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

This study is currently recruiting participants.
Verified December 2012 by Seoul National University Hospital
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: December 18, 2012
Last verified: December 2012
History of Changes

August 17, 2011
December 18, 2012
August 2011
December 2013   (final data collection date for primary outcome measure)
Postoperative complication rate [ Time Frame: 7weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01421680 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients
A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Malnourished
  • Stomach Neoplasms
  • Gastrointestinal Stromal Tumors
Dietary Supplement: Ensure powder
Ensure powder(500kcal) per day for 7 weeks
Other Name: Ensure powder (Abbott)
  • Active Comparator: Ensure powder
    Oral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals
    Intervention: Dietary Supplement: Ensure powder
  • No Intervention: Standard care
    Standard care without oral nutritional supplements
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
192
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Han-Kwang Yang, M.D. 82-2-2072-3797 hkyang@snu.ac.kr
Contact: Hyuk-Joon Lee, M.D. 82-2-2072-1957 appe98@snu.ac.kr
Korea, Republic of
 
NCT01421680
ANSK1101
Yes
Han-Kwang Yang, Seoul National University Hospital
Seoul National University Hospital
Abbott
Principal Investigator: Han-Kwang Yang, M.D. Department of Surgery, Seoul National University Hospital
Seoul National University Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP