Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Seoul National University Hospital
Sponsor:
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01838109
First received: April 10, 2013
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Gastric Cancer
Colon Cancer
Pancreatic Cancer
Duodenal Cancer
Biliary Cancer
Peptic Ulcer
Inflammatory Bowel Diseases
Dietary Supplement: oral nutritional supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Body weight decrease rate 8weeks after discharge compared with preoperative body weight [ Time Frame: 8weeks after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in body weight before and after surgery [ Time Frame: preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge ] [ Designated as safety issue: No ]
  • Change of body mass index before and after surgery [ Time Frame: preoperatively, at the time of discharge after surgery, and 8 weeks after discharge ] [ Designated as safety issue: No ]
  • changes in PG-SGA score and grade [ Time Frame: preoperatively, and 2,4,8 weeks after discharge ] [ Designated as safety issue: No ]
  • serum hemoglobin [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ] [ Designated as safety issue: No ]
  • serum total lymphocyte count [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ] [ Designated as safety issue: No ]
  • serum total cholesterol [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ] [ Designated as safety issue: No ]
  • serum total protein [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ] [ Designated as safety issue: No ]
  • serum albumin [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional [ Time Frame: pre-operatively, and 2,4,8 weeks after discharge ] [ Designated as safety issue: No ]
  • ONS related gastrointestinal adverse event [ Time Frame: upto 8weeks after discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 174
Study Start Date: April 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Encover
No Intervention: Control group
no intervention total 87 patients

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838109

Contacts
Contact: Hyuk-Joon Lee, MD. PhD appe98@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyuk-Joon Lee, MD, PhD       appe98@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
JW Pharmaceutical
Investigators
Principal Investigator: Hyuk-Joon Lee, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01838109     History of Changes
Other Study ID Numbers: KSSMN-01
Study First Received: April 10, 2013
Last Updated: September 4, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Duodenal Diseases
Colonic Neoplasms
Duodenal Neoplasms
Inflammatory Bowel Diseases
Intestinal Diseases
Stomach Neoplasms
Pancreatic Neoplasms
Peptic Ulcer
Ulcer
Biliary Tract Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Gastroenteritis
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Pathologic Processes
Biliary Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014