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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Umbilical Hernia Liver Cirrhosis Ascites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative treatment

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

Group Type ACTIVE_COMPARATOR

Conservative treatment

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Surgical repair

Intervention Type PROCEDURE

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

Interventions

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Conservative treatment

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No