Title: ROCSS - Reinforcement of Closure of Stoma Site Randomised ControlledTrial
Funder: Department of Health and Social Care

Abstract: Background: Stoma sites are complex and contaminated wounds, and so their reversal is associated with frequent post-operative complications, leading to poor patient outcome. With 6000 new temporary stomas per year in the UK, stoma closure also represents a common surgical procedure. When reversed, over 40% of patients suffer an early complication. Hernia formation at the closed site is the most common late complication, developing in one in three patients, meaning that 1000 patients per year are affected. Half of these patients are then subject to complex re-operation in order to repair the hernia. Reoperation is hazardous and has a high failure rate, with 50% of repairs failing. Since many of these patients are elderly and frail, they often choose not to undergo further surgery, but would prefer to live with a reduced quality of life instead. There is also a small but important risk of the need for emergency repair, which will carry even higher risk of complications. The ROCSS trial seeks to address this problem by use of biologic mesh reinforcement at the time of stoma closure in an attempt to reduce the frequency of incisional hernia formation. Potential benefits to patients and the NHS: Incisional hernias at closed stoma sites are the most frequent and important late complication. Preventing this would benefit the patient not only by preventing hernias, but also by avoiding the need for hazardous further surgery. A surgical procedure that reduces the occurrence of hernias after stoma closure will improve patients quality of life, reduce surgical complications and remove the need for repeated operations. This should lead to major health benefits for patients and the wider health service, including reducing costs associated with expensive and complex re-operations. Research question: ROCSS is a randomised controlled trial assessing the impact of placement of a biological mesh at the site of stoma closure on clinical hernia rate. We hypothesise that reinforcing the stoma closure site with a collagen mesh is superior to the standard technique in preventing herniation at 2 years. Aim: To assess whether a biologic mesh reduces the incidence of clinically detectable stoma closure site hernias at two years compared to standard closure techniques. Design: A 1:1 RCT of mesh insertion verses standard surgery, with blinding of the patient and assessor. An internal feasibility study has recruited its target 90 patients from nine centres. Independent DMEC review has assessed 30-day morbidity, and given approval to continue into the full trial. Outcomes: The primary outcome is the occurrence of clinically detectable hernias at two years post closure, using a standardised assessment technique. Secondary Outcomes include patient reported quality of life, patient reported symptoms at closed stoma site, surgical re-intervention rate, surgical complications at 30 days and 1 year, the radiological hernia rate at one year post closure (an exploratory analysis will compare radiological hernia rate at 1 year with clinical hernia rate at 2 years to assess the value of using a CT scan as an early diagnostic tool of incisional hernias). Health economic analysis: A pre-planned health economic analysis will prospectively assess resource usage in 100 consecutive patients. This will allow (1) direct determination of cost-benefits in this sample and (2) health economic modeling of benefits across the whole trial. This will help inform upon identifying groups where benefit is greatest.

Lay abstract: An incisional hernia forms when a surgical wound fails to heal and a defect remains in the muscle wall. Closure of a stoma wound (stomas are formed when the bowel is brought to the tummy skin) is a frequent cause of incisional hernia, occurring in over 1,000 UK patients every year. Surgical repair of these hernias is hazardous and up to 1 in 2 repairs will fail. These patients can be elderly, with multiple medical problems, so further attempts at repair may be too risky meaning they must tolerate the symptoms of pain, swelling and discomfort and live with the risk of life threatening complications. An intervention that reduces the occurrence of hernias after stoma closure would improve patients quality of life, reduce surgical complications and remove the need for further operations. The ROCSS trial seeks to address this problem by the use of a mesh to support the wound while it heals. A mesh is widely used in hernia repair, to support the muscles while they heal. However the mesh increases the problems of infection when the wound is contaminated by bacteria (as is the case in stoma closure). We are using a type of biological mesh made from animal tissue which is incorporated into the body tissues. Animal and human studies indicate that long-term infection problems are, as a consequence, reduced. Our preliminary study of 90 patients has shown this procedure can be performed safely. The ROCSS study, if completed, will be the largest ever study of stoma-site closure, including 560 patients from 30 UK hospitals. It will test this new mesh against the standard procedure. Patients entering the study will be carefully monitored for two years, to record whether there is a long-term reduction in the occurrence of incisional hernias and how this affects quality of life.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: ORAL AND GASTROINTESTINAL