Comparing antibiotic use after appendectomy
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
This study tests if using antibiotics for a shorter time after appendix surgery can lower side effects while keeping patients safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2275 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Denver Health and Hospital Authority Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT05002829 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether a restricted duration of antibiotic use after appendectomy can reduce the risk of adverse effects associated with antibiotics while maintaining patient safety. Participants will be assigned to either a restricted or liberal antibiotic regimen following their surgery for appendicitis. The study will monitor outcomes related to safety and effectiveness of the different antibiotic durations. By analyzing the results, researchers hope to determine the optimal approach to antibiotic use in post-operative care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for an appendectomy due to simple or complicated appendicitis.
Not a fit: Patients who are immunocompromised, pregnant, or have other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer post-operative care with fewer antibiotic-related complications for patients undergoing appendectomy.
How similar studies have performed: Other studies have shown promising results in reducing antibiotic use in surgical settings, suggesting that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 * Uncontrolled hyperglycemia or Type 1 Diabetes * Surgeon preference * Patient preference * Research team unavailable
Where this trial is running
Denver, Colorado
- Denver Health and Hospital Authority — Denver, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Daniel D Yeh, MD, MHPE — Denver Health and Hospital Authority
- Study coordinator: Daniel D Yeh, MD, MHPE
- Email: dante.yeh@dhha.org
- Phone: 1-303-602-1830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.