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

Wake Forest University (WFU)

Status: Completed

Conditions: Appendicitis Surgery

Treatments: Other: Antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT05746520

IRB00086118

Details and patient eligibility

About

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: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 4 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 (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics.

Treatment:

Other: Antibiotic

Restricted Duration of SOC Antibiotic Use

Other group

Description:

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

Treatment:

Other: Antibiotic

Liberal Post-Operative Antibiotics Group

Active Comparator group

Description:

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.

Treatment:

Other: Antibiotic

Liberal Duration of SOC Antibiotic Use

Other group

Description:

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

Treatment:

Other: Antibiotic