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

a study on Appendicitis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Lucy Kornblith, MD
Headshot of Lucy Kornblith
Lucy Kornblith

Description

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

Official 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

Details

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.

Keywords

Appendicitis, Anti-Bacterial Agents, Antitubercular Antibiotics

Eligibility

You can join if…

Open to people ages 18 years and up

Age ≥ 18 years

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

You CAN'T join if...

  • 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

Location

  • Zuckerberg San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Lucy Kornblith, MD
    Lucy Zumwinkle Kornblith, M.D., F.A.C.S. received her undergraduate degree from University of California Santa Barbara, her M.D.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05966454
Phase
Phase 4 Appendicitis Research Study
Study Type
Interventional
Participants
Expecting 145 study participants
Last Updated
Contact us about this trial