Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy (vNOTESHC)

vNOTEsHC: Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hysteromyoma
• Intervention / Treatment: Procedure: laparoscopic hysterectomy; Procedure: vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florence RANCON; Phone Number: +33 0477829458; Email: florence.rancon@chu-st-etienne.fr
• Study Contact Backup: Name: Céline CHAULEUR, PhD; Phone Number: +33 0477828383; Email: celine.chauleur@chu-st-etienne.fr

Study Locations

• France
  • Bron, France, 69677
    • HFME - Hospices Civils de Lyon
    • Principal Investigator: Géry LAMBLIN
    • Contact: Géry LAMBLIN; Email: gery.lamlin@chu-lyon.fr
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand
    • Sub-Investigator: Sandra CURINIER, PH
    • Contact: Sandrine CAMPAGNE-LOISEAU, PH; Email: scampagne-loiseau@chu-clermontferrand.fr
    • Principal Investigator: Sandrine CAMPAGNE-LOISEAU, PH
  • Issoire, France, 63500
    • Ch Issoire
    • Contact: Aslam MANSOOR; Email: amansoor@ch-issoire.fr
    • Principal Investigator: Aslam MANSOOR, PH
  • Saint-Étienne, France, 42055
    • CHU Saint-Etienne
    • Contact: Céline CHAULEUR, PhD; Phone Number: 0477828383; Email: celine.chauleur@chu-st-etienne.fr
    • Principal Investigator: Thomas CORSINI
    • Sub-Investigator: Céline CHAULEUR
    • Sub-Investigator: Ahamd MEDHI
  • Saint-Étienne, France, 42100
    • Clinique Mutualiste de Saint-Etienne
    • Contact: Quentin REBOUL, MD; Email: quentinreboul@free.fr
    • Principal Investigator: Quentin REBOUL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laparoscopic hysterectomy; Laparoscopic Hysterectomy will be performed in a standardized manner	Procedure: laparoscopic hysterectomy; laparoscopic hysterectomy uses a standardized procedure
Experimental: natural vaginal orifice transluminal endoscopic system for hysterectomies (vNOTES); Vaginal hysterectomy will be performed in a standardized manner using transluminal endoscopic system	Procedure: vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies; hysterectomy via the vaginal approach by vNOTES (natural vaginal orifice transluminal endoscopic system for hysterectomies)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion	Number of patients with conversion during surgery	During surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	Maximal Pain measured by a numerical scale : 0 no pain / 10 maximum pain	From surgery to 3 hours of surgery
Short-term postoperative pain	Maximal short-term postoperative pain the first week after surgery measured by a numerical scale (0 no pain / 10 maximum pain) by a daily telephone call	From surgery to 1 week after surgery
Duration of postoperative reflex ileus	Duration of post-operative reflex ileus between the day of the operation and the resumption of a transit (appearance of the first gas) in hours	Day 0
Duration of the operation	operative time will be evaluated between the incision and the end of the closure, in minutes.	Surgery
Duration of hospitalization and the possibility of returning home	The length of hospital stay will be assessed in days and the possibility of return home by the time in hours from surgical incision to a Chung≥ score of 9/10. The Chung score assesses the possibility of a return home in ambulatory surgery.	last day of hospitalization
Sexual dysfunction	Sexual disorders: sexual life will be assessed by the difference in the specific validated score (self-questionnaire) (PISQ12 with a score ranging from 0 to 48) between the inclusion date and 3 months after surgery for sexually active women.	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Céline CHAULEUR, PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: natural orifice transluminal endoscopy system; large uteri
• Other Study ID Numbers: 21PH265; 2023-A01013-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No