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

March 12, 2014 updated by: Han-Kwang Yang, Seoul National University Hospital

A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Department of Surgery, Seoul National University Hospital

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.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative complication rate
Time Frame: 7weeks
7weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 7weeks
7weeks
Body composition indices
Time Frame: 7weeks
7weeks
Length of hospital stay
Time Frame: 7weeks
7weeks
Quality of life
Time Frame: 7weeks
7weeks
Postoperative 30-day mortality
Time Frame: 7weeks
7weeks
Biochemical assessment of nutritional status
Time Frame: 7weeks
7weeks
Readmission rate
Time Frame: 7weeks
7weeks
Patient compliance of oral nutritional supplements
Time Frame: 7weeks
7weeks

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Abbott

Investigators

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

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 Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 23, 2011

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANSK1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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