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RecruitingNCT05348590FASE-GERMUpdated Jul 19, 2024

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

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

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

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:

  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.

02

Conditions studied

  • Surgery
  • Nutrition Disorders

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03

In context

Nutrition Disorders

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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)

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Urgent Surgery. Patients ASA (American Society of Anesthesiology) IV or higher.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Number of patients with malnutrition

    Number of patient operated on with malnutrition

    Time frame: 1 month perioperatory

  2. To asses the value of Morphofunctional tools in detect malnutrition

    Accuracy of morphofunctional test in diagnosing malnutrition

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitario de Elche
    Elche, Alicante, Spain
    • Antonio Arroyo, Prof · Contact
    Recruiting
08

References and documents

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 26198373 ↗
  • 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. PubMed 33749304 ↗
  • 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. PubMed 22698802 ↗
  • 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. PubMed 26220573 ↗
  • 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. PubMed 28548972 ↗
  • 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. PubMed 20039074 ↗
  • 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. PubMed 30705541 ↗
  • 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. PubMed 27918868 ↗
  • 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. PubMed 1991946 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05348590
Lead sponsor
Universidad de Zaragoza
Collaborators
Hospital Universitario Virgen de la Victoria, Hospital Clínico Universitario Lozano Blesa, Hospital General Universitario Elche
Responsible party
Jose-M Ramirez (Prof., Universidad de Zaragoza) — Principal investigator
First posted
Apr 27, 2022
Start date
Sep 10, 2023
Primary completion
Feb 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jul 19, 2024

Study contacts

Jose M Garcia-almeida
Contact
jgarciaalmeida@gmail.com
+34 646 314 182
Jose M Garcia-Almeida
Contact
Jose M Ramirez
study director · Universidad de Zaragoza

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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