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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Appendectomy within 24 hours of admission
Initial antibiotic treatment followed by appendectomy at 6-8 weeks
LeBonheur Children's Medical Center
Memphis, Tennessee, United States
time (days) away from normal activities (or time until returns to normal activities)
Time frame: At completion of study
complication rates of each treatment arm:
Time frame: At completion of study
Wound infection or dehiscence
Time frame: Throughout study period
Intra-abdominal abscess
Time frame: Throughout study period
Requires reoperation
Time frame: Throughout study period
Bowel obstruction
Time frame: Throughout study period
central venous catheter-related infection
Time frame: Throughout study period
interventional radiology-related complication
Time frame: Throughout study period
Total hospital length of stay
Time frame: At study completion
# patients with central venous line
Time frame: At study completion
# with interventional radiology drainage
Time frame: At study completion
# of return visits to pediatrician, ED, surgery office
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Time frame: At study completion
Other complication
Time frame: At study completion
quality of life questionnaire (SF10)
Time frame: At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment
hospital costs
Time frame: At study completion