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

NCT ID: NCT03458845

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-30

Study Completion Date

2021-04-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Cirrhosis Sarcopenia Malnutrition Hernia, Abdominal

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

This group consists of cirrhotic patients with any abdominal hernia

Computed Tomography Scan

Intervention Type 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.

Group 2

This group consists of cirrhotic patients without any hernias

Computed Tomography Scan

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Hand-grip test (dynamometer) Royal Free Hospital-Global Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Alberto Meyer, MD PhD FACS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Meyer, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 25009378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26139982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17006918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20392703 (View on PubMed)

Other Identifiers

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81063817.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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