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

NCT ID: NCT05966454

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2026-06-30

Brief Summary

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

Detailed Description

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.

Conditions

Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Restricted Post-Operative Antibiotics Group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Liberal Post-Operative Antibiotics Group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucy Kornblith, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lucy Kornblith, MD

Role: CONTACT

Lucy.Kornblith@ucsf.edu

628-206-6946

Brenda Nunez-Garcia

Role: CONTACT

Brenda.Nunez-Garcia@ucsf.edu

628-206-6942

Facility Contacts

Lucy Kornblith, MD

Role: primary

Lucy.Kornblith@ucsf.edu

415-206-6946

Other Identifiers

21-35457

Identifier Type: -

Identifier Source: org_study_id