Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
Condition: Postoperative Ileus
MeSH terms: Ileus
Intervention: Daikenchuto (TU-100); Placebo
Intervention description: Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.; Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastrointestinal Quality of Life Index (GIQLI); Postoperative Quality of Life; Abdominal Bloating; Laparoscopic colectomy; Postoperative ileus (POI)

Summary:

      TU-100 is a gastrointestinal drug produced from the three botanical raw materials, Asian
      ginseng, Zanthoxylum fruit (Japanese pepper), and ginger, based on proprietary aqueous
      decoction and granulation technology. The aim of this study is to assess the effect of TU-100
      on post-operative quality of life during the 4 week postoperative period after straight,
      hand-assisted, or robot-assisted laparoscopic colectomy. Optimal efficacy parameters for
      subsequent outcome studies also will be explored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age

          -  Has a current diagnosis of colon cancer, diverticulitis, or benign colonic neoplasm

          -  Requires straight, hand-assisted, or robot-assisted laparoscopic colectomy

          -  Requires hospitalization for surgery and recovery

        Exclusion Criteria:

          -  Has been diagnosed with rectal cancer, advanced or metastatic colon cancer, Crohn
             disease, ulcerative colitis, or volvulus

          -  Requires resection of rectal lesion

          -  Has received or is scheduled to receive chemotherapy during the duration of the study

          -  Is a pregnant or lactating female

          -  Has diabetic neuropathy

          -  Has a history or presence of diabetic gastroparesis

          -  Has a compromised immune system, either from treatment with corticosteroids or other
             immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease
             (e.g., human immunodeficiency virus)

          -  Has any other serious condition that might adversely affect suitability for
             participation in this study, such as liver disorder (including alanine
             aminotransferase or aspartate aminotransferase level greater than 2.5 times the upper
             limit of normal), kidney disorders, heart failure, blood disorders, or metabolic
             disorders

          -  Has a history or presence of interstitial pneumonia

          -  Has a history of allergic reaction to ginseng, ginger or Zanthoxylum fruit (Japanese
             pepper)

          -  Plans to receive any abdominal irradiation

          -  Is clinically lactose intolerant