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

Wake Forest University Health Sciences268 enrolled

Overview

To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

268

Conditions

Appendicitis Surgery

Interventions

AntibioticOTHER

Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Number of participants with no antibiotic related adverse effects

All subjects will be contacted at least 30 days after appendectomy by telephone if unable to contact subject, then electronic medical record will be reviewed. Outcomes will be assessed by Desirability of Outcome Ranking (DOOR), with the lowest ranking of 1 indicating no adverse effects. Infectious/antibiotic complications requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, operative intervention, and death ranked 2 through 7. A lower score indicates a more desirable outcome. For subjects of same DOOR score, Response Adjusted for Duration of Antibiotic Risk (RADAR) scores will be used to determine the better outcome. The distribution of DOOR scores and associated statistical analyses will be reported.

Time frame: Day 30

Secondary Outcomes

Incidence of Infectious/Antibiotic Complications

All subjects will be monitored from consent until follow up at least 30 days after appendectomy for number of complications. Each event will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, with the lowest grade being 1 and the highest grade of 5 indicating death. A higher grade indicates a more serious event.

Time frame: Day 30

Data from ClinicalTrials.gov

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