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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
Sponsor:
Information provided by (Responsible Party):
Wellington Andraus, University of Sao Paulo General Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. post operative mortality [ Time Frame: 30 days ]
    mortality after elective or urgent hernia repair in cirrhotic patients

  2. post operative morbidity [ Time Frame: 30 days ]
    post operative complications after elective or urgent hernia repair in cirrhotic patients

  3. incidence of complications in patients clinical follow up [ Time Frame: 4 years ]
    Incidence of hernia complications leading to emergency hernia repair



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with chronic liver disease (cirrhosis) and abdominal wall hernia.

Exclusion Criteria:

  • patients who didn´t want to underwent hernia repair.

Publications:

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Responsible Party: Wellington Andraus, Prof. PhD. MD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02787772    
Other Study ID Numbers: 0937/09
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Hernia
Ascites
Hernia, Abdominal
Pathologic Processes
Pathological Conditions, Anatomical
Liver Diseases
Digestive System Diseases