VaNoLaH trial : a study protocol—a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy
(2024) In BMJ Open 14(4).- Abstract
Introduction Hysterectomy 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 hysterectomy. Hysterectomy 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, vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH). Methods Multicentre pragmatic RCT aiming to recruit 1000 women aged 18–75 years undergoing hysterectomy for benign disease. The RCT includes two identical substudies (groups A and B). If VH... (More)
Introduction Hysterectomy 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 hysterectomy. Hysterectomy 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, vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH). Methods Multicentre pragmatic RCT aiming to recruit 1000 women aged 18–75 years undergoing hysterectomy for benign disease. The RCT includes two identical substudies (groups A and B). If VH is considered safe and feasible, the patient will be randomised within group A (VH vs vNOTES). If VH is not considered safe or feasible, patients will be randomised within group B (LH vs vNOTES). Analysis Primary outcome is the proportion of women leaving the hospital within 12 hours after surgery. Secondary outcomes are hospitalisation time, conversion rates, duration of the surgical procedure, intraoperative complications, postoperative complications and readmission. Ethics and dissemination The Ethical Board Committee at Imelda Hospital, Bonheiden, Belgium, has approved the research protocol 230704 (principal investigator). 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.
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- author
- Baekelandt, Jan Filip LU ; Stuart, Andrea LU ; Wagenius, Johanna LU ; Laenen, Annouschka LU ; Mol, Ben W. ; Deprest, Jan and Bosteels, Jan J.A.
- organization
- publishing date
- 2024-04
- type
- Contribution to journal
- publication status
- published
- subject
- in
- BMJ Open
- volume
- 14
- issue
- 4
- article number
- e081979
- publisher
- BMJ Publishing Group
- external identifiers
-
- pmid:38658010
- scopus:85191408433
- ISSN
- 2044-6055
- DOI
- 10.1136/bmjopen-2023-081979
- language
- English
- LU publication?
- yes
- id
- da3169ff-213f-42a0-9e80-b5f9c4f6d7e4
- date added to LUP
- 2024-05-03 14:42:40
- date last changed
- 2024-05-17 17:07:39
@article{da3169ff-213f-42a0-9e80-b5f9c4f6d7e4,
abstract = {{<p>Introduction Hysterectomy 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 hysterectomy. Hysterectomy 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, vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH). Methods Multicentre pragmatic RCT aiming to recruit 1000 women aged 18–75 years undergoing hysterectomy for benign disease. The RCT includes two identical substudies (groups A and B). If VH is considered safe and feasible, the patient will be randomised within group A (VH vs vNOTES). If VH is not considered safe or feasible, patients will be randomised within group B (LH vs vNOTES). Analysis Primary outcome is the proportion of women leaving the hospital within 12 hours after surgery. Secondary outcomes are hospitalisation time, conversion rates, duration of the surgical procedure, intraoperative complications, postoperative complications and readmission. Ethics and dissemination The Ethical Board Committee at Imelda Hospital, Bonheiden, Belgium, has approved the research protocol 230704 (principal investigator). 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.</p>}},
author = {{Baekelandt, Jan Filip and Stuart, Andrea and Wagenius, Johanna and Laenen, Annouschka and Mol, Ben W. and Deprest, Jan and Bosteels, Jan J.A.}},
issn = {{2044-6055}},
language = {{eng}},
number = {{4}},
publisher = {{BMJ Publishing Group}},
series = {{BMJ Open}},
title = {{VaNoLaH trial : a study protocol—a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy}},
url = {{http://dx.doi.org/10.1136/bmjopen-2023-081979}},
doi = {{10.1136/bmjopen-2023-081979}},
volume = {{14}},
year = {{2024}},
}