Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health

Study Overview
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Brief Summary
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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)

Conditions
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Appendicitis Surgery

Intervention / Treatment
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* Other: Antibiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Planned appendectomy (laparoscopic or open) Willing and able to provide informed consent 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 Acquired immunodeficiency syndrome (AIDS) Heart Failure Allergy to Bupivacaine Unlikely to comply with treatment or follow-up Inpatient consultation for appendicitis Clinically suspected sepsis based on Sepsis-3 definition Current use of antibiotics for other indications Type 1 Diabetes or uncontrolled hyperglycemia

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 (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics. | Other: Antibiotic<br>* Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.<br>* Other names: antibiotics are per standard of care (SOC);|
| Other: Restricted Duration of SOC Antibiotic Use<br>Use of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively. | Other: Antibiotic<br>* Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.<br>* Other names: antibiotics are per standard of care (SOC);|
| Active Comparator: Liberal Post-Operative Antibiotics Group<br>Participants undergoing standard of care (SOC) with simple appendicitis will receive 24 hours of post-operative antibiotics. Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 4 days of SOC post-operative antibiotics. | Other: Antibiotic<br>* Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.<br>* Other names: antibiotics are per standard of care (SOC);|
| Other: Liberal Duration of SOC Antibiotic Use<br>Use of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively. | Other: Antibiotic<br>* Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.<br>* Other names: antibiotics are per standard of care (SOC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with no antibiotic related adverse effects | All subjects will be contacted at least 30 days after appendectomy by telephone. Outcomes will be assessed by Desirability of Outcome Ranking (DOOR), with the lowest ranking of 1 indicating no adverse effects. Infectious/antibiotic complications requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, operative intervention, and death ranked 2 through 7. A lower score indicates a more desirable outcome. For subjects of same DOOR score, Response Adjusted for Duration of Antibiotic Risk (RADAR) scores will be used to determine the better outcome. The distribution of DOOR scores and associated statistical analyses will be reported. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Infectious/Antibiotic Complications | All subjects will be monitored from consent until follow up call at least 30 days after appendectomy for number of complications. Each event will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, with the lowest grade being 1 and the highest grade of 5 indicating death. A higher grade indicates a more serious event. | Day 30 | 

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