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

April 26, 2021 updated by: Alberto Meyer, MD PhD FACS, University of Sao Paulo
The study evaluates whether sarcopenia influences the prevalence of abdominal hernias in patients with cirrhosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Sarcopenia
Time Frame: Through study completion (an average of 1 year)
Prevalence of Sarcopenia in patients with cirrhosis
Through study completion (an average of 1 year)
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
Through study completion (an average of 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Alberto Meyer, PhD, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

April 20, 2021

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81063817.0.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hernia, Abdominal

Clinical Trials on Computed Tomography Scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe