Clinical Trial: Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Abdominal Hernia in Cirrhotic Patients: Surgery or Conservative Treatment?

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


Detailed Summary:

Abdominal wall hernias are frequent in cirrhotic patients. The incidence of umbilical hernia´s reaches over 20% in compensated cirrhosis and even 40% in patients with ascites. Several risk factors explain the development of umbilical hernia in these patients, such as, increased intra-abdominal pressure caused by ascites; abdominal aponeurosis weakness due sarcopenia ; and recanalization of the umbilical vein. These hernias develop great hernial sacs, especially when ascites is present. All these risk factors also explain their high complication rate due to the development of pressure ulcers, skin rupture, ascites leak and bacterial peritonitis. Moreover pain is a common associated symptom.

Inguinal hernias also develop due to higher intra-abdominal pressure due to ascites; they often result in large hernia sacs reaching the scrotum. In addition such large hernias are responsible for reduced mobility and quality of life.

The ideal treatment would be to correct both the abdominal wall hernia and the underlying liver disease. However, there are insufficient liver´s donors, so the liver transplantation (LT) waiting list continuously grows. This explains why the majority of abdominal wall hernias in cirrhotic patients remain untreated for several years.

Therefore, most cirrhotic hernia patients are followed conservatively, the surgical treatment being reserved when complications occur. Such expectative attitude is explained by the high postoperative morbidity and mortality. Although, urgent surgery in such patients impose a higher morbidity and mortality compared to elective hernia surgery.

No prospective study is reported comparing the incidence of complications in cirrhotic hernia patients which are just observed or s
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: 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.


Original Primary Outcome:

  • 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 maintened in clinical follow up.
  • incidence of complications in patients clinical follow up [ Time Frame: 4 years ]
    incidence of complications of abdominal wall hernias requiring urgent surgery in cirrhotic patients during clinical follow up


Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • 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


Information By: University of Sao Paulo General Hospital

Dates:
Date Received: May 26, 2016
Date Started: January 2009
Date Completion:
Last Updated: June 8, 2016
Last Verified: June 2016