Phase-Germ Project: Muscle Mass and Phase Angle in Surgical Patient

Surgery Clinical Trial

— FASE-GERM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348590
• Other study ID #: UZaragoza 4
• Status: Recruiting
• Start date: September 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Universidad de Zaragoza
• Contact: Jose M Garcia-almeida
• Phone: +34 646 314 182
• Email: jgarciaalmeida[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nutrition Disorders
• Surgery

Locations

Country	Name	City	State
Spain	Hospital Universitario de Elche	Elche	Alicante

Sponsors (4)

Lead Sponsor	Collaborator
Universidad de Zaragoza	Hospital Clínico Universitario Lozano Blesa, Hospital General Universitario Elche, Hospital Universitario Virgen de la Victoria

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Barata AT, Santos C, Cravo M, Vinhas MD, Morais C, Carolino E, Mendes L, Roldao Vieira J, Fonseca J. Handgrip Dynamometry and Patient-Generated Subjective Global Assessment in Patients with Nonresectable Lung Cancer. Nutr Cancer. 2017 Jan;69(1):154-158. doi: 10.1080/01635581.2017.1250923. Epub 2016 Dec 5. — View Citation

Garcia Almeida JM, Garcia Garcia C, Vegas Aguilar IM, Bellido Castaneda V, Bellido Guerrero D. Morphofunctional assessment of patient s nutritional status: a global approach. Nutr Hosp. 2021 Jun 10;38(3):592-600. doi: 10.20960/nh.03378. — View Citation

Grundmann O, Yoon SL, Williams JJ. The value of bioelectrical impedance analysis and phase angle in the evaluation of malnutrition and quality of life in cancer patients--a comprehensive review. Eur J Clin Nutr. 2015 Dec;69(12):1290-7. doi: 10.1038/ejcn.2015.126. Epub 2015 Jul 29. — View Citation

Lukaski HC, Kyle UG, Kondrup J. Assessment of adult malnutrition and prognosis with bioelectrical impedance analysis: phase angle and impedance ratio. Curr Opin Clin Nutr Metab Care. 2017 Sep;20(5):330-339. doi: 10.1097/MCO.0000000000000387. — View Citation

Norman K, Stobaus N, Pirlich M, Bosy-Westphal A. Bioelectrical phase angle and impedance vector analysis--clinical relevance and applicability of impedance parameters. Clin Nutr. 2012 Dec;31(6):854-61. doi: 10.1016/j.clnu.2012.05.008. Epub 2012 Jun 12. — View Citation

Nunez M, Nunez E, Moreno JM, Segura V, Lozano L, Maurits NM, Segur JM, Sastre S. Quadriceps muscle characteristics and subcutaneous fat assessed by ultrasound and relationship with function in patients with knee osteoarthritis awaiting knee arthroplasty. J Clin Orthop Trauma. 2019 Jan-Feb;10(1):102-106. doi: 10.1016/j.jcot.2017.11.014. Epub 2017 Nov 24. — View Citation

Paiva SI, Borges LR, Halpern-Silveira D, Assuncao MC, Barros AJ, Gonzalez MC. Standardized phase angle from bioelectrical impedance analysis as prognostic factor for survival in patients with cancer. Support Care Cancer. 2010 Feb;19(2):187-92. doi: 10.1007/s00520-009-0798-9. Epub 2009 Dec 29. — View Citation

Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. — View Citation

Sjoblom B, Gronberg BH, Benth JS, Baracos VE, Flotten O, Hjermstad MJ, Aass N, Jordhoy M. Low muscle mass is associated with chemotherapy-induced haematological toxicity in advanced non-small cell lung cancer. Lung Cancer. 2015 Oct;90(1):85-91. doi: 10.1016/j.lungcan.2015.07.001. Epub 2015 Jul 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with malnutrition	Number of patient operated on with malnutrition	1 month perioperatory
Primary	To asses the value of Morphofunctional tools in detect malnutrition	Accuracy of morphofunctional test in diagnosing malnutrition	1 month

External Links

•   Web of the Spanish Group on MUltimodal Rehabilitation