Elderly gastric cancer patients who are scheduled for gastrectomy
Conditions
Interventions
Oral administration of Hochuekkito (2.5g t.i.d before or between meals) for 2 weeks until the day before surgery and from the second day up to 6 months after surgery.
No treatment
Sponsors
Department of Surgery, Iwate Medical University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients complain of loss of appetite 2)Patients scheduled to enforce a total gastrectomy or distal gastrectomy 3)Preoperative staging:IA-IIIA 4)Operative procedure*Open surgery, laparoscopic surgery, laparoscopic assisted surgery 5)Reconstruction: Roux-en-Y, Billroth-I 6)PS(ECOG Performance Status Scale):0-1 7)Age:over65 8)Gender:No object 9)Out patient or inpatient:Out patient 10)Patient oral administration is possible 11)Agreement to sign an informed consent
Exclusion criteria
Exclusion criteria: 1)Patients who are scheduled for radiation therapy in the preoperative orintraoperative 2)Patients with a history of radiation therapy to the abdomen 3)Patients who are scheduled to management by artificial respiration after surgery 4)Patients with either a history has been complicated by inflammatory bowel diseases such as ulcerative colitis or Crohn's disease 5)Patients who underwent emergency surgery 6)Patients with double cancer 7)Patients with peritoneal metastasis (Peritoneal Lavage Cytology or Pathological diagnosis) 8)Patients who are scheduled to bowel resection 9)Patients with major organs (bone marrow, heart, liver, kidney, lungs, etc.) the function of the not retained 10)Patients with a history of bowel resection 11)Patients with a history of abdominal surgery and peritonitis (Except for patients with appendectomy) 12)Patients with diabetes to have performed insulin therapy 13)Patients receiving steroids 14)Patients taking the Kampo Products within 4 weeks prior to study drug administration 15)Patients were considered to be inappropriate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Appetite(VAS:Visual Analog Scale) 2)CONUT(Controlling Nutritional Status) score 3)Skeletal muscle mass evaluated at 3 and 6 month after operation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Postoperative complications 2)PNI(Prognostic Nutritional Index) 3)Changes in body weight 4)Frailty(Muscle mass, Muscle strength, Physical ability) 5)QOL(Quality of Life)evaluation: SF-12 standard version 6)IADL(Instrumental Activities of Daily Living) evaluation:TMIG Index of Competence 7)Preoperative depression score: K6/K10 Japanese version 8)Postoperative hospital stay 9)Feasibility 10)Clinical examination:Alb, Lym, T-Cho, T-Bil, ALT, AST, GTP, CRP, BUN, Cr, Na, K, Cl 11)Adverse events 12)Side effects | — |
Countries
Japan
Contacts
Public ContactKeisuke Koeda
Iwate Medical University, School of Medicine Department of Surgery
Outcome results
None listed