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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hysteromyoma

Intervention / Treatment
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* Procedure: vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies
* Procedure: laparoscopic hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, multicenter, randomized, parallel-group, non-inferiority open superiority study
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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natural orifice transluminal endoscopy system, large uteri