Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Gastric Cancer; Pancreatic Cancer; Peptic Ulcer; Colon Cancer; Duodenal Cancer; Biliary Cancer
• Intervention / Treatment: Dietary supplement: oral nutritional supplement

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: oral nutritional supplement; Other Names: Encover
No Intervention: Control group; no intervention total 87 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight decrease rate 8weeks after discharge compared with preoperative body weight	8weeks after discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
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 lymphocyte count	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

Other Outcome Measures

Outcome Measure	Time Frame
Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional	pre-operatively, and 2,4,8 weeks after discharge
ONS related gastrointestinal adverse event	upto 8weeks after discharge

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: JW Pharmaceutical
• Investigators: Principal Investigator: Hyuk-Joon Lee, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 23, 2013

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 25, 2015
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Intestinal Neoplasms; Duodenal Diseases; Inflammatory Bowel Diseases; Peptic Ulcer; Duodenal Neoplasms
• Other Study ID Numbers: KSSMN-01