Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery
N/A
20 Years
80 Years
20 Years
80 Years
Not Enrolling
Both
Gastric Cancer, Colon Cancer, Pancreatic Cancer, Duodenal Cancer, Biliary Cancer, Peptic Ulcer, Inflammatory Bowel Diseases
Both
Gastric Cancer, Colon Cancer, Pancreatic Cancer, Duodenal Cancer, Biliary Cancer, Peptic Ulcer, Inflammatory Bowel Diseases
Trial Information
Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery
Inclusion Criteria:
- Male or female who are 20 or more years old and not more than 80 years old
- Discharge from a hospital is planned within 2 weeks after major gastrointestinal
surgery (except when ileostomy is performed)
- oral intake is possible at the time of discharge
- no preoperative chemotherapy or preoperative radiotherapy
- voluntarily agreed with the informed consent of this clinical trial
Exclusion Criteria:
- Intravenous or other specific nutritional treatment is needed
- BMI >25 and postoperative weight loss is not > 5% of preoperative body weight at the
time of discharge
- Allergy to milk, whey, bean, salmon, or the investigational product
- Residual of cancer in the abdominal cavity postoperatively if it is cancer case
- Presence of synchronous other cancers that needs treatment.
- When investigator judged that the patient is not eligible to the trial
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Body weight decrease rate 8weeks after discharge compared with preoperative body weight
Outcome Time Frame:
8weeks after discharge
Safety Issue:
No
Principal Investigator
Hyuk-Joon Lee, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Hospital
Authority:
Korea: Institutional Review Board
Study ID:
KSSMN-01
NCT ID:
NCT01838109
Start Date:
April 2013
Completion Date:
Related Keywords:
- Gastric Cancer
- Colon Cancer
- Pancreatic Cancer
- Duodenal Cancer
- Biliary Cancer
- Peptic Ulcer
- Inflammatory Bowel Diseases
- Colonic Neoplasms
- Duodenal Neoplasms
- Inflammatory Bowel Diseases
- Intestinal Diseases
- Stomach Neoplasms
- Pancreatic Neoplasms
- Peptic Ulcer
- Ulcer
- Biliary Tract Neoplasms
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