Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure - UCSF
- Conditions
- Appendicitis
- Interventions
- Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion
- Registration Number
- NCT05966454
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 145
Age ≥ 18 years
- Age ≥ 18 years
- Planned appendectomy (laparoscopic or open)
- Working telephone number or reliable method to contact patient after hospital discharge
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Restricted Post-Operative Antibiotics Group Multiple standard of care antibiotics for appendicitis, at physicians' discretion 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. Liberal Post-Operative Antibiotics Group Multiple standard of care antibiotics for appendicitis, at physicians' discretion 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.
- Primary Outcome Measures
Name Time Method Incidence of Infectious/Antibiotic Complications Up to 30 days after appendicitis surgery Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.
Number of participant deaths Up to 30 days after appendicitis surgery Up to 30 days after appendicitis surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zuckerberg San Francisco General Hospital
🇺🇸San Francisco, California, United States