Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

Ruptured Appendicitis Clinical Trial

— RAPTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435032
• Other study ID #: R073223335
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2007
• Last updated: January 11, 2010
• Start date: October 2006

Study information

• Verified date: January 2010
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of ruptured appendicitis

Exclusion Criteria:

• Inability to have usual follow up care (e.g. transient to area)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis
• Rupture
• Ruptured Appendicitis

Intervention

Procedure:
• early appendectomy
Appendectomy within 24 hours of admission
• interval appendectomy
Initial antibiotic treatment followed by appendectomy at 6-8 weeks

Locations

Country	Name	City	State
United States	LeBonheur Children's Medical Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time (days) away from normal activities (or time until returns to normal activities)		At completion of study	No
Secondary	complication rates of each treatment arm:		At completion of study	No
Secondary	Wound infection or dehiscence		Throughout study period	No
Secondary	Intra-abdominal abscess		Throughout study period	No
Secondary	Requires reoperation		Throughout study period	No
Secondary	Bowel obstruction		Throughout study period	No
Secondary	central venous catheter-related infection		Throughout study period	No
Secondary	interventional radiology-related complication		Throughout study period	No
Secondary	Total hospital length of stay		At study completion	No
Secondary	# patients with central venous line		At study completion	No
Secondary	# with interventional radiology drainage		At study completion	No
Secondary	# of return visits to pediatrician, ED, surgery office		At study completion	No
Secondary	Other complication		At study completion	No
Secondary	quality of life questionnaire (SF10)		At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment	No
Secondary	hospital costs		At study completion	No