Complex and Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX)
CASA-RELAX
1 other identifier
interventional
50
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2023
CompletedFirst Submitted
Initial submission to the registry
April 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
October 15, 2024
October 1, 2024
3.4 years
April 3, 2023
October 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Survival
30 days
Infectious/antibiotic complication requiring antibiotic treatment only only or no specific treatment
30 days
Infectious/antibiotic complication requiring Emergency Department visit
30 days
Infectious/antibiotic complication requiring hospital readmission
30 days
Infectious/antibiotic complication requiring percutaneous drainage
30 days
Infectious/antibiotic complication requiring operative intervention
30 days
Cure
Resolution of appendicitis without sequelae
30 days
Study Arms (8)
under 65 years simple appendicitis restricted duration
ACTIVE COMPARATORsimple appendicitis restricted duration of no postop antibiotics
Under 65 simple appendicitis liberal duration
ACTIVE COMPARATORsimple appendicitis liberal duration of 24 hours postop antibiotics
Under 65 complex appendicitis restricted duration
ACTIVE COMPARATORcomplex appendicitis restricted duration of 24 hours postop antibiotics
Under 65 complex appendicitis liberal duration
ACTIVE COMPARATORcomplex appendicitis liberal duration of 4 days of postop antibiotics
Over 65 simple appendicitis restricted antibiotic duration
ACTIVE COMPARATORsee above for under 65
Over 65 simple appendicitis liberal antibiotic duration
ACTIVE COMPARATORsee above for under 65
Over 65 complex appendicitis restricted antibiotic duration
ACTIVE COMPARATORsee above for under 65
Over 65 appendicitis liberal antibiotic duration
ACTIVE COMPARATORsee above for under 65
Interventions
Duration of antibiotic treatment post appendectomy
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Planned appendectomy (laparoscopic or open)
- Willing and able to provide informed consent
- Working telephone number or reliable method to contact patient after hospital discharge
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jewish Hospital UL
Louisville, Kentucky, 40202, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Related Publications (2)
Sawyer RG, Claridge JA, Nathens AB, Rotstein OD, Duane TM, Evans HL, Cook CH, O'Neill PJ, Mazuski JE, Askari R, Wilson MA, Napolitano LM, Namias N, Miller PR, Dellinger EP, Watson CM, Coimbra R, Dent DL, Lowry SF, Cocanour CS, West MA, Banton KL, Cheadle WG, Lipsett PA, Guidry CA, Popovsky K; STOP-IT Trial Investigators. Trial of short-course antimicrobial therapy for intraabdominal infection. N Engl J Med. 2015 May 21;372(21):1996-2005. doi: 10.1056/NEJMoa1411162.
PMID: 25992746BACKGROUNDYeh DD, Eid AI, Young KA, Wild J, Kaafarani HMA, Ray-Zack M, Kana'an T, Lawless R, Cralley AL, Crandall M; EAST Appendicitis Study Group. Multicenter Study of the Treatment of Appendicitis in America: Acute, Perforated, and Gangrenous (MUSTANG), an EAST Multicenter Study. Ann Surg. 2021 Mar 1;273(3):548-556. doi: 10.1097/SLA.0000000000003661.
PMID: 31663966BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD
Study Record Dates
First Submitted
April 3, 2023
First Posted
May 1, 2023
Study Start
January 24, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
October 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be transferred to Denver Health on an ongoing basis as patients complete the 30 day evaluation period.
- Access Criteria
- Only PI and their designates will have access to the de-identified data
Data sharing agreement between University of Louisville Health and Denver Health. De-identified patient data