A randomised controlled trial of Reinforcement of Closure of Stoma Site using a biological mesh: the ROCSS trials
Abdominal wall hernias are common and are a significant cause of morbidity. Incisional hernias form following closure of the abdominal wall musculature, including at the site of stoma closure. Closure of complex and contaminated abdominal wounds is challenging and carries risks, including wound infection and dehiscence. In these cases, the hernia rate increases to over 50% (Schuster et al). Stoma closure provides a homogeneous subgroup of contaminated complex wound closure for study. Use of biological meshes in this situation may provide a safe method of reducing complications, notably the development of incisional hernias. ROCSS will investigate stoma site closure using biological mesh within the setting of a randomised controlled trial.
Potential benefits to patients and the NHS:
Incisional hernias at stoma sites are a frequent problem, occurring in up to 30% of cases (Bhangu et al, Cingi et al). They occur over time and are frequently under-reported, due to the elderly population, the significant co-morbidities and early discharge from hospital follow up. In up to 10% of cases, patients are exposed to complex re-operation, which carries significant additional morbidity. Because of this, many patients will choose not to undergo re-operation. Therefore, low re-operation rates do not necessarily indicate a problem free stoma closure, as re-operations are affected by other factors such as patient age, co-morbidities and patient preference. Incisional hernias are also associated with significant morbidity, which impacts on a person’s quality of life, so preventing the development of incisional hernias may improve quality of life for patients. Thus, reinforcement of stoma site closure with a biological mesh may potentially reduce costs in the health service by improving quality of life and reducing the re-operation rate.
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.
An embedded feasibility study has recruited its target 90 patients. Ten sites opened and all recruited 1-4 patients per month. Independent DMEC review has assessed 30-day morbidity, and given approval to continue. Twenty further UK sites are ready to open, and as occurred in the feasibility study, will be trained before opening for the phase III study. A further 470 patients will be recruited. A pre-planned health economic analysis will assess cost-effectiveness.
- Bhangu A, Nepogodiev D, Futaba K. Systematic review and meta-analysis of the incidence of incisional hernia at the site of stoma closure. World J Surg, 2012; 36(5):973-983.
- Bhangu A, Fletcher L, Kingdon S, Smith E, Nepogodiev D, Janjua U. A clinical and radiological assessment of incisional hernias following closure of temporary stomas. Surgeon 2012;10(6):321-5