Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.
- Conditions
- Abdominal pain or bloating after hepatectomy
- Registration Number
- JPRN-UMIN000028950
- Lead Sponsor
- agasaki University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
1) Emergency surgery 2) With history of hepatectomy 3) Patient who have constitutional ICG excretory defect 4) With history of gastrointestinal surgery (excluding appendectomy) 5) Patient who are scheduled to enforce a gut surgery with hepatectomy (including biliary reconstruction) 6)With inflammatory bowel disease such as ulcerative colitis or Crohn disease (including anamnestic case) 7)With history of stoma 8)Patient who are scheduled for chemotherapy, radiation therapy or radiofrequency ablation therapy within 4 weeks before enrollment, during surgery or within 14 days after surgery (during individual study period) 9) Patient who took kampo medicine or lactobacillus preparation within 4 weeks before enrollment 10) Patient who are pregnancy, possibly pregnancy, considering pregnancy or lactating 11) Patient who are determined not applicable for the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient assessment of Postoperative abdominal pain or bloating (NRS).
- Secondary Outcome Measures
Name Time Method 1. Postoperative hospital stay 2. Assessment of intestinal injury and nutritional status (DAO, GLP-2, RBP, TTR, Tf, Alb) 3. Liver function (AST, ALT, Al-P,GGTP, T-Bil, PT) 4. Incidence and rate of postoperative complications (Clavien-Dindo Classification) 5. Incidence and rate of postoperative infection (wound, intraperitoneal, respiratory, urinary tract and systemic infection)