NCT00435032

Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

Early Versus Interval Appendectomy for Ruptured Appendicitis in Children. Ruptured Appendicitis Pilot Trial (RAPTOR)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: University of Tennessee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized trial is to compare two commonly utilized surgical treatments for children with ruptured appendicitis: early appendectomy, versus interval appendectomy. The primary outcome measure is time away from normal activities.

Detailed description

There are two surgical treatment options for children with ruptured appendicitis. Early appendectomy is one option and typically involves removing the ruptured appendix after several hours of optimizing the patient medically with intravenous fluids and intravenous antibiotics. Another option, interval appendectomy, uses the same initial fluid and antibiotic management, but delays removing the appendix until 6-8 weeks later. The rationale for delaying the appendectomy is to perform the operation at a time when the patient is perhaps more stable and the abdominal cavity is free from contamination. Both of these treatment options are currently used by many pediatric surgeons across the United States and both appear to work well. The two treatment have never been compared in any prospective study. The primary outcome of the study is the time that a patient (and family) is away from normal activities, due to the disease and its treatment. Secondary outcome measures include complication rates, quality of life measures (SF10), hospital cost analysis, and others.

Conditions

• Ruptured Appendicitis

Interventions

Type	Name	Description
PROCEDURE	early appendectomy	Appendectomy within 24 hours of admission
PROCEDURE	interval appendectomy	Initial antibiotic treatment followed by appendectomy at 6-8 weeks

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-09-01
• First posted: 2007-02-14
• Last updated: 2010-01-12

Locations

1 site across 1 country: United States