<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/NCT04454112</url>
  </required_header>
  <id_info>
    <org_study_id>2019/192</org_study_id>
    <nct_id>NCT04454112</nct_id>
  </id_info>
  <brief_title>Pre and Post-gastrostomy Evaluation of GER in Children Using 24-hour pH Monitoring</brief_title>
  <official_title>Pre and Post-gastrostomy Evaluation of Gastroesophageal Reflux in Children Using 24-hour pH Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatma Demirbaş</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ondokuz Mayıs University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate 24-hour pH monitoring results before and after&#xD;
      gastrostomy in neurological impaired (NI) children who underwent gastrostomy or Nissen&#xD;
      fundoplication (NF) concurrently with gastrostomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastrointestinal (GI) problems causing malnutrition may develop quite frequently in patients&#xD;
      with neuromotor developmental delay. Diagnosis of GERD in patients with neurological&#xD;
      impairment (NI) might be more difficult due to the absence of characteristic features in many&#xD;
      cases. One of the best methods for the diagnosis of GER is the 24-hour esophageal pH&#xD;
      monitoring.Even though there are some statements in the literature advocating that&#xD;
      gastroesophageal reflux may develop in the late period in patients undergoing only&#xD;
      gastrostomy, there are also reports supporting that gastrostomy does not contribute to the&#xD;
      development of reflux.Regardless of whether the patient received anti-reflux surgery or not,&#xD;
      the long-term follow-up is necessary in patients feeding with gastrostomy.The aim of this&#xD;
      study is to compare the results of pre- and postoperative 24-hour pH monitoring in patients&#xD;
      who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy&#xD;
      and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2018</start_date>
  <completion_date type="Actual">December 12, 2018</completion_date>
  <primary_completion_date type="Actual">December 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>to compare the results of pre- and postoperative 24-hour pH monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring</measure>
    <time_frame>2 month</time_frame>
    <description>NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring</measure>
    <time_frame>7 month</time_frame>
    <description>NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Gastroesophageal Reflux</condition>
  <arm_group>
    <arm_group_label>24-hour esophageal pH monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24-hour esophageal pH monitoring was conducted using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands). This system consists of a portable data logger (MMS Investigation and Diagnostic Software®) and a disposable catheter which contains two pH electrodes (Unisensor, Attikon, Switzerland). Before recording, the pH electrode was calibrated in the special buffer solutions at pH values of 1 and 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>24-hour esophageal pH monitoring using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands).</intervention_name>
    <description>24-hour esophageal pH monitoring application</description>
    <arm_group_label>24-hour esophageal pH monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of neurological damage Must be able to apply gastrostomy or Nissen&#xD;
        fundoplication concurrently with gastrostomy.&#xD;
&#xD;
        exclusion Criteria: to use anti-reflux medications long period of time gastroesophageal&#xD;
        reflux disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Berat Dilek Demirel</last_name>
    <role>Study Chair</role>
    <affiliation>she underwent gastrostomy to patients with neurological damage</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ondokuz Mayıs University Faculty of Medicine, Department of Pediatric Gastroenterology, Hepatology and Nutrition,</name>
      <address>
        <city>Kurupelit/</city>
        <state>Samsun</state>
        <zip>55200/</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ondokuz Mayıs University</investigator_affiliation>
    <investigator_full_name>Fatma Demirbaş</investigator_full_name>
    <investigator_title>Doctor of Pediatric Gastroenterology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</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/NCT04454112
org study id: 2019/192
nct id: NCT04454112
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this study was to evaluate 24-hour pH monitoring results before and after
      gastrostomy in neurological impaired (NI) children who underwent gastrostomy or Nissen
      fundoplication (NF) concurrently with gastrostomy.
Gastrointestinal (GI) problems causing malnutrition may develop quite frequently in patients
      with neuromotor developmental delay. Diagnosis of GERD in patients with neurological
      impairment (NI) might be more difficult due to the absence of characteristic features in many
      cases. One of the best methods for the diagnosis of GER is the 24-hour esophageal pH
      monitoring.Even though there are some statements in the literature advocating that
      gastroesophageal reflux may develop in the late period in patients undergoing only
      gastrostomy, there are also reports supporting that gastrostomy does not contribute to the
      development of reflux.Regardless of whether the patient received anti-reflux surgery or not,
      the long-term follow-up is necessary in patients feeding with gastrostomy.The aim of this
      study is to compare the results of pre- and postoperative 24-hour pH monitoring in patients
      who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy
      and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: to compare the results of pre- and postoperative 24-hour pH monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring
time frame: 2 month
description: NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.
measure: Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring
time frame: 7 month
description: NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.
arm group label: 24-hour esophageal pH monitoring
arm group type: Experimental
description: 24-hour esophageal pH monitoring was conducted using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands). This system consists of a portable data logger (MMS Investigation and Diagnostic Software®) and a disposable catheter which contains two pH electrodes (Unisensor, Attikon, Switzerland). Before recording, the pH electrode was calibrated in the special buffer solutions at pH values of 1 and 2.
intervention type: Device
intervention name: 24-hour esophageal pH monitoring using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands).
description: 24-hour esophageal pH monitoring application
arm group label: 24-hour esophageal pH monitoring
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Berat Dilek Demirel
role: Study Chair
affiliation: she underwent gastrostomy to patients with neurological damage
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Ondokuz Mayıs University
investigator full name: Fatma Demirbaş
investigator title: Doctor of Pediatric Gastroenterology
mesh term: Gastroesophageal Reflux
sharing ipd: No