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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03458845
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Actual Duration (Months): 34.7
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 140 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Prevalence of Sarcopenia and Undernutrition in Patients With Cirrhosis and Abdominal Hernia
• Actual Study Start Date: May 30, 2018
• Actual Primary Completion Date: Jan 15, 2021
• Actual Study Completion Date: Apr 20, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Prevalence of Sarcopenia [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 [Through study completion (an average of 1 year)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP	Brazil

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková 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.
• 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.
• 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. Review.
• 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.

• Responsible Party: Alberto Meyer, MD PhD FACS, Principal Investigator, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT03458845
• Other Study ID Numbers: 81063817.0.0000.0068
• First Posted: Mar 8, 2018
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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, Principal Investigator, University of Sao Paulo: Cirrhosis; Sarcopenia; Malnutrition; Inguinal hernia; Umbilical hernia; Undernutrition
• Additional relevant MeSH terms: Liver Cirrhosis; Sarcopenia; Malnutrition; Fibrosis; Hernia; Hernia, Abdominal; Internal Hernia

Study Results

No Results Posted as of Apr 27, 2021