NCT03980704

Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Stanley Dudrick's Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.

Detailed description

Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

Conditions

• General Surgery
• Cancer of Colon

Interventions

Type	Name	Description
DRUG	IMPACT	Administration of oral immunostimulating oral supplement
DRUG	resource protein	Administration of oral high-protein oral supplement

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2019-06-10
• Last updated: 2021-07-26

Locations

1 site across 1 country: Poland