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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05746520
Collaborator
(none)
400
Enrollment
1
Location
4
Arms
30.1
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

Condition or Disease Intervention/Treatment Phase
  • Other: Antibiotic
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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 (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics.

Other: Antibiotic
Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
Other Names:
  • antibiotics are per standard of care (SOC)

    		•
    Other: Restricted Duration of SOC Antibiotic Use

    Use of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively.

    Other: Antibiotic
    Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
    Other Names:
  • antibiotics are per standard of care (SOC)

    		•
    Active Comparator: Liberal Post-Operative Antibiotics Group

    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.

    Other: Antibiotic
    Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
    Other Names:
  • antibiotics are per standard of care (SOC)

    		•
    Other: Liberal Duration of SOC Antibiotic Use

    Use of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively.

    Other: Antibiotic
    Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
    Other Names:
  • antibiotics are per standard of care (SOC)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with no antibiotic related adverse effects [Day 30]

      All subjects will be contacted 30 days (± 3 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

    1. Incidence of Infectious/Antibiotic Complications [Day 30]

      All subjects will be monitored from consent until follow up call at 30 days (± 3 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

    • Principal Investigator: Rafael Torres Fajardo, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05746520
    Other Study ID Numbers:
    • IRB00086118
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Feb 27, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Wake Forest University Health Sciences
    post-operative antibiotics
    acute appendicitis
    complicated appendicitis
    Additional relevant MeSH terms:
    Appendicitis
    Anti-Bacterial Agents
    Antibiotics, Antitubercular

    Study Results

    No Results Posted as of Feb 27, 2023