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CompletedNCT03458845Updated Apr 27, 2021

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

An observational study in Cirrhosis, Sarcopenia and Malnutrition, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by University of Sao Paulo · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
140
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Cirrhosis
  • Sarcopenia
  • Malnutrition
  • Hernia, Abdominal

Keywords

  • Cirrhosis
  • Sarcopenia
  • Malnutrition
  • Inguinal hernia
  • Umbilical hernia
  • Undernutrition
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • ≥ 18 years
  • Previous diagnosis of cirrhosis

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
140 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testComputed 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.

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

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What researchers measure

Primary outcomes

  1. Prevalence of Sarcopenia

    Prevalence of Sarcopenia in patients with cirrhosis

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

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

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

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

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Study locations

1 site
  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
    São Paulo, SP, Brazil
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References and documents

Publications

  • 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. PubMed 25009378 ↗
  • 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. PubMed 26139982 ↗
  • 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. PubMed 17006918 ↗
  • 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. PubMed 20392703 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT03458845
Lead sponsor
University of Sao Paulo
Responsible party
Alberto Meyer, MD PhD FACS (Principal Investigator, University of Sao Paulo) — Principal investigator
First posted
Mar 8, 2018
Start date
May 30, 2018
Primary completion
Jan 15, 2021
Completion
Apr 20, 2021
Last update
Apr 27, 2021

Study contacts

Alberto Meyer, PhD
principal investigator · Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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