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

Last updated: August 22, 2011
Sponsor: Erasmus Medical Center
Overall Status: Trial Status Unknown

Phase

3

Condition

Liver Disease

Hyponatremia

Pentalogy Of Cantrell

Treatment

N/A

Clinical Study ID

NCT01421550
CRUCIAL trial
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary Umbilical hernia

  • Liver cirrhosis

  • Ascites (US proven)

  • Age ≥ 18 years

  • Signed Informed consent

Exclusion

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

Study Design

Total Participants: 100
Study Start date:
January 01, 2011
Estimated Completion Date:
December 31, 2015

Connect with a study center

  • Erasmus Medical Center

    Rotterdam, Zuid-Holland 3015CE
    Netherlands

    Active - Recruiting

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