<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/NCT03025932</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01510</org_study_id>
    <nct_id>NCT03025932</nct_id>
  </id_info>
  <brief_title>Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia</brief_title>
  <official_title>Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof Urs Zingg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spital Limmattal Schlieren</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who underwent laparoscopic repair of large hiatal hernias and anterior&#xD;
      fundoplication with mesh are examined for their recurrence rate one year after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">January 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2027</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan</measure>
    <time_frame>minimum 1 year after surgery</time_frame>
    <description>To evaluate the radiological recurrence rate of hiatal hernia at least one year after surgery by performing a computer tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life by GIQLI</measure>
    <time_frame>minimum 1 year after surgery</time_frame>
    <description>Estimate the quality of life using a standardized questionnaire (Gastrointestinal Qualitiy of Life Index = GIQLI) at least one year after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome</measure>
    <time_frame>minimum 1 year after surgery</time_frame>
    <description>Evaluate the clinical outcome at least one year after surgery by examining the patient and asking targeted questions on the symptoms regarding the former hiatal hernia (using visual analogue scale questions on dysphagia, meteorism, bloating, reflux and retrosternal pain). Furthermore the patients are asked about their general satisfaction regarding the performed surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri- and postoperative morbidity / mortality</measure>
    <time_frame>minimum 1 year after surgery</time_frame>
    <description>Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hiatal Hernia Large</condition>
  <arm_group>
    <arm_group_label>Patient cohort</arm_group_label>
    <description>Patients who underwent laparoscopic hernia repair of giant hiatal hernia with mesh and received anterior fundoplication</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>repair of giant hiatal hernia with mesh and anterior fundoplication</intervention_name>
    <arm_group_label>Patient cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion of all patients older than 18 years with initial large hiatal hernia (&gt;20%&#xD;
        herniated into thoracic cavity) and laparoscopic hiatoplasty with mesh and anterior&#xD;
        fundoplication&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age older than 18 years&#xD;
&#xD;
          -  Initially suffering from large hiatal hernia (&gt;20% of the stomach in the thoracic&#xD;
             cavity)&#xD;
&#xD;
          -  Performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication&#xD;
&#xD;
          -  Informed Consent as documented by signature (Appendix: Informed Consent Form)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication&#xD;
&#xD;
          -  Performance of anterior fundoplication without mesh&#xD;
&#xD;
          -  Women who meet the inclusion criteria but are pregnant or breast feeding or have the&#xD;
             intention to become pregnant during the course of the study&#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>Urs Zingg</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Spital Limmattal Schlieren</investigator_affiliation>
    <investigator_full_name>Prof Urs Zingg</investigator_full_name>
    <investigator_title>PD Dr. med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Hernia, Hiatal</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/NCT03025932
org study id: 2016-01510
nct id: NCT03025932
lead sponsor: 
has dmc: No
Patients who underwent laparoscopic repair of large hiatal hernias and anterior
      fundoplication with mesh are examined for their recurrence rate one year after surgery.
observational model: Case-Only
time perspective: Retrospective
measure: Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan
time frame: minimum 1 year after surgery
description: To evaluate the radiological recurrence rate of hiatal hernia at least one year after surgery by performing a computer tomography
measure: Quality of life by GIQLI
time frame: minimum 1 year after surgery
description: Estimate the quality of life using a standardized questionnaire (Gastrointestinal Qualitiy of Life Index = GIQLI) at least one year after surgery
measure: Clinical outcome
time frame: minimum 1 year after surgery
description: Evaluate the clinical outcome at least one year after surgery by examining the patient and asking targeted questions on the symptoms regarding the former hiatal hernia (using visual analogue scale questions on dysphagia, meteorism, bloating, reflux and retrosternal pain). Furthermore the patients are asked about their general satisfaction regarding the performed surgical intervention.
measure: Peri- and postoperative morbidity / mortality
time frame: minimum 1 year after surgery
description: Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination
arm group label: Patient cohort
description: Patients who underwent laparoscopic hernia repair of giant hiatal hernia with mesh and received anterior fundoplication
intervention type: Procedure
intervention name: repair of giant hiatal hernia with mesh and anterior fundoplication
arm group label: Patient cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Urs Zingg
role: Principal Investigator
affiliation: Principal Investigator
responsible party type: Sponsor-Investigator
investigator affiliation: Spital Limmattal Schlieren
investigator full name: Prof Urs Zingg
investigator title: PD Dr. med.
mesh term: Hernia
mesh term: Recurrence
mesh term: Hernia, Hiatal
sharing ipd: No