Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery

Conditions
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Gastric Cancer, Colon Cancer, Pancreatic Cancer, Duodenal Cancer, Biliary Cancer, Peptic Ulcer, Inflammatory Bowel Diseases

Intervention / Treatment
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* Dietary Supplement: oral nutritional supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONS group<br>oral administration of Encover 2 package for day starting at the time of discharge (200ml/package x 2, total 400Kcal/day) total 87 patients | Dietary Supplement: oral nutritional supplement<br> <br> * Other names: Encover;|
| No Intervention: Control group<br>no intervention total 87 patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight decrease rate 8weeks after discharge compared with preoperative body weight |  | 8weeks after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 |