Laparoscopic versus open colorectal surgery in the acute setting (LaCeS trial): a multicentre randomized feasibility trial
Williams, M.; Nassa, H.; Hicks, L.; Jayamanne, H.; Kelly, S.; Lockwood, S.; Madhavan, A.; McCallum, I.; Moriarty, C.; Plusa, S.; Harries, D.; Priestley, M.; Scott, J.; Stephenson, S.; Swarnkar, K.; Taylor, G.; White, L.; Williams, G.; Harries, R.; Evans, M.; Davies, J.; Coyne, P.; Codd, R.; Chapman, S.; Cardozo, W.; Berger, C.; Baker, R.; Harji, D. P.; Marshall, H.; Gordon, K.; Twiddy, M.; Pullan, A.; Meads, D.; Croft, J.; Burke, D.; Griffiths, B.; Verjee, A.; Sagar, P.; Stocken, D.; Brown, J.
D. P. Harji
Dr Maureen Twiddy M.Twiddy@hull.ac.uk
Senior Lecturer in Mixed Methods Research
Approximately 30,000 people per annum undergo major, emergency abdominal, gastrointestinal surgery, of which 36% (~10,800) are carried out for emergency colorectal pathology. Approximately 14% of all patients requiring emergency surgery undergo laparoscopic surgery.
The aims of the LaCeS feasibility trial (Laparoscopic versus Open Colorectal Surgery in the Acute Setting) were to assess the feasibility, safety and acceptability of performing a large-scale definitive phase III randomised controlled trial with a comparison of emergency laparoscopic with open surgery for acute colorectal pathology.
LaCeS was designed as a prospective, multicentre, single blind, parallel group, pragmatic, randomised controlled feasibility trial with an integrated qualitative study. Randomisation was performed centrally with patients being randomised on a 1:1 basis between laparoscopic or open surgery.
A total of 64 patients were recruited across 5 centres. The overall average steady state recruitment rate was 1.2 patients/month. Baseline compliance for clinical and HrQoL data was 99.8% and 93.8% respectively. The conversion rate from laparoscopic to open surgery was 39.4% (95% CI 22.9% – 57.9%). The 30 day post-operative complication rate was 27.3% (95% CI 13.3- 45.5) in the laparoscopic arm and 41.9% (95% CI 24.6 – 60.9) in the open arm.
The LaCeS feasibility trial has demonstrated that it is possible to evaluate laparoscopic surgery in the emergency colorectal setting within the context of a randomised controlled trial. LaCeS has demonstrated that it is possible to recruit to a surgical trial in the emergency setting, with good compliance to trial procedures and processes, and overall acceptability by patients and clinicians. The safety data obtained for laparoscopic emergency colorectal surgery indicate an acceptable safety profile, particularly when considering it to that observed in the open arm.
Trial Registration ISRCTN15681041 https://doi.org/10.1186/ISRCTN15681041.
Funding body: National Institute of Health Research – Research for Patient Benefit
Cardozo, W., Baker, R., Berger, C., Chapman, S., Codd, R., Coyne, P., …Brown, J. (in press). Laparoscopic versus open colorectal surgery in the acute setting (LaCeS trial): a multicentre randomized feasibility trial. British journal of surgery, https://doi.org/10.1002/bjs.11703
|Journal Article Type||Article|
|Acceptance Date||Apr 22, 2020|
|Online Publication Date||Jun 23, 2020|
|Deposit Date||Jun 8, 2020|
|Publicly Available Date||Jun 24, 2021|
|Journal||British Journal of Surgery|
|Peer Reviewed||Peer Reviewed|
|Additional Information||currently at proof stage|
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© 2020 The Authors. British Journal of Surgery published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.