Appendicitis Clinical Trial
— CASA RELAXOfficial 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
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
Status | Recruiting |
Enrollment | 145 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Zuckerberg San Francisco General Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Number of participant deaths | Up to 30 days after appendicitis surgery | Up to 30 days after appendicitis surgery |
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