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
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.
Description
All patients will be recruited into the study and these patients will be randomized in permuted blocks of 4 to 6 to one of two arms. Each arm will have two treatments which will be given to the patient depending on the case nature: acute or complicated. Comparisons in DOOR outcome will be compared only within the case nature strata by treatment; since the stratification criteria makes comparisons between strata not feasible. In order to attempt to retrieve the expected rates of DOOR outcomes from a Randomized Controlled Trial (RCT) propensity score matching via the MatchIt algorithm was utiliz…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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 bupivac…
Interventions
- Otherantibiotic duration
Duration of antibiotic treatment post appendectomy
Locations (2)
- Jewish Hospital ULLouisville, Kentucky
- University of Louisville HospitalLouisville, Kentucky