Exploratory study of clinical effectiveness and safety of daikenchuto (TJ-100) for gastrointestinal symptoms such as abdominal pain and distention following laparoscopic colectomy in colon cancer patients

Not Applicable

Recruiting

• Conditions: Colon cancer

• Registration Number: JPRN-UMIN000023318
• Lead Sponsor: Department of gastrointestinal surgery, Kyoto University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

In order to participate in this study, a patient must meet all of the following criteria.
1) Patients who qualify for curative resection for colon cancer.
Preoperative TNM category distribution: T=1a-3, N=0-2,M=0
2) Patients who suffer from abdominal pain and distention on postoperative day 1.
3)PS (ECOG Performance Status Scale): 0-2
4) Age: over 20 yo.
5) Gender: no specification
6) Inpatient/Outpatient: Inpatient
7) Patients who can orally take Daikenchuto
8) Patients who can provide written informed
consent

Exclusion Criteria

1) Patients who can orally take Daikenchuto on postoperative day 1.
2) Patients with history of laparotomy
3) Patients with history of ileum.
4) Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease.
5) Patients with concomitant endometriosis
6) Patients requiring emergency surgery
7) Patients who have been treated or will be treated by chemotherapy or radiotherapy for primary disease
8) Patients with serious concomitant diseases
9) Patients who took prohibited concomitant drugs 4 weeks before treatment.
10) Patients with history of allergy for other Kampo
formulation(s)
11) Patients with infection of HBV or HCV
12) Others, including patients who are unfit for the study as determined by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Numerical Rating Scale of abdominal pain<br>2) Numerical Rating Scale of abdominal distention<br>3) Gastrointestinal Quality of Life Index (GIQLI)