Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.

JRCT ID: jRCTs071180028

Registered date:04/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: postoperative abdominal pain or bloating after hepatectomy
• Date of first enrollment: 30/11/2017
• Target sample size: 40
• Study type: Interventional

Intervention(s)

arm A: Oral administration of Daikenchuto 5.0 g (2.5g/pack x 2 packs) per dose three times a day from postoperative day 1 to 14.
arm B:Non-treatment of daikenchuto.

Outcome(s)

• Primary Outcome: Patient assessment of Postoperative abdominal pain or bloating (NRS).

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Selection criteria at the time of obtaining informed consent
1) Patient who are scheduled to undergo hepatectomy (>= partial hepatectomy) due to liver cirrhosis or liver cancer
2) Liver Damage A
3) Age: >= 20 years
4) Patient who are orally take daikenchuto
5) Adeguate organ functions and operable patient
6) Patient who are provide written informed consent
2. Selection criteria at the time of enrollment
7) With abdominal pain or bloating on postoperative day 1
8) Patient who are enforced hepatectomy (>=partial hepatectomy)

Exclude criteria

1) Emergency surgery
2) With history of hepatectomy
3) Patients scheduled to undergo partial resection of the liver due to metastatic liver cancer
4) Patient who have constitutional ICG excretory defect
5) With history of gastrointestinal surgery (excluding appendectomy)
6) Patient who are scheduled to enforce a gut surgery with hepatectomy (including biliary reconstruction)
7)With inflammatory bowel disease such as ulcerative colitis or Crohn disease (including anamnestic case)
8)With history of stoma
9)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)
10) Patient who took kampo medicine or lactobacillus preparation within 4 weeks before enrollment
11) Patient who are pregnancy, possibly pregnancy, considering pregnancy or lactating
12) Patient who are determined not applicable for the study by the physician

Related Information

• Primary Sponsor: Eguchi Susumu
• Secondary Sponsor: TSUMURA and Co.
• Secondary ID(s): UMIN000028950