Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 145
- Locations
- 2
- Primary Endpoint
- Complications per or post Operative
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: vNOTES (Procedure)
Laparoscopy
In this Arm, patient will have the traditional hysterectomy by laparoscopy. This is the type of surgery that we realize everyday.
Intervention: Laparoscopy (Procedure)
Outcomes
Primary Outcomes
Complications per or post Operative
Time Frame: one month after surgery
Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection
Secondary Outcomes
- 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)