Appendicitis Clinical Trial
Official title:
Non-operative Management of Early Appendicitis in Children
Verified date | August 2023 |
Source | Nationwide Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.
Status | Active, not recruiting |
Enrollment | 102 |
Est. completion date | August 22, 2023 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility | Inclusion Criteria: - Age : 7-17 years - Ultrasound (US) or CT scan confirmed early appendicitis (US: hyperemia, <1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; CT: hyperemia, fat stranding, <1.1 cm in diameter, no abscess, no fecalith, no phlegmon) - White blood cell count (WBC) < 15,000 - C reactive protein (CRP) <4 (if obtained) - Focal abdominal pain </= 36 hours prior to receiving antibiotics Exclusion Criteria: - English is not the primary language of either the child or parent/guardian - Other significant co-morbidities: cardiovascular disease, malignancy, pulmonary disease, diabetes, obesity (BMI = 95th percentile for age and sex), severe developmental delay - Positive urine pregnancy test - Diffuse peritonitis - Fecalith - History of chronic intermittent abdominal pain - WBC >/= 15 - CRP>/= 4 (if obtained) - Pain > 36 hours prior to first antibiotic dose or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon |
Country | Name | City | State |
---|---|---|---|
United States | Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Peter Minneci |
United States,
Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2016 May 1;151(5):408-15. — View Citation
Minneci PC, Sulkowski JP, Nacion KM, Mahida JB, Cooper JN, Moss RL, Deans KJ. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014 Aug;219(2):272-9. doi: 10.1016/j.jamcollsurg.2014.02.031 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Failure of Non-operative management | The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate. | 1 year | |
Secondary | Adverse Outcomes | The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures. | 1 year |
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