Trial Information
A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Postoperative complication rate
Outcome Time Frame:
7weeks
Safety Issue:
No
Principal Investigator
Han-Kwang Yang, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Surgery, Seoul National University Hospital
Authority:
Korea: Institutional Review Board
Study ID:
ANSK1101
NCT ID:
NCT01421680
Start Date:
August 2011
Completion Date:
December 2013
Related Keywords:
- Malnourished
- Stomach Neoplasms
- Gastrointestinal Stromal Tumors
- Neoplasms
- Stomach Neoplasms
- Malnutrition
- Gastrointestinal Stromal Tumors