Skip to main content
OpenTrials
Completed

NCT Number: NCT03980704

Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

General Surgery Cancer of Colon Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • resectable GI cancer
  • written consent

Exclusion criteria

  • inoperable GI cancer
  • known allergy to the drug

Treatment and study plan

IMPACT

Drug

Administration of oral immunostimulating oral supplement

resource protein

Drug

Administration of oral high-protein oral supplement

Primary outcomes

  1. Infectious complications

    Time frame: 6 months

    Number and type of infectious complications

Secondary outcomes

  1. Surgical complications

    Time frame: 6 months

    Number and type of surgical complications

  2. Length of stay

    Time frame: 14 days

    Hospital length of stay

Sponsors and collaborators

Lead sponsor

Stanley Dudrick's Memorial Hospital

Other

Registry information

Official study title

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

Acronym: Preop immuno

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 10, 2019
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.