RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2023-01-24
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05838248

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Planned appendectomy (laparoscopic or open)
  3. * Willing and able to provide informed consent
  4. * Working telephone number or reliable method to contact patient after hospital discharge
  1. * Unable to consent
  2. * Pregnant Women
  3. * Prisoners
  4. * 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
  5. * Heart failure
  6. * Allergy to bupivacaine
  7. * Unlikely to comply with treatment or follow-up
  8. * Inpatient consultation for appendicitis
  9. * Clinically suspected of sepsis based on Sepsis-3 definition
  10. * Current use of antibiotics for other indications
  11. * Type 1 Diabetes or uncontrolled hyperglycemia
  12. * Surgeon preference
  13. * Patient preference
  14. * Research team unavailable

Contacts and Locations

Study Contact

William G Cheadle, MD
CONTACT
5028525675
wg.cheadle@louisville.edu
Nick G Nash
CONTACT
5028525675
nicholas.nash@louisville.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-24
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-01-24
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • appendicitis
  • appendectomy
  • antibiotic duration

Additional Relevant MeSH Terms

  • Appendicitis