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

Liver Cirrhosis Clinical Trial

— CRUCIAL  

Official title:

Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01421550
• Other study ID #: CRUCIAL trial
• Status: Recruiting
• Phase: Phase 3
• First received: August 19, 2011
• Last updated: August 22, 2011
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: August 2011
• Source: Erasmus Medical Center
• Contact: B. de Goede, Msc
• Phone: +31 6280661102
• Email: b.degoede[@]erasmusmc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Hernia
• Hernia, Umbilical
• Liver Cirrhosis
• Umbilical Hernia

Intervention

Procedure:
• Conservative treatment
Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
• Surgical repair
Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications	The primary endpoint in this study is a composite endpoint of the overall morbidity after 24 months, which includes; Reoperation for complication (e.g. hemorrhage; Decompensated liver failure(e.g. Portal vein thrombosis; Non-closure of surgical wound at 4 weeks; Haematoma; Seroma; Rupture of hernia; Bowel incarceration; Necrosis and rupture of the overlying skin; Evisceration; Pneumonia; Urinal tract infection; Postoperative surgical site infection (superficial/deep/organ space); Postoperative leakage of ascites more than 2 weeks after surgery	2 years	Yes
Secondary	Recurrence		2 years	No
Secondary	Mortality		2 years	Yes
Secondary	Length of hospital stay		3 months	No
Secondary	Quality of life		2 years	No
Secondary	Cost effectiveness		2 years	No