Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 11/17/2018 |
| Start Date: | December 2016 |
| End Date: | May 2020 |
| Contact: | Akila Ramaraj |
| Email: | Akila.Ramaraj@med.nyu.edu |
This is a randomized controlled trial of 190 subjects 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. The primary outcome will be survey scores on the Pediatric Quality of Life
Inventory (PedsQL) Generic Core Scale Parent-proxy report. Secondary outcomes will include
child scores on the PedsQL; length of stay; immediate, 1-week, 2-week, 30-day, and 60-day
success of non-operative management; readmission rates for both groups; and long-term
complications over one year.
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. The primary outcome will be survey scores on the Pediatric Quality of Life
Inventory (PedsQL) Generic Core Scale Parent-proxy report. Secondary outcomes will include
child scores on the PedsQL; length of stay; immediate, 1-week, 2-week, 30-day, and 60-day
success of non-operative management; readmission rates for both groups; and long-term
complications over one year.
Inclusion Criteria:
- first episode of appendicitis
- Pain < 48 hours
- White blood cell count < 18,000
- temperature < 103º F
- radiographic evidence of acute appendicitis on ultrasound or CT without evidence of
perforation
- appendiceal diameter < 11 mm
- ability to take oral antibiotics
Exclusion Criteria:
- Prior antibiotic treatment for appendicitis
- presence of medical condition prohibiting surgical therapy
- radiographic or clinical evidence of abscess or perforation
- appendiceal mass, positive pregnancy test
- other diagnosis equally as likely as appendicitis
- pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or
appendiceal diameter ≥ 11 mm
- inability to take oral antibiotics.
We found this trial at
1
site
70 Washington Square S
New York, New York 10012
New York, New York 10012
(212) 998-1212
Principal Investigator: Jason Fisher, ND
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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