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)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Kentucky
Jewish Hospital UL
RECRUITING
Louisville
University of Louisville Hospital
RECRUITING
Louisville
Contact Information
Primary
William G Cheadle, MD
wg.cheadle@louisville.edu
5028525675
Backup
Nick G Nash
nicholas.nash@louisville.edu
5028525675
Time Frame
Start Date: 2023-01-24
Estimated Completion Date: 2026-06
Participants
Target number of participants: 50
Treatments
Active_comparator: under 65 years simple appendicitis restricted duration
simple appendicitis restricted duration of no postop antibiotics
Active_comparator: Under 65 simple appendicitis liberal duration
simple appendicitis liberal duration of 24 hours postop antibiotics
Active_comparator: Under 65 complex appendicitis restricted duration
complex appendicitis restricted duration of 24 hours postop antibiotics
Active_comparator: Under 65 complex appendicitis liberal duration
complex appendicitis liberal duration of 4 days of postop antibiotics
Active_comparator: Over 65 simple appendicitis restricted antibiotic duration
see above for under 65
Active_comparator: Over 65 simple appendicitis liberal antibiotic duration
see above for under 65
Active_comparator: Over 65 complex appendicitis restricted antibiotic duration
see above for under 65
Active_comparator: Over 65 appendicitis liberal antibiotic duration
see above for under 65
Related Therapeutic Areas
Sponsors
Leads: University of Louisville