<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/NCT04476498</url>
  </required_header>
  <id_info>
    <org_study_id>JWGUHMED1-013</org_study_id>
    <nct_id>NCT04476498</nct_id>
  </id_info>
  <brief_title>Prospective Comparison of Pull-PEG and Pull-PEG With Gastropexy</brief_title>
  <official_title>Incidence of Peristomal Infection After Pull-PEG Compared to Pull-PEG With Gastropexy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johann Wolfgang Goethe University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johann Wolfgang Goethe University Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to compare the conventional pull-percutaneous endoscopic gastrostomy&#xD;
      (pull-PEG) with a pull-PEG with gastropexy suture regarding the peristomal infection rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pull-percutaneous endoscopic gastrostomy (Pull-PEG) is currently the standard technique for&#xD;
      enteral nutrition in patients with swallowing disorders. Fistula and peristomal infection&#xD;
      rates are one of the most common early complications which are caused by bacterial&#xD;
      transmission through the oropharyngeal passage of the tube and by bacterial translocation out&#xD;
      of the stomach into the abdominal wall. Retrospective data have shown that if pull-PEGs are&#xD;
      attached with a gastropexy suture, the abdominal wall and stomach are fixed tightly and&#xD;
      peristomal infection rates can be reduced significantly.&#xD;
&#xD;
      This randomised study wants to compare the peristomal infection rate of standard pull-PEGs&#xD;
      and pull-PEGs with gastropexy suture. Peristomal infection rate is detected by classical&#xD;
      inflammation rates including erythema, exsudates, and induration, development of pus, or&#xD;
      focal peritonitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">August 3, 2022</completion_date>
  <primary_completion_date type="Actual">July 18, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>This study is a randomised prospective monocentric study with a one to one allocation in two different treatment arms.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The participants don't know which arm they were allocated to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Peristomal infection rate</measure>
    <time_frame>36 months</time_frame>
    <description>Peristomal infection rate will be compared after conventional pull-PEG and pull-PEG with gastropexy. Peristomal infection is detected classical inflammation parameters (erythema, indulation, exsudate, ulcer and bleeding).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postinterventional bleeding</measure>
    <time_frame>36 months</time_frame>
    <description>Postinterventional bleeding after PEG insertion with and without gastropexy will be observed by clinical bleeding signs and control of laboratory parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postinterventional occurrence of fistulas</measure>
    <time_frame>36 months</time_frame>
    <description>Occurence of fistulas after PEG-insertion with and without gastropexy will be detected by clinical signs and laboratory parameters</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Peristomal Infection Rate</condition>
  <condition>Postinterventional Bleeding</condition>
  <condition>Postinterventional Mortality Rate</condition>
  <arm_group>
    <arm_group_label>Standard pull-PEG</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard pull-PEG&#xD;
In this group the participants receive a conventional pull-PEG as firstly described by Ponsky and Gauderer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pull-PEG with gastropexy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pull-PEG with gastropexy&#xD;
In this group the participants firstly receive a gastropexy with the Funada style gastropexy device. Afterwards a conventional pull-PEG will be inserted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pull-PEG with Gastropexy</intervention_name>
    <description>Additionally to a conventional pull-PEG a gastropexy will be performed.</description>
    <arm_group_label>Pull-PEG with gastropexy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 and over with an indication for a PEG-insertion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA-classification &gt;4&#xD;
&#xD;
          -  female patients who are pregnant or breast feeding&#xD;
&#xD;
          -  existing contraindications for a PEG-implantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mireen Friedrich-Rust, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Universitätsklinikum Frankfurt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum der J. W. Goethe-Universität</name>
      <address>
        <city>Frankfurt am Main</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johann Wolfgang Goethe University Hospital</investigator_affiliation>
    <investigator_full_name>Georg Dultz</investigator_full_name>
    <investigator_title>Senior physician</investigator_title>
  </responsible_party>
  <keyword>Pull-PEG</keyword>
  <keyword>Pull-PEG with gastropexy</keyword>
  <keyword>Peristomal infection rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</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/NCT04476498
org study id: JWGUHMED1-013
nct id: NCT04476498
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to compare the conventional pull-percutaneous endoscopic gastrostomy
      (pull-PEG) with a pull-PEG with gastropexy suture regarding the peristomal infection rate.
Pull-percutaneous endoscopic gastrostomy (Pull-PEG) is currently the standard technique for
      enteral nutrition in patients with swallowing disorders. Fistula and peristomal infection
      rates are one of the most common early complications which are caused by bacterial
      transmission through the oropharyngeal passage of the tube and by bacterial translocation out
      of the stomach into the abdominal wall. Retrospective data have shown that if pull-PEGs are
      attached with a gastropexy suture, the abdominal wall and stomach are fixed tightly and
      peristomal infection rates can be reduced significantly.

      This randomised study wants to compare the peristomal infection rate of standard pull-PEGs
      and pull-PEGs with gastropexy suture. Peristomal infection rate is detected by classical
      inflammation rates including erythema, exsudates, and induration, development of pus, or
      focal peritonitis.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study is a randomised prospective monocentric study with a one to one allocation in two different treatment arms.
primary purpose: Treatment
masking: Single (Participant)
masking description: The participants don't know which arm they were allocated to.
measure: Peristomal infection rate
time frame: 36 months
description: Peristomal infection rate will be compared after conventional pull-PEG and pull-PEG with gastropexy. Peristomal infection is detected classical inflammation parameters (erythema, indulation, exsudate, ulcer and bleeding).
measure: Postinterventional bleeding
time frame: 36 months
description: Postinterventional bleeding after PEG insertion with and without gastropexy will be observed by clinical bleeding signs and control of laboratory parameters
measure: Postinterventional occurrence of fistulas
time frame: 36 months
description: Occurence of fistulas after PEG-insertion with and without gastropexy will be detected by clinical signs and laboratory parameters
arm group label: Standard pull-PEG
arm group type: No Intervention
description: Standard pull-PEG
In this group the participants receive a conventional pull-PEG as firstly described by Ponsky and Gauderer.
arm group label: Pull-PEG with gastropexy
arm group type: Active Comparator
description: Pull-PEG with gastropexy
In this group the participants firstly receive a gastropexy with the Funada style gastropexy device. Afterwards a conventional pull-PEG will be inserted.
intervention type: Procedure
intervention name: Pull-PEG with Gastropexy
description: Additionally to a conventional pull-PEG a gastropexy will be performed.
arm group label: Pull-PEG with gastropexy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mireen Friedrich-Rust, Professor
role: Study Chair
affiliation: Universitätsklinikum Frankfurt
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Georg Dultz
investigator title: Senior physician
mesh term: Infections
sharing ipd: No