학술논문
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.
Document Type
Academic Journal
Author
Baekelandt JF; Imeldaziekenhuis, Bonheiden, Belgium.; Stuart A; Obstetrics and Gynecology, Lund University Department of Clinical Sciences Lund, Lund, Sweden andrea.stuart@med.lu.se.; Department of Obstetrics and Gynecology, Helsingborg, Sweden.; Wagenius J; Obstetrics and Gynecology, Lund University Department of Clinical Sciences Lund, Lund, Sweden.; Department of Obstetrics and Gynecology, Helsingborg, Sweden.; Laenen A; Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Leuven, Belgium.; Mol BW; OB/GYN, School of Medicine, Monash University, Melbourne, Clayton, Victoria, Australia.; Deprest J; Gynaecology, University Hospital Leuven, Leuven, Belgium.; Bosteels JJA; Imeldaziekenhuis, Bonheiden, Belgium.
Source
Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Subject
Language
English
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 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.
Trial Registration Number: NCT05971875.
Competing Interests: Competing interests: JFJB, AS and JW to consultancy for Applied Medical.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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.
Trial Registration Number: NCT05971875.
Competing Interests: Competing interests: JFJB, AS and JW to consultancy for Applied Medical.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)