Restricted or Liberal Antibiotics After Appendectomy - Denver Health

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Other: Restricted Duration of SOC Antibiotic Use
* Other: Liberal Duration of SOC Antibiotic Use


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restricted Post-Operative Antibiotics Group<br>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. | Other: Restricted Duration of SOC Antibiotic Use<br>* Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.<br>|
| Active Comparator: Liberal Post-Operative Antibiotics Group<br>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. | Other: Liberal Duration of SOC Antibiotic Use<br>* Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with no antibiotic related adverse effects | As assessed by treating physician | Up to 40 days after appendicitis surgery | 
| Incidence of Infectious/Antibiotic Complications | Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician. | Up to 30 days after appendicitis surgery | 
| Number of participant deaths | As assessed by treating physician | Up to 30 days after appendicitis surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-operative, antibiotics