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

Study acronym: vNOTESHC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 2026 → Oct 2026
See other at-risk trials from Centre Hospitalier Universitaire de Saint Etienne

Record History

  1. Minor Primary completion pushed from Jun 2026 to Oct 2026 Completion pushed from Aug 2026 to Dec 2026 · Eligibility criteria expanded, about 8 words · Site details revised at 1 of 6 sites Show 3 more changesShow less
    • Completion pushed from Aug 2026 to Dec 2026
    • Eligibility criteria expanded, about 8 words
    • Site details revised at 1 of 6 sites
  2. Minor Study sites: 5 to 6v13
  3. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2024 to Dec 23, 2024 · Site details revised at 5 of 5 sitesv12 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2024 to Dec 23, 2024
    • Site details revised at 5 of 5 sites
  4. Minor Start date: Nov 2024 to Dec 2024v11
  5. Minor Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Start date: Sep 2024 to Nov 2024v9
  2. Notable Start date: Jul 2024 to Sep 2024v8
  3. Minor Start date: Jun 2024 to Jul 2024v7
  4. Minor Start date: May 2024 to Jun 2024v6
  5. Notable Start date: Feb 2024 to May 2024v5
  6. Notable Start date: Dec 2023 to Feb 2024v4
  7. Notable Start date: Sep 2023 to Dec 2023v3
  8. Notable Start date: Jun 1, 2023 to Sep 2023 Primary completion date: Jun 1, 2026 to Jun 2026 · Completion date: Aug 31, 2026 to Aug 2026v2 Show 2 more changesShow less
    • Primary completion date: Jun 1, 2026 to Jun 2026
    • Completion date: Aug 31, 2026 to Aug 2026
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05884658
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Ministry of Health, France
Conditions Hysterectomy, Vaginal
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov