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Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

This study has been completed.
JW Pharmaceutical
Information provided by (Responsible Party):
Seoul National University Hospital Identifier:
First received: April 10, 2013
Last updated: May 25, 2015
Last verified: September 2013
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.

Condition Intervention
Gastric Cancer
Colon Cancer
Pancreatic Cancer
Duodenal Cancer
Biliary Cancer
Peptic Ulcer
Inflammatory Bowel Diseases
Dietary Supplement: oral nutritional supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Body weight decrease rate 8weeks after discharge compared with preoperative body weight [ Time Frame: 8weeks after discharge ]

Secondary Outcome Measures:
  • Changes in body weight before and after surgery [ Time Frame: preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge ]
  • Change of body mass index before and after surgery [ Time Frame: preoperatively, at the time of discharge after surgery, and 8 weeks after discharge ]
  • changes in PG-SGA score and grade [ Time Frame: preoperatively, and 2,4,8 weeks after discharge ]
  • serum hemoglobin [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]
  • serum total lymphocyte count [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]
  • serum total cholesterol [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]
  • serum total protein [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]
  • serum albumin [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]

Other Outcome Measures:
  • Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional [ Time Frame: pre-operatively, and 2,4,8 weeks after discharge ]
  • ONS related gastrointestinal adverse event [ Time Frame: upto 8weeks after discharge ]

Enrollment: 174
Study Start Date: April 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ONS group
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
Other Name: Encover
No Intervention: Control group
no intervention total 87 patients


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT01838109

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
JW Pharmaceutical
Principal Investigator: Hyuk-Joon Lee, MD, PhD Seoul National University Hospital
  More Information

Responsible Party: Seoul National University Hospital Identifier: NCT01838109     History of Changes
Other Study ID Numbers: KSSMN-01
Study First Received: April 10, 2013
Last Updated: May 25, 2015

Additional relevant MeSH terms:
Stomach Neoplasms
Pancreatic Neoplasms
Inflammatory Bowel Diseases
Peptic Ulcer
Duodenal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Intestinal Diseases
Duodenal Diseases
Intestinal Neoplasms processed this record on May 25, 2017