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

Erasmus University

Status and phase: Unknown; Phase 3

Conditions: Umbilical Hernia; Liver Cirrhosis; Ascites

Treatments: Procedure: Surgical repair; Procedure: Conservative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01421550

CRUCIAL trial

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Conservative treatment

Active Comparator group

Description:

Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.

Treatment:

Procedure: Conservative treatment

Surgical repair

Active Comparator group

Description:

Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.

Treatment:

Procedure: Surgical repair