Prevalence of Sarcopenia and Undernutrition in Patients With Cirrhosis and Abdominal Hernia

NCT03458845 | Completed DMC

• 1 other identifier: 81063817.0.0000.0068
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates whether sarcopenia influences the prevalence of abdominal hernias in patients with cirrhosis.

Conditions

Cirrhosis; Sarcopenia; Malnutrition; Hernia, Abdominal

Keywords

Cirrhosis; Sarcopenia; Malnutrition; Inguinal hernia; Umbilical hernia; Undernutrition

Outcome Measures

Primary Outcomes (2)

• Prevalence of Sarcopenia

  Prevalence of Sarcopenia in patients with cirrhosis

  Through study completion (an average of 1 year)

• Influence of Sarcopenia in Prevalence of Abdominal Hernias in Patients with Cirrhosis

  Influence of Sarcopenia in Prevalence of Abdominal Hernias in Patients with Cirrhosis

  Through study completion (an average of 1 year)

Study Arms (2)

Group 1

This group consists of cirrhotic patients with any abdominal hernia

Diagnostic Test: Computed Tomography Scan

Group 2

This group consists of cirrhotic patients without any hernias

Diagnostic Test: Computed Tomography Scan

Interventions

Computed Tomography Scan DIAGNOSTIC_TEST

The results of the CT scan and the hand-grip test will be used for diagnosis of sarcopenia. The Royal Free Hospital-Global Assessment (RFH-GA) results will classify the nutritional status of the patient.

Also known as: Hand-grip test (dynamometer), Royal Free Hospital-Global Assessment

Group 1; Group 2

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

Tertiary care adult patients with cirrhosis, with and without abdominal hernias.

You may qualify if:

• ≥ 18 years
• Previous diagnosis of cirrhosis

You may not qualify if:

• Acutely decompensated cirrhosis
• Other chronic diseases in advanced stage (e.g. cardiac failure, chronic obstructive pulmonary disease, cancer)
• Cognitive impairment, delirium, non-controlled psychosis

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (4)

• Montano-Loza AJ. Clinical relevance of sarcopenia in patients with cirrhosis. World J Gastroenterol. 2014 Jul 7;20(25):8061-71. doi: 10.3748/wjg.v20.i25.8061.

  PMID: 25009378 BACKGROUND

• Kalafateli M, Konstantakis C, Thomopoulos K, Triantos C. Impact of muscle wasting on survival in patients with liver cirrhosis. World J Gastroenterol. 2015 Jun 28;21(24):7357-61. doi: 10.3748/wjg.v21.i24.7357.

  PMID: 26139982 BACKGROUND

• Morgan MY, Madden AM, Soulsby CT, Morris RW. Derivation and validation of a new global method for assessing nutritional status in patients with cirrhosis. Hepatology. 2006 Oct;44(4):823-35. doi: 10.1002/hep.21358.

  PMID: 17006918 BACKGROUND

• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

  PMID: 20392703 BACKGROUND

MeSH Terms

Conditions

Fibrosis; Sarcopenia; Malnutrition; Hernia, Abdominal; Hernia, Inguinal; Hernia, Umbilical

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Hernia; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Alberto Meyer, PhD

  Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 8, 2018
• Study Start: May 30, 2018
• Primary Completion: January 15, 2021
• Study Completion: April 20, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

BR (1)