Journal of the European Society for Gynaecological Endoscopy


vNOTEsHC : Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopic for large uteri: study protocol for a multicentre randomised controlled trial

J. Druenne1, E. Presles2, T. Corsini1, S. Campagne Loiseau3, S. Curinier3, A. Mansour4, G. Lamblin5, Q. Reboul6, C. Chauleur1,7

1 Univ Jean Monnet, Department of gynaecologic and Obstetrics, University Hospital of Saint-Etienne, France
2 Univ Jean Monnet, URCIP
3 Department of Gynaecology and Obstetrics, University Hospital of Clermont-Ferrand, France
4 Department of Gynaecology and Obstetrics, University Hospital of Issoire, France
5 Department of Gynaecology and Obstetrics, University Hospital of Lyon, France
6 Department of Gynaecology, Clinique Mutualiste, Saint-Etienne, France
7 INSERM, U 1059, 42023, Saint-Étienne, France


Hysterectomy, benign indications, large uterus, vNOTES, laparoscopy

Published online: Sep 24 2023


Background: 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.

Objectives: 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)

Materials and Methods: 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.

Main outcome measures: 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.

Results: 248 women will be randomised.

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

What’s new? This trial will evaluate the vNotes for large uteri.