Status:
RECRUITING
Complex and Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX)
Lead Sponsor:
University of Louisville
Conditions:
Appendicitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, patie...
Detailed 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 patien...
Eligibility Criteria
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 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
Key Trial Info
Start Date :
January 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05838248
Start Date
January 24 2023
End Date
June 1 2026
Last Update
October 15 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Jewish Hospital UL
Louisville, Kentucky, United States, 40202
2
University of Louisville Hospital
Louisville, Kentucky, United States, 40202