Restricted or Liberal Antibiotics After Appendectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

657 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-07-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Restricted Duration of SOC Antibiotic Use

Intervention Type OTHER

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

Liberal Duration of SOC Antibiotic Use

Intervention Type OTHER

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

Interventions

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Restricted Duration of SOC Antibiotic Use

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

Intervention Type OTHER

Liberal 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No