Early closure compared to late closure of temporary ileostomy in rectal cancer: a randomized controlled trial study.

Background: A temporary loop ileostomy is one of the most common methods for the prevention of anastomotic leakage in rectal cancer patients who underwent low anterior resection. However, the optimal timing of loop ileostomy reversal remains unknown. The main objective of this study was to evaluate the debilitating complications caused by early closure of ileostomy in comparison with late closure in rectal cancer patients. Design: A randomized, controlled, unblinded, and monocentric trial. Methods: A total of 104 rectal cancer patients were randomly assigned to the case group of early closure of ileostomy (n = 50) and the control group of late closure of ileostomy (n = 54). This trial was undertaken in a single colorectal institution, a university-affiliated teaching hospital in Tehran, Iran. Randomization and allocation to the trial group were conducted by using variable block randomization based on quadruple numbers. The primary endpoint of this trial was determined by the complications of early ileostomy closure versus those of late closure in rectal cancer patients who had undergone low anterior resection. In early closure, loop ileostomy is reversed 2–3 weeks after the first two courses of adjuvant chemotherapy, while in late closure, the ileostomy is reversed 2–3 weeks after the last course of adjuvant chemotherapy. Results: Follow-up of 1 year demonstrated a reduction in the risk of complications and an improved quality of life in patients with rectal cancer following low anterior resection and chemotherapy (neoadjuvant and adjuvant) in the case group but did not reach a significant difference (p = 0.555). In addition, there was no significant difference in perioperative outcomes, such as blood loss, operative time, readmission, and reoperation; also, no statistically significant differences were reported between the groups in patients’ quality of life or LARS score. Conclusion: In summary, it seems that early closure of ileostomy is not better than late closure in improving patients’ quality of life with rectal cancer following low anterior resection and chemotherapy (neoadjuvant and adjuvant); no statistical difference was observed for reduction of risk of ostomy complications. Thus, neither of these methods (early closure versus late closure) is superior to the other, and controversy still exists. Trial registration number and date of registration: IRCT20201113049373N1 [ABSTRACT FROM AUTHOR]