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

Phase 3

• Conditions: Umbilical Hernia; Liver Cirrhosis; Ascites
• Interventions: Procedure: Conservative treatment; Procedure: Surgical repair

• Registration Number: NCT01421550
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-08
• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-22
• Last Update Submitted: 2011-08-22
• Study First Posted: 2011-08-23
• Last Update Posted: 2011-08-23
• Primary Completion: 2013-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Conservative treatment	Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
Surgical repair	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.

Primary Outcome Measures

Name	Time	Method
complications	2 years	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

Secondary Outcome Measures

Name	Time	Method
Recurrence	2 years
Mortality	2 years
Length of hospital stay	3 months
Quality of life	2 years
Cost effectiveness	2 years

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands