Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05966454

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

Led by University of California, San Francisco · Updated on 2025-05-08

145

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and practicality of shorter courses of antibiotics after surgery for simple and complicated appendicitis. This study aims to see if reducing antibiotic use can lower the chance of side effects while still keeping patients safe after their appendectomy. The trial is a randomized controlled study conducted at a single center. Participants are assigned to one of two groups based on their type of appendicitis and post-operative antibiotic treatment. Those in the restrictive group with simple appendicitis receive no post-operative antibiotics, while those with complicated appendicitis receive up to 24 hours of antibiotics. In the liberal group, participants with simple appendicitis receive 24 hours of antibiotics, and those with complicated appendicitis receive up to 4 days of antibiotics. Treatments use standard antibiotics chosen by physicians. During the study, participants will be monitored for up to 30 days after surgery to track any infections or antibiotic-related complications, as well as any deaths. Researchers will assess safety by reviewing these outcomes and gather follow-up information through phone contact. The total involvement includes post-surgery monitoring to evaluate the impact of different antibiotic durations on recovery and adverse events.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Planned appendectomy (laparoscopic or open)
  • Working telephone number or reliable method to contact patient after hospital discharge
Not Eligible

You will not qualify if you...

  • Unable to consent
  • Pregnant women
  • Prisoners
  • Immunocompromised patients or those receiving steroids, chemotherapy, immunosuppressing drugs, or with active hematologic malignancy, leukopenia, or end-stage AIDS
  • Heart failure
  • Allergy to bupivacaine
  • Unlikely to comply with treatment or follow-up
  • Inpatient consultation for appendicitis
  • Clinically suspected 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 4 days post-surgery

Participants undergo appendicitis surgery followed by randomized post-operative antibiotic treatment either with restricted (none or up to 24 hours) or liberal (24 hours to 4 days) antibiotic use depending on appendicitis complexity.

1 baseline surgery visit and antibiotic treatment during hospital stay

Follow-up

Duration - Up to 30 days after appendicitis surgery

Participants are monitored for infectious or antibiotic complications and safety outcomes after surgery and antibiotic treatment.

Approximately 1 to 2 follow-up visits post-discharge

Trial Site Locations

Total: 1 location

1

Zuckerberg San Francisco General Hospital

San Francisco, California, United States, 94110

Actively Recruiting

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Research Team

L

Lucy Kornblith, MD

B

Brenda Nunez-Garcia

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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