Actively Recruiting
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).
Led by Elsan · Updated on 2024-06-24
132
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 benign disease
- No contraindication to conventional laparoscopy, V-NOTES, or robot-assisted laparoscopy
- Eligible for outpatient treatment
- Affiliated or beneficiary of a social security regimen
- Provided free, informed, written consent before any research exams
You will not qualify if you...
- Endometriosis with associated procedures like digestive surgery or extended adhesiolysis
- Severe physical or psychological health impairment affecting understanding or compliance
- Participation in another research study
- Exclusion period from another ongoing research at inclusion
- Legal protection status (guardianship, curatorship, deprivation of liberty)
- Hospitalized without consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Polyclinique Jean Villar
Bruges, France, 33520
Actively Recruiting
Research Team
C
Charlène PY, Eng
CONTACT
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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