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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458845
• Other study ID #: 81063817.0.0000.0068
• Status: Completed
• Start date: May 30, 2018
• Est. completion date: April 20, 2021

Study information

• Verified date: April 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 20, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hernia
• Hernia, Abdominal
• Liver Cirrhosis
• Malnutrition
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Sarcopenia	Prevalence of Sarcopenia in patients with cirrhosis	Through study completion (an average of 1 year)
Primary	Influence of Sarcopenia in Prevalence of Abdominal Hernias in Patients with Cirrhosis	Influence of Sarcopenia in Prevalence of Abdominal Hernias in Patients with Cirrhosis	Through study completion (an average of 1 year)