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).
NCT ID: NCT06471049
Last Updated: 2024-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
132 participants
INTERVENTIONAL
2024-05-21
2027-09-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES)
Benign Hysterectomy
removal of the uterus
Conventional laparoscopy
Benign Hysterectomy
removal of the uterus
Robot-assisted laparoscopy
Benign Hysterectomy
removal of the uterus
Interventions
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Benign Hysterectomy
removal of the uterus
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
Yes
Sponsors
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Elsan
OTHER
Responsible Party
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Locations
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Polyclinique Jean Villar
Bruges, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-A02112-43
Identifier Type: -
Identifier Source: org_study_id
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