CompletedPhase 4

Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children

United States39 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent

Timeframe: 1 Year

Trial details

NCT IDNCT02991937

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-01

Results submitted2021-11-23