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

Laparoscopy Clinical Trial

— VLAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031182
• Other study ID #: RBHP 2021 CURINIER
• Secondary ID: 2021-A01218-33
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: April 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

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.

Related Conditions & MeSH terms

• Hysterectomy
• Laparoscopy

Intervention

Procedure:
• Laparoscopy
The hysterectomy is performed by laparoscopy as described in the EMC.
• vNOTES
The hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand
France	CH d'Issoire	Issoire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measure of pain	Quantification of postoperative pain: 6 hours, 24 hours, day 2, 5, 7, 14 and at one month	Until one month
Secondary	Duration of operation	From skin opening to skin or vaginal closure	one day
Secondary	Assessment of quality of life	Respond to SF-36 questionnaire to assess and compare quality of life before and after surgery	Six month
Secondary	Assessment of satisfaction	Respond to FSFI questionnaire to assess and compare sexuality before and after surgery	Six month
Secondary	Duration of work stoppage	Patients will inquire if they needed to prolong the sick leave.	one month