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Restricted or Liberal Antibiotics After Appendectomy (CASA RELAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05002829
Recruitment Status : Active, not recruiting
First Posted : August 12, 2021
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
Daniel Yeh, Denver Health and Hospital Authority

Brief Summary:
The purpose of this study is to see 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.

Condition or disease Intervention/treatment Phase
Appendicitis Other: Restricted Duration of SOC Antibiotic Use Other: Liberal Duration of SOC Antibiotic Use Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2275 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): A Randomized Controlled Trial
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


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.

Other: Restricted Duration of SOC Antibiotic Use
Standard of Care Antibiotic use will be restricted to none or up to 24 hours 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.

Other: Liberal Duration of SOC Antibiotic Use
Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.




Primary Outcome Measures :
  1. Number of participants with no antibiotic related adverse effects [ Time Frame: Up to 40 days after appendicitis surgery ]
    As assessed by treating physician

  2. Incidence of Infectious/Antibiotic Complications [ Time Frame: Up to 30 days after appendicitis surgery ]
    Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.

  3. Number of participant deaths [ Time Frame: Up to 30 days after appendicitis surgery ]
    As assessed by treating physician



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Planned appendectomy (laparoscopic or open) for simple or complicated (perforated or gangrenous) appendicitis
  • 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
  • Uncontrolled hyperglycemia or Type 1 Diabetes
  • Surgeon preference
  • Patient preference
  • Research team unavailable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05002829


Locations
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United States, California
University of California san Francisco
San Francisco, California, United States, 94143
United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204-4507
United States, Florida
Ryder Trauma Center / Jackson Memorial Hospital
Miami, Florida, United States, 33101
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
NYU Langone Brooklyn
Brooklyn, New York, United States, 11220
NYU Langone Manhattan
New York, New York, United States, 10016
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28207
Atrium Health Cabarrus
Concord, North Carolina, United States, 28025
United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Texas Health Resources
Fort Worth, Texas, United States, 76104
United States, Virginia
Inova
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
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Principal Investigator: Daniel D Yeh, MD, MHPE Denver Health and Hospital Authority
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Yeh, Professor of Surgery, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT05002829    
Other Study ID Numbers: 20191238
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Yeh, Denver Health and Hospital Authority:
post-operative
antibiotics
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents