Strengths and limitations
stoma, Stoma
MINOR, RECTAL CANCER, COMPLICATIONS, POSTOPERATIVE COMPLICATIONS
The present design with randomization prior to surgery is a strength because it reduces the risk of patient selection and outlines the problems and shortcomings in early stoma reversal in surgery for rectal cancer. Another strength is the intention-to-treat analysis. No blinding of the randomization for patients, surgeons or medical staff at index surgery has an inherent bias with respect to decisions on the choice and preference of surgical procedure.An obvious limitation was the long inclusion period with the risk of changes in clinical practice over time. Including only four centres is a strength, which ensures a more homogeneous treatment of patients throughout the study period. The different surgical approaches (robotic, laparoscopic and transanal total mesorectal excision) are not considered a limitation because none of them has proven to be superior or inferior with respect to postoperative complicationsAn important limitation might be the registration of postoperative complications. In those patients in the late reversal group who underwent early reversal for various reasons, the postoperative complications of stoma reversal were included in the 90-day complications. Stoma reversal occurred in only a minority of patients, with few minor complications. This might explain the trend with a higher CCI in the late reversal group compared to the early reversal group, but this difference might also be due to stoma-related complications.Another important limitation or consideration might be the change in the primary outcome form complicate rates to CCI. The design of the study remained otherwise unchanged, and the change probably decreased the risk of a type 2 error.