A Randomized Controlled Trial of Daikenchuto for the Improvement of Defecatory Dysfunction After Ileostomy Closure Following Low Anterior Resection and Intersphincteric Resection (D-CLOSE)
A Randomized Controlled Trial of Daikenchuto for the Improvement of Defecatory Dysfunction After Ileostomy Closure Following Low Anterior Resection and Intersphincteric Resection (D-CLOSE trial)
Kinugasa Yusuke
Institute of Science Tokyo Hospital
1-5-45, Yushima, Bunkyo-ku, Tokyo
+81-3-5803-5254
kinugasa.srg1@tmd.ac.jp
Kagawa Hiroyasu
Institute of Science Tokyo Hospital
1-5-45, Yushima, Bunkyo-ku, Tokyo
+81-3-5803-5254
kagawa.hiroyasu@tmd.ac.jp
Recruiting
April. 17, 2026
June. 29, 2026
84
Interventional
randomized controlled trial
open(masking not used)
no treatment control/standard of care control
parallel assignment
treatment purpose
Patients meeting all of the following criteria are eligible:
1) Patients who underwent a planned temporary ileostomy using a double-aperture approach at the time of (ultra) low anterior resection or intersphincteric resection for rectal cancer (excluding Stage IV), excluding cases in which the
ileostomy was created for anastomotic leakage.
2) Patients scheduled for stoma closure within one year after primary tumor resection.
3) Patients with an ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) of 0 to 2.
4) Patients aged 20 years or older and under 85 years at the time of informed consent.
5) Patients meeting the following criteria in blood tests within 30 days prior to registration:
Creatinine (Cr): Cr =< 1.5 mg/dL
Aspartate aminotransferase (AST): AST =< 100 IU/L
Alanine aminotransferase (ALT): ALT =< 100 IU/L
Sodium (Na): Na >= 130 mEq/L
Potassium (K): K >= 3.0 mEq/L
6) Patients who provided written informed concent voluntarily after receiving an adequate explanation of the study and demonstrating sufficient understanding.
The following individuals are excluded from eligibility:
1) Patients who took Daikenchuto between the time of primary tumor resection and the time consent was obtained
2) Patients with a history of hypersensitivity to any component of Daikenchuto
3) Patients with a history of interstitial pneumonia
4) Patients with inflammatory bowel diseases such as ulcerative colitis or Crohn's disease, or irritable bowel syndrome
5) Patients with a history of mechanical intestinal obstruction
6) Patients with a history of emergency surgery for peritonitis (including cases of colostomy creation for postoperative anastomotic leakage)
7) Patients with obvious external anal sphincter injury or resection
8) Patients for whom concomitant procedures such as cholecystectomy, inguinal hernia repair, or abdominal wall incisional hernia repair are planned during stoma closure
9) Patients with confirmed recurrence of rectal cancer prior to stoma closure surgery
10) Patients with chronic renal failure requiring hemodialysis or requiring immunosuppressive agents
11) Patients with systemic active infection or fever (greater than or equal to 38 degrees Celsius) where infection is suspected
12) Patients who are pregnant, may be pregnant, within 28 days postpartum, or breastfeeding
13) Patients with severe psychiatric disorders or dementia
14) Other patients deemed unsuitable for safe participation in this study by the principal investigator
20age old over
85age old not
Both
Patients with a diverting ileostomy during LAR/ISR, planned closure within 1 year.
[DKT Group]
For 28 days prior to ileostomy closure surgery, patients take Daikenchuto 15g/day (before breakfast, lunch, and dinner).
[Control Group]
For 28 days prior to surgery, patients do not take Daikenchuto.
LARS score at 1 month post stoma closure surgery
1. LARS Score (3, 6, and 12 months after stoma closure)
2. Wexner Score (1, 3, 6, and 12 months after stoma closure)
3. QOL Assessment (EORTC QLQ-C30) (1, 3, 6, and 12 months after stoma closure)
4. QOL Assessment (EORTC QLQ-CR29) (1, 3, 6, 12 months after stoma closure)
5. Incidence of Complications Within 30 Days After Stoma Closure (Clavien-Dindo Grade II or higher)
6. Length of hospital stay after stoma closure surgery
7. Inflammatory findings after stoma closure surgery
8. Maximum daily number of bowel movements during hospitalization
