Clinical Trial: Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial
Brief Summary:
The purpose of the present study is to investigate whether or not to perform elective surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are no other randomized controlled trials in this area. The optimal management in patients with umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical opinion is that umbilical hernias in patients with ascites should not be corrected because of the supposedly high operative risks and high recurrence rates. Conservative treatment, however, can have severe complications resulting in emergency repair. Such operations carry a higher risk of complications than elective operations, particularly in this group of patients. Prospective and retrospective series showed us that elective hernia repair in this specific patient group is safe without major complications or high recurrence rates.
The aim of this study is to asses the optimal timing of correction of umbilical hernia in patients with liver cirrhosis and ascites.
Detailed Summary:
Sponsor: Erasmus Medical Center
Current Primary Outcome: complications [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Recurrence [ Time Frame: 2 years ]
- Mortality [ Time Frame: 2 years ]
- Length of hospital stay [ Time Frame: 3 months ]
- Quality of life [ Time Frame: 2 years ]
- Cost effectiveness [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Erasmus Medical Center
Dates:
Date Received: August 19, 2011
Date Started: January 2011
Date Completion: December 2015
Last Updated: August 22, 2011
Last Verified: August 2011