Risk Factors of Incisional Hernias After Emergency Midline Laparotomy

Study Overview
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Brief Summary
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The aim of this study is to identify risk factors for the development of incisional hernias in emergency midline laparotomies.

Detailed Description
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All patients operated with an emergency midline laparotomy and attending 1-year follow-up in our clinic is potential participants and will be screened for participation. Potential participants will be briefly informed about the project by the hospital staff. If the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge. Data will be obtained from the participants hospital files and by patient survey/interview. All data will be entered into a database using RedCap by trial investigators or their delegates. Enrolled patients will be followed for two years. The trial involves two clinical examinations and evaluations (one and two years) after surgery. Clinical examination involves interview with a standardized questionnaire and abdominal wall examination including inspection, palpation and ultrasound examination.

Official Title
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Risk Factors of Incisional Hernias After Emergency Midline Laparotomy: a Danish Prospective Single-center, Non-randomized, Non-interventional, Descriptive Follow-up Study

Conditions
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Incisional Hernia, Emergency Midline Laparotomy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years or above and Unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and Crohn's disease), abscesses, non-traumatic intraabdominal bleeding and any emergency re-operation to elective surgery Exclusion Criteria: Age below 18 years Patients with mental or physical disorders making follow-up impossible Patients were no fascial closure is performed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of incisional hernia after emergency midline laparotomy | Multivariate analysis on selected variables evaluated for long-term complications, including sex, age, high BMI, active smoking, hernia in the midline, length of incision, rectus muscle diastasis, sarcopenia, peritonitis and multiple laparotomies | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of incisional hernias one and two years after surgery |  | 2 years | 
| 30-day, 90-day, 1-year and 2-year mortality |  | 2 years | 
| Rates of asymptomatic versus symptomatic incisional hernias |  | 2 years | 
| Rate of surgery for incisional hernias 2-years post index surgery |  | 2 years |