Clinical trial NCT00435032: Early Versus Interval Appendectomy for Ruptured Appendicitis in Children
Official title: Early Versus Interval Appendectomy for Ruptured Appendicitis in Children. Ruptured Appendicitis Pilot Trial (RAPTOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ruptured Appendicitis
Keywords: ruptured appendicitis
children
surgery
randomized trial
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2007-02-14
Enrollment: 128
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ruptured appendicitis

Exclusion Criteria:

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

Primary outcomes:
measure: time (days) away from normal activities (or time until returns to normal activities)
timeFrame: At completion of study
Secondary outcomes:
measure: complication rates of each treatment arm:
timeFrame: At completion of study
measure: Wound infection or dehiscence
timeFrame: Throughout study period
measure: Intra-abdominal abscess
timeFrame: Throughout study period
measure: Requires reoperation
timeFrame: Throughout study period
measure: Bowel obstruction
timeFrame: Throughout study period
measure: central venous catheter-related infection
timeFrame: Throughout study period
measure: interventional radiology-related complication
timeFrame: Throughout study period
measure: Total hospital length of stay
timeFrame: At study completion
measure: # patients with central venous line
timeFrame: At study completion
measure: # with interventional radiology drainage
timeFrame: At study completion
measure: # of return visits to pediatrician, ED, surgery office
timeFrame: At study completion
measure: Other complication
timeFrame: At study completion
measure: quality of life questionnaire (SF10)
timeFrame: At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment
measure: hospital costs
timeFrame: At study completion
Other outcomes:
Locations:
city: Memphis
country: United States
facility: LeBonheur Children's Medical Center
state: Tennessee
Study officials:
affiliation: University of Tennessee Health Science Center, LeBonheur Children's Medical Center
name: Martin L Blakely, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee Health Science Center, LeBonheur Children's Medical Center
name: Barbara Culbreath, RN
role: STUDY_DIRECTOR
References:
citation: Blakely ML, Williams R, Dassinger MS, Eubanks JW 3rd, Fischer P, Huang EY, Paton E, Culbreath B, Hester A, Streck C, Hixson SD, Langham MR Jr. Early vs interval appendectomy for children with perforated appendicitis. Arch Surg. 2011 Jun;146(6):660-5. doi: 10.1001/archsurg.2011.6. Epub 2011 Feb 21.