Complex and Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX)
Stopped early · Not applicable
Conditions studied: Appendicitis
In brief
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.
Key facts
- Study ID
- NCT05838248
- Run by
- University of Louisville
- People needed
- 23
- Starts
- 2023-01-24
- Expected to finish
- 2025-10-31
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jewish Hospital UL — Louisville, Kentucky, United States
- University of Louisville Hospital — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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