<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/NCT04435340</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00122</org_study_id>
    <nct_id>NCT04435340</nct_id>
  </id_info>
  <brief_title>Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh</brief_title>
  <official_title>Clinical and Sonographic Outcome After Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh in the Retro-rectus (Sublay) Position</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spital Limmattal Schlieren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spital Limmattal Schlieren</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>
      Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in&#xD;
      sublay position are examined for their recurrence rate&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study includes all patients operated from 11.03.2014 to 31.12.2020. Patients will undergo&#xD;
      a Sonography at least one year after surgery. The patients operated form 11.03.2014 to date&#xD;
      are therefore a retrospective cohort, the patients from to date until 31.12.2020 a&#xD;
      prospective cohort. This method is used to achieve the highest possible number of patients in&#xD;
      a define period of time with no alteration of surgical technique.&#xD;
&#xD;
      All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3&#xD;
      years after surg ery via phone call or letter, informed about the study and asked to&#xD;
      participate. In case of informed consent, they are invited to the study site. They are asked&#xD;
      to complete the questionnaires and they undergo a Sonography of the ventral abdomen.&#xD;
&#xD;
      All patients in the prospective cohort are informed about the study and asked to participate&#xD;
      in the outpatient clinic before surgery. In case of informed consent, they are invited to the&#xD;
      study site at least one year and three years, respectively, after surgery. They are asked to&#xD;
      complete the questionnaires and they undergo an ultrasound of the ventral abdomen.&#xD;
&#xD;
      The latest follow up should be completed by 31.03.2022.&#xD;
&#xD;
      For both, the retro- and prospective arm, the time needed for the follow-up appointment is&#xD;
      approximately 1 hour. The completion of the ultrasound is estimated to take 20 minutes, the&#xD;
      questionnaires is estimated to take 20-30 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2018</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>retro- and prospective arm</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrance rate in sonography</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination and sonography. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrance rate clinically</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Clinical subjective outcome 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Limitations in quality of life questionnaire</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Clinical subjective outcome 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily activities measured HerQLes questionnaire</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Clinical subjective outcome 3</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Abdominal Hernia</condition>
  <arm_group>
    <arm_group_label>Retrospective</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surgery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prospective</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Selective Sonography of the ventral abdominal hernia level</intervention_name>
    <description>The primary outcome of the study is measured by an radiologist experienced in abdominal ultrasound with a linear ultrasound transducer (ML 6-15 Hz). In case of aggravated examination circumstances a different ultrasound transducer is used (linear 9 L or convex C 1-6 Hz)</description>
    <arm_group_label>Prospective</arm_group_label>
    <arm_group_label>Retrospective</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age older than 18 years&#xD;
&#xD;
          -  Initially suffering from ventral abdominal hernia&#xD;
&#xD;
          -  Performance of open ventral abdominal hernia repair with self-adhering, atraumatic&#xD;
             mesh (Adhesix ®)&#xD;
&#xD;
          -  Informed Consent as documented by signature (Appendix: Informed Consent Form)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to comply with the study protocol&#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>Study Chair</role>
    <affiliation>Spital Limmattal Schlieren</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spital Limmattal</name>
      <address>
        <city>Schlieren</city>
        <state>Zurich</state>
        <zip>8952</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spital Limmattal Schlieren</investigator_affiliation>
    <investigator_full_name>Prof Urs Zingg</investigator_full_name>
    <investigator_title>Head of Department of Surgery</investigator_title>
  </responsible_party>
  <keyword>Abdominal Hernia</keyword>
  <keyword>Ventral Hernia</keyword>
  <keyword>Atraumatic mesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Abdominal</mesh_term>
    <mesh_term>Internal Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</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/NCT04435340
org study id: 2018-00122
nct id: NCT04435340
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in
      sublay position are examined for their recurrence rate
The study includes all patients operated from 11.03.2014 to 31.12.2020. Patients will undergo
      a Sonography at least one year after surgery. The patients operated form 11.03.2014 to date
      are therefore a retrospective cohort, the patients from to date until 31.12.2020 a
      prospective cohort. This method is used to achieve the highest possible number of patients in
      a define period of time with no alteration of surgical technique.

      All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3
      years after surg ery via phone call or letter, informed about the study and asked to
      participate. In case of informed consent, they are invited to the study site. They are asked
      to complete the questionnaires and they undergo a Sonography of the ventral abdomen.

      All patients in the prospective cohort are informed about the study and asked to participate
      in the outpatient clinic before surgery. In case of informed consent, they are invited to the
      study site at least one year and three years, respectively, after surgery. They are asked to
      complete the questionnaires and they undergo an ultrasound of the ventral abdomen.

      The latest follow up should be completed by 31.03.2022.

      For both, the retro- and prospective arm, the time needed for the follow-up appointment is
      approximately 1 hour. The completion of the ultrasound is estimated to take 20 minutes, the
      questionnaires is estimated to take 20-30 minutes.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: retro- and prospective arm
primary purpose: Diagnostic
masking: Single (Participant)
measure: Recurrance rate in sonography
time frame: 12 months after surgery
description: The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination and sonography. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .
measure: Recurrance rate clinically
time frame: 12 months after surgery
description: The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .
measure: Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire
time frame: 12 months after surgery
description: Clinical subjective outcome 1
measure: Limitations in quality of life questionnaire
time frame: 12 months after surgery
description: Clinical subjective outcome 2
measure: Daily activities measured HerQLes questionnaire
time frame: 12 months after surgery
description: Clinical subjective outcome 3
arm group label: Retrospective
arm group type: Other
description: All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surgery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen.
arm group label: Prospective
arm group type: Other
description: All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen.
intervention type: Diagnostic Test
intervention name: Selective Sonography of the ventral abdominal hernia level
description: The primary outcome of the study is measured by an radiologist experienced in abdominal ultrasound with a linear ultrasound transducer (ML 6-15 Hz). In case of aggravated examination circumstances a different ultrasound transducer is used (linear 9 L or convex C 1-6 Hz)
arm group label: Prospective
arm group label: Retrospective
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Urs Zingg
role: Study Chair
affiliation: Spital Limmattal Schlieren
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Spital Limmattal Schlieren
investigator full name: Prof Urs Zingg
investigator title: Head of Department of Surgery
mesh term: Hernia
mesh term: Hernia, Abdominal
mesh term: Internal Hernia
mesh term: Hernia, Ventral
sharing ipd: No