Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?
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|ClinicalTrials.gov Identifier: NCT02787772|
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : June 9, 2016
Cirrhotic patients have a high incidence of abdominal wall hernias. Ascites and sarcopenia are risk factors to development of bigger hernias and frequent need for urgent surgery due parietal complications. However, hernia surgery is usually delayed in cirrhotic patients because of high morbidity and mortality.
Methods: A prospective study of cirrhotic patients with abdominal wall hernia during January 2009 to November 2014. Demographics, characteristics of underlying liver disease, type of hernia, complications and mortality of 246 enrolled patients were collected. Elective hernia repair was performed in 57 unselected patients, 186 patients were kept in clinical follow up. During follow up urgent hernia surgery was performed when unavoidable
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Hernia Ascites Surgery||Procedure: Elective Hernia repair||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||246 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||January 2016|
Experimental: Elective Hernia Repair
Elective abdominal wall hernia surgery was performed in randomized cirrhotic patients.
Procedure: Elective Hernia repair
abdominal wall hernia repair using onlay mesh.
No Intervention: Clinical follow up
Cirrhotic patients were kept in clinical follow up concerning their abdominal wall hernia.
If a complication occured at the hernia site (such as skin rupture, bowel strangulation,..) the patient underwent emergency hernia repair.
- mortality during follow up [ Time Frame: 4 years ]Compare long-term survival in cirrhotic patients with abdominal wall hernia who underwent elective hernia repair or maintained in clinical follow up.
- post operative mortality [ Time Frame: 30 days ]mortality after elective or urgent hernia repair in cirrhotic patients
- post operative morbidity [ Time Frame: 30 days ]post operative complications after elective or urgent hernia repair in cirrhotic patients
- incidence of complications in patients clinical follow up [ Time Frame: 4 years ]Incidence of hernia complications leading to emergency hernia repair