<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/NCT04434573</url>
  </required_header>
  <id_info>
    <org_study_id>20_213</org_study_id>
    <nct_id>NCT04434573</nct_id>
  </id_info>
  <brief_title>Consensus in Surgical Community for Asymptomatic Abdominal Wall and Incisional Hernias</brief_title>
  <official_title>Asymptomatic Abdominal Wall and Incisional Hernias: Is Therapeutic Decision Consensual An International Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hernia pathology is one of the leading causes of surgery worldwide. For asymptomatic&#xD;
      patients, surgery remains questionable. Although there are new European recommendations, the&#xD;
      practice of digestive surgeons regarding the management of asymptomatic hernias is unknown.&#xD;
      The objective of this study was to evaluate the practices of a large population of digestive&#xD;
      surgeons with asymptomatic hernia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number and type of clinical cases for which a consensus, defined by an arbitrary value of 75% of surgeons with the same therapeutic attitude</measure>
    <time_frame>The outcome measure is evaluated after 6 months during which the survey is online (from october 2016 to march 2017), time during which surgeons had access to answer it</time_frame>
    <description>The survey consists of general questions about the surgeons' activity and then 13 clinical situations where a decision is requested. The clinical cases are developed by the authors of the study in order to solve the frequent problems with the treatment of hernias and incisional hernias</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">204</enrollment>
  <condition>Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias</condition>
  <condition>Comparison With International Recommendations</condition>
  <arm_group>
    <arm_group_label>french-speaking digestive surgeons</arm_group_label>
    <description>french-speaking digestive surgeons are visceral and digestive surgeons that have a general surgical activity too. They can have or not an expertise on hernia pathology. They are questioned by survey on decisions about different patient asymptomatic hernia clinical situations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation study</intervention_name>
    <description>French-speaking digestive surgeons are invited to respond to an online survey consisting of 13 common clinical situations concerning primary or asymptomatic incisional hernia pathology where a therapeutic decision is requested.</description>
    <arm_group_label>french-speaking digestive surgeons</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        French-speaking surgeons&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Ile De France</state>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Incisional Hernia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04434573
org study id: 20_213
nct id: NCT04434573
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hernia pathology is one of the leading causes of surgery worldwide. For asymptomatic
      patients, surgery remains questionable. Although there are new European recommendations, the
      practice of digestive surgeons regarding the management of asymptomatic hernias is unknown.
      The objective of this study was to evaluate the practices of a large population of digestive
      surgeons with asymptomatic hernia.
observational model: Other
time perspective: Prospective
measure: number and type of clinical cases for which a consensus, defined by an arbitrary value of 75% of surgeons with the same therapeutic attitude
time frame: The outcome measure is evaluated after 6 months during which the survey is online (from october 2016 to march 2017), time during which surgeons had access to answer it
description: The survey consists of general questions about the surgeons' activity and then 13 clinical situations where a decision is requested. The clinical cases are developed by the authors of the study in order to solve the frequent problems with the treatment of hernias and incisional hernias
arm group label: french-speaking digestive surgeons
description: french-speaking digestive surgeons are visceral and digestive surgeons that have a general surgical activity too. They can have or not an expertise on hernia pathology. They are questioned by survey on decisions about different patient asymptomatic hernia clinical situations.
intervention type: Other
intervention name: Observation study
description: French-speaking digestive surgeons are invited to respond to an online survey consisting of 13 common clinical situations concerning primary or asymptomatic incisional hernia pathology where a therapeutic decision is requested.
arm group label: french-speaking digestive surgeons
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Hernia
mesh term: Incisional Hernia