Clinical trial NCT05884658: Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy
Official title: vNOTEsHC: Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hysterectomy, Vaginal
Keywords: natural orifice transluminal endoscopy system
large uteri
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2023-06-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, multicenter, randomized, parallel-group, non-inferiority open superiority study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patient with complications
timeFrame: From surgery to 6 weeks of surgery
Secondary outcomes:
measure: Conversion
timeFrame: During surgery
Other outcomes:
measure: Post-operative pain
timeFrame: From surgery to 3 hours of surgery
measure: Short-term postoperative pain
timeFrame: From surgery to 1 week after surgery
measure: Duration of postoperative reflex ileus
timeFrame: Day 0
measure: Duration of the operation
timeFrame: Surgery
measure: Duration of hospitalization and the possibility of returning home
timeFrame: last day of hospitalization
measure: Sexual dysfunction
timeFrame: 3 months
Locations:
city: Bron
country: France
facility: HFME - Hospices Civils de Lyon
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Issoire
country: France
facility: Ch Issoire
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Saint-Étienne
country: France
facility: Clinique Mutualiste de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Céline CHAULEUR, PhD
role: PRINCIPAL_INVESTIGATOR
References: