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

Appendicitis Clinical Trial

— CASA RELAX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966454
• Other study ID #: 21-35457
• Status: Recruiting
• Phase: Phase 4
• Start date: June 6, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: Lucy Kornblith, MD
• Phone: 628-206-6946
• Email: Lucy.Kornblith[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age = 18 years

• Age = 18 years

• Planned appendectomy (laparoscopic or open)

• Working telephone number or reliable method to contact patient after hospital discharge

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• Multiple 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.
• Multiple 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

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Infectious/Antibiotic Complications	Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.	Up to 30 days after appendicitis surgery
Primary	Number of participant deaths	Up to 30 days after appendicitis surgery	Up to 30 days after appendicitis surgery