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

Last updated: January 27, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Appendicitis

Treatment

Antibiotic

Clinical Study ID

NCT05746520
IRB00086118
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 hospitaldischarge

Exclusion

Exclusion Criteria:

  • Unable to consent

  • Pregnant Women

  • Prisoners

  • immunocompromised as determined by clinical team, or patients actively receivingsteroids, 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

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Antibiotic
Phase:
Study Start date:
March 02, 2023
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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