ROCSS is a prospective, multi-centre randomised controlled trial.
ROCSS is designed in two stages:
i) a feasibility study
ii) a Phase III multi-centre RCT
The feasibility phase assessed recruitment, the randomisation process and deliverability of the treatment.
The Phase III study is a prospective, multi-centre RCT to determine if the use of a collagen tissue matrix (Strattice®) reduces the incidence of clinically detectable stoma closure site hernias at two years as compared to standard closure techniques.
The trial aims to randomise 560 patients in 2 years. The end date for recruitment is 31-May-2015 with trial follow-up being completed in summer 2017.
UPDATE: Recruitment has been extended until 31-Oct-2015 with the aim of increasing the sample size to 790 as recruiment is going so strongly. This will increase the statistical power from 80% to 90%.