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).

NCT06471049 | Recruiting

• 1 other identifier: 2023-A02112-43
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Gynecologic Disease

Keywords

hysterectomy; vnotes; laparoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  Success rate of outpatient treatment

  6 hours post-surgery

Secondary Outcomes (19)

• Compare the success rate he success rate of outpatient treatment of the conventional laparoscopic route and the robot-assisted laparoscopic route.

  6 hours post-surgery

• Compare the readmission rate in post-operative night for all patients.

  24 hours post-surgery

• Compare the readmission rate within 7 days post-surgery for all patients.

  7 days post-surgery

• Evaluate the reason for the failure of outpatient treatment

  6 hours post-surgery

• Compare patient satisfaction for all technique by 5-modal Likert scale

  3 months post-surgery

Study Arms (3)

Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES)

EXPERIMENTAL

Procedure: Benign Hysterectomy

Conventional laparoscopy

ACTIVE COMPARATOR

Procedure: Benign Hysterectomy

Robot-assisted laparoscopy

ACTIVE COMPARATOR

Procedure: Benign Hysterectomy

Interventions

Benign Hysterectomy PROCEDURE

removal of the uterus

Conventional laparoscopy; Robot-assisted laparoscopy; Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Patient hospitalized without consent

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Polyclinique Jean Villar

Bruges, 33520, France

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Charlène PY, Eng

CONTACT

0556003048; charlene.py@elsan.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 24, 2024
• Study Start: May 21, 2024
• Primary Completion (Estimated): May 21, 2027
• Study Completion (Estimated): September 21, 2027
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)