Clinical trial NCT02232893
Conditions: Postoperative Ileus
Keywords: Gastrointestinal Quality of Life Index (GIQLI) Postoperative Quality of Life Abdominal Bloating Laparoscopic colectomy Postoperative ileus (POI)
Sponsor: Tsumura USA
Start date: 2014-09-01; Completion date: 2017-05-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:

Arms: arm 1: Daikenchuto (TU-100) 5g TID (15g/day) arm 2: Placebo TID
Interventions: intervention 1: Daikenchuto (TU-100) intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents:
Prot_SAP_000.pdf: 
NCT 02232893                                                        22 Apr 2020 
 
 
A Randomized, Double-Blinded, Placebo-Controlled Trial of 
TU-100 in Patients Undergoing Laparoscopic Colectomy 
Study Protocol and Statistical Analysis Plan 
 
 


NCT 02232893                                                        22 Apr 2020 
Objectives 
The primary objective of this study was to assess the effect of TU-100 on postoperative 
quality of life in patients undergoing laparoscopic colectomy. 
 
Methodology 
This multicenter, randomized, double-blinded, placebo-controlled study evaluated the 
effect of TU 100 on postoperative quality of life in patients undergoing straight, hand-
assisted, or robot-assisted laparoscopic colectomy. A total daily dose of 15 g TU 100 or 
matching placebo (1:1) was administered for 3 days before surgery and for 28 days after 
surgery. 
 
 
 
 
Number of Patients (planned and analyzed) 
Approximately 68 patients were planned to be included in the study.  
 
Diagnosis and Main Criteria for Eligibility 
Inclusion Criteria: 
・ Were at least 18 years of age  
・ Had a current diagnosis of colon cancer, diverticulitis, or benign colonic neoplasm  
・ Required straight, hand-assisted, or robot-assisted laparoscopic colectomy 
・ Required hospitalization for surgery and recovery 
 
Exclusion Criteria: 
・ Had been diagnosed with rectal cancer, advanced or metastatic colon cancer, Crohn’s 


NCT 02232893                                                        22 Apr 2020 
disease, ulcerative colitis, or volvulus. 
・ Required resection of rectal lesion 
・ Had received or is scheduled to receive preoperative or postoperative chemotherapy 
during the duration of the study 
・ Required emergency surgery or surgery in the presence of ongoing infection, bowel 
obstruction or perforated bowel 
・ Had any other serious condition that might adversely affect suitability for 
participation in this study, such as liver disorder, kidney disorders, heart failure, 
blood disorders, or metabolic disorders 
・ Had a history of any invasive abdominal or thoracic surgery in the past 12 weeks.  
・ Planned to receive any abdominal irradiation 
・ The patient required the formation of a stoma (ileostomy or colostomy) 
 
Dose and Duration of Treatment 
Patients receiving the 15 g/d dose ingested two 2.5 g sachets of TU 100 t.i.d. for 3 days 
preoperatively and 28 days postoperatively; patients receiving placebo followed the same 
dosing schedule as the patients receiving TU-100. 
 
Criteria for Evaluation 
Primary efficacy endpoint: 
・ Change in GIQLI questionnaire global score from baseline to Visit 4 
Secondary efficacy endpoints, including but not limited to, as follows: 
・ Change in GIQLI global score from baseline to Visit 5 
・ Incidence of postoperative complication (i.e., surgical site infection, prolonged and 
recurrent postoperative ileus, and anastomotic leak) 
 
Statistical Analysis Plan 
The overall effect of TU-100 on the primary endpoint was assessed by using an analysis 
of covariance (ANCOVA) model with change from baseline value as the dependent 
variable and treatment group, baseline GIQLI global score, scheduled surgical location 
in the colon, and solid food before/after the first flatus as explanatory variables. The 
secondary endpoints were assessed by using an ANCOVA model or a Cox proportional 
hazards model. 
The intent-to-treat (ITT) population was used for all efficacy analyses. The safety 
population was used for all safety analyses. 
The frequencies of AEs were summarized by treatment group and by severity within 
treatment group. AEs were coded using the Medical Dictionary for Regulatory Activities 
(version 16.0).  All AEs were reported.