Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Children treated a tertiary care Children's Hospital
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter C Minneci, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26676711 | Result | 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. doi: 10.1001/jamasurg.2015.4534. | |
| 24951281 | Result | 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. Epub 2014 Apr 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |