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

Seoul National University Hospital1 site in 1 country144 target enrollmentAugust 2011

ConditionsMalnourished Stomach Neoplasms Gastrointestinal Stromal Tumors

Overview

Phase: N/A
Intervention: Not specified
Conditions: Malnourished
Sponsor: Seoul National University Hospital
Enrollment: 144
Locations: 1
Primary Endpoint: Postoperative complication rate
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Han-Kwang Yang

Professor

Seoul National University Hospital

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