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

NCT05031182 | Completed

• 2 other identifiers: RBHP 2021 CURINIER2021-A01218-33
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hysterectomy; Laparoscopy; vNOTES

Outcome Measures

Primary Outcomes (1)

• Complications per or post Operative

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

  one month after surgery

Secondary Outcomes (5)

• Measure of pain

  Until one month

• Duration of operation

  one day

• Assessment of quality of life

  Six month

• Assessment of satisfaction

  Six month

• Duration of work stoppage

  one month

Study Arms (2)

Laparoscopy

PLACEBO COMPARATOR

In this Arm, patient will have the traditional hysterectomy by laparoscopy. This is the type of surgery that we realize everyday.

Procedure: Laparoscopy

vNOTES

ACTIVE COMPARATOR

In this Arm, patient will have the hysterectomy by vNOTES (vaginal natural orifices Transluminal surgery). It's the new type of surgery that we want prove the no-inferiority.

Procedure: vNOTES

Interventions

Laparoscopy PROCEDURE

The hysterectomy is performed by laparoscopy as described in the EMC.

Laparoscopy

vNOTES PROCEDURE

The hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team.

vNOTES

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

CH d'Issoire

Issoire, France

Location

Related Publications (1)

• Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.

  PMID: 37642285 DERIVED

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sandra CURINIER

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 1, 2021
• Study Start: October 11, 2021
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: February 2, 2026

Record last verified: 2025-03

Locations

FR (2)