Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure - UCSF

Phase 4RecruitingNCT05966454

University of California, San Francisco145 enrolled

Overview

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

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

145

Conditions

Appendicitis

Interventions

Multiple standard of care antibiotics for appendicitis, at physicians' discretionDRUG

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

Multiple standard of care antibiotics for appendicitis, at physicians' discretionDRUG

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 * 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

Locations (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Up to 30 days after appendicitis surgery

Time frame: Up to 30 days after appendicitis surgery

Central Contacts

Lucy Kornblith, MD

CONTACT

628-206-6946 Lucy.Kornblith@ucsf.edu

Brenda Nunez-Garcia

CONTACT

628-206-6942 Brenda.Nunez-Garcia@ucsf.edu

Data from ClinicalTrials.gov

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