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
Dr Maureen Twiddy M.Twiddy@hull.ac.uk
Senior Lecturer in Mixed Methods Research
© 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.
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||Oct 27, 2022|
|Publisher||BMJ Publishing Group|
|Peer Reviewed||Peer Reviewed|
|Keywords||Colorectal surgery; Feasibility study; Randomised controlled trial; Emergency surgery|
Publisher Licence URL
This is an Open Access article distributed in accordance with the<br /> 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/<br /> © 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.