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

Not Applicable

Completed

• Conditions: Malnourished; Stomach Neoplasms; Gastrointestinal Stromal Tumors
• Interventions: Dietary Supplement: Ensure powder

• Registration Number: NCT01421680
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-23
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ensure powder	Ensure powder	Oral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals

Primary Outcome Measures

Name	Time	Method
Postoperative complication rate	7weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Surgery, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of