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Non-operative Management of Pediatric Appendicitis With an Appendicoltih

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ClinicalTrials.gov Identifier: NCT02189668
Recruitment Status : Terminated (High failure rate)
First Posted : July 14, 2014
Results First Posted : April 17, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Minneci, Nationwide Children's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Appendicitis Drug: Antibiotics only (Zosyn then Augmentin) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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Arms and Interventions
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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 Name: non operative management
No Intervention: Surgery
Usual care with urgent appendectomy


Outcome Measures
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Primary Outcome Measures :
  1. 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


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


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02189668


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Peter Minneci
Investigators
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Principal Investigator: Peter C Minneci, MD Nationwide Children's Hospital
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Peter Minneci, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02189668    
Other Study ID Numbers: IRB14-00218
First Posted: July 14, 2014    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: November 27, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter Minneci, Nationwide Children's Hospital:
Appendicitis
Non-operative
Children
 Appendicolith
fecalith
Pediatrics
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
 Intestinal Diseases
Anti-Bacterial Agents
Amoxicillin-Potassium Clavulanate Combination
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action