<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/NCT04493801</url>
  </required_header>
  <id_info>
    <org_study_id>HLNS ( 29BRC18.0257)</org_study_id>
    <nct_id>NCT04493801</nct_id>
  </id_info>
  <brief_title>Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap</brief_title>
  <acronym>HLNS</acronym>
  <official_title>Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Determine and compare prospectively the incidence of rhinological adverse events during&#xD;
      pituitary surgery with or without nasoseptal flap&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 23, 2019</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>post operative epistaxis</measure>
    <time_frame>during two month after surgery</time_frame>
    <description>no epistaxis - begnin epistaxis - severe epistaxis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>post operative rhinoliquorrhea</measure>
    <time_frame>during two month after surgery</time_frame>
    <description>physical examination and symptomatic rhinorrhea</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Surgery--Complications</condition>
  <arm_group>
    <arm_group_label>with nasoseptal flap</arm_group_label>
    <description>patient who undergo a pituitary gland surgery with nasoseptal flap</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without nasoseptal flap</arm_group_label>
    <description>patient who undergo a pituitary gland surgery without nasoseptal flap</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients who undergoing a pituary gland surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  to be over 18 years old&#xD;
&#xD;
          -  to be operated on for pituitary surgery&#xD;
&#xD;
          -  to have express no objection to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal to participate in the study&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  to be Under the age of 18&#xD;
&#xD;
          -  not being able to understand and accept participation in the study&#xD;
&#xD;
          -  to have a life expectancy of less than a year&#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_contact>
    <last_name>Emmanuel Mornet</last_name>
    <phone>330298223004</phone>
    <email>emmanuel.mornet@chu-brest.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Romuald seizeur</last_name>
    <phone>330298342585</phone>
    <email>romuald.seizeur@chu-brest.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuel MORNET</last_name>
      <email>emmanuel.mornet@chu-brest.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 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>Pituitary Diseases</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/NCT04493801
org study id: HLNS ( 29BRC18.0257)
nct id: NCT04493801
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Determine and compare prospectively the incidence of rhinological adverse events during
      pituitary surgery with or without nasoseptal flap
observational model: Case-Control
time perspective: Prospective
measure: post operative epistaxis
time frame: during two month after surgery
description: no epistaxis - begnin epistaxis - severe epistaxis.
measure: post operative rhinoliquorrhea
time frame: during two month after surgery
description: physical examination and symptomatic rhinorrhea
arm group label: with nasoseptal flap
description: patient who undergo a pituitary gland surgery with nasoseptal flap
arm group label: without nasoseptal flap
description: patient who undergo a pituitary gland surgery without nasoseptal flap
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanuel Mornet
phone: 330298223004
email: emmanuel.mornet@chu-brest.fr
last name: Romuald seizeur
phone: 330298342585
email: romuald.seizeur@chu-brest.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Pituitary Diseases