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NCT03980704 Clinical Trial

Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

General Surgery Clinical Trial

— Preop immuno  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03980704
Other study ID # Imm1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 1, 2019
Est. completion date March 31, 2021

Study information
Verified date July 2021
Source Stanley Dudrick's Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 299
Est. completion date March 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - resectable GI cancer - written consent Exclusion Criteria: - inoperable GI cancer - known allergy to the drug

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IMPACT
Administration of oral immunostimulating oral supplement
• resource protein
Administration of oral high-protein oral supplement

Locations
Country Name City State
Poland Stanley Dudrick's Memorial Hospital Skawina

Sponsors (1)
Lead Sponsor Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Infectious complications Number and type of infectious complications 6 months
Secondary Surgical complications Number and type of surgical complications 6 months
Secondary Length of stay Hospital length of stay 14 days
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