SurgeryFASE-GERMNCT05348590
Phase-Germ Project: Muscle Mass and Phase Angle in Surgical Patient
An observational study of Surgery and Nutrition Disorders, run by Universidad de Zaragoza at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Nutrition Disorders
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 10 Sep 2023to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes.
Who cannot join
- Urgent Surgery. Patients ASA (American Society of Anesthesiology) IV or higher.
Trial locations and contacts
1 site in 1 country.
Jose M Garcia-Almeida contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Elche
Elche, Alicante
Antonio Arroyo, Prof
About this study
Official title: 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.
Read the 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:
- To establish a record of the prevalence of malnutrition in the surgical area based on morpho-functional techniques (adapted GLIM criteria).
- To evaluate the implementation of morpho-functional diagnostic tools in said area (Bioimpedanciometry, muscle ultrasound and dynamometry).
- 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.
- Conditions
- Surgery, Nutrition Disorders
- Medical subject headings
- Nutrition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with malnutrition
Number of patient operated on with malnutrition
Measured: 1 month perioperatory
To asses the value of Morphofunctional tools in detect malnutrition
Accuracy of morphofunctional test in diagnosing malnutrition
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start10 Sep 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Victoria, Hospital Clínico Universitario Lozano Blesa, Hospital General Universitario Elche
- Responsible party
- Principal investigator, Jose-M Ramirez, Universidad de Zaragoza
- Investigators
- Jose M Ramirez, Study director, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348590
- Sponsor's protocol ID
- UZaragoza 4
- Acronym
- FASE-GERM
- Status last verified
- Dec 2023
- First submitted
- 20 Apr 2022
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26198373Garcia 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.
PubMed 33749304Norman 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.
PubMed 22698802Grundmann 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.
PubMed 26220573Lukaski 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.
PubMed 28548972Paiva 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.
PubMed 20039074Nunez 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.
PubMed 30705541Barata 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.
PubMed 27918868Podsiadlo 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.
PubMed 1991946
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment Project In Surgical Patients Focused On Body Composition And Functionality
- ClinicalTrials.gov ID
- NCT05348590
- Acronym / sponsor ID
- FASE-GERM / UZaragoza 4
- Conditions
- Surgery, Nutrition Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Victoria, Hospital Clínico Universitario Lozano Blesa, Hospital General Universitario Elche
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To establish a record of the prevalence of malnutrition in the surgical area based on morpho-functional techniques (adapted GLIM criteria).
- To evaluate the implementation of morpho-functional diagnostic tools in said area (Bioimpedanciometry, muscle ultrasound and dynamometry).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes.
Key exclusion criteria (1 listed)
- Urgent Surgery. Patients ASA (American Society of Anesthesiology) IV or higher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with malnutrition
Time frame: 1 month perioperatory
Number of patient operated on with malnutrition
To asses the value of Morphofunctional tools in detect malnutrition
Time frame: 1 month
Accuracy of morphofunctional test in diagnosing malnutrition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 26198373Sjoblom 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.
- Background: PubMed 33749304Garcia 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.
- Background: PubMed 22698802Norman 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.
- Background: PubMed 26220573Grundmann 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.
- Background: PubMed 28548972Lukaski 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.
- Background: PubMed 20039074Paiva 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.
- Background: PubMed 30705541Nunez 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.
- Background: PubMed 27918868Barata 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.
- Background: PubMed 1991946Podsiadlo 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.
- Web of the Spanish Group on MUltimodal RehabilitationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose M Garcia-Almeida contact
Jose M Ramirez study director
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Nutrition Disorders, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose M Garcia-almeida (+34 646 314 182, jgarciaalmeida@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with malnutrition (time frame: 1 month perioperatory). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348590, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.