Non-operative Management of Early Appendicitis in Children

NCT01718275 | Unknown

• 1 other identifier: IRB12-00406
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appendicitis

Keywords

Appendicitis; Pediatrics; Children; Non-operative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Outcomes

  1 year

Study Arms (2)

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

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children treated a tertiary care Children's Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter Minneci: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• 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.

  PMID: 26676711 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.

  PMID: 24951281 RESULT

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Peter C Minneci, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: August 22, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)