Clinical trial NCT06471049: 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).
Official title: 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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Gynecologic Disease
Keywords: hysterectomy
vnotes
laparoscopy
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 hours post-surgery
Secondary outcomes:
measure: Compare the success rate he success rate of outpatient treatment of the conventional laparoscopic route and the robot-assisted laparoscopic route.
timeFrame: 6 hours post-surgery
measure: Compare the readmission rate in post-operative night for all patients.
timeFrame: 24 hours post-surgery
measure: Compare the readmission rate within 7 days post-surgery for all patients.
timeFrame: 7 days post-surgery
measure: Evaluate the reason for the failure of outpatient treatment
timeFrame: 6 hours post-surgery
measure: Compare patient satisfaction for all technique by 5-modal Likert scale
timeFrame: 3 months post-surgery
measure: Compare patient satisfaction for all techniques by her opinion on: if this had to be done again (yes/no)
timeFrame: 3 months post-surgery
measure: Compare the occurence of intraoperative adverse events and up to one month postoperatively.
timeFrame: 1 month post-surgery
measure: Evaluate sequelae for all surgical approaches.
timeFrame: 3 months post-surgery
measure: Evaluate post-operative pain by Digital scale.
timeFrame: 6 hours post-surgery
measure: Evaluate the use of analgesic.
timeFrame: 8 days post-surgery
measure: Compare patient's Hospital Anxiety and Depression Scale score during their treatment.
timeFrame: baseline, 1 month post-surgery, 3 months post-surgery
measure: Compare patient's quality of life.
timeFrame: baseline, 1 month post-surgery, 3 months post-surgery
measure: Compare the recuperation of sexual function between baseline and 3 months post-surgery.
timeFrame: baseline, 3 months post-surgery
measure: Compare the resumption of usual activity and work.
timeFrame: 3 months post-surgery
measure: Compare intraoperative bleeding.
timeFrame: Day of surgery
measure: Compare hemoglobin decrease during intervention.
timeFrame: Day of surgery
measure: Compare skin-to-skin duration.
timeFrame: Day of surgery
measure: Compare room occupancy time.
timeFrame: 3 months post-surgery
measure: Evaluate the medico-economic value of the use of each technique.
timeFrame: 3 months post-surgery
Other outcomes:
Locations:
city: Bruges
country: France
facility: Polyclinique Jean Villar
Study officials:
References: