Saireito (TJ-114) for Preventing High-Output Syndrome After Temporary Ileostomy in Rectal Cancer Surgery.

PURPOSE: In rectal cancer surgery, a temporary ileostomy is often created to prevent clinical anastomotic leakage. However, high-output syndrome (HOS) frequently arises as a postoperative complication. We aimed to investigate the preventive effect of Saireito, a traditional Japanese herbal medicine, on HOS in patients with a temporary ileostomy. METHODS: At the University of Osaka Hospital, Saireito has been routinely administered to patients undergoing rectal cancer surgery with a temporary ileostomy since October 2022. Patients received 9 g/day of Saireito in three divided doses starting from the afternoon of postoperative day 1 (POD1). Among 68 consecutive patients, five were excluded due to incomplete administration of Saireito according to the planned postoperative schedule. The remaining 63 patients were included in the analysis and divided into two groups: the Saireito group (n = 37) and the control group (n = 26). HOS was defined as stoma output ≥ 1,500 mL/day by POD10. RESULTS: There were no significant differences in patient background characteristics between the two groups (p > 0.05). HOS occurred in 13 patients (20.6%). The incidence of HOS was significantly lower in the Saireito group (4 / 37, 10.8%) compared with the control group (9 / 26, 34.6%) (p = 0.0291). CONCLUSION: Postoperative administration of Saireito in rectal cancer patients with temporary ileostomy was associated with a reduced incidence of high-output syndrome. Saireito may be a promising option for preventing HOS in such cases.