<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01718275</url>
  </required_header>
  <id_info>
    <org_study_id>IRB12-00406</org_study_id>
    <nct_id>NCT01718275</nct_id>
  </id_info>
  <brief_title>Non-operative Management of Early Appendicitis in Children</brief_title>
  <official_title>Non-operative Management of Early Appendicitis in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peter Minneci</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the feasibility of non-operative management of&#xD;
      early appendicitis in children. We hypothesize that non-operative management of early&#xD;
      appendicitis in children with antibiotics alone will be successful in 80% of children at 1&#xD;
      year follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-operative management of appendicitis with antibiotics alone has recently emerged as a&#xD;
      viable treatment alternative to appendectomy. There have been several clinical trials in&#xD;
      adults which conclude that antibiotics alone are a safe initial treatment for appendicitis;&#xD;
      none of these studies included children.&#xD;
&#xD;
      The primary objective of this study is to determine: conversion to surgery (failure of&#xD;
      nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in&#xD;
      children treated with non-operative management. Recurrence is defined as need for&#xD;
      appendectomy. The secondary objective is to compare adverse outcomes, length of stay, days to&#xD;
      return to school, costs of care and quality of life measures between the study group and&#xD;
      those that receive standard of care.We hypothesize that non-operative management of early&#xD;
      appendicitis in children with antibiotics alone will be successful in 80% of children at 1&#xD;
      year follow-up.&#xD;
&#xD;
      This is a prospective, non-randomized single-site trial measuring the feasibility of treating&#xD;
      children (7-17 years old) with early appendicitis with antibiotics only (non-operative&#xD;
      management). There will be two cohorts; those who agree to receive non-operative management&#xD;
      (Non-Operative Group) and those that permit us to track their standard treatment course&#xD;
      (Surgery Group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Anticipated">August 22, 2023</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Failure of Non-operative management</measure>
    <time_frame>1 year</time_frame>
    <description>The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Outcomes</measure>
    <time_frame>1 year</time_frame>
    <description>The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Appendicitis</condition>
  <arm_group>
    <arm_group_label>Non-operative Group</arm_group_label>
    <description>Patients and caregivers who agree to receive non-operative management with antibiotics alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgery Group</arm_group_label>
    <description>Patients and caregivers who decide to undergo appendectomy that permit us to track their standard treatment course</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children treated a tertiary care Children's Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age : 7-17 years&#xD;
&#xD;
          -  Ultrasound (US) or CT scan confirmed early appendicitis (US: hyperemia, &lt;1.1 cm in&#xD;
             diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; CT:&#xD;
             hyperemia, fat stranding, &lt;1.1 cm in diameter, no abscess, no fecalith, no phlegmon)&#xD;
&#xD;
          -  White blood cell count (WBC) &lt; 15,000&#xD;
&#xD;
          -  C reactive protein (CRP) &lt;4 (if obtained)&#xD;
&#xD;
          -  Focal abdominal pain &lt;/= 36 hours prior to receiving antibiotics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  English is not the primary language of either the child or parent/guardian&#xD;
&#xD;
          -  Other significant co-morbidities: cardiovascular disease, malignancy, pulmonary&#xD;
             disease, diabetes, obesity (BMI ≥ 95th percentile for age and sex), severe&#xD;
             developmental delay&#xD;
&#xD;
          -  Positive urine pregnancy test&#xD;
&#xD;
          -  Diffuse peritonitis&#xD;
&#xD;
          -  Fecalith&#xD;
&#xD;
          -  History of chronic intermittent abdominal pain&#xD;
&#xD;
          -  WBC &gt;/= 15&#xD;
&#xD;
          -  CRP&gt;/= 4 (if obtained)&#xD;
&#xD;
          -  Pain &gt; 36 hours prior to first antibiotic dose or any evidence on imaging studies&#xD;
             concerning for evolving perforated appendicitis including abscess or phlegmon&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter C Minneci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>26676711</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>24951281</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Peter Minneci</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Appendicitis</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Children</keyword>
  <keyword>Non-operative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01718275
org study id: IRB12-00406
nct id: NCT01718275
lead sponsor: 
has dmc: No
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.
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).
observational model: Case-Control
time perspective: Prospective
measure: Failure of Non-operative management
time frame: 1 year
description: The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.
measure: Adverse Outcomes
time frame: 1 year
description: The secondary endpoints are: adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures.
arm group label: Non-operative Group
description: Patients and caregivers who agree to receive non-operative management with antibiotics alone
arm group label: Surgery Group
description: Patients and caregivers who decide to undergo appendectomy that permit us to track their standard treatment course
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Peter C Minneci, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
citation: 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
citation: 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
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Peter Minneci
investigator title: Principal Investigator
mesh term: Appendicitis
sharing ipd: No