Clincosm LogoSign in Get a demo

The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01421680
Collaborator
Abbott (Industry)
144
Enrollment
1
Location
2
Arms
28
Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ensure powder
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ensure powder

Oral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals

Dietary Supplement: Ensure powder
Ensure powder(500kcal) per day for 7 weeks
Other Names:
  • Ensure powder (Abbott)

    		•
    No Intervention: Standard care

    Standard care without oral nutritional supplements

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative complication rate [7weeks]

    Secondary Outcome Measures

    1. Body weight [7weeks]

    2. Body composition indices [7weeks]

    3. Length of hospital stay [7weeks]

    4. Quality of life [7weeks]

    5. Postoperative 30-day mortality [7weeks]

    6. Biochemical assessment of nutritional status [7weeks]

    7. Readmission rate [7weeks]

    8. Patient compliance of oral nutritional supplements [7weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients older than 20 years

    • Patients who undergo distal, total, proximal, or pylorus-preserving gastrectomy

    • Patients who are assessed as moderate or severe malnourished according to PG-SGA or patients with BMI lower than 18.5 kg/m2

    • Patients who can take oral meals

    • Patients who agree on the informed consent

    Exclusion Criteria:

    • Emergent operation

    • Patients who received preoperative chemotherapy or radiation therapy within 6 months

    • Pregnant patients

    • Patients who cannot consume the Ensure powder

    • Patients who enrolled another clinical trials

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Surgery, Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital
    • Abbott

    Investigators

    • Principal Investigator: Han-Kwang Yang, M.D., Department of Surgery, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han-Kwang Yang, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01421680
    Other Study ID Numbers:
    • ANSK1101
    First Posted:
    Aug 23, 2011
    Last Update Posted:
    Mar 14, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Gastrointestinal Stromal Tumors
    Stomach Neoplasms
    Malnutrition

    Study Results

    No Results Posted as of Mar 14, 2014