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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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