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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 268
- Locations
- 1
- Primary Endpoint
- Number of participants with no antibiotic related adverse effects
Study Overview
Brief Summary
To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Liberal Duration of SOC Antibiotic Use
Use of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively.
Intervention: Antibiotic (Other)
Liberal Post-Operative Antibiotics Group
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.
Intervention: Antibiotic (Other)
Restricted Duration of SOC Antibiotic Use
Use of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively.
Intervention: Antibiotic (Other)
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 (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics.
Intervention: Antibiotic (Other)
Outcomes
Primary Outcomes
Number of participants with no antibiotic related adverse effects
Time Frame: Day 30
All subjects will be contacted at least 30 days after appendectomy by telephone if unable to contact subject, then electronic medical record will be reviewed. 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.
Secondary Outcomes
- Incidence of Infectious/Antibiotic Complications(Day 30)