Clinical trial NCT05348590: Phase-Germ Project: Muscle Mass and Phase Angle in Surgical Patient
Official title: Nutritional Assessment Project In Surgical Patients Focused On Body Composition And Functionality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Nutrition Disorders
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen de la Victoria
name: Hospital Clínico Universitario Lozano Blesa
name: Hospital General Universitario Elche
First posted: 2022-04-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with malnutrition
timeFrame: 1 month perioperatory
measure: To asses the value of Morphofunctional tools in detect malnutrition
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital Universitario de Elche
state: Alicante
Study officials:
affiliation: Universidad de Zaragoza
name: Jose M Ramirez
role: STUDY_DIRECTOR
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