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Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: The LaCeS feasibility trial protocol

Harji, Deena; Marshall, Helen; Gordon, Katie; Crow, Hannah; Hiley, Victoria; Burke, Dermot; Griffiths, Ben; Moriarty, Catherine; Twiddy, Maureen; O'Dwyer, John; Verjee, Azmina; Brown, Julia; Sagar, Peter

Authors

Deena Harji

Helen Marshall

Katie Gordon

Hannah Crow

Victoria Hiley

Dermot Burke

Ben Griffiths

Catherine Moriarty

John O'Dwyer

Azmina Verjee

Julia Brown

Peter Sagar



Abstract

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. Introduction Acute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection. Methods and analysis The LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive either laparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes. Ethics and dissemination The LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The results from the trial will be presented at national and international colorectal conferences and will be submitted for publication to peer-reviewed journals. Trial registration number ISRCTN15681041; Pre-results.

Citation

Harji, D., Marshall, H., Gordon, K., Crow, H., Hiley, V., Burke, D., …Sagar, P. (2018). Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: The LaCeS feasibility trial protocol. BMJ open, 8(2), Article e018618. https://doi.org/10.1136/bmjopen-2017-018618

Journal Article Type Article
Acceptance Date Oct 24, 2017
Publication Date Feb 1, 2018
Deposit Date Dec 11, 2017
Publicly Available Date Mar 29, 2024
Journal BMJ Open
Print ISSN 2044-6055
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 8
Issue 2
Article Number e018618
DOI https://doi.org/10.1136/bmjopen-2017-018618
Keywords Colorectal surgery; Feasibility study; Randomised controlled trial; Emergency surgery
Public URL https://hull-repository.worktribe.com/output/485081
Publisher URL https://bmjopen.bmj.com/content/8/2/e018618

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Copyright Statement
This is an Open Access article distributed in accordance with the
terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.





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