Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure - UCSF

Study Overview
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Brief Summary
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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

Detailed Description
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This is a single center, randomized controlled trial to determine 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
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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

Conditions
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Appendicitis

Intervention / Treatment
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* Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion
* Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Age ≥ 18 years Planned appendectomy (laparoscopic or open) 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 Type 1 Diabetes or uncontrolled hyperglycemia Surgeon preference Patient preference Research team unavailable

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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. | Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion<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. | Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion<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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 30 days after appendicitis surgery | Up to 30 days after appendicitis surgery |