Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial

Conditions
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Umbilical Hernia, Liver Cirrhosis, Ascites

Intervention / Treatment
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* Procedure: Conservative treatment
* Procedure: Surgical repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative treatment<br>Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward. | Procedure: Conservative treatment<br>* Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.<br>|
| Active Comparator: Surgical repair<br>Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up. | Procedure: Surgical repair<br>* Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence |  | 2 years | 
| Mortality |  | 2 years | 
| Length of hospital stay |  | 3 months | 
| Quality of life |  | 2 years | 
| Cost effectiveness |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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umbilical, hernia, cirrhosis, ascites, conservative, surgery, optimal management