vNOTEsHC : Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopic for large...

In France, 62,000 hysterectomies are performed per year, 70% of which are benign. The choice of approach (laparotomy, laparoscopy or vaginal route) is particularly important in the case of large uterus (> 280g) which are associated with a higher risk of complications. The current data are not sufficient to favour one or other approach. A new medical device, the vNOTES (Natural Vaginal Orifice Transluminal Endoscopy System), offers the advantage of both laparoscopic and vaginal route for pelvic surgery.

To demonstrate the superiority in terms of intraoperative and postoperative complications of the use of a natural orifice transluminal endoscopic hysterectomy system (vNOTES) versus laparoscopic hysterectomy for benign pathologies on estimated large volume uteri (>280g).

A randomised, double-blind, superiority trial will be performed at five hospital centres. Women with benign uterine pathology requiring hysterectomy and with a large uterus (> 280g) will be randomised to receive either laparoscopic or vNOTES hysterectomy.

The primary outcome will be the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Secondary outcomes will be conversion during surgery, duration of surgery and hospitalisation, postoperative pain, postoperative complications, resumption of sexual life and satisfaction with the surgical team.

248 women will be randomised.

This trial will provide a better understanding of the approach to large uteri optimise the care of these thousands of women undergoing hysterectomy.

This trial will evaluate the vNotes for large uteri.