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

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Appendicitis

Treatments: Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion

Study type: Interventional

Funder types: Other

Identifiers

NCT05966454

21-35457

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

Full 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.

Enrollment: 145 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years

• Age ≥ 18 years
• Planned appendectomy (laparoscopic or open)
• 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
• Type 1 Diabetes or uncontrolled hyperglycemia
• 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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145 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:

Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion

Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion

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:

Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion

Drug: Multiple standard of care antibiotics for appendicitis, at physicians' discretion