Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Aug 30, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new surgical technique called vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) for total hysterectomy, which is the removal of the uterus, compared to the traditional laparoscopic method. The goal is to see if vNOTES is just as safe and effective as laparoscopy for women having this surgery for non-cancerous (benign) conditions. If you are a woman between the ages of 18 and 74 and are considering a total hysterectomy for a benign reason, you may be eligible to participate in this study.
Participants will first have a consultation where they will learn more about the trial and, if interested, provide consent. After that, they will be randomly assigned to have either the vNOTES or laparoscopic surgery performed by experienced surgeons. The trial will track any complications that may occur before and after the surgery for up to six months. It’s important to note that certain conditions, like being pregnant, having specific medical issues, or being under legal guardianship, may prevent someone from participating. This study aims to gather valuable information to help improve surgical options for women in the future.
Gender
FEMALE
Eligibility 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.
About University Hospital, Clermont Ferrand
The University Hospital of Clermont-Ferrand is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its multidisciplinary approach, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes collaboration among healthcare professionals, researchers, and academic partners. With a strong commitment to improving patient outcomes, the institution actively engages in a wide array of clinical studies, ranging from early-phase trials to large-scale interventions, aimed at addressing critical health challenges and enhancing treatment modalities. Its state-of-the-art facilities and expertise make it a pivotal contributor to clinical research in the region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Clermont Ferrand, , France
Issoire, , France
Patients applied
Trial Officials
Sandra CURINIER
Principal Investigator
University Hospital, Clermont-Ferrand
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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