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

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ClinicalTrials.gov Identifier: NCT01421680
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : March 14, 2014
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Han-Kwang Yang, Seoul National University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Malnourished Stomach Neoplasms Gastrointestinal Stromal Tumors Dietary Supplement: Ensure powder Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Postoperative complication rate [ Time Frame: 7weeks ]

Secondary Outcome Measures :
  1. Body weight [ Time Frame: 7weeks ]
  2. Body composition indices [ Time Frame: 7weeks ]
  3. Length of hospital stay [ Time Frame: 7weeks ]
  4. Quality of life [ Time Frame: 7weeks ]
  5. Postoperative 30-day mortality [ Time Frame: 7weeks ]
  6. Biochemical assessment of nutritional status [ Time Frame: 7weeks ]
  7. Readmission rate [ Time Frame: 7weeks ]
  8. Patient compliance of oral nutritional supplements [ Time Frame: 7weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Han-Kwang Yang, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01421680     History of Changes
Other Study ID Numbers: ANSK1101
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Stomach Neoplasms
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
Nutrition Disorders