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Clinical Trials in France / NCT07895953
Recruiting Observational

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

NCT07895953 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Observational
Started
2026-03-20
Last updated
2026-10-26

Condition(s) studied

Uterine FibroidsHysterectomyVaginal Natural Orifice Transluminal Endoscopic Surgery (v-NOTES)

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Women aged 18 years or older. * Patients who underwent v-NOTES hysterectomy for a large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025. The uterine weight threshold for defining a large uterus remains to be determined (280 g or 500 g). * Patients who have not objected to the reuse of their data for scientific research. Exclusion Criteria: * Patients who have objected to the reuse of their data for scientific research.

Primary outcome measure(s)

  • Successful completion of v-NOTES hysterectomy without conversion to another surgical approach — During surgery, for procedures performed between January 1, 2024, and December 31, 2025
    Proportion of v-NOTES hysterectomies for large and very large uteri completed without conversion to another surgical approach, based on the operative report. Potential predictors of success or conversion include body mass index, parity, uterine weight, FIGO fibroid location, adenomyosis, preoperative vaginal access assessment, previous cesarean delivery or pelvic surgery, and preoperative medical treatment intended to reduce uterine volume or inflammation.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07895953 on ClinicalTrials.gov ↗ ← All trials in France