Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy

NCT05884658 | Recruiting

• 2 other identifiers: 21PH2652023-A01013-42
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

In France, there are approximately 62,000 hysterectomies per year, 70% of which are benign. It is the most frequent surgical procedure in gynecology. Hysterectomies are performed via 3 routes: laparotomy, laparoscopy or vaginal route. This choice of approach is particularly important in the case of large uteri (50% of uteri \> 280g), which increase the risks of laparoconversion and bladder injury (NP3). The vaginal route reduces the operating time and postoperative pain. Laparoscopy allows a better anatomical view and easier access to the neighbouring organs, which makes it the preferred approach, especially for young surgeons and when the uterus is large. However, the laparoscopic route is associated with an increase in the rate of conversion to laparotomy according to the volume of the uterus, as well as the rate of general per and postoperative complications compared with vaginal hysterectomy for uteri \> 280 g. In a meta-analysis comparing laparoscopy and vaginal hysterectomy, the total prevalence of perioperative complications according to the classification of Clavien and Dindo was 27%. For large uteruses, complications by the vaginal route amounted to 15% and those by the laparoscopic route to 37.5%. The data are not sufficient to give preference to one or other of the approaches, but for benign pathologies, for large uteri (\>280 g), the minimally invasive laparoscopic or vaginal approaches are recommended by the CNGOF (grade C). A new Medical Device (MD), the vNOTES (Vaginal Natural Orifice Transluminal Endoscopy System) offers the advantage of two approaches for pelvic surgery by allowing minimally invasive surgery to be performed by endoscopy through the vagina, offering perfect vision for the assistants and the operator and without scarring. Two randomized trials have shown that vNOTES allows, compared to laparoscopy, to perform adnexectomies and hysterectomies without conversion with less pain, fewer postoperative complications and a shorter hospitalization time. The first evaluations of vNOTES are encouraging and suggest a new era for pelvic surgery: less postoperative pain, fewer complications and facilitation of ambulatory care. Also the videoscopic assistance of the vNOTES is a pedagogical tool for the vaginal route because the field of vision is no longer limited to the operator alone. However, the vNOTES has only been evaluated by the developers of the tool, in monocentric studies and in small numbers. The hysterectomy study evaluated only 35 patients with vNOTES, half of whom had a uterus of less than 280 g. The benefit of vNOTES for uteri smaller than 280 g is not obvious because of the ease of the surgical procedure and the cost of the "classic" vaginal route. Our study would be the first multicentric and academic study on vNOTES to focus specifically on large volume uteri, the most difficult to operate and prone to postoperative complications.

Conditions

Hysterectomy, Vaginal

Keywords

natural orifice transluminal endoscopy system; large uteri

Outcome Measures

Primary Outcomes (1)

• Proportion of patient with complications

  The proportion of patients with at least one pre- and post-operative complication at 6 weeks will be estimated along with its 95% confidence interval in each surgical strategy group. The primary endpoint is a composite endpoint including the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Postoperative complications were Infectious complications, Bleeding complications and All hospital readmissions related to the procedure Postoperative complications will be classified according to the Clavien-Dindo classification Intraoperative complications will be defined as : * wounds of nearby organs (bladder, ureters, rectum, colon, small intestine) * and bleeding defined as bleeding requiring immediate resumption, intraoperative transfusion and/or decreasing the patient's hemoglobin by more than 2 points compared to the last known preoperative blood sample

  From surgery to 6 weeks of surgery

Secondary Outcomes (1)

• Conversion

  During surgery

Other Outcomes (6)

• Post-operative pain

  From surgery to 3 hours of surgery

• Short-term postoperative pain

  From surgery to 1 week after surgery

• Duration of postoperative reflex ileus

  Day 0

Study Arms (2)

laparoscopic hysterectomy

ACTIVE COMPARATOR

Laparoscopic Hysterectomy will be performed in a standardized manner with or without surgical robot

Procedure: laparoscopic hysterectomy

natural vaginal orifice transluminal endoscopic system for hysterectomies (vNOTES)

EXPERIMENTAL

Vaginal hysterectomy will be performed in a standardized manner using transluminal endoscopic system

Procedure: vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies

Interventions

vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies PROCEDURE

hysterectomy via the vaginal approach by vNOTES (natural vaginal orifice transluminal endoscopic system for hysterectomies)

natural vaginal orifice transluminal endoscopic system for hysterectomies (vNOTES)

laparoscopic hysterectomy PROCEDURE

laparoscopic hysterectomy uses a standardized procedure with or without surgical robot

laparoscopic hysterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any woman received in preoperative consultation in the Gynecology-Obstetrics Department for a benign pathology of a uterus estimated to be large requiring a hysterectomy.
• Patient affiliated or entitled to a social security system
• Patients over 18 years of age
• Patients having given their agreement to participate and after signing the consent form

You may not qualify if:

• Woman refusing to participate in the study (lack of consent)
• Non-French speaking woman (unable to conduct a good quality interview of the pregnant woman)
• Participation in another interventional study.
• Patient subject to a legal protection measure or unable to express her consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (6)

HFME - Hospices Civils de Lyon

Bron, 69677, France

NOT YET RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Ch Issoire

Issoire, 63500, France

NOT YET RECRUITING

CHU LIMOGES - Hôpital de la mère et de l'Enfant

Limoges, 87042, France

NOT YET RECRUITING

CHU Saint-Etienne

Saint-Etienne, 42055, France

NOT YET RECRUITING

Clinique Mutualiste de Saint-Etienne

Saint-Etienne, 42100, France

NOT YET RECRUITING

MeSH Terms

Interventions

Hysterectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Céline CHAULEUR, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline CHAULEUR, PhD

CONTACT

0477828383; celine.chauleur@chu-st-etienne.fr

Florence RANCON

CONTACT

0477829458; florence.rancon@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, multicenter, randomized, parallel-group, non-inferiority open superiority study

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 1, 2023
• Study Start: December 23, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)