Ruptured Appendicitis
Conditions
Keywords
ruptured appendicitis, children, surgery, randomized trial
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.
Interventions
PROCEDUREearly appendectomy
Appendectomy within 24 hours of admission
PROCEDUREinterval appendectomy
Initial antibiotic treatment followed by appendectomy at 6-8 weeks
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of ruptured appendicitis
Exclusion criteria
* Inability to have usual follow up care (e.g. transient to area)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time (days) away from normal activities (or time until returns to normal activities) | At completion of study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| complication rates of each treatment arm: | At completion of study |
| # 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 |
| Total hospital length of stay | At study completion |
Countries
United States
Outcome results
None listed