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

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

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

Study Overview

• Status: Recruiting
• Conditions: Appendicitis
• Intervention / Treatment: Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion; Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 145
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lucy Kornblith, MD; Phone Number: 628-206-6946; Email: Lucy.Kornblith@ucsf.edu
• Study Contact Backup: Name: Brenda Nunez-Garcia; Phone Number: 628-206-6942; Email: Brenda.Nunez-Garcia@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • Zuckerberg San Francisco General Hospital
      • Principal Investigator: Lucy Kornblith, MD
      • Contact: Lucy Kornblith, MD; Phone Number: 415-206-6946; Email: Lucy.Kornblith@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restricted Post-Operative Antibiotics Group; Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics. Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.	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.; Drug: 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.
Active Comparator: Liberal Post-Operative Antibiotics Group; Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.	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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of participant deaths	Up to 30 days after appendicitis surgery	Up to 30 days after appendicitis surgery

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Lucy Kornblith, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: 21-35457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient data will be shared with Denver health and combined with data from other independent sites for final analysis
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No