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).

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
France
Polyclinique Jean Villar
RECRUITING
Bruges
Contact Information
Primary
Charlène PY, Eng
charlene.py@elsan.care
0556003048
Time Frame
Start Date: 2024-05-21
Estimated Completion Date: 2027-09-21
Participants
Target number of participants: 132
Treatments
Experimental: Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES)
Active_comparator: Conventional laparoscopy
Active_comparator: Robot-assisted laparoscopy
Related Therapeutic Areas
Sponsors
Leads: Elsan

This content was sourced from clinicaltrials.gov