Methods against bias
stoma, small bowel distention, tumor
TUMOR
To address potential bias and ensure the integrity of the study, several methods have been implemented. As mentioned above, randomization and stratification will be used to allocate patients into the control and intervention groups. This process will be conducted using a secure online computer randomization system and will consider factors such as age, tumor stage, gender, ASA classification, presence of small bowel distention, and study center. By stratifying these variables, a balanced distribution can be achieved, reducing the risk of bias. To account for the delay between decompressing stoma placement and tumor resection in the intervention group, the primary endpoint of perioperative mortality has been adjusted to 120-day. This extension allows for a comprehensive evaluation of mortality rates in both groups with an appropriate timeframe.The primary endpoint will be analyzed using the intention-to-treat (ITT) principle, and the final study report, in line with transparent reporting standards, will adhere to the CONSORT (Consolidated Standards of Reporting Trials) statement.