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

NCT ID: NCT01421680

Last Updated: 2014-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Malnourished Stomach Neoplasms Gastrointestinal Stromal Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Ensure powder

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

Group Type ACTIVE_COMPARATOR

Ensure powder

Intervention Type DIETARY_SUPPLEMENT

Ensure powder(500kcal) per day for 7 weeks

Standard care

Standard care without oral nutritional supplements

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ensure powder

Ensure powder(500kcal) per day for 7 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ensure powder (Abbott)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han-Kwang Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han-Kwang Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Seoul National University Hospital

Locations

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Department of Surgery, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ANSK1101

Identifier Type: -

Identifier Source: org_study_id

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