Editor's Choice

Feasibility study for a randomized controlled trial of standard closure of stoma site vs biological mesh reinforcement. On behalf of the Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and the West Midlands Research Collaborative. 1 I have enjoyed reading the feasibility study from the ROCCS trial (‘randomised controlled trial of standard closure of stoma site vs biologic mesh reinforcement’). Although the results are interesting, these are not the best part of the paper. It is above all an inspiring example of how surgical research can be, and should be performed. All involved in multicenter trials know the difficulty of fulfilling predicted accrual rates. Disturbing reports are emerging demonstrating that up to 50% of initiated trials is stopped prematurely, most often due to disappointing recruitment 2. The majority of studies that have been published took much longer than anticipated, and include only a fraction of eligible patients. This results in questionable outcomes with reduced validity and limited generalizability. The current feasibility study, led by a trainee research group, evaluated recruitment, percentage of eligible patients randomized, and safety of the surgical technique for mesh placement in different hospitals, before continuation to the main phase III trial. It was demonstrated that actual accrual rates exceeded anticipated rates. Within 12 months, > 90 patients were randomized in five centers (87% of eligible patients), and short-term results demonstrated safe incorporation of a biologic mesh into contaminated abdominal wound closure. This report shows that ‘IDEAL’ preparation and good research infrastructure can improve trial delivery. It also emphasizes the value of engaging trainee research networks, facilitating recruitment and assuring rapid site set up. The successful model has been embraced by various European centers, leading to a multi-country phase III trial, recruiting 790 patients from 30 centers within 2,5 years! Hopefully, this inspiring initiative will lead to a culture of international surgical research practice.