Expired Study
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Sylmar, California 91342


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02447224


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Sylmar, California 91342
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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