Comparing two methods for performing hysterectomy
vNOTEsHC: Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy: a Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 6 sites (Bron and 5 other locations) |
| Trial ID | NCT05884658 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with benign uterine conditions requiring hysterectomy and whose uteri are estimated to be large.
Not a fit: Patients who do not speak French or those who refuse to participate will not benefit from this study.
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 performed: Previous studies have shown promising results for the vNOTES approach, suggesting it may offer advantages over traditional laparoscopic methods.
Eligibility criteria
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 this trial is running
Bron and 5 other locations
- HFME - Hospices Civils de Lyon — Bron, France (Not_yet_recruiting)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.