Comparing vNOTES and laparoscopic techniques for total hysterectomy
Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
This study is testing a new surgical method called vNOTES for total hysterectomy in women with benign conditions to see if it works as well as the standard laparoscopic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 2 sites (Clermont-Ferrand and 1 other locations) |
| Trial ID | NCT05031182 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the tolerance of the vNOTES surgical technique for total hysterectomy in women with benign lesions, comparing its outcomes to the traditional laparoscopic approach. Eligible participants will be randomly assigned to either the vNOTES or laparoscopic group, with surgeries performed by experienced surgeons. The study will monitor and document per and postoperative complications for up to six months following the procedures. The aim is to determine if vNOTES is a non-inferior alternative to laparoscopic surgery.
Who should consider this trial
Good fit: Ideal candidates are adult women eligible for total hysterectomy due to benign lesions who can provide informed consent.
Not a fit: Patients with contraindications to laparoscopic or vNOTES approaches, or those requiring hysterectomy for malignant lesions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive surgical option for women undergoing hysterectomy, potentially leading to improved recovery times and fewer complications.
How similar studies have performed: While the vNOTES technique is relatively novel, similar studies have shown promising results in minimally invasive surgery, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy. * Able to give informed consent to participate in research. * Affiliation to a Social Security scheme. Exclusion Criteria: * Pregnant or breastfeeding women * Contraindication to the laparoscopic approach * Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection * Indications for another concomitant surgical procedure (other than procedure on the appendix) * Indication of hysterectomy for malignant lesion. * Any concomitant pathology deemed incompatible with the study. * COVID not cured or SARS-COv2 positivity dating less than 3 days before surgery. * Adult patient protected, under guardianship or curatorship or legal safeguard * Refusal of participation.
Where this trial is running
Clermont-Ferrand and 1 other locations
- CHU clermont-ferrand — Clermont-Ferrand, France (Recruiting)
- CH d'Issoire — Issoire, France (Recruiting)
Study contacts
- Principal investigator: Sandra CURINIER — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
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.