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).

Launched by ELSAN · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to perform a total hysterectomy, which is a common surgery to remove the uterus, using a technique called V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery). This method is less invasive than traditional laparoscopic surgeries, which use small cuts in the abdomen. The trial aims to compare how successful V-NOTES is for outpatient treatment with two other methods: conventional laparoscopic surgery and robot-assisted laparoscopic surgery. The goal is to see if V-NOTES can help women recover more quickly and easily after surgery.

To be eligible for this trial, participants need to be at least 18 years old and scheduled for a total hysterectomy for benign (non-cancerous) reasons. They should not have any serious health issues that would affect their ability to participate, and they must be able to provide informed consent. If you participate, you can expect to receive care from experienced medical professionals and will be monitored closely throughout the process. This study is currently recruiting women, and participation could help improve surgical options for others in the future.

Gender

FEMALE

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