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Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01838109
First Posted: April 23, 2013
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Seoul National University Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]
  • Change of body mass index before and after surgery [ Time Frame: preoperatively, at the time of discharge after surgery, and 8 weeks after discharge ]
  • changes in PG-SGA score and grade [ Time Frame: preoperatively, and 2,4,8 weeks after discharge ]
  • serum hemoglobin [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]
  • serum total lymphocyte count [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]
  • serum total cholesterol [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]
  • serum total protein [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]
  • serum albumin [ Time Frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge ]

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 ]
  • ONS related gastrointestinal adverse event [ Time Frame: upto 8weeks after discharge ]

Enrollment: 174
Study Start Date: April 2013
Study Completion Date: April 2014
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

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838109


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
JW Pharmaceutical
Investigators
Principal Investigator: Hyuk-Joon Lee, MD, PhD Seoul National University Hospital
  More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01838109     History of Changes
Other Study ID Numbers: KSSMN-01
First Submitted: April 10, 2013
First Posted: April 23, 2013
Last Update Posted: May 27, 2015
Last Verified: September 2013

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Inflammatory Bowel Diseases
Peptic Ulcer
Duodenal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Gastroenteritis
Intestinal Diseases
Duodenal Diseases
Intestinal Neoplasms