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Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Primary Purpose

Gastric Cancer, Colon Cancer, Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oral nutritional supplement
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ONS group

Control group

Arm Description

oral administration of Encover 2 package for day starting at the time of discharge (200ml/package x 2, total 400Kcal/day) total 87 patients

no intervention total 87 patients

Outcomes

Primary Outcome Measures

Body weight decrease rate 8weeks after discharge compared with preoperative body weight

Secondary Outcome Measures

Changes in body weight before and after surgery
Change of body mass index before and after surgery
changes in PG-SGA score and grade
serum hemoglobin
serum total lymphocyte count
serum total cholesterol
serum total protein
serum albumin

Full Information

First Posted
April 10, 2013
Last Updated
May 25, 2015
Sponsor
Seoul National University Hospital
Collaborators
JW Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01838109
Brief Title
Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery
Official Title
Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
JW Pharmaceutical

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Colon Cancer, Pancreatic Cancer, Duodenal Cancer, Biliary Cancer, Peptic Ulcer, Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ONS group
Arm Type
Experimental
Arm Description
oral administration of Encover 2 package for day starting at the time of discharge (200ml/package x 2, total 400Kcal/day) total 87 patients
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention total 87 patients
Intervention Type
Dietary Supplement
Intervention Name(s)
oral nutritional supplement
Other Intervention Name(s)
Encover
Primary Outcome Measure Information:
Title
Body weight decrease rate 8weeks after discharge compared with preoperative body weight
Time Frame
8weeks after discharge
Secondary Outcome Measure Information:
Title
Changes in body weight before and after surgery
Time Frame
preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge
Title
Change of body mass index before and after surgery
Time Frame
preoperatively, at the time of discharge after surgery, and 8 weeks after discharge
Title
changes in PG-SGA score and grade
Time Frame
preoperatively, and 2,4,8 weeks after discharge
Title
serum hemoglobin
Time Frame
preoperatively, at the time of discharge, 2,4,8 weeks after discharge
Title
serum total lymphocyte count
Time Frame
preoperatively, at the time of discharge, 2,4,8 weeks after discharge
Title
serum total cholesterol
Time Frame
preoperatively, at the time of discharge, 2,4,8 weeks after discharge
Title
serum total protein
Time Frame
preoperatively, at the time of discharge, 2,4,8 weeks after discharge
Title
serum albumin
Time Frame
preoperatively, at the time of discharge, 2,4,8 weeks after discharge
Other Pre-specified Outcome Measures:
Title
Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional
Time Frame
pre-operatively, and 2,4,8 weeks after discharge
Title
ONS related gastrointestinal adverse event
Time Frame
upto 8weeks after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyuk-Joon Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

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