Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

Study Overview
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Brief Summary
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The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.

Detailed Description
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This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.

Official Title
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A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis

Conditions
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Acute Uncomplicated Appendicitis

Intervention / Treatment
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* Drug: 1 gm IV ertapenem at enrollment
* Drug: 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days
* Procedure: Appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult or child ages ≥5 years; Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon; Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and Negative pregnancy test for subjects who are women of childbearing potential. Exclusion Criteria: instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotics<br>Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy. | Drug: 1 gm IV ertapenem at enrollment<br> <br> Drug: 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days<br> <br> |
| Active Comparator: Appendectomy<br>Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery. | Drug: 1 gm IV ertapenem at enrollment<br> <br> Procedure: Appendectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Complications | The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent appendicitis |  | 30 days | 
| QOL outcomes |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appendicitis, non operative management, appendectomy