Comparing outpatient management of hysterectomy using different surgical techniques

Prospective, Controlled, Randomized Study Evaluating the Success Rate of Outpatient Management of the Total Benign Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Each of the Two Laparoscopic Routes (Conventional and Robot-assisted).

This study is testing which of three different surgical methods for outpatient hysterectomy helps women recover better and feel less pain after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Elsan (other)
• Locations: 1 site (Bruges)
• Trial ID: NCT06471049 on ClinicalTrials.gov

What this trial studies

This study evaluates the success rates of outpatient management for total benign hysterectomy using three surgical approaches: conventional laparoscopy, robot-assisted laparoscopy, and a newer technique called V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery). The goal is to determine which method offers the best outcomes in terms of surgical trauma, pain, recovery time, and overall patient autonomy. Women scheduled for a total hysterectomy due to benign conditions will be enrolled to compare these minimally invasive techniques. The study aims to enhance outpatient treatment options for patients undergoing this common gynecological procedure.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older who require a total hysterectomy for benign conditions and are eligible for outpatient treatment.

Not a fit: Patients with severe physical or psychological health impairments or those requiring additional procedures alongside hysterectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outpatient management options for women undergoing hysterectomy, resulting in less pain and quicker recovery.

How similar studies have performed: Other studies have shown promising results with minimally invasive surgical techniques, suggesting potential success for this approach as well.

Eligibility criteria

Inclusion Criteria:

* Participant aged 18 years old and over
* Participant for whom a total hysterectomy with or without adnexectomy for the treatment of a benign pathology must be scheduled
* Participant with no contraindication to being operated on by one of the three approaches under study (conventional laparoscopy, V-Notes, robot-assisted laparoscopy)
* Patient eligible for outpatient treatment
* Participant affiliated or beneficiary of a social security regimen
* Participant having been informed and having given her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research)

Exclusion Criteria:

* Participant with endometriosis with procedure associated with hysterectomy (digestive procedure, extended adhesiolysis, or other procedure)
* Participant whose physical and/or psychological health is severely impaired, which according to the investigator may affect the participant's understanding and compliance with the study
* Participant in another research
* Participant in a period of exclusion from another research still in progress at the time of inclusion
* Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Patient hospitalized without consent

Where this trial is running

Bruges

• Polyclinique Jean Villar — Bruges, France (RECRUITING)

Study contacts

• Study coordinator: Charlène PY, Eng

Conditions: Surgery, Gynecologic Disease, hysterectomy, vnotes, laparoscopy