Restricted or Liberal Antibiotics After Appendectomy - Denver Health

Denver Health and Hospital Authority657 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

657

Conditions

Appendicitis

Interventions

Restricted Duration of SOC Antibiotic UseOTHER

Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.

Liberal Duration of SOC Antibiotic UseOTHER

Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Denver Health and Hospital Authority

Denver, Colorado, United States

Outcomes

Primary Outcomes

Number of participants with no antibiotic related adverse effects

As assessed by treating physician

Time frame: Up to 40 days after appendicitis surgery

Incidence of Infectious/Antibiotic Complications

Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician.

Time frame: Up to 30 days after appendicitis surgery

Number of participant deaths

As assessed by treating physician

Time frame: Up to 30 days after appendicitis surgery

Data from ClinicalTrials.gov

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