Non-operative Management of Pediatric Appendicitis With an Appendicoltih
- Conditions
- Appendicitis
- Interventions
- Drug: Antibiotics only (Zosyn then Augmentin)
- Registration Number
- NCT02189668
- Lead Sponsor
- Peter Minneci
- Brief Summary
To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.
- Detailed Description
This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
-
Age : 7-17 years
-
Abdominal pain </= 48hours prior to receiving antibiotics
-
White Blood Cell Count >5 but < 18
-
US or CT confirmed early appendicitis plus:
- US: </=1.1 cm in diameter, presence of appendicolith
- CT: </= 1.1cm in diameter, presence of appendicolith
- Positive urine pregnancy test
- Pain > 48 hours prior to first antibiotic dose
- Diffuse peritonitis
- History of chronic intermittent abdominal pain
- White Blood Cell count ≤ 5 or ≥ 18
- Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-operative Management Antibiotics only (Zosyn then Augmentin) Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic
- Primary Outcome Measures
Name Time Method Number of Participants That Did Not Have an Appendectomy 1 year Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge
- Secondary Outcome Measures
Name Time Method Number of Participants With Complicated Appendicitis 1 year Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States