysterectomy for large and very large uteri. Approximately 50 adult women who underwent v-NOTES hysterectomy for a large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025, will be included. Data will be extracted retrospectively from medical records. The primary outcome is successful completion of the v-NOTES procedure without conversion to another surgical approach. Potential predictive factors include body mass index, parity, uterine weight, fibroid location, adenomyosis, vaginal access, previous cesarean deliveries or pelvic surgery, and preoperative medical treatments intended to reduce uterine volume or inflammation. Secondary outcomes include surgical complications, operative duration, length of hospital stay, and unplanned readmission within 30 days of surgery.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-03-20

Completion Date

2027-03-20

Last Updated

2026-10-26

Healthy Volunteers

No

Locations (1)

Service de Chirurgie gynécologique - CMCO - Hôpitaux universitaires de Strasbourg - France

Strasbourg, France