Composition of the data monitoring committee, its role and reporting structure {21a}
hernia
SECONDARY, RECRUITMENT, COMPLICATIONS, POSTOPERATIVE COMPLICATIONS
The trial’s Data Safety and Monitoring Board (DSMB) will be composed of two independent clinical experts in the field of hernia surgery. Furthermore, an independent statistician will be part of the DSMB. 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 (see secondary endpoints SSO) and of major (≥ grade 3) postoperative complications according to Dindo-Clavien (within 30 days after ileostomy closure). Furthermore, they should review adherence to protocol especially for the trial-relevant primary outcome measure and will inform the coordinating investigator about relevant imbalances between groups. DSMB members will also be asked to give advice on whether results from other relevant trials justify continuing recruitment of further patients. The working procedures of the DSMB will be recorded in the DSMB charter of this trial.