Complex and Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX)

Description

This prospective trial will randomize patients who have had an appendectomy to two different durations of antibiotic therapy depending on the status of the appendicitis. For simple appendicitis, patients will be randomized to peri-operative antibiotics or 24 hours duration. For complex appendicitis, patients will be randomized to 24 hours or 4 days duration. Data will be collected prospectively and test the hypothesis that shorter durations of antibiotics will be non-inferior to the longer durations.

Conditions

Appendicitis

Talk to us

Study Overview

On this page

Study Details

Study overview

This prospective trial will randomize patients who have had an appendectomy to two different durations of antibiotic therapy depending on the status of the appendicitis. For simple appendicitis, patients will be randomized to peri-operative antibiotics or 24 hours duration. For complex appendicitis, patients will be randomized to 24 hours or 4 days duration. Data will be collected prospectively and test the hypothesis that shorter durations of antibiotics will be non-inferior to the longer durations.

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)

Complex and Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX)

Condition
Appendicitis
Intervention / Treatment

-

Contacts and Locations

Louisville

Jewish Hospital UL, Louisville, Kentucky, United States, 40202

Louisville

University of Louisville Hospital, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Louisville,

Study Record Dates

2026-06