The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Han-Kwang Yang, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01421680
First received: August 17, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy.


Condition Intervention
Malnourished
Stomach Neoplasms
Gastrointestinal Stromal Tumors
Dietary Supplement: Ensure powder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Postoperative complication rate [ Time Frame: 7weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight [ Time Frame: 7weeks ] [ Designated as safety issue: No ]
  • Body composition indices [ Time Frame: 7weeks ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 7weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 7weeks ] [ Designated as safety issue: No ]
  • Postoperative 30-day mortality [ Time Frame: 7weeks ] [ Designated as safety issue: No ]
  • Biochemical assessment of nutritional status [ Time Frame: 7weeks ] [ Designated as safety issue: No ]
  • Readmission rate [ Time Frame: 7weeks ] [ Designated as safety issue: No ]
  • Patient compliance of oral nutritional supplements [ Time Frame: 7weeks ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: August 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ensure powder
Oral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals
Dietary Supplement: Ensure powder
Ensure powder(500kcal) per day for 7 weeks
Other Name: Ensure powder (Abbott)
No Intervention: Standard care
Standard care without oral nutritional supplements

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 20 years
  • Patients who undergo distal, total, proximal, or pylorus-preserving gastrectomy
  • Patients who are assessed as moderate or severe malnourished according to PG-SGA or patients with BMI lower than 18.5 kg/m2
  • Patients who can take oral meals
  • Patients who agree on the informed consent

Exclusion Criteria:

  • Emergent operation
  • Patients who received preoperative chemotherapy or radiation therapy within 6 months
  • Pregnant patients
  • Patients who cannot consume the Ensure powder
  • Patients who enrolled another clinical trials
  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: NCT01421680

Locations
Korea, Republic of
Department of Surgery, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Abbott
Investigators
Principal Investigator: Han-Kwang Yang, M.D. Department of Surgery, Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Han-Kwang Yang, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01421680     History of Changes
Other Study ID Numbers: ANSK1101
Study First Received: August 17, 2011
Last Updated: March 12, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Stomach Neoplasms
Nutrition Disorders
Malnutrition
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on September 22, 2014