Trials / Completed
CompletedNCT02991937
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. This study will be a randomized controlled trial comparing non-operative management with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis in children.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Piperacillin/Tazobactam | 24 hours of IV antibiotic administration |
| PROCEDURE | Surgical Treatment | Appendectomy |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2016-12-14
- Last updated
- 2022-01-21
- Results posted
- 2022-01-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02991937. Inclusion in this directory is not an endorsement.