Biliary Cancer, Colon Cancer, Duodenal Cancer, Gastric Cancer, Inflammatory Bowel Diseases, Pancreatic Cancer, Peptic Ulcer
Conditions
Brief summary
Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption function, and/or metabolic changes after surgery. The postoperative malnutrition is associated with low quality of life and seems to be related long-term nutritional status. This study is a multicenter, open-labeled prospective randomized clinical trial to examine the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal surgery by comparing the change of body weight and other nutritional parameters between the experiment group that is supplied with ONS and the control group without ONS.
Interventions
DIETARY_SUPPLEMENToral nutritional supplement
Sponsors
JW Pharmaceutical
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight decrease rate 8weeks after discharge compared with preoperative body weight | 8weeks after discharge |
Secondary
| Measure | Time frame |
|---|---|
| serum hemoglobin | preoperatively, at the time of discharge, 2,4,8 weeks after discharge |
| serum total lymphocyte count | preoperatively, at the time of discharge, 2,4,8 weeks after discharge |
| serum total cholesterol | preoperatively, at the time of discharge, 2,4,8 weeks after discharge |
| Changes in body weight before and after surgery | preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge |
| Change of body mass index before and after surgery | preoperatively, at the time of discharge after surgery, and 8 weeks after discharge |
| changes in PG-SGA score and grade | preoperatively, and 2,4,8 weeks after discharge |
| serum total protein | preoperatively, at the time of discharge, 2,4,8 weeks after discharge |
| serum albumin | preoperatively, at the time of discharge, 2,4,8 weeks after discharge |
Other
| Measure | Time frame |
|---|---|
| ONS related gastrointestinal adverse event | upto 8weeks after discharge |
| Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional | pre-operatively, and 2,4,8 weeks after discharge |
Countries
South Korea
Outcome results
None listed