Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

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

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-04-30

Brief Summary

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Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption function, and/or metabolic changes after surgery. The postoperative malnutrition is associated with low quality of life and seems to be related long-term nutritional status. This study is a multicenter, open-labeled prospective randomized clinical trial to examine the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal surgery by comparing the change of body weight and other nutritional parameters between the experiment group that is supplied with ONS and the control group without ONS.

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Detailed Description

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Conditions

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Gastric Cancer Colon Cancer Pancreatic Cancer Duodenal Cancer Biliary Cancer Peptic Ulcer Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ONS group

oral administration of Encover 2 package for day starting at the time of discharge (200ml/package x 2, total 400Kcal/day) total 87 patients

Group Type EXPERIMENTAL

oral nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

Control group

no intervention total 87 patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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oral nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Encover

Eligibility Criteria

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Inclusion Criteria

* Male or female who are 20 or more years old and not more than 80 years old
* Discharge from a hospital is planned within 2 weeks after major gastrointestinal surgery (except when ileostomy is performed)
* oral intake is possible at the time of discharge
* no preoperative chemotherapy or preoperative radiotherapy
* voluntarily agreed with the informed consent of this clinical trial

Exclusion Criteria

* Intravenous or other specific nutritional treatment is needed
* BMI \>25 and postoperative weight loss is not \> 5% of preoperative body weight at the time of discharge
* Allergy to milk, whey, bean, salmon, or the investigational product
* Residual of cancer in the abdominal cavity postoperatively if it is cancer case
* Presence of synchronous other cancers that needs treatment.
* When investigator judged that the patient is not eligible to the trial

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No