Elective Umbilical Hernia Repair in Patients With Cirrhosis
- Conditions
- Cirrhosis, Umbilical Hernia
- Interventions
- Other: ScreeningProcedure: Preoperative optimizationProcedure: Umbilical hernia repair
- Registration Number
- NCT04687579
- Lead Sponsor
- Hvidovre University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Umbilical hernia repair Preoperative optimization Patients with cirrhosis undergoing umbilical hernia repair with or without preoperative optimization. See the section about interventions. Umbilical hernia repair Screening Patients with cirrhosis undergoing umbilical hernia repair with or without preoperative optimization. See the section about interventions. Watchful waiting Screening Patients who do not agree for operation but consent for follow-up. Patients will be followed in the whole inclusion period and can at any time change their preference if they wish to undergo surgery. Umbilical hernia repair Umbilical hernia repair Patients with cirrhosis undergoing umbilical hernia repair with or without preoperative optimization. See the section about interventions.
- Primary Outcome Measures
Name Time Method Serious Adverse Events 6 months after umbilical hernia repair and/or inclusion 1. Death
2. Life-threatening adverse experience after surgery
3. Inpatient hospitalization or prolongation of existing hospitalization (for \> 24 hours)
4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- Secondary Outcome Measures
Name Time Method Adverse Events 6 months after umbilical hernia repair and/or inclusion 1. A new event which was not pre-existing before intervention.
2. A pre-existing event which recurs with increased intensity or increased frequency in the follow-up period.
3. An event which is present at the time of intervention which is exacerbated following initial intervention.