Back to resultsComplex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure - UCSF (CASA RELAX)
Primary Purpose
Appendicitis
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Multiple standard of care antibiotics for appendicitis, at physicians' discretion
Multiple standard of care antibiotics for appendicitis, at physicians' discretion
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis
Eligibility Criteria
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
Sites / Locations
- Zuckerberg San Francisco General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Restricted Post-Operative Antibiotics Group
Liberal Post-Operative Antibiotics Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Number of participant deaths
Up to 30 days after appendicitis surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT05966454
First Posted
June 30, 2023
Last Updated
July 25, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT05966454
Brief Title
Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure - UCSF
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Restricted Post-Operative Antibiotics Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Liberal Post-Operative Antibiotics Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Multiple standard of care antibiotics for appendicitis, at physicians' discretion
Intervention Description
Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.
Intervention Type
Drug
Intervention Name(s)
Multiple standard of care antibiotics for appendicitis, at physicians' discretion
Intervention Description
Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.
Primary Outcome Measure Information:
Title
Incidence of Infectious/Antibiotic Complications
Description
Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.
Time Frame
Up to 30 days after appendicitis surgery
Title
Number of participant deaths
Description
Up to 30 days after appendicitis surgery
Time Frame
Up to 30 days after appendicitis surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucy Kornblith, MD
Phone
628-206-6946
Email
Lucy.Kornblith@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda Nunez-Garcia
Phone
628-206-6942
Email
Brenda.Nunez-Garcia@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Kornblith, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Kornblith, MD
Phone
415-206-6946
Email
Lucy.Kornblith@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Lucy Kornblith, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure - UCSF
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