NCT04886791: VANH

Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy

Recruiting now NA Last updated 14 August 2025

What this trial tests

NA trial testing Vaginal NOTES hysterectomy in Hysterectomy in 124 participants. Currently enrolling.

Timeline

5 July 2021

Primary endpoint
1 August 2025

31 December 2025

Quick facts

Lead sponsor	Zuyderland Medisch Centrum
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	124
Start date	5 July 2021
Primary completion	1 August 2025
Estimated completion	31 December 2025
Sites	2 locations across Netherlands

Drugs / interventions tested

• Vaginal NOTES hysterectomy
• Vaginal hysterectomy

Conditions studied

• Hysterectomy — all drugs for Hysterectomy →
• Natural Orifice Transluminal Endoscopic Surgery — all drugs for Natural Orifice Transluminal Endoscopic Surgery →
• Vaginal Hysterectomy — all drugs for Vaginal Hysterectomy →

Sponsor

Zuyderland Medisch Centrum — full company profile →

Who can join

18 and older, female only, with Hysterectomy or Natural Orifice Transluminal Endoscopic Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed. Potential benefits of vNOTES hysterectomy, also called the vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less pain and a shorter hospital stay compared with laparoscopic hysterectomy as shown in the HALON trial. Up to now, no studies have compared the vNOTES hysterectomy with vaginal hysterectomy.

Objective: The aim of this study is to compare the vNOTES hysterectomy with the vaginal hysterectomy for same day-discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.

Study design: The study concerns a single-blinded, multicentre, randomised controlled trial.

Study population: Eligible women who fulfill the inclusion criteria and will undergo a hysterectomy for benign indication.

Intervention: The study population will be randomly allocated to the VANH-group, who undergo a vaginal assisted NOTES hysterectomy (intervention group) or the vaginal hysterectomy group (control-group) and the participants will be single blinded. The pre- and postoperative care will be the same for both groups.

Main study parameters/endpoints: Primary outcome is the percentage of patients that underwent the hysterectomy as in SDD setting. A total of 41 patients should be included in the control group and a total of 83 patients in the intervention group, using an enrollment ratio of 1:2, with an alpha of 0.05 and a power of 0.8.

The secondary outcomes are complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

vNOTES is a new surgical technique, but a combination of two existing techniques namely the vaginal hysterectomy and the laparoscopic hysterectomy. Only one randomized controlled trial has been published, comparing the total laparoscopic hysterectomy (TLH) with the VANH, which shows no inferiority of the vNOTES technique compared to a laparoscopy. A recent case series study has been published about the complication rate in VANH. There was a total complication rate in the hysterectomy group of 5.2%, in which 1.4% was intra-operative and 3.8% postoperative. Theoretically it is possible that the VANH causes less intra-operative complications because of an improved view during the procedure. No further literature is known about VH versus VANH. Participants of the study should fill in multiple questionnaires before randomization and postoperative about their general health, pain experience and used analgesics.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Surgical approach to hysterectomy for benign gynaecological disease.
   Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, et al · · 2023 · cited 59× · PMID 37642285 · DOI 10.1002/14651858.cd003677.pub6
2. Clinical relevance of vaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecology.
   Kim JC, Yim GW, Kim YT. · · 2024 · cited 9× · PMID 38225904 · DOI 10.5468/ogs.23205
3. Vaginal hysterectomy versus vaginal assisted NOTES hysterectomy (VANH): a protocol for a randomised controlled trial
   Bekkers I, Hoen L, van Vliet H, Smeets N, et al · · 2022