Comparing two methods for performing hysterectomy
Official title: vNOTEsHC: Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy: a Randomized Controlled Trial
Run by Centre Hospitalier Universitaire de Saint Etienne · NCT05884658 · Data updated 2026-11-12
This study is testing whether a new way of doing hysterectomy through the vagina is safer and easier for women with larger uteri compared to the traditional laparoscopic method.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 6 sites (Bron and 5 other locations) |
| Status | Recruiting |
| Started | December 23, 2024 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT05884658 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women over 18 years old with benign uterine conditions requiring hysterectomy and whose uteri are estimated to be large.
✕Probably not a fit
Patients who do not speak French or those who refuse to participate will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares the effectiveness and safety of hysterectomy performed using the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) technique versus the traditional laparoscopic approach. It focuses on women with large uteri, which pose higher risks during surgery. The study aims to determine which method results in less operating time and postoperative pain while minimizing complications. Participants will be women undergoing hysterectomy for benign conditions, and the trial will be conducted at multiple hospitals in France.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recovery times for women undergoing hysterectomy.
How similar studies have gone: Previous studies have shown promising results for the vNOTES approach, suggesting it may offer advantages over traditional laparoscopic methods.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any woman received in preoperative consultation in the Gynecology-Obstetrics Department for a benign pathology of a uterus estimated to be large requiring a hysterectomy. * Patient affiliated or entitled to a social security system * Patients over 18 years of age * Patients having given their agreement to participate and after signing the consent form Exclusion Criteria: * Woman refusing to participate in the study (lack of consent) * Non-French speaking woman (unable to conduct a good quality interview of the pregnant woman) * Participation in another interventional study. * Patient subject to a legal protection measure or unable to express her consent
Where it's running
-
CHU Clermont-Ferrand
Clermont-Ferrand, France Recruiting -
HFME - Hospices Civils de Lyon
Bron, France Not yet recruiting -
Ch Issoire
Issoire, France Not yet recruiting -
CHU LIMOGES - Hôpital de la mère et de l'Enfant
Limoges, France Not yet recruiting -
CHU Saint-Etienne
Saint-Etienne, France Not yet recruiting -
Clinique Mutualiste de Saint-Etienne
Saint-Etienne, France Not yet recruiting
Study contacts
- Principal investigator: Céline CHAULEUR, PhD — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Céline CHAULEUR, PhD
- Email: celine.chauleur@chu-st-etienne.fr
- Phone: 0477828383
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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.