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): A Randomized Controlled Trial at Denver Health
Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to see if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Planned appendectomy (laparoscopic or open) for simple or complicated (perforated or gangrenous) appendicitis
• Working telephone number or reliable method to contact patient after hospital discharge
Locations
United States
Colorado
Denver Health and Hospital Authority
Denver
Time Frame
Start Date: 2021-11-01
Completion Date: 2025-07-16
Participants
Target number of participants: 657
Treatments
Experimental: Restricted Post-Operative Antibiotics Group
Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics.~Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.
Active_comparator: Liberal Post-Operative Antibiotics Group
Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics~Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.
Authors
Related Therapeutic Areas
Sponsors
Leads: Denver Health and Hospital Authority