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Antibiotic Use After Appendectomy for Appendicitis (CASA RELAX Trial)

N/A

Recruiting

Led By Daniel D Yeh, MD, MHPE

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Planned appendectomy (laparoscopic or open) for simple or complicated (perforated or gangrenous) appendicitis

Must not have

Uncontrolled hyperglycemia or Type 1 Diabetes

Unable to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after appendicitis surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if using less antibiotics after appendicitis surgery can lower the chance of negative effects from antibiotics, while still keeping patients safe.

Who is the study for?

This trial is for adults over 18 who are having their appendix removed due to appendicitis. They must have a reliable way to be contacted after leaving the hospital. People with uncontrolled diabetes, pregnant women, prisoners, those unable to follow treatment plans or give consent, immunocompromised individuals, and patients on current antibiotics for other conditions cannot participate.

What is being tested?

The study is testing if using antibiotics for a shorter (restricted) or longer (liberal) time after appendectomy surgery affects patient safety and reduces side effects linked with antibiotic use. The goal is to find out whether less antibiotic use can still keep patients safe post-surgery.

What are the potential side effects?

Potential side effects from different durations of antibiotic use may include allergic reactions, gastrointestinal issues like diarrhea or nausea, increased risk of infection resistance to antibiotics, and possibly others depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for an appendectomy, whether my appendix is ruptured or not.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have high blood sugar that is not under control or I have Type 1 Diabetes.

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I am unable to give consent by myself.

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I am in the hospital for appendicitis.

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I am immunocompromised due to medication, a condition, or treatment I am receiving.

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I am currently taking antibiotics for a condition other than cancer.

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I have heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after appendicitis surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after appendicitis surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after appendicitis surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Infectious/Antibiotic Complications

Number of participant deaths

Number of participants with no antibiotic related adverse effects

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Restricted Post-Operative Antibiotics GroupExperimental Treatment1 Intervention

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 II: Liberal Post-Operative Antibiotics GroupActive Control1 Intervention

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.

0 / 8Eligibility criteria met