Restricted or Liberal Antibiotics After Appendectomy - Denver Health (CASA RELAX)

Denver Health and Hospital Authority

Status: Enrolling

Conditions: Appendicitis

Treatments: Other: Restricted Duration of SOC Antibiotic Use; Other: Liberal Duration of SOC Antibiotic Use

Study type: Interventional

Funder types: Other

Identifiers

NCT05002829

20191238

Details and patient eligibility

About

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.

Enrollment: 2,275 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,275 participants in 2 patient groups

Restricted Post-Operative Antibiotics Group

Experimental group

Description:

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.

Treatment:

Other: Restricted Duration of SOC Antibiotic Use

Liberal Post-Operative Antibiotics Group

Active Comparator group

Description:

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.

Treatment:

Other: Liberal Duration of SOC Antibiotic Use