Non-operative Management of Early Appendicitis in Children
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Appendicitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Non-operative Management of Early Appendicitis in Children |
- Failure of Non-operative management [ Time Frame: 1 year ] [ Designated as safety issue: No ]The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.
- Adverse Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures.
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2023 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Non-operative Group
Patients and caregivers who agree to receive non-operative management with antibiotics alone
|
|
Surgery Group
Patients and caregivers who decide to undergo appendectomy that permit us to track their standard treatment course
|
Detailed Description:
Non-operative management of appendicitis with antibiotics alone has recently emerged as a viable treatment alternative to appendectomy. There have been several clinical trials in adults which conclude that antibiotics alone are a safe initial treatment for appendicitis; none of these studies included children.
The primary objective of this study is to determine: conversion to surgery (failure of nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in children treated with non-operative management. Recurrence is defined as need for appendectomy. The secondary objective is to compare adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures between the study group and those that receive standard of care.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.
This is a prospective, non-randomized single-site trial measuring the feasibility of treating children (7-17 years old) with early appendicitis with antibiotics only (non-operative management). There will be two cohorts; those who agree to receive non-operative management (Non-Operative Group) and those that permit us to track their standard treatment course (Surgery Group).
Eligibility| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Children treated a tertiary care Children's Hospital
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
Contacts and Locations| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Katherine J Deans, MD 614-722-3066 katherine.deans@nationwidechildrens.org | |
| Contact: Peter C Minneci, MD 6147223066 peter.minneci@nationwidechildrens.org | |
| Principal Investigator: Katherine J Deans, MD | |
| Principal Investigator: | Katherine J Deans, MD | Nationwide Children's Hospital |
More Information
No publications provided
| Responsible Party: | Katherine Deans, Principal Investigator, Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01718275 History of Changes |
| Other Study ID Numbers: | IRB12-00406 |
| Study First Received: | October 29, 2012 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nationwide Children's Hospital:
|
Appendicitis Pediatrics Children Non-operative |
Additional relevant MeSH terms:
|
Appendicitis Acute Disease Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Cecal Diseases Intestinal Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013