Umbilical Hernia, Liver Cirrhosis, Ascites
Conditions
Keywords
umbilical, hernia, cirrhosis, ascites, conservative, surgery, optimal management
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.
Interventions
PROCEDUREConservative treatment
Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
PROCEDURESurgical repair
Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary Umbilical hernia * Liver cirrhosis * Ascites (US proven) * Age ≥ 18 years * Signed Informed consent
Exclusion criteria
* Recurrent umbilical hernia * Midline laparotomy in medical history * ASA1 score IV or above * Incarcerated hernia related emergency procedures * Patent umbilical vein; \>5mm * Expected time to Ltx \<3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complications | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence | 2 years |
| Mortality | 2 years |
| Length of hospital stay | 3 months |
| Quality of life | 2 years |
| Cost effectiveness | 2 years |
Countries
Netherlands
Contacts
Primary ContactB. de Goede, Msc
Backup ContactH.H. Eker, MD
Outcome results
None listed