Actively Recruiting
Prospective Controlled Randomized Study Comparing Outpatient Success of Total Benign Hysterectomy by vNOTES Versus Conventional and Robot-Assisted Laparoscopy
Led by Elsan · Updated on 2026-06-08
132
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the success rates of outpatient management following total benign hysterectomy performed by three different minimally invasive surgical approaches: the vaginal trans-laparoscopic technique called Vaginal-Natural Orifice Transluminal Endoscopic Surgery (vNOTES), conventional laparoscopy, and robot-assisted laparoscopy. The study focuses on women scheduled for total hysterectomy with or without annexectomy to treat benign gynecological conditions. It seeks to evaluate which method has better outcomes for outpatient treatment and recovery. Participants will undergo total benign hysterectomy using one of the three approaches: vNOTES, conventional laparoscopy, or robot-assisted laparoscopy. The study is randomized and controlled, with participants assigned to one of these surgical routes. The surgeries aim to minimize invasiveness, surgical trauma, pain, and recovery time. The study compares these techniques, including their feasibility for outpatient care and their surgical and anesthetic impacts. During the study, participants will be monitored closely at defined time points, including 6 hours, 24 hours, 7 days, 1 month, and 3 months after surgery. Researchers will assess outpatient treatment success, readmission rates, pain levels, analgesic use, patient satisfaction, adverse events, quality of life, sexual function recovery, and economic value of each technique. Various scales and questionnaires will be used for evaluations, and safety will be monitored throughout. The total participation period includes short-term and longer follow-up assessments to capture comprehensive outcomes.
CONDITIONS
Brief Title
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).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant aged 18 years old and over
- Scheduled for total hysterectomy with or without adnexectomy for treatment of a benign condition
- No contraindication to surgery by conventional laparoscopy, vNOTES, or robot-assisted laparoscopy
- Eligible for outpatient treatment
- Affiliated or beneficiary of a social security system
- Provided free, informed, and written consent before any study procedures
You will not qualify if you...
- Endometriosis requiring associated procedures like digestive surgery or extended adhesiolysis
- Severely impaired physical or psychological health affecting study compliance
- Currently participating in another research study
- Within exclusion period from another ongoing research
- Under legal protection such as guardianship or deprived of liberty by judicial or administrative decision
- Hospitalized without consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo a total benign hysterectomy by one of three surgical methods: transvaginal natural orifice transluminal endoscopic surgery (vNOTES), conventional laparoscopy, or robot-assisted laparoscopy.
1 surgical visit (in-person)
Duration - Up to 3 months post-surgery
Participants are monitored for outpatient treatment success, readmission, pain, use of analgesics, adverse events, and recovery including quality of life, sexual function, and return to usual activities.
Visits at 6 hours, 24 hours, 7 days, 1 month, and 3 months post-surgery
Trial Site Locations
Total: 1 location
1
Polyclinique Jean Villar
Bruges, France, 33520
Actively Recruiting
Research Team
C
Charlène PY, Eng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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