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

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Anti-Bacterial Agents; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

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.