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

University Hospital, Clermont-Ferrand145 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

145

Conditions

Hysterectomy Laparoscopy vNOTES

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Complications per or post Operative

Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection

Time frame: one month after surgery

Secondary Outcomes

Measure of pain

Quantification of postoperative pain: 6 hours, 24 hours, day 2, 5, 7, 14 and at one month

Time frame: Until one month

Duration of operation

From skin opening to skin or vaginal closure

Time frame: one day

Assessment of quality of life

Respond to SF-36 questionnaire to assess and compare quality of life before and after surgery

Time frame: Six month

Assessment of satisfaction

Respond to FSFI questionnaire to assess and compare sexuality before and after surgery

Time frame: Six month

Duration of work stoppage

Patients will inquire if they needed to prolong the sick leave.

Time frame: one month