Postoperative Ileus
Conditions
Keywords
Gastrointestinal Quality of Life Index (GIQLI), Postoperative Quality of Life, Abdominal Bloating, Laparoscopic colectomy, Postoperative ileus (POI)
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Cato Research
Tsumura USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4. | Baseline and 15 days | 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. |
Countries
United States
Participant flow
Recruitment details
The study was carried out at 16 sites in the United States (US).
Participants by arm
| Arm | Count |
|---|---|
| TU-100 TU-100: 5g TID (15g/day)
TU-100: Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose for 3 days before surgery and for 28 days after surgery. | 34 |
| Placebo Placebo TID
Placebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose for 3 days before surgery and for 28 days after surgery. | 31 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Developed exclusion criteria | 0 | 1 |
| Overall Study | Other | 0 | 3 |
| Overall Study | Sponsor request early termination | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | TU-100 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 9.76 | 58.4 years STANDARD_DEVIATION 12.4 | 58.6 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 30 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 34 participants | 31 participants | 65 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 |
| other Total, other adverse events | 29 / 34 | 23 / 32 |
| serious Total, serious adverse events | 3 / 34 | 4 / 32 |
Outcome results
Primary
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.
Time frame: Baseline and 15 days
Population: Among the ITT population, patients who provided GIQLI scores both at baseline and Visit 4 were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TU-100 | Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4. | -17.20 score on a scale | Standard Error 2.76 |
| Placebo | Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4. | -10.10 score on a scale | Standard Error 2.99 |
p-value: >0.05ANCOVA