ClinicalTrials.gov
ClinicalTrials.gov Menu

Non-operative Management of Early Appendicitis in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01718275
Recruitment Status : Active, not recruiting
First Posted : October 31, 2012
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Katherine Deans, Nationwide Children's Hospital

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.

Condition or disease
Appendicitis

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).


Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Non-operative Management of Early Appendicitis in Children
Study Start Date : October 2012
Actual Primary Completion Date : February 2014
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Group/Cohort
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



Primary Outcome Measures :
  1. Failure of Non-operative management [ Time Frame: 1 year ]
    The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.


Secondary Outcome Measures :
  1. Adverse Outcomes [ Time Frame: 1 year ]
    The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Katherine Deans, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01718275     History of Changes
Other Study ID Numbers: IRB12-00406
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Katherine Deans, Nationwide Children's Hospital:
Appendicitis
Pediatrics
Children
Non-operative

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases