Is better early closure compared to late closure of temporary ileostomy in rectal cancer? A randomized controlled trial study

Abstract Purpose 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 purpose of this study is to assess the suitable time for a reversal of temporary loop ileostomy in rectal cancer patients. Methods We conducted a prospective, randomized trial at Sina Hospital, Tehran, Iran from 2020 to 2021 to determine the appropriate time for closure of temporary loop ileostomy in rectal cancer patients who underwent low anterior resection. Results The results of this prospective randomized controlled trial are as shown: significantly difference in body mass index, the time interval between creation and closure of stoma, and distance from last chemotherapy. No significant difference was found between the two groups in terms of complications based on the Clavien-Dindo classification. As well as, there is no significant difference in perioperative outcomes, such as blood loss, operative time, re-admission, and re-operation. Also, statistically significant differences had reported between patients' quality of life and LARS score. Conclusion In summary, it seems that early closure of ileostomy is generally effective and safe in reducing the risk of complications and improving quality of life in patients with rectal cancer following low anterior resection and chemotherapy (neoadjuvant and adjuvant). Trial registration number and date of registration: IRCT20201113049373N1 (January 2,2021)