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 aimed to randomise 560 patients in 2 years with the end date for recruitment is 31-May-2015 and trial follow-up being completed in summer 2017. However, recruitment was extended to allow the sample size to be increased to 790 as recruitment is going so strongly. This increased the statistical power from 80% to 90%. Recruitment was competed o n 11-Nov-2015 and trial follow-up will be completed at the end of 2017.