Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Not Applicable

Completed

• Conditions: Gastric Cancer; Duodenal Cancer; Biliary Cancer; Peptic Ulcer; Inflammatory Bowel Diseases; Pancreatic Cancer; Colon Cancer
• Interventions: Dietary Supplement: oral nutritional supplement

• Registration Number: NCT01838109
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-23
• Status Verified: 2013-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2015-05-25
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONS group	oral nutritional supplement	oral administration of Encover 2 package for day starting at the time of discharge (200ml/package x 2, total 400Kcal/day) total 87 patients

Primary Outcome Measures

Name	Time	Method
Body weight decrease rate 8weeks after discharge compared with preoperative body weight	8weeks after discharge

Secondary Outcome Measures

Name	Time	Method
serum total lymphocyte count	preoperatively, at the time of discharge, 2,4,8 weeks after discharge
Changes in body weight before and after surgery	preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge
Change of body mass index before and after surgery	preoperatively, at the time of discharge after surgery, and 8 weeks after discharge
changes in PG-SGA score and grade	preoperatively, and 2,4,8 weeks after discharge
serum hemoglobin	preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum total cholesterol	preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum total protein	preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum albumin	preoperatively, at the time of discharge, 2,4,8 weeks after discharge

Trial Locations

Locations (1)

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