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| Name | Class |
|---|---|
| JW Pharmaceutical | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONS group | Experimental | oral administration of Encover 2 package for day starting at the time of discharge (200ml/package x 2, total 400Kcal/day) total 87 patients |
|
| Control group | No Intervention | no intervention total 87 patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral nutritional supplement | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight decrease rate 8weeks after discharge compared with preoperative body weight | 8weeks after discharge |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional | pre-operatively, and 2,4,8 weeks after discharge | |
| ONS related gastrointestinal adverse event | upto 8weeks after discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyuk-Joon Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D003110 | Colonic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004379 | Duodenal Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D010437 | Peptic Ulcer |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| 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 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D004378 | Duodenal Diseases |
| D001660 | Biliary Tract Diseases |
| D005759 | Gastroenteritis |