Frequency and plans for auditing trial conduct {23}
RECRUITMENT, COMPLICATIONS, POSTOPERATIVE COMPLICATIONS
Clinical monitoring will be performed regularly by the independent monitoring department of the Furthermore, for a specific number of long-term postoperative visits (12 and 24 months postoperative), monitoring will confirm that primary outcome assessment is performed by blinded outcome assessors. For other items, the proportion of source data verification will be at least 20% but can be increased according to centres’ experience and needs. The frequency of monitoring visits will be determined depending on recruitment numbers and individual performance of each centre based on feedback from project and data management and according to the risk-based monitoring approach.The steering committee will meet at least twice a year. Furthermore, the DSMB members will receive a written report twice a year and should advise whether to continue, modify or stop the trial based on the rate and severity of specific intervention-associated complications and of major (≥ grade 3) postoperative complications according to Dindo-Clavien (within 30 days after ileostomy closure). The decision to discontinue recruitment will be made by the coordinating investigator and the steering committee after the DSMB gave its recommendation. The coordinating investigator and/or the steering committee may call upon the DSMB in case a safety issue arises during the course of the trial.