Early Versus Interval Appendectomy for Ruptured Appendicitis in Children (RAPTOR)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Clinical diagnosis of ruptured appendicitis
Exclusion criteria
- Inability to have usual follow up care (e.g. transient to area)
Trial design
Primary purpose
Allocation
Interventional model
Masking
128 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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