Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.

Last updated: July 9, 2025
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

vNOTES

Laparoscopy

Clinical Study ID

NCT05031182
RBHP 2021 CURINIER
2021-A01218-33
  • Ages 18-70
  • Female
  • Accepts Healthy Volunteers

Study Summary

During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult woman eligible for total hysterectomy for benign lesions with or withoutbilateral adnexectomy.

  • Able to give informed consent to participate in research.

  • Affiliation to a Social Security scheme.

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding women

  • Contraindication to the laparoscopic approach

  • Contraindication to first vNOTES, in particular: virginity, history of rectalsurgery, rectovaginal endometriosis, high active genital infection

  • Indications for another concomitant surgical procedure (other than procedure on theappendix)

  • 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.

Study Design

Total Participants: 145
Treatment Group(s): 2
Primary Treatment: vNOTES
Phase:
Study Start date:
October 11, 2021
Estimated Completion Date:
February 25, 2025

Connect with a study center

  • CHU clermont-ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • CH d'Issoire

    Issoire,
    France

    Site Not Available

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