ulcerative colitis
Conditions
Interventions
Saireito (Tsumura Saireito Extract Granules, TJ-114) will be administered orally at a dose of 9 g/day (3 g three times daily after meals) from postoperative day 2 (POD2) for 14 consecutive days. Conc
Sponsors
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with ulcerative colitis (UC) undergoing total proctocolectomy (two- or three-stage surgery) with creation of a temporary ileostomy Age >=18 years at the time of informed consent Patients considered capable of oral intake according to the postoperative management protocol Patients who have provided written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: History of hypersensitivity to Kampo medicines Patients judged to be unable to receive oral medication in the early postoperative period Severe hepatic dysfunction, severe heart failure, or other conditions judged inappropriate by the principal investigator Pregnant or breastfeeding women, or women who may be pregnant Any other condition deemed inappropriate for participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of early high-output stoma (HOS) within 21 days after surgery. Early HOS is defined as a stoma output of >1,500 mL/day for three consecutive days within 21 days postoperatively. Stoma output will be measured daily during hospitalization based on nursing records and electronic medical records. | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay Incidence of >20% decline in eGFR at 1 month postoperatively and immediately before stoma closure, compared with preoperative baseline Requirement for unplanned intravenous fluid administration within 21 days after surgery Readmission within 21 days after surgery Incidence of adverse events assessed according to CTCAE version 5.0 | — |
Countries
Japan
Contacts
Public ContactYusuke Sato
Nagoya University Graduate School of Medicine Division of Gastroenterological Surgery, Department of Surgery
Outcome results
None listed