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

NCT ID: NCT05031182

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2025-02-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopy

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

Group Type: PLACEBO_COMPARATOR

Laparoscopy

Intervention Type: PROCEDURE

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

vNOTES

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.

Group Type: ACTIVE_COMPARATOR

vNOTES

Intervention Type: PROCEDURE

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

Interventions

Laparoscopy

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

Intervention Type: PROCEDURE

vNOTES

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra CURINIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU clermont-ferrand

Clermont-Ferrand, , France

CH d'Issoire

Issoire, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37642285 (View on PubMed)

Other Identifiers

2021-A01218-33

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2021 CURINIER

Identifier Type: -

Identifier Source: org_study_id