A multicentre, randomised controlled trial of Laparoscopic versus Open Colorectal Surgery in the Acute Setting

Research Question Does laparoscopic surgery in the emergency colorectal setting improve post-operative outcomes compared to open surgery? Background The National Emergency Laparotomy Audit (NELA) reports approximately 30,000 people/year undergo major, abdominal, gastrointestinal surgery, of which 36% are carried out for emergency colorectal pathology. The majority of patients undergo open surgery (laparotomy), which is associated with significant post-operative morbidity and mortality, and has an adverse effect on patients’ well-being and quality of life. There are emerging reports that the use of laparoscopic surgery in the emergency setting may be associated with improved clinical and patient-reported outcomes. However, the current evidence base is not robust enough to inform clinical practice due to the methodological weaknesses of cohort studies and case series, coupled with the lack of randomised controlled trials (RCT). Aims and Objectives Aim: To test the hypothesis that laparoscopic surgery in the emergency colorectal setting improves post-op outcomes compared to open surgery. Objective: To conduct a definitive randomised controlled trial comparing laparoscopic with open colorectal resection in the emergency setting, reporting clinical, patient-reported and health economic outcome data for 12 months post-operatively. Methods A pragmatic, multicentre, randomised controlled superiority trial, with internal pilot and embedded qualitative and cost-effectiveness studies. 512 patients are required to detect a 15% absolute reduction in the 30-day complication rate with 90% power and 5% 2-sided significance level. Patients will be randomised on a 1:1 basis to laparoscopic or open resection, stratified by intended consultant surgeon, age, BMI, ASA, nature of underlying colorectal pathology & intended procedure. Data will be collected at baseline, 30 days (patient-reported outcomes), 6 weeks (clinical data), 90 days, 6 months, 9 months (patient-reported outcomes only) & 12 months. The primary outcome will be 30-day post-op complication rate defined as the number of patients with a complication (any grade) occurring within 30 days of surgery as a proportion of all randomised patients. Patient-reported QoL is included as a secondary outcome measure Timelines for Delivery 9 months is required for protocol development, ethical /HRA approval and trial/site set-up. Recruitment will take 36 months (12 month pilot phase), with a 12 month minimum follow up period during which short term outcomes will be analysed followed by an additional 3 month analysis phase. Anticipated impact and dissemination The anticipated impact to patients is improved post-operative recovery and quality of life benefitting current health services and the NHS overall. This will be the first RCT to provide evidence for the use of laparoscopic colorectal resection in the emergency setting, providing the evidence required for adoption into clinical practice with the potential of reducing the high economical burden of emergency surgery. The results of the trial will be disseminated through international conference presentations, publications in high impact peer reviewed journals and to patients and the wider public under the guidance of the LaCeS2 PPI group.