Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Drug: Daikenchuto (TU-100)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daikenchuto (TU-100)<br>Daikenchuto (TU-100) 5g TID (15g/day) | Drug: Daikenchuto (TU-100)<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo TID | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4. | The primary endpoint was change in The Gastrointestinal Quality of Life Index (GIQLI) global score from baseline to Visit 4 (Day 15 minus baseline). The global score could range from 0 (lowest quality of life) to 144 (highest quality of life). The effect of TU-100 on the change in GIQLI global score from baseline was assessed by using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and with baseline GIQLI global score, scheduled surgical location in the colon, and solid food before/after the first flatus as covariates. | Baseline and 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Quality of Life Index (GIQLI), Postoperative Quality of Life, Abdominal Bloating, Laparoscopic colectomy, Postoperative ileus (POI)