Standard and Immunostimulating Enteral Nutrition in Surgical Patients

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study was to assess the clinical effect of immunomodulating enteral nutrition in patients undergoing resection for gastrointestinal cancer. 196 subjects were randomly assigned into two study groups: standard and immunostimulating. The study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jagiellonian University

Criteria

Inclusion Criteria:

• Adults aged 18-80 years undergoing subtotal and total gastric resection with lymphadenectomy and pancreatoduodenectomy/ total pancreatectomy with lymphadenectomy, in good general status (Karnofsky > 80, Eastern Cooperative Oncology Group (ECOG) grade 0 or 1); with no confirmed neoplastic dissemination nor distant metastases

• No severe concomitant disease (heart failure, chronic obstructive pulmonary disease [COPD], coronary aortic bypass graft [CABG], etc.)

• No history of known allergies or drug intolerance

Exclusion Criteria:

• Patients with metastatic or unresectable disease

• Pregnant

• In poor general status (Karnofsky <80, Eastern Cooperative Oncology Group (ECOG) > 1)

• With recent history of severe heart, lung, kidney or liver failure

• With history of allergies or drug intolerance