Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ruptured Appendicitis

Intervention / Treatment
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* Procedure: early appendectomy
* Procedure: interval appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ruptured appendicitis Exclusion Criteria: Inability to have usual follow up care (e.g. transient to area)

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Early appendectomy | Procedure: early appendectomy<br>* Appendectomy within 24 hours of admission<br>|
| Active Comparator: 2<br>Interval appendectomy | Procedure: interval appendectomy<br>* Initial antibiotic treatment followed by appendectomy at 6-8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time (days) away from normal activities (or time until returns to normal activities) |  | At completion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rates of each treatment arm: |  | At completion of study | 
| Wound infection or dehiscence |  | Throughout study period | 
| Intra-abdominal abscess |  | Throughout study period | 
| Requires reoperation |  | Throughout study period | 
| Bowel obstruction |  | Throughout study period | 
| central venous catheter-related infection |  | Throughout study period | 
| interventional radiology-related complication |  | Throughout study period | 
| Total hospital length of stay |  | At study completion | 
| # patients with central venous line |  | At study completion | 
| # with interventional radiology drainage |  | At study completion | 
| # of return visits to pediatrician, ED, surgery office |  | At study completion | 
| Other complication |  | At study completion | 
| quality of life questionnaire (SF10) |  | At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment | 
| hospital costs |  | At study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ruptured appendicitis, children, surgery, randomized trial