Clinical trial NCT03458845: Prevalence of Sarcopenia and Undernutrition in Patients With Cirrhosis and Abdominal Hernia
Official title: Prevalence of Sarcopenia and Undernutrition in Patients With Cirrhosis and Abdominal Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Sarcopenia
Malnutrition
Hernia, Abdominal
Keywords: Cirrhosis
Sarcopenia
Malnutrition
Inguinal hernia
Umbilical hernia
Undernutrition
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care adult patients with cirrhosis, with and without abdominal hernias.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Sarcopenia
timeFrame: Through study completion (an average of 1 year)
measure: Influence of Sarcopenia in Prevalence of Abdominal Hernias in Patients with Cirrhosis
timeFrame: Through study completion (an average of 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
name: Alberto Meyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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. doi: 10.1002/hep.21358.
citation: 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.