Non-operative Management of Pediatric Appendicitis With an Appendicoltih

October 28, 2018 updated by: Peter Minneci

Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children

To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age : 7-17 years
  • Abdominal pain </= 48hours prior to receiving antibiotics
  • White Blood Cell Count >5 but < 18

  • US or CT confirmed early appendicitis plus:

    • US: </=1.1 cm in diameter, presence of appendicolith
    • CT: </= 1.1cm in diameter, presence of appendicolith

Exclusion Criteria:

  • Positive urine pregnancy test
  • Pain > 48 hours prior to first antibiotic dose
  • Diffuse peritonitis
  • History of chronic intermittent abdominal pain
  • White Blood Cell count ≤ 5 or ≥ 18
  • Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-operative Management
Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic
Drug: Antibiotics only (Zosyn then Augmentin)
Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic
Other Names:
  • non operative management
No Intervention: Surgery
Usual care with urgent appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants That Did Not Have an Appendectomy
Time Frame: 1 year
Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Complicated Appendicitis
Time Frame: 1 year
Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Minneci

Investigators

  • Principal Investigator: Peter C Minneci, MD, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

October 28, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-00218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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