Complex and Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX)
Complex and Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)
University of Louisville
50 participants
Jan 24, 2023
INTERVENTIONAL
Conditions
Summary
This prospective trial will randomize patients who have had an appendectomy to two different durations of antibiotic therapy depending on the status of the appendicitis. For simple appendicitis, patients will be randomized to peri-operative antibiotics or 24 hours duration. For complex appendicitis, patients will be randomized to 24 hours or 4 days duration. Data will be collected prospectively and test the hypothesis that shorter durations of antibiotics will be non-inferior to the longer durations.
Eligibility
Inclusion Criteria4
- Age ≥ 18 years
- Planned appendectomy (laparoscopic or open)
- Willing and able to provide informed consent
- Working telephone number or reliable method to contact patient after hospital discharge
Exclusion Criteria14
- Unable to consent
- Pregnant Women
- Prisoners
- Immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage AIDS
- Heart failure
- Allergy to bupivacaine
- Unlikely to comply with treatment or follow-up
- Inpatient consultation for appendicitis
- Clinically suspected of sepsis based on Sepsis-3 definition
- Current use of antibiotics for other indications
- Type 1 Diabetes or uncontrolled hyperglycemia
- Surgeon preference
- Patient preference
- Research team unavailable
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Interventions
Duration of antibiotic treatment post appendectomy
Locations(2)
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NCT05838248