Criteria for discontinuing the study
stoma
EVENTS, EVENT, RECRUITMENT
The following termination rules or criteria are applicable:Individual patient termination: In the event that a patient, who has previously undergone a decompressive stoma procedure within the intervention group, becomes medically ineligible for the subsequent two-stage operation, their informed consent will be withdrawn.Exclusion of participating investigative centers: Investigative centers that deviate from the study protocol, primarily due to inadequate patient recruitment (less than one per year) and compromised data quality, will be excluded from the analysis.Study suspension: The entire study will be temporarily suspended following the occurrence of any of the subsequent events until evaluated by the data and safety monitoring board (DSMB):Elevated incidence of severe morbidity and/or postoperative mortality observed within either the intervention or control groupIncreased frequency of surgical interventions within either the intervention or control groupReceipt of a recommendation from the DSMB to prematurely terminate the study due to participant safety concerns in either of the two groups