Clinical trial NCT04687579: Elective Umbilical Hernia Repair in Patients With Cirrhosis
Official title: Elective Umbilical Hernia Repair in Patients With Cirrhosis - a Prospective, Controlled Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis, Umbilical Hernia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 %. Patients with liver cirrhosis are often neglected and are not offered equal surgical treatments compared with other patient groups with chronic diseases due to fear of postoperative complications. The current literature is sparse, and many questions remain to be answered, such as timing of repair, risk profile, preoperative staging of the liver disease, possible optimization before surgery, repair technique, and postoperative care. Moreover, nationwide data are lacking.

The management of umbilical hernias in patients with cirrhosis is debated. Recently, European Hernia Society published guidelines stating that elective hernia repair may be safe, and that emergency repair is associated with a high rate of morbidity and mortality. Nonetheless, surgeons remain reluctant to perform elective surgery on these patients due to fear of complications and mortality. The evidence supporting the guidelines is sparse and consists of small, low quality studies. One of the major concerns is that the existing studies failed to use clear and well-described definitions of the underlying severity of the liver disease. The rate of emergency repair may be much higher in patients with liver cirrhosis compared with the general population but there is no data available. The rate of emergency vs elective repair in patients with liver cirrhosis in Denmark is unknown, as well as the rate of reoperation for complications and readmission. Finally, we hypothesize that these patients may benefit from a more proactive approach with early diagnosis of their umbilical hernia by screening, preoperative optimization, and early elective hernia repair, but the effect of this hypothesis needs further evaluation.


Eligibility criteria: 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

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 6 months after umbilical hernia repair and/or inclusion
Secondary outcomes:
measure: Adverse Events
timeFrame: 6 months after umbilical hernia repair and/or inclusion
Other outcomes:
Locations:
Study officials:
References: