Laparoscopic versus open colorectal surgery in the acute setting (LaCeS trial): a multicentre randomized feasibility trial.

Deena Harji ,Azmina Verjee ,P M Sagar ,Kathryn Gordon ,Alison Pullan ,Deborah Stocken ,Dermot Burke ,Hannah Marshall ,Maureen Twiddy ,Ben Griffiths ,David Meads ,Julie Croft ,Julia Brown

doi:10.1002/bjs.11703

Abstract

Approximately 30 000 people undergo major emergency abdominal gastrointestinal surgery annually, and 36 per cent of these procedures (around 10 800) are carried out for emergency colorectal pathology. Some 14 per cent of all patients requiring emergency surgery have a laparoscopic procedure. The aims of the LaCeS (laparoscopic versus open colorectal surgery in the acute setting) feasibility trial were to assess the feasibility, safety and acceptability of performing a large-scale definitive phase III RCT, with a comparison of emergency laparoscopic versus open surgery for acute colorectal pathology. LaCeS was designed as a prospective, multicentre, single-blind, parallel-group, pragmatic feasibility RCT with an integrated qualitative study. Randomization was undertaken centrally, with patients randomized on a 1 : 1 basis between laparoscopic or open surgery. A total of 64 patients were recruited across five centres. The overall mean steady-state recruitment rate was 1·2 patients per month per site. Baseline compliance for clinical and health-related quality-of-life data was 99·8 and 93·8 per cent respectively. The conversion rate from laparoscopic to open surgery was 39 (95 per cent c.i. 23 to 58) per cent. The 30-day postoperative complication rate was 27 (13 to 46) per cent in the laparoscopic arm and 42 (25 to 61) per cent in the open arm. Laparoscopic emergency colorectal surgery may have an acceptable safety profile. Registration number: ISRCTN15681041 ( http://www.controlled-trials.com).

Highlights

30 000 people undergo major emergency abdominal gastrointestinal surgery annually, and 36 per cent of these procedures are carried out for emergency colorectal pathology
The management of emergency colorectal pathology can be challenging owing to the range of presenting pathology, including colorectal cancer, inflammatory bowel disease and diverticular disease, combined with variable patient physiology, associated sepsis and potentially advanced disease
The observed conversion rate is close to current practice; NELA1 reported a rate of 47 per cent

Summary

Introduction

30 000 people undergo major emergency abdominal gastrointestinal surgery annually, and 36 per cent of these procedures (around 10 800) are carried out for emergency colorectal pathology. The UK National Emergency Laparotomy Audit (NELA)[1] has reported that approximately 30 000 people per annum undergo major abdominal gastrointestinal surgery, and that 36 per cent of these operations (around 10 800) are carried out for emergency colorectal pathology. Emergency colorectal surgery is associated with significant morbidity, with reported rates of postoperative morbidity and mortality of 33–71 and 14–17 per cent respectively[2,3]. The current evidence base informing the use of laparoscopic surgical resection in the emergency colorectal setting is weak, being limited to a small number of population-based registries and retrospective cohort studies[10,11,12]. There are a number of emerging trials[13,14,15] successfully investigating the role

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Conclusion