Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery (a randomized, double-blind, multi-center, placebo-controlled study) Additional study:Gastrointestinal transit time as an indicator

UMIN ID: UMIN000001793

Registered date:24/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colon cancer (Sigmoidal and Rectosigmoidal regions)
• Date of first enrollment: 2009/03/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A capsule of radiopaque markers is taken with test drug(Daikenchuto) orally at 8:00 a.m. on postoperative day 2.
A capsule of radiopaque markers is taken with test drug(placebo) orally at 8:00 a.m. on postoperative day 2.

Outcome(s)

• Primary Outcome: Total number of elimination of the markers

Secondary Outcome

1) Time to first flatus (hr) after nasogastric tube removal
2) Segmental transit time (gastric emptying, small intestinal transit, and colonic transit (right, left, and rectosigmoid colon))

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female

Include criteria

1)Participate in JFMC39-0902
2)Amenable to curative resection in colon cancer (Sigmoidal and Rectosigmoidal regions)
3)Patients who can provide written informed consent

• Exclude criteria: 1)Patients who are unfit for the study as determined by the attending physician

Related Information

• Primary Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer
• Source(s) of Monetary Support: Japanese Foundation for Multidisciplinary Treatment of Cancer