An observational study in Surgery and Nutrition Disorders, sponsored by Universidad de Zaragoza. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by Universidad de Zaragoza · Observational
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.
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:
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:
Abdominal and muscle ultrasound (mindray z6 probe 7l4p):
Analytical parameters: A blood test will be requested which will include the following determinations:
Functional parameters:
Data collection and analysis: Record of described variables were be included in an "on line"database available to all centers.
275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 108 across 74 observational studies indexed under Nutrition Disorders.
Browse Nutrition Disorders studies →Universidad de Zaragoza is the lead sponsor of 109 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
Number of patients with malnutrition
Number of patient operated on with malnutrition
Time frame: 1 month perioperatory
To asses the value of Morphofunctional tools in detect malnutrition
Accuracy of morphofunctional test in diagnosing malnutrition
Time frame: 1 month
Plan to share: Undecided
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Universidad de Zaragoza