Status:
UNKNOWN
Elective Umbilical Hernia Repair in Patients With Cirrhosis
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Cirrhosis, Umbilical Hernia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Liver cirrhosis is a frequent and severe chronic disease. About 20 % of patients with liver cirrhosis develop umbilical hernias. In comparison, the prevalence in the general population is around 2 %. ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients must meet all the following criteria to be eligible to enrol in the study:
- Age ≥18 years and ≤80 years
- ASA I-III
- Patients with a diagnosis of liver cirrhosis
- Patients with a diagnosis of umbilical hernia (primary or recurrent umbilical hernia)
- Hernia defect size 0,5 cm - 6 cm, only one defect
- Patients who have given written informed consent to participate in the study after having understood this
- Exclusion criteria Patients who meet one or more of the following criteria are not eligible to be enrolled in this study
- Patients who cannot cooperate with the trial.
- Patients who cannot read and understand Danish.
- Alcohol- and/or drug abuse - to the discretion of the investigator.
- Fascial gap \> 6 cm
- Umbilical hernia repair secondary to another procedure
- If a patient withdraws his/her inclusion consent
- Patients in dialysis
- Exclusion from operation
- Patients who meet one or more of following criteria on procedure day will not undergo surgery, but can undergo surgery at a later date if none of the criteria are fulfilled:
- ASA IV
- Culture verified infection within two weeks prior to umbilical hernia repair
- Anemia (Hgb \< 5?)
- International Normalized Ratio \> 1.7
- Thrombocytopenia (\<100 mill/mL)
- Large amount of ascitic fluid
- If the operation is considered too risky by any investigator, a patient can always be excluded from surgical intervention based on individual assessment.
- Patients presenting with complicated umbilical hernia (incarceration, rupture, strangulation or ulceration) and the need for acute surgical intervention.
- Patients with BMI \> 35 will not undergo surgery. If the patient during inclusion period does not fulfil this criterion (BMI \< 35), other exclusion criteria and the rest of inclusion criteria are met then the patient can undergo surgery.
- Thrombolysis within 3 months from umbilical hernia repair
Exclusion
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04687579
Start Date
August 1 2021
End Date
September 1 2023
Last Update
April 30 2021
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