Back to resultsComplex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health
Primary Purpose
Appendicitis Surgery
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antibiotic
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis Surgery focused on measuring post-operative antibiotics, acute appendicitis, complicated appendicitis
Eligibility Criteria
Inclusion Criteria: 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 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 Acquired immunodeficiency syndrome (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
Sites / Locations
- Wake Forest University Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Active Comparator
Other
Arm Label
Restricted Post-Operative Antibiotics Group
Restricted Duration of SOC Antibiotic Use
Liberal Post-Operative Antibiotics Group
Liberal Duration of SOC Antibiotic Use
Arm Description
Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics. Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics.
Use of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively.
Participants undergoing standard of care (SOC) with simple appendicitis will receive 24 hours of post-operative antibiotics. Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 4 days of SOC post-operative antibiotics.
Use of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively.
Outcomes
Primary Outcome Measures
Number of participants with no antibiotic related adverse effects
All subjects will be contacted at least 30 days after appendectomy by telephone. Outcomes will be assessed by Desirability of Outcome Ranking (DOOR), with the lowest ranking of 1 indicating no adverse effects. Infectious/antibiotic complications requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, operative intervention, and death ranked 2 through 7. A lower score indicates a more desirable outcome. For subjects of same DOOR score, Response Adjusted for Duration of Antibiotic Risk (RADAR) scores will be used to determine the better outcome. The distribution of DOOR scores and associated statistical analyses will be reported.
Secondary Outcome Measures
Incidence of Infectious/Antibiotic Complications
All subjects will be monitored from consent until follow up call at least 30 days after appendectomy for number of complications. Each event will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, with the lowest grade being 1 and the highest grade of 5 indicating death. A higher grade indicates a more serious event.
Full Information
NCT ID
NCT05746520
First Posted
February 16, 2023
Last Updated
September 19, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05746520
Brief Title
Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
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
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 Surgery
Keywords
post-operative antibiotics, acute appendicitis, complicated appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (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 (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics.
Arm Title
Restricted Duration of SOC Antibiotic Use
Arm Type
Other
Arm Description
Use of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively.
Arm Title
Liberal Post-Operative Antibiotics Group
Arm Type
Active Comparator
Arm Description
Participants undergoing standard of care (SOC) with simple appendicitis will receive 24 hours of post-operative antibiotics.
Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 4 days of SOC post-operative antibiotics.
Arm Title
Liberal Duration of SOC Antibiotic Use
Arm Type
Other
Arm Description
Use of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively.
Intervention Type
Other
Intervention Name(s)
Antibiotic
Other Intervention Name(s)
antibiotics are per standard of care (SOC)
Intervention Description
Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
Primary Outcome Measure Information:
Title
Number of participants with no antibiotic related adverse effects
Description
All subjects will be contacted at least 30 days after appendectomy by telephone. Outcomes will be assessed by Desirability of Outcome Ranking (DOOR), with the lowest ranking of 1 indicating no adverse effects. Infectious/antibiotic complications requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, operative intervention, and death ranked 2 through 7. A lower score indicates a more desirable outcome. For subjects of same DOOR score, Response Adjusted for Duration of Antibiotic Risk (RADAR) scores will be used to determine the better outcome. The distribution of DOOR scores and associated statistical analyses will be reported.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Incidence of Infectious/Antibiotic Complications
Description
All subjects will be monitored from consent until follow up call at least 30 days after appendectomy for number of complications. Each event will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, with the lowest grade being 1 and the highest grade of 5 indicating death. A higher grade indicates a more serious event.
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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 Acquired immunodeficiency syndrome (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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitlyn Infante
Phone
704-446-8221
Email
Kaitlyn.Infante@atriumhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Brake
Phone
704-618-2754
Email
Julia.Brake@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Torres Fajardo, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaitlyn Infante
Phone
704-446-8221
Email
Kaitlyn.Infante@atriumhealth.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
de-identified 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 (CASA RELAX) - Atrium Health
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