Non-operative Management of Early Appendicitis in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Katherine Deans, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01718275
First received: October 29, 2012
Last updated: July 3, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: February 2024
Primary Completion Date: February 2014 (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
Study Population

Children treated a tertiary care Children's Hospital

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718275

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Katherine Deans
Investigators
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: July 3, 2014
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
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014