Phase-Germ Project: Muscle Mass and Phase Angle in Surgical Patient (FASE-GERM)

July 18, 2024 updated by: Jose-M Ramirez, Universidad de Zaragoza

Nutritional Assessment Project In Surgical Patients Focused On Body Composition And Functionality

Current nutritional diagnostic tools have serious limitations in certain groups of patients such as colon or ovarian cancer with high rates of overweight and obesity in which traditional anthropometric assessment is limited.

The objective of the project is to establish a comprehensive nutritional assessment in surgical patients assessed in intensified recovery programs in Surgery at a national level, including new techniques aimed at measuring muscular and functional affection.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Current nutritional diagnostic tools have serious limitations in certain groups of patients such as colon or ovarian cancer with high rates of overweight and obesity in which traditional anthropometric assessment is limited with underdiagnosis of malnutrition and possible effect on therapeutic toxicity and other complications.

The objective of the project is to establish a comprehensive nutritional assessment in surgical patients assessed in intensified recovery programs in Surgery at a national level, including new techniques aimed at measuring muscular and functional affection in order to make a more precise diagnosis and a better prediction of complications and morbidity and mortality.

In this group of patients with moderate or severe malnutrition, it is important to evaluate new techniques aimed at nutritional assessment with assessment tools focused on the morpho-functional diagnosis of malnutrition.

From a scientific point of view, the following nutritional assessment techniques are being incorporated:

1- BIOIMPEDANCIOMETRY: Non-invasive technique, relatively inexpensive and easily transportable. 2- MUSCLE ULTRASOUND: The application of ultrasound for the morphological and structural study of muscle mass is an emerging technique.

3- DYNAMOMETRY: Dynamometry is one of the 6 criteria that define malnutrition according to ASPEN. It is a very sensitive parameter. 4- FUNCTIONAL TESTS: The execution or performance tests consist of the development of a series of physical activities related to mobility, walking or balance. Their results are related to those of the scales that assess the Activities of Daily Living (IADL).

The main OBJECTIVES of the study are:

  1. To establish a record of the prevalence of malnutrition in the surgical area based on morpho-functional techniques (adapted GLIM criteria).
  2. To evaluate the implementation of morpho-functional diagnostic tools in said area (Bioimpedanciometry, muscle ultrasound and dynamometry).
  3. To correlate the clinical-prognostic aspects with the clinical situation of the patient (morbidity-mortality, adverse effects associated with the disease itself or with the treatment, adaptation of the therapeutic regimen, quality of life...)

Design: Prospective observational study, following the usual clinical practice without altering the flow of visits to clinical nutrition clinics.

Patients: Patients presenting with acute or chronic disease-related protein calorie malnutrition on outpatient follow-up treatment by a multimodal salvage surgery program.

Variables:

  • Assessment of Nutritional Status:

    • Global Subjective Assessment (GSV) Questionnaire: ANNEX 2
    • Current weight (measured or estimated), usual weight, weight for calculations (adjusted weight in obese, weight without edema in malnourished), height (measured or estimated), BMI (measured or estimated), arm circumference.
    • Electrical bioimpedance measurement (model (50khz) Akern BIA 101): The following data will be obtained: TBW (total body water, L), ECW (extracellular water, L), ICW (intracellular water, L), FFM (lean mass, Kg ), FM (fat mass, Kg), BCM (cell mass, Kg), ASMM (appendicular muscle mass, Kg), SMI (muscle mass index, Kg), Hydration %.
    • Electrical bioimpedance measurement (TANITA Model TBF-300): Fat mass, in percent, Lean mass, in kilograms, Total body water, in percent, Body mass index, basal metabolism.

    • Abdominal and muscle ultrasound (mindray z6 probe 7l4p):

      • Abdominal echo: total, superficial and pre-peritoneal adipose tissue. Muscle echo (measured in centimeters).
      • Muscle echo: Area, circumference, axes and adipose tissue (measured in centimeters)

  • Analytical parameters: A blood test will be requested which will include the following determinations:

    • Total cholesterol and triglycerides, in milligrams per deciliter.
    • C-reactive protein, in milligrams per deciliter.
    • Albumin, in grams per deciliter.
    • Prealbumin, in milligrams per deciliter.
    • Lymphocytes, in microliters,

  • Functional parameters:

    • Get Up and Go Test: "get up and go" test: The patient sits on a chair, tells him to get up (start of test and timing), walks 3 meters and sits back on the initial chair (end of timing). ). Interpretation: < 20 seconds: normal, > 20 seconds: increased risk of falling.
    • Jamar® type dynamometers are the most widely used in international studies and have various grip positions. Make 3 measurements with their subsequent average, measured in Kilograms.

Data collection and analysis: Record of described variables were be included in an "on line"database available to all centers.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Jose M Garcia-Almeida

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain
        • Recruiting
        • Hospital Universitario de Elche
        • Contact:
          • Antonio Arroyo, Prof

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes (It is defined as complex major surgery that lasts more than two hours or it is estimated that it may require the transfusion of at least 2 red cell concentrates or it is estimated a loss greater than or equal to 15% of the patient's blood volumen)

Description

Inclusion Criteria:

  • Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes.

Exclusion Criteria:

  • Urgent Surgery. Patients ASA (American Society of Anesthesiology) IV or higher.

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
Number of patients with malnutrition
Time Frame: 1 month perioperatory
Number of patient operated on with malnutrition
1 month perioperatory
To asses the value of Morphofunctional tools in detect malnutrition
Time Frame: 1 month
Accuracy of morphofunctional test in diagnosing malnutrition
1 month

Collaborators and Investigators

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

Sponsor

Universidad de Zaragoza

Collaborators

Hospital General Universitario Elche
Hospital Universitario Virgen de la Victoria
Hospital Clínico Universitario Lozano Blesa

Investigators

  • Study Director: Jose M Ramirez, Universidad de Zaragoza

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

Helpful Links

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)

September 10, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZaragoza 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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