Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT03980704
Status:
COMPLETED
Last Update Posted:
2021-07-26
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative High Protein vs Immunodiet in Surgical Cancer Patients
Sponsor:
Stanley Dudrick's Memorial Hospital
Organization:
Study Overview
Official Title:
Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Preop immuno
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: