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

Seoul National University

Status: Completed

Conditions: Gastrointestinal Stromal Tumors; Malnourished; Stomach Neoplasms

Treatments: Dietary Supplement: Ensure powder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01421680

ANSK1101

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Ensure powder

Active Comparator group

Description:

Oral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals

Treatment:

Dietary Supplement: Ensure powder

Standard care

No Intervention group

Description:

Standard care without oral nutritional supplements