Postoperative ileus in subjects undergoing hepatectomy
Conditions
Interventions
Test drug: TJ-100 daikenchuto TJ-100 daikenchuto, 5g, extract granules. Tree times daily beginning on preoperative 3 days until postoperative 10 days of perioperative treatment.
Sponsors
Department of Surgery, Kochi Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study, a patient must meet all of the following criteria: 1)Is scheduled hepatectomy 2)Is diagnosed with abdominal distention as pre-operative CTCAE grade is at least 2 ; 3)Is possible to take daikenchuto orally; 4)Has a pre-operative ECOG performance status of 0 to 2; 5)Is at least 20 years of age; 6)Is male or female; 7)Has confirmed that it has been for 4 weeks after receiving anticancer radiation or chemotherapy; 8)Is maintenance in function of bone marrow, hart, liver, kidney and lung; 9)Is hospitalized for surgery and recovery; and 10)Provides written informed consent prior to participation in the study.
Exclusion criteria
Exclusion criteria: In order to participate in this study, a patient must not meet any of the following criteria: 1)With a history of laparoscopic surgery 2)Requires emergency surgery 3)Has a history of taking kampo medicine within 4 weeks of taking test drug; 4)Has history of gastrectomy (synchrony and/or asynchrony) ; 5)Has history of colectomy (synchrony) ; 6)Has history of RFA; 7)Has been diagnosed with ulcerative colitis, Crohn's disease, or irritable bowel syndrome; 8)Requires chemotherapy or anticancer radiation in the perioperative period or within 4 weeks prior to surgery; 9)Requires chemotherapy, including TAE or anticancer radiation within postoperative 10 days; 10)Has serious condition of liver that might adversely affect their ability to participate in this study; 11)Is a pregnant, possibly pregnant, considering pregnancy or lactating female; and 12)Is otherwise unacceptable for enrollment in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Patient assessment of abdominal distension [ Time Frame: Baseline and following 14 days of treatment ] * Patient assessment of gastrointestinal symptoms rating scale [ Time Frame: Baseline and following 14 days of treatment ] | — |
Secondary
| Measure | Time frame |
|---|---|
| * Time to first flatus and time to first bowel movement after endotracheal intubation removal [ Time Frame: Baseline and following 12 days of treatment ] * Blood ammonia level [ Time Frame: Baseline and following 12 days of treatment ] * Blood CRP level [ Time Frame: Baseline and following 12 days of treatment ] * Ascertain presence of bowel obstruction after surgery [ Time Frame: Baseline and following 14 days of treatment ] | — |
Countries
Japan
Outcome results
None listed