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). (HYSTERAMBU)

Elsan

Status: Enrolling

Conditions: Surgery; Gynecologic Disease

Treatments: Procedure: Benign Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06471049

2023-A02112-43

Details and patient eligibility

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.

Enrollment: 132 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES)

Experimental group

Treatment:

Procedure: Benign Hysterectomy

Conventional laparoscopy

Active Comparator group

Treatment:

Procedure: Benign Hysterectomy

Robot-assisted laparoscopy

Active Comparator group

Treatment:

Procedure: Benign Hysterectomy