vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies
Procedurehysterectomy via the vaginal approach by vNOTES (natural vaginal orifice transluminal endoscopic system for hysterectomies)
NCT Number: NCT05884658
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
HFME - Hospices Civils de Lyon, Bron, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
hysterectomy via the vaginal approach by vNOTES (natural vaginal orifice transluminal endoscopic system for hysterectomies)
laparoscopic hysterectomy uses a standardized procedure with or without surgical robot
Time frame: From surgery to 6 weeks of surgery
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 :
Time frame: During surgery
Number of patients with conversion during surgery
Time frame: From surgery to 3 hours of surgery
Maximal Pain measured by a numerical scale : 0 no pain / 10 maximum pain
Time frame: From surgery to 1 week after surgery
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
Time frame: Day 0
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
Time frame: Surgery
operative time will be evaluated between the incision and the end of the closure, in minutes.
Time frame: last day of hospitalization
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.
Time frame: 3 months
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.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Saint Etienne
Other
vNOTEsHC: Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy: a Randomized Controlled Trial
Acronym: vNOTESHC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07626684
Analgesic Consumption, Bowel Functions
Muğla, Turkey (Türkiye)
View Trial DetailsNCT03281460
Hysterectomy, Vaginal, Laparoscopy
Bron, France
View Trial DetailsNCT06776718
Hysterectomy, Hysterectomy, Benign Uterine Diseases
Istanbul, Turkey (Türkiye)
View Trial Details