RecruitingPhase 4NCT05966454

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

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


Sponsor

University of California, San Francisco

Enrollment

145 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age ≥ 18 years
  • Age ≥ 18 years
  • Planned appendectomy (laparoscopic or open)
  • Working telephone number or reliable method to contact patient after hospital discharge

Exclusion Criteria14

  • 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

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Interventions

DRUGMultiple standard of care antibiotics for appendicitis, at physicians' discretion

Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.

DRUGMultiple standard of care antibiotics for appendicitis, at physicians' discretion

Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.


Locations(1)

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

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NCT05966454


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