Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Study Overview

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.

N/A

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

DIETARY_SUPPLEMENT: oral nutritional supplement

KSSMN-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-04-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-05-25
First Submitted that Met QC Criteria 2013-04-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-05-27
First Posted (ESTIMATED) 2013-04-23	Results First Posted N/A	Last Verified 2013-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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
NO_INTERVENTION: Control group no intervention total 87 patients

Participant Group/Arm

Intervention/Treatment

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

NO_INTERVENTION: Control group

no intervention total 87 patients

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

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

JW Pharmaceutical

Investigators

PRINCIPAL_INVESTIGATOR: Hyuk-Joon Lee, MD, PhD, Seoul National University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record