Study Evaluating the Success Rate of Outpatient Management of the Total Benign Hysterectomy by Tr… (NCT06471049) | Clinical Trial Compass
TerminatedNot Applicable
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).
Stopped: The study was discontinued for practical reasons, due to logistical and organisational constraints (the investigator centre no longer has a surgical robot).
France1 participantsStarted 2024-05-21
Plain-language summary
Benign total hysterectomy is one of the most commonly performed gynecological surgery.
Conventionally performed by a classical surgical approach, it is now provided routinely and for several years by laparoscopy and more recently by Robotic-Assisted Laparoscopy.
A third minimally invasive option is currently being developed and proposed to avoid trans-peritoneal access, using a vaginal trans-laparoscopic technique, defined by the name V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery).
These minimally invasive approaches have simplified this intervention on many surgical and anesthetic parameters (signing, surgical trauma, pain and post-operative ileus, recovery of autonomy) and consider possible management in the outpatient sector.
This study aims at enrolling women for which a total hysterectomy with or without annexectomy for the treatment of a benign pathology must be scheduled.
The objective of the study is to compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the laparoscopic route assisted robot.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the robot-assisted laparoscopic route.