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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37979

Enrollment

Registered

2010-11-05

Start date

2011-02-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

navelbreuken bij patienten met levercirrhose umbilical hernia

Interventions

Elective umbilical hernia repair.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Every umbilical hernia in patients with liver cirrhosis and ascites

Exclusion criteria

Exclusion criteria: Emergency procedures Umbilical vein >5mm

Design outcomes

Primary

Measure	Time frame
Primary endpoint in this study is a composite endpoint of the overall morbidity (% of patients with at least one hernia related complication) after 24 months related to umbilical hernia or correction of the umbilical hernia.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)