Conservative treatment versus elective repair of the umbilical hernia in patients with ascites and liver cirrhosis, a randomized controlled trial

Completed

• Conditions: navelbreuken bij patienten met levercirrhose; umbilical hernia

• Registration Number: NL-OMON37979
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Every umbilical hernia in patients with liver cirrhosis and ascites

Exclusion Criteria

Emergency procedures
Umbilical vein >5mm

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint in this study is a composite endpoint of the overall morbidity<br /><br>(% of patients with at least one hernia related complication) after 24 months<br /><br>related to umbilical hernia or correction of the umbilical hernia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cumulative recurrence of umbilical hernia after repair in the separate groups,<br /><br>grading of the primaire endpoint (overall morbidity) with the *Landelijke<br /><br>Heelkundige Complicatie Registratie* (LHCR). Per patient the maximal observed<br /><br>grade will be determined and compared between the two groups. Furthermore pain,<br /><br>QOL, cost-effectiveness are secondary endpoints.</p><br>