ClinicalTrials.gg
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.

Primary conditionSarcopeniaRegistry: FibrosisReclassifiedWhy we changed it
Registry
Fibrosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sarcopenia
Why
  1. Fibrosis is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Sarcopenia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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
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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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In context

Sarcopenia Reclassified

1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.

This study's enrollment of 140 is above the median of 120 across 455 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Sarcopenia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, , cancer)
  • Cognitive impairment, delirium, non-controlled psychosis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03458845
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 ↗

Not currently enrolling

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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