Gastric cancer patients with gastrointestinal symptom (abdominal pain, distention) after distal gastrectomy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to participate in this study, a patient must meet all of the following criteria. 1) Patietnt with Clinical Stage: IA-IIB before surgery 2) Patient who recieved open or laparoscopic gastrectomy 3) Patient with abdominal pain and distention 1day after surgery 4) Patient with reconstruction: Billroth I 5) Patient with PS (ECOG Performance Status Scale): 0,1 6) Age: 20 years or older, under 75 years 7) Gender: no specification 8) Inpatient/Outpatient: Inpatient 9) Patient who can provide written informed consent
Exclusion criteria
Exclusion criteria: In order to participate in this study, a patient must not meet any of the following criteria. 1) Patients scheduled to be under postoperative artificial respiration 2) Patients with concomitant or history of inflammatory bowel disease such as ulcerative colitis and Crohn's disease 3) Patients with double cancer 4) Patients with peritoneal metastasis 5) Patients with history of the intestine and colon resections 6) Patient having the dysfunction of the main organ (bone marrrow, heart, liver, kidney, lung and others) 7) Patients with history of laparotomy or peritonitis (excluding surgery for appendicitis) 8) Patients who are administered another Kampo medicines for treatment within 4 weeks before the test drug administration 9) Patients who is an impossible to have oral administration of the test drug 10) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy 11) Others, patients who are unfit for the study as determined by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) gastrointestinal symptom (abdominal pain/distention/number of bowel movements per day after operation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) QOL assessment by the GSRS questionnaire 2) The evaluation of gastrointestinal motility using the cine MRI | — |
Countries
Japan
Contacts
SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL Gastroenterological Surgery