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

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ClinicalTrials.gov Identifier: NCT03458845
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Alberto Meyer, MD PhD FACS, University of Sao Paulo

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

Condition or disease Intervention/treatment
Cirrhosis Sarcopenia Malnutrition Hernia, Abdominal Diagnostic Test: Computed Tomography Scan

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prevalence of Sarcopenia and Undernutrition in Patients With Cirrhosis and Abdominal Hernia
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
This group consists of cirrhotic patients with any abdominal hernia
Diagnostic Test: Computed Tomography Scan
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

Group 2
This group consists of cirrhotic patients without any hernias
Diagnostic Test: Computed Tomography Scan
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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary care adult patients with cirrhosis, with and without abdominal hernias.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458845


Contacts
Contact: Carlos Baptista, MD +55(11)2661-3323 cgbaptista55@gmail.com

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, SP, Brazil
Contact: Carlos Baptista    11-2661-7561    gastrousppg.ichc@hc.fm.usp.br   
Contact       cgbaptista55@gmail.com   
Sub-Investigator: Carlos Baptista, MD         
Principal Investigator: Alberto Meyer, PhD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Alberto Meyer, PhD Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Publications:
Responsible Party: Alberto Meyer, MD PhD FACS, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03458845     History of Changes
Other Study ID Numbers: 81063817.0.0000.0068
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alberto Meyer, MD PhD FACS, University of Sao Paulo:
Cirrhosis
Sarcopenia
Malnutrition
Inguinal hernia
Umbilical hernia
Undernutrition

Additional relevant MeSH terms:
Hernia
Hernia, Abdominal
Fibrosis
Liver Cirrhosis
Malnutrition
Sarcopenia
Pathologic Processes
Liver Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Nutrition Disorders
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Signs and Symptoms