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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The purpose of this study is to demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Age ≥ 18 years
• Planned appendectomy (laparoscopic or open)
• Working telephone number or reliable method to contact patient after hospital discharge
Locations
United States
California
Zuckerberg San Francisco General Hospital
RECRUITING
San Francisco
Contact Information
Primary
Lucy Kornblith, MD
Lucy.Kornblith@ucsf.edu
628-206-6946
Backup
Brenda Nunez-Garcia
Brenda.Nunez-Garcia@ucsf.edu
628-206-6942
Time Frame
Start Date: 2023-06-06
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 145
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco