Title: Laparoscopic versus Open Colorectal Emergency Surgery: The LACES Feasibility Study
Funder: Department of Health and Social Care

Abstract: Background: There is substantial evidence demonstrating the benefits of laparoscopic colorectal surgery in the elective setting, with little equivalent evidence regarding its use in the acute setting. Patients requiring emergency surgery present with different physiology, varying degrees of sepsis & advanced disease that has the potential to make laparoscopic surgery more technically challenging. The evidence from the elective setting cannot readily be translated to this acute setting. It is therefore imperative to evaluate the role of laparoscopic surgery specifically in the acute setting in order to provide an evidence base to aid clinical decision making. Aims: To undertake a study to assess the safety, acceptability and feasibility of performing a definitive, phase III randomised controlled trial to compare laparoscopic surgery with open surgery in patients requiring an emergency, unplanned colorectal resection. The aims and objectives of this feasibility study are: &sum; Safety: to quantitatively assess the safety profile of laparoscopic emergency surgery &sum; Feasibility: to quantitatively assess the screening and eligibility rates and qualitatively assess acceptability of the study from patient and clinicians' perspectives. &sum; Outcomes: to explore the optimal primary endpoint and its timing for a definitive phase III trial. Outcomes: The main outcomes of this study are to demonstrate the safety and feasibility of undertaking an emergency laparoscopic single-blinded colorectal trial and to establish the optimal endpoint to reflect patient and clinical benefit or harm to inform a future definitive phase III randomised controlled trial. Data Collection: All data will be collected on CRFs at pre-defined time points. Patient-reported outcomes will be documented using the Gastrointestinal Quality of Life Index (GIQLI), SF-12 and EQ-5D. Pain scores will be collected using visual analogue scores. The success of our blinding protocol will be assessed by the Bang Blinding Index. Qualitative data will be collected through semi-structured interviews with surgeons and patients. Follow-up: Patients will be followed at pre-specified time intervals which includes 3, 7 and 30 days post&shy;-operatively and 3 and 6 months post-randomisation. In addition, patients recruited in the first 9 months (estimated to be at least half the number of patients recruited) will also be followed up at 12 months post-randomisation, to assess the feasibility of collecting data out to this time point. A dedicated follow up schedule has been uploaded as a separate document. Sample size: We expect to recruit at least 66 patients from 5 centres. Data Analysis: The analysis will be descriptive as opposed to employing formal hypothesis testing. Quantitative analysis will include summaries of recruitment rates, the safety profile of the intervention and the success of blinding. Qualitative evaluation of potential outcome measures, non-participation, and the acceptability of the trial will be carried out. Future: If the objectives of this feasibility study are met, this would support our application to the HTA for a definitive, large scale, phase III superiority, randomised controlled trial involving an additional 15 centres. Benefits: A definitive phase III trial would provide the highest possible level of evidence for the use of laparoscopic surgery in the acute setting. If laparoscopic surgery is deemed superior compared to open surgery, with the associated reductions in complications and length of stay, earlier return of pre-morbid status and less utilisation of primary and secondary health services, the potential cost savings to the NHS and the clinical benefits to patients will be substantial.

Lay abstract: Emergency general surgery is one of the commonest reasons for admission to hospital. A wide range of problems can lead to an emergency admission and diseases that affect the large bowel make up a third of diseases that present as an emergency. There are two different types of operation which can be used; keyhole and open surgery (where a bigger cut is made). Emergency appendectomy and gall stone operations are already carried out using keyhole surgery, resulting in shorter recovery time, reduced pain and shorter length of stay compared to open surgery. Currently, keyhole surgery is used in planned (elective) surgery involving the large bowel, but in the emergency setting surgeons opt for open surgery more often than keyhole surgery. Surgeons speculate that using keyhole surgery in the emergency setting would be beneficial; however we are not sure, as the current evidence is not strong enough to draw any firm conclusions. A large trial is needed to answer the question. However, we first need to do a smaller study to determine the safety of keyhole surgery in the emergency setting and the feasibility of running a large trial. Half of the patients who agree to take part in this study will be treated with open surgery and half with keyhole surgery. Treatment will not be chosen by the patient or the doctor, but through a process called randomisation. This study will also determine the willingness of patients and surgeons to participate. We will collect information about why patients choose to take part or not and ask patients and surgeons what they think about the design of the trial. This study will determine whether a larger trial is feasible and will help us to finalise the design of a future a large trial.

Research activity codes: 6.4 SURGERY
Health categories: ORAL AND GASTROINTESTINAL