Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI). (NUFAGI)

December 27, 2023 updated by: Maximos Frountzas

Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI): a Prospective Cohort Study.

Several patients that suffer from gastrointestinal (GI) cancer are characterized by malnutrition and impairment of their functional status. The aim of the present study is to evaluate the nutritional condition of patients undergoing surgery due to GI cancer and compare it with their functional status. All consecutive patients with esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer, that underwent a surgical operation will be included. Demographic characteristics, nutritional assessment and anthropometric measurements of the patients will be recorded.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11527
        • Hippocration General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer, that underwent a surgical operation.

Description

Inclusion Criteria:

  • Patients undergoing a surgical operation due to esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer.

Exclusion Criteria:

  • Under 18 years old or above 99 years old.
  • Surgery due to benign conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity.
Time Frame: 30 days
Complications after surgery.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality.
Time Frame: 30 days
Number of deaths.
30 days
Disease stage
Time Frame: 1 month
TNM after histological examination
1 month
Recurrence
Time Frame: 1 year
Disease recurrence
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maximos Frountzas

Investigators

  • Principal Investigator: Konstantinos G Toutouzas, MD PhD, National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

December 20, 2023

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUFAGI 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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