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Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01838109
Collaborator
JW Pharmaceutical (Industry)
174
Enrollment
1
Location
2
Arms
12
Duration (Months)
14.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: oral nutritional supplement
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
174 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

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
Other Names:
  • Encover

    		•
    No Intervention: Control group

    no intervention total 87 patients

    Outcome Measures

    Primary Outcome Measures

    1. Body weight decrease rate 8weeks after discharge compared with preoperative body weight [8weeks after discharge]

    Secondary Outcome Measures

    1. Changes in body weight before and after surgery [preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge]

    2. Change of body mass index before and after surgery [preoperatively, at the time of discharge after surgery, and 8 weeks after discharge]

    3. changes in PG-SGA score and grade [preoperatively, and 2,4,8 weeks after discharge]

    4. serum hemoglobin [preoperatively, at the time of discharge, 2,4,8 weeks after discharge]

    5. serum total lymphocyte count [preoperatively, at the time of discharge, 2,4,8 weeks after discharge]

    6. serum total cholesterol [preoperatively, at the time of discharge, 2,4,8 weeks after discharge]

    7. serum total protein [preoperatively, at the time of discharge, 2,4,8 weeks after discharge]

    8. serum albumin [preoperatively, at the time of discharge, 2,4,8 weeks after discharge]

    Other Outcome Measures

    1. Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional [pre-operatively, and 2,4,8 weeks after discharge]

    2. ONS related gastrointestinal adverse event [upto 8weeks after discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital
    • JW Pharmaceutical

    Investigators

    • Principal Investigator: Hyuk-Joon Lee, MD, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01838109
    Other Study ID Numbers:
    • KSSMN-01
    First Posted:
    Apr 23, 2013
    Last Update Posted:
    May 27, 2015
    Last Verified:
    Sep 1, 2013
    Additional relevant MeSH terms:
    Duodenal Neoplasms
    Inflammatory Bowel Diseases
    Peptic Ulcer

    Study Results

    No Results Posted as of May 27, 2015