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

NCT05348590 | Unknown

• 1 other identifier: UZaragoza 4
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Nutrition Disorders

Outcome Measures

Primary Outcomes (2)

• Number of patients with malnutrition

  Number of patient operated on with malnutrition

  1 month perioperatory

• To asses the value of Morphofunctional tools in detect malnutrition

  Accuracy of morphofunctional test in diagnosing malnutrition

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Hospital Universitario Virgen de la Victoria: collaborator
• Hospital Clínico Universitario Lozano Blesa: collaborator
• Hospital General Universitario Elche: collaborator

Study Sites (1)

Hospital Universitario de Elche

Elche, Alicante, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 26198373 BACKGROUND

• 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.

  PMID: 33749304 BACKGROUND

• 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.

  PMID: 22698802 BACKGROUND

• 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.

  PMID: 26220573 BACKGROUND

• 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.

  PMID: 28548972 BACKGROUND

• 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.

  PMID: 20039074 BACKGROUND

• 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.

  PMID: 30705541 BACKGROUND

• 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.

  PMID: 27918868 BACKGROUND

• 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.

  PMID: 1991946 BACKGROUND

Related Links

• Web of the Spanish Group on MUltimodal Rehabilitation

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Jose M Ramirez

  Universidad de Zaragoza

  STUDY DIRECTOR

Central Study Contacts

Jose M Garcia-almeida

CONTACT

+34 646 314 182; jgarciaalmeida@gmail.com

Jose M Garcia-Almeida

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 27, 2022
• Study Start: September 10, 2023
• Primary Completion: February 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 19, 2024

Record last verified: 2023-12

Locations

ES (1)