Clinical trial NCT01421550: Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis
Official title: Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Umbilical Hernia
Liver Cirrhosis
Ascites
Keywords: umbilical
hernia
cirrhosis
ascites
conservative
surgery
optimal management
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: complications
timeFrame: 2 years
Secondary outcomes:
measure: Recurrence
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
measure: Length of hospital stay
timeFrame: 3 months
measure: Quality of life
timeFrame: 2 years
measure: Cost effectiveness
timeFrame: 2 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: G Kazemier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: J.F. Lange, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Goede B, van Rooijen MMJ, van Kempen BJH, Polak WG, de Man RA, Taimr P, Lange JF, Metselaar HJ, Kazemier G. Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results of a randomized controlled trial (CRUCIAL trial). Langenbecks Arch Surg. 2021 Feb;406(1):219-225. doi: 10.1007/s00423-020-02033-4. Epub 2020 Nov 25.