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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028950
Enrollment
40
Registered
2017-09-01
Start date
2017-11-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal pain or bloating after hepatectomy

Interventions

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. Non-treatment of daikenchuto.

Sponsors

Nagasaki University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Selection criteria at the time of obtaining informed consent 1) Patient who are scheduled to undergo hepatectomy (>= subsegmentectomy) 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 (>= subsegmentectomy)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Patient assessment of Postoperative abdominal pain or bloating (NRS).

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactMasaaki Hidaka

Nagasaki University Graduate School of Biomedical Sciences Department of Surgery

mahidaka@nagasaki-u.ac.jp095-819-7316

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026