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RecruitingNCT07895953PRE v-NOTESUpdated Oct 26, 2026

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

An observational study in Uterine Fibroids, Hysterectomy and Vaginal Natural Orifice Transluminal Endoscopic Surgery (v-NOTES), sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Updated Oct 26, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
Female
01

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.

02

Conditions studied

  • Uterine Fibroids
  • Hysterectomy
  • Vaginal Natural Orifice Transluminal Endoscopic Surgery (v-NOTES)

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Keywords

  • v-NOTES hysterectomy
  • Large uterus
  • Predictors of surgical success and conversion
03

In context

Leiomyoma

496 studies on the registry are indexed under Leiomyoma; 79 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 120 observational studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 994 studies on the registry; 353 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult women who underwent v-NOTES hysterectomy for a large or very large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025, and who have not objected to the reuse of their medical data for scientific research. The estimated sample size is approximately 50 patients.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who have objected to the reuse of their data for scientific research.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Successful completion of v-NOTES hysterectomy without conversion to another surgical approach

    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.

    Time frame: During surgery, for procedures performed between January 1, 2024, and December 31, 2025

07

Study locations

1 of 1 sites recruiting
  • Service de Chirurgie gynécologique - CMCO - Hôpitaux universitaires de Strasbourg - France
    Strasbourg, 67091, France
    • Victor Gabriele, MD · Contact · victor.gabriele@chru-strasbourg.fr · 33 3 69 55 34 55
    • Victor Gabriele, MD · Principal investigator
    • Cyrine Korchane, MD · Sub investigator
    Recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 26, 2026
StartActual
Mar 20, 2026
Primary completionEst.
Jan 20, 2027
CompletionEst.
Mar 20, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07895953
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Mar 20, 2026
Primary completion
Jan 20, 2027 (estimated)
Completion
Mar 20, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Victor Gabriele, MD
Contact
victor.gabriele@chru-strasbourg.fr
33 3 69 55 34 55

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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