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 ]

The primary endpoint in this study is a composite endpoint of the overall morbidity after 24 months, which includes; Reoperation for complication (e.g. hemorrhage; Decompensated liver failure(e.g. Portal vein thrombosis; Non-closure of surgical wound at 4 weeks; Haematoma; Seroma; Rupture of hernia; Bowel incarceration; Necrosis and rupture of the overlying skin; Evisceration; Pneumonia; Urinal tract infection; Postoperative surgical site infection (superficial/deep/organ space); Postoperative leakage of ascites more than 2 weeks after surgery


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