Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

NCT01838109 | Completed

• 1 other identifier: KSSMN-01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Body weight decrease rate 8weeks after discharge compared with preoperative body weight

  8weeks after discharge

Secondary Outcomes (8)

• 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

Other Outcomes (2)

• 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

Study Arms (2)

ONS group

EXPERIMENTAL

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

Control group

NO INTERVENTION

no intervention total 87 patients

Interventions

oral nutritional supplement DIETARY_SUPPLEMENT

Also known as: Encover

ONS group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• JW Pharmaceutical: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Colonic Neoplasms; Pancreatic Neoplasms; Duodenal Neoplasms; Biliary Tract Neoplasms; Peptic Ulcer; Inflammatory Bowel Diseases

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Duodenal Diseases; Biliary Tract Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hyuk-Joon Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 23, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2013-09

Locations

KR (1)