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

Recruiting
18 - 70 years of age
Female
Phase N/A

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Overview

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

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.

Study details

Hysterectomy, Laparoscopy, vNOTES

NCT05031182

University Hospital, Clermont-Ferrand

26 January 2024

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