Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 2015 |
| End Date: | December 31, 2017 |
A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis
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.
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.
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.
appendicitis are randomized to one of two initial treatment strategies, surgery with
peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.
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.
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