Unique ID issued by UMIN | UMIN000028950 |
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Receipt number | R000031976 |
Scientific Title | Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy. |
Date of disclosure of the study information | 2017/09/01 |
Last modified on | 2018/10/08 13:36:19 |
Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.
Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.
Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.
Exploratory study evaluating efficacy and safety of daikenchuto for the treatment of the postoperative abdominal pain or bloating in patients undergoing hepatectomy.
Japan |
Abdominal pain or bloating after hepatectomy
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate efficacy and safety of daikenchuto on postoperative abdominal pain or bloating after hepatectomy, and to explore an effect of the drug on small intestinal mucosal injury after abdominal surgery by assessing DAO and GLP-2.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Patient assessment of Postoperative abdominal pain or bloating (NRS).
1. Postoperative hospital stay
2. Assessment of intestinal injury and nutritional status (DAO, GLP-2, RBP, TTR, Tf, Alb)
3. Liver function (AST, ALT, Al-P,GGTP, T-Bil, PT)
4. Incidence and rate of postoperative complications (Clavien-Dindo Classification)
5. Incidence and rate of postoperative infection (wound, intraperitoneal, respiratory, urinary tract and systemic infection)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
YES
Central registration
2
Treatment
Medicine |
Oral administration of Daikenchuto 5.0 g (2.5g/pack x 2 packs) per dose three times a day from postoperative day 1 to 14.
Non-treatment of daikenchuto.
20 | years-old | <= |
Not applicable |
Male and Female
1. Selection criteria at the time of obtaining informed consent
1) Patient who are scheduled to undergo hepatectomy (>= subsegmentectomy)
2) Liver Damage A
3) Age: >= 20 years
4) Patient who are orally take daikenchuto
5) Adeguate organ functions and operable patient
6) Patient who are provide written informed consent
2. Selection criteria at the time of enrollment
7) With abdominal pain or bloating on postoperative day 1
8) Patient who are enforced hepatectomy (>= subsegmentectomy)
1) Emergency surgery
2) With history of hepatectomy
3) Patient who have constitutional ICG excretory defect
4) With history of gastrointestinal surgery (excluding appendectomy)
5) Patient who are scheduled to enforce a gut surgery with hepatectomy (including biliary reconstruction)
6)With inflammatory bowel disease such as ulcerative colitis or Crohn disease (including anamnestic case)
7)With history of stoma
8)Patient who are scheduled for chemotherapy, radiation therapy or radiofrequency ablation therapy within 4 weeks before enrollment, during surgery or within 14 days after surgery (during individual study period)
9) Patient who took kampo medicine or lactobacillus preparation within 4 weeks before enrollment
10) Patient who are pregnancy, possibly pregnancy, considering pregnancy or lactating
11) Patient who are determined not applicable for the study by the physician
40
1st name | |
Middle name | |
Last name | Susumu Eguchi |
Nagasaki University Graduate School of Biomedical Sciences
Department of Surgery
1-7-1 Sakamoto, Nagasaki
095-819-7316
sueguchi@nagasaki-u.ac.jp
1st name | |
Middle name | |
Last name | Masaaki Hidaka |
Nagasaki University Graduate School of Biomedical Sciences
Department of Surgery
1-7-1 Sakamoto, Nagasaki
095-819-7316
mahidaka@nagasaki-u.ac.jp
Nagasaki University
TSUMURA and Co.
Profit organization
Japan
NO
2017 | Year | 09 | Month | 01 | Day |
Unpublished
Open public recruiting
2017 | Year | 06 | Month | 01 | Day |
2017 | Year | 11 | Month | 18 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2017 | Year | 09 | Month | 01 | Day |
2018 | Year | 10 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031976
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