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  • Multi-Institutional Trial of Non-Oper...

Multi-Institutional Trial of Non-Operative Management of Uncomplicated Pediatric Appendicitis

Project Summary  

Appendicitis is one of the most common causes of abdominal pain in both adults and children. The standard treatment for appendicitis is an operation to remove the appendix, called an appendectomy. Over 250,000 appendectomies are performed every year in the United States; 70,000 of these are performed in children. Although less than 10 percent of patients will experience a complication following appendectomy, the procedure is associated with pain and disability following surgery. A non-operative management strategy to treat appendicitis with antibiotics alone instead of surgery may be preferred by patients and families, given its potential for less negative impact on the child and family. This study will determine how well non-operative management works in children with early appendicitis at 10 hospitals. The most important results we will examine are

  1. the amount of time the child misses from everyday activities (disability for the child) and
  2. the success of non-operative management at one year.

Other important results include disability for the caregiver, quality of life after treatment, satisfaction with care, percentage of patients with worse appendicitis (complicated appendicitis), and treatment complications.

Our research team comprises various stakeholders, each of whom represents a different perspective. These partners are an integral part of our research team. They include pediatric patients, families, primary care practitioners, specialized physicians, payers, and health educators. Non-English-speaking persons, lower-income families, and both parent and grandparent caregivers are represented within the subgroup of family stakeholders. Together, this diverse group of individuals agreed that we should perform a patient choice trial that allows for families to choose the best treatment option for their child. They felt this would respect the family’s preferences for a particular treatment, make patients and families from different backgrounds feel comfortable participating in the study, and allow our results to be easily used at other hospitals. Our stakeholder partners also helped us choose which results to measure in order to provide patients and families the information they need to make an informed decision between non-operative management and surgery. All of our stakeholders have agreed to ongoing participation, including monitoring study progress and assisting in dissemination plans.
 
We expect non-operative management to be successful in 75 percent of patients at one-year follow-up, and to cause less disability and fewer complications than surgery. If non-operative management is proved effective, three out of every four patients would never need surgery, meaning that over 45,000 patients each year would not experience the pain and disability that occurs after surgery or be put at risk for a complication from surgery.

Project Details

Principal Investigator
Peter Minneci, MD
Project Status
Awarded; In progress-Recruiting
Project Start Date
April 2016
Project End Date
January 2020
Organization
The Research Institute at Nationwide Children's Hospital
Year Awarded
2016
State
Ohio
Funding Announcement
Assessment of Prevention, Diagnosis, and Treatment Options
Primary Condition/Disease 
Digestive Systems Diseases
Project Budget
$2,785,554
Study Registration Information
HSRP20163047

Partners

Patient/Caregiver Partners

  • William Hawke
  • Nicholas Hawke
  • Rebeccah Abanukam
  • Trinity Patten
  • Amanda Monroe
  • Alyssa Gillman
  • Diana Godwin
  • William Blake Godwin
  • Darcy Moulin
  • Lorelei Moulin
  • Melissa Blom
  • Maxwell Blom
  • Iluminado Castellano
  • Tanner Goodman
  • Joshua Montalvo
  • Aubrey Gibson
  • Jason Gibson
  • Aria Gibson
  • Liz Sullivan
  • Kaleb Boyd
  • Luanne Farr
  • Nolan Chehak
  • Mrs. Caldwell
  • Rheya
  • Maurilio Valdes
  • Nicolas Valdes
  • Lisa Valdes
  • Lisa Shrader

Other Stakeholder Partners

  • Alisa McQueen, MD, Physician
  • C. Stephen Baum, MD, Pediatrician
  • Kathryn E. Nuss, MD, Physician
  • Sean Gleeson, MD, President of Partners for Kids
  • Paul Seese, RN, MSN Home Health Manager
  • Robert T. Rohloff, MD, Physician and Director of Quality and Patient Safety
  • Lawrence Moss, MD, Surgeon-in-Chief
  • Dana Schinasi MD, Pediatric Emergency Medicine
  • Darryl Robbins, DO, Physician
  • Michael Levas, MD, MS, Assistant Professor of Pediatrics
  • Courtney Porter, RN, MS, Clinical Leader at Canal Winchester Urgent
  • Gian Musarra, MD, Assistant Professor
Page Last Updated: 
May 12, 2017

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