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

Sponsor
Maximos Frountzas (Other)
Overall Status
Recruiting
CT.gov ID
NCT05795374
Collaborator
(none)
300
Enrollment
1
Location
21
Anticipated Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI): a Prospective Cohort Study.
    Actual Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative morbidity. [30 days]

      Complications after surgery.

    Secondary Outcome Measures

    1. Mortality. [30 days]

      Number of deaths.

    2. Disease stage [1 month]

      TNM after histological examination

    3. Recurrence [1 year]

      Disease recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hippocration General Hospital Athens Greece 11527

    Sponsors and Collaborators

    • Maximos Frountzas

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maximos Frountzas, Study Coordinator, National and Kapodistrian University of Athens
    ClinicalTrials.gov Identifier:
    NCT05795374
    Other Study ID Numbers:
    • NUFAGI 2022
    First Posted:
    Apr 3, 2023
    Last Update Posted:
    Apr 3, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maximos Frountzas, Study Coordinator, National and Kapodistrian University of Athens
    nutritional status
    functional status
    gastrointestinal cancer
    Additional relevant MeSH terms:
    Gastrointestinal Neoplasms

    Study Results

    No Results Posted as of Apr 3, 2023