Clinical Trial: Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children

Brief 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.

Detailed Summary:
Sponsor: New York University School of Medicine

Current Primary Outcome: Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale Parent [ Time Frame: 1 Year ]

Measurement model for the pediatric quality of life inventory.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Child scores on the PedsQL [ Time Frame: 1 Year ]
    Brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model.
  • Immediate, 1-week, 2-week, 30-day, and 60-day success of non-operative management [ Time Frame: 60 Days ]
  • Readmission rates for both groups [ Time Frame: 1 Year ]
  • Long-term complications over one year [ Time Frame: 1 Year ]


Original Secondary Outcome: Same as current

Information By: New York University School of Medicine

Dates:
Date Received: December 5, 2016
Date Started: December 2016
Date Completion: May 2020
Last Updated: December 9, 2016
Last Verified: December 2016