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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
RECRUITINGcomplications
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
Time frame: 2 years
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
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