Restricted or Liberal Antibiotics After Appendectomy - Denver Health

Not Applicable

Recruiting

• Conditions: Appendicitis
• Interventions: Other: Restricted Duration of SOC Antibiotic Use; Other: Liberal Duration of SOC Antibiotic Use

• Registration Number: NCT05002829
• Lead Sponsor: Denver Health and Hospital Authority

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-12
• Study Start: 2021-11-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2275

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restricted Post-Operative Antibiotics Group	Restricted Duration of SOC Antibiotic Use	Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics. Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.
Liberal Post-Operative Antibiotics Group	Liberal Duration of SOC Antibiotic Use	Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.

Primary Outcome Measures

Name	Time	Method
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 participants with no antibiotic related adverse effects	Up to 40 days after appendicitis surgery	As assessed by treating physician
Number of participant deaths	Up to 30 days after appendicitis surgery	As assessed by treating physician

Trial Locations

Locations (1)

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States