Gastrointestinal Stromal Tumors, Malnourished, Stomach Neoplasms
Conditions
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.
Interventions
DIETARY_SUPPLEMENTEnsure powder
Ensure powder(500kcal) per day for 7 weeks
Sponsors
Abbott
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative complication rate | 7weeks |
Secondary
| Measure | Time frame |
|---|---|
| Body composition indices | 7weeks |
| Length of hospital stay | 7weeks |
| Quality of life | 7weeks |
| Body weight | 7weeks |
| Biochemical assessment of nutritional status | 7weeks |
| Readmission rate | 7weeks |
| Patient compliance of oral nutritional supplements | 7weeks |
| Postoperative 30-day mortality | 7weeks |
Countries
South Korea
Outcome results
None listed