Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

ADNOLA trial : a study-protocol – a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy

Olsson, Kristin Stuhr LU ; Baekelandt, Jan Filip ; Källén, Karin LU ; Matak, Luka ; Caretto, Marta ; Wassen, Martine M.L.H. ; Simoncini, Tommaso and Stuart, Andrea LU (2026) In BMJ Open 16(5).
Abstract

Introduction: Adnexal surgery is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal surgery. Adnexal surgery by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES and conventional laparoscopy. Methods and analysis: A multicentre pragmatic RCT aiming to recruit 200 women aged 18 years and above undergoing adnexal surgery for benign disease or prophylactic reasons. Patients will be randomised to vNOTES or... (More)

Introduction: Adnexal surgery is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal surgery. Adnexal surgery by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES and conventional laparoscopy. Methods and analysis: A multicentre pragmatic RCT aiming to recruit 200 women aged 18 years and above undergoing adnexal surgery for benign disease or prophylactic reasons. Patients will be randomised to vNOTES or laparoscopy. Recruitment will start Q4 2025, and the study is estimated to end 2028.The primary outcome is postoperative pain. Secondary outcomes are units of postoperative opioid and non-opioid analgesics used, perioperative complications, operation time, postoperative complications, readmission, conversion rate and the surgeon’s experience. Ethics and dissemination: The national Swedish ethical board at the main centre, Helsingborg Hospital, Sweden, has given ethical agreement (dated 20 March 2025). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals. Trial registration number: NCT06964594.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Minimally invasive surgery, Randomized Controlled Trial, SURGERY
in
BMJ Open
volume
16
issue
5
article number
e112126
publisher
BMJ Publishing Group
external identifiers
  • pmid:42191199
  • scopus:105040338447
ISSN
2044-6055
DOI
10.1136/bmjopen-2025-112126
language
English
LU publication?
yes
id
c55f8199-ef03-40eb-b30e-787ab2a56094
date added to LUP
2026-06-30 10:36:25
date last changed
2026-09-09 21:00:58
@article{c55f8199-ef03-40eb-b30e-787ab2a56094,
  abstract     = {{<p>Introduction: Adnexal surgery is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal surgery. Adnexal surgery by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES and conventional laparoscopy. Methods and analysis: A multicentre pragmatic RCT aiming to recruit 200 women aged 18 years and above undergoing adnexal surgery for benign disease or prophylactic reasons. Patients will be randomised to vNOTES or laparoscopy. Recruitment will start Q4 2025, and the study is estimated to end 2028.The primary outcome is postoperative pain. Secondary outcomes are units of postoperative opioid and non-opioid analgesics used, perioperative complications, operation time, postoperative complications, readmission, conversion rate and the surgeon’s experience. Ethics and dissemination: The national Swedish ethical board at the main centre, Helsingborg Hospital, Sweden, has given ethical agreement (dated 20 March 2025). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals. Trial registration number: NCT06964594.</p>}},
  author       = {{Olsson, Kristin Stuhr and Baekelandt, Jan Filip and Källén, Karin and Matak, Luka and Caretto, Marta and Wassen, Martine M.L.H. and Simoncini, Tommaso and Stuart, Andrea}},
  issn         = {{2044-6055}},
  keywords     = {{Minimally invasive surgery; Randomized Controlled Trial; SURGERY}},
  language     = {{eng}},
  number       = {{5}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{ADNOLA trial : a study-protocol – a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2025-112126}},
  doi          = {{10.1136/bmjopen-2025-112126}},
  volume       = {{16}},
  year         = {{2026}},
}