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Completed

NCT Number: NCT03458845

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

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

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Key information

Conditions

Cirrhosis Atrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fibrosis Hernia Hernia, Abdominal Hernia, Inguinal Hernia, Umbilical Hernia, Ventral Infant, Newborn, Diseases Malnutrition Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

São Paulo, Brazil

About this study

Sarcopenia is a common condition in patients with cirrhosis, with a prevalence of around 50%. It is unknown if the presence of sarcopenia may influence the prevalence of abdominal hernias in this group of patients. Clinical, nutritional and radiological evaluation will be performed in two groups of cirrhotic patients to evaluate this hypothesis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • Previous diagnosis of cirrhosis

Exclusion criteria

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

Treatment and study plan

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.

Other names: Hand-grip test (dynamometer), Royal Free Hospital-Global Assessment

Primary outcomes

  1. Prevalence of Sarcopenia

    Time frame: Through study completion (an average of 1 year)

    Prevalence of Sarcopenia in patients with cirrhosis

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

    Time frame: Through study completion (an average of 1 year)

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2018
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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