Appendicitis
Conditions
Keywords
post-operative, antibiotics
Brief summary
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.
Interventions
OTHERRestricted Duration of SOC Antibiotic Use
Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.
OTHERLiberal Duration of SOC Antibiotic Use
Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.
Sponsors
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Infectious/Antibiotic Complications | Up to 30 days after appendicitis surgery | Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician. |
| Number of participant deaths | Up to 30 days after appendicitis surgery | As assessed by treating physician |
| Number of participants with no antibiotic related adverse effects | Up to 40 days after appendicitis surgery | As assessed by treating physician |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel D Yeh, MD, MHPE
Denver Health and Hospital Authority
Outcome results
None listed