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

Primary Purpose

Malnourished, Stomach Neoplasms, Gastrointestinal Stromal Tumors

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

About this trial

This is an interventional supportive care trial for Malnourished

Eligibility Criteria

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

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

Sites / Locations

  • Department of Surgery, Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Ensure powder

Standard care

Arm Description

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

Standard care without oral nutritional supplements

Outcomes

Primary Outcome Measures

Postoperative complication rate

Secondary Outcome Measures

Body weight
Body composition indices
Length of hospital stay
Quality of life
Postoperative 30-day mortality
Biochemical assessment of nutritional status
Readmission rate
Patient compliance of oral nutritional supplements

Full Information

First Posted
August 17, 2011
Last Updated
March 12, 2014
Sponsor
Seoul National University Hospital
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT01421680
Brief Title
The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients
Official Title
A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnourished, Stomach Neoplasms, Gastrointestinal Stromal Tumors

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ensure powder
Arm Type
Active Comparator
Arm Description
Oral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care without oral nutritional supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure powder
Other Intervention Name(s)
Ensure powder (Abbott)
Intervention Description
Ensure powder(500kcal) per day for 7 weeks
Primary Outcome Measure Information:
Title
Postoperative complication rate
Time Frame
7weeks
Secondary Outcome Measure Information:
Title
Body weight
Time Frame
7weeks
Title
Body composition indices
Time Frame
7weeks
Title
Length of hospital stay
Time Frame
7weeks
Title
Quality of life
Time Frame
7weeks
Title
Postoperative 30-day mortality
Time Frame
7weeks
Title
Biochemical assessment of nutritional status
Time Frame
7weeks
Title
Readmission rate
Time Frame
7weeks
Title
Patient compliance of oral nutritional supplements
Time Frame
7weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Kwang Yang, M.D.
Organizational Affiliation
Department of Surgery, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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