<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/NCT04499469</url>
  </required_header>
  <id_info>
    <org_study_id>91672218400005327</org_study_id>
    <nct_id>NCT04499469</nct_id>
  </id_info>
  <brief_title>The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment</brief_title>
  <official_title>The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Nasal obstruction is one of the majors concerns in reduction rhinoseptoplasty, because it&#xD;
      affects quality of life and surgical outcomes. Is the association of middle third grafts with&#xD;
      reduction rhinoseptoplasty responsible for an increase in quality of life related to nasal&#xD;
      obstruction when compared to reduction rhinoseptoplasty without the placement of these&#xD;
      grafts?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reduction rhinoplasty and rhinoseptoplasty are among the most accomplished aesthetic&#xD;
      procedures in Plastic Surgery and Otorhinolaryngology. Nasal obstruction is one of the majors&#xD;
      concerns in this procedures, because it affects quality of life and surgical outcomes. Nasal&#xD;
      surgeons have paid much attention to nasal valve area to prevent nasal obstruction and some&#xD;
      assert reconstruction of the middle vault after dorsal reduction with grafts. The gold&#xD;
      standard for middle vault reconstruction after dorsal reduction has been the spreader graft,&#xD;
      first advocated by Sheen. Studies in surgical techniques for the treatment of nasal valve&#xD;
      collapse focus much more in techniques than in evidence of its efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 3, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nasal Obstruction Symptom Evaluation Scale (NOSE)</measure>
    <time_frame>180 postoperative days</time_frame>
    <description>The NOSE will be used to measure the quality of life related to nasal obstruction. It is a validated instrument specifically designed for use in patients with nasal obstruction. According to this scale patients are asked to evaluate difficulty breathing in a general way and specifically the difficulty in breathing through the nose, breathing during sleep, and severity of their nasal congestion. The severity of the symptoms is recorded on a scale of 0 to 4, with 0 being the absence of a problem and 4 being a serious problem. The possible scores range from 0 to 20 and the higher scores indicate a higher degree of nasal obstruction. The sum of the scores is multiplied by 5 so as to obtain a final score ranging from 0 to 100, with higher values associated with poorer quality of life.&#xD;
The scale will be applied at the base line and at 30, 90 and 180 postoperative days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rhinoplasty Outcome Evaluation (ROE) Scale</measure>
    <time_frame>180 postoperative days</time_frame>
    <description>The ROE scale is a questionnaire, designed for the evaluation of rhinoplasty results. This instrument is composed of six questions that assess three domains of quality of life: physical, mental / emotional and social. Each question is scored on a scale of 0 to 4 and converted to a total score of 0 to 100, dividing the value by 24 and multiplying by 100. A score above 85 is considered excellent and generally means that the patient is very satisfied. However, the comparison of pre and postoperative values usually provide the most relevant information. Patients will be asked to respond to this scale in the base line and at 30, 90 and 180 postoperative days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale - Nasal Obstruction</measure>
    <time_frame>180 postoperative days</time_frame>
    <description>Patients will be asked to complete an analogue-visual scale indicating the degree of nasal obstruction, with the instrument Visual Analogue Scale (VAS). The VAS for nasal obstruction has 100 mm and this scale will be converted into a scale ranging from 0 to 100, and the value &quot;0&quot; represents no nasal obstruction and the value &quot;100&quot; correspond to the highest nasal obstruction level possible. The scale will be applied in the base line as well as in the 30,90 and 180 postoperative days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Diagnosis of Allergic Rhinitis</measure>
    <time_frame>Base line and 180 postoperative days</time_frame>
    <description>A questionnaire of symptoms and intensity based in Allergic Rhinitis and its Impact on Asthma (ARIA) recommendations and treatment of Allergic Rhinitis is applied in the base line and 30, 90 and 180 postoperative days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>7 until 180 postoperative days</time_frame>
    <description>The protocol includes data such as bleeding, signs of graft detachment, presence of crusts, residual septal deviation, synechiae and septal perforation to be to be evaluated on the 7th, 30th, 90th and 180th postoperative days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anterior Rhinoscopy and Nasal Endoscopy</measure>
    <time_frame>Base line and 180 postoperative days</time_frame>
    <description>All patients will be submitted to anterior rhinoscopy and nasal endoscopy using a 0 degree rigid nasal endoscope. The septal deviation will be classified considering the side of maximum deviation (right / left), the severity of the obstruction caused by the septal deviation (&lt;25% of obstruction, 25-50% of obstruction, 50-75% of obstruction;&gt; 75% of obstruction) and the location of the point of greatest deviation based on the classification of the five Cottle areas.&#xD;
The evaluation of this outcome will be performed in the preoperative consultation, 30, 90 and 180 after the surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Rhinoplasty</condition>
  <condition>Nasal Obstruction</condition>
  <arm_group>
    <arm_group_label>Spreader Graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placement and attachment with 5.0 polydioxanone (PDS) suture 2 grafts in the middle third of the nose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without Spreader Graft</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No engraftment in the middle third</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spreader Graft</intervention_name>
    <description>To place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose</description>
    <arm_group_label>Spreader Graft</arm_group_label>
    <other_name>Middle Third Grafts</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients eligible for reduction rhinoseptoplasty who agreed to participate in the&#xD;
             study and who did not meet the exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of nasal obstruction;&#xD;
&#xD;
          -  Previous nasosinusal surgery;&#xD;
&#xD;
          -  Symmetrical or asymmetric insufficiency of the middle third that would justify the&#xD;
             placement of middle third grafts for the treatment of these problems;&#xD;
&#xD;
          -  Presence of nasal valve insufficiency as the only cause of nasal obstruction;&#xD;
&#xD;
          -  Cranio-facial anomalies;&#xD;
&#xD;
          -  Presence of nasosinusal tumors;&#xD;
&#xD;
          -  Active acute rhinosinusitis;&#xD;
&#xD;
          -  Patients undergoing treatment of other entities concomitant to rhinoseptoplasty such&#xD;
             as: sinus inflammatory surgery, adenoid hypertrophy removal, septal perforation&#xD;
             correction, otoplasty or blepharoplasty.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle Lavinsky-Wolff, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of Health Science of Porto Alegre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michelle Lavinsky-Wolff, PhD</last_name>
    <phone>555133598249</phone>
    <email>mlavinsky@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Raphaella Migliavacca, MsC</last_name>
    <phone>555133598249</phone>
    <email>raphaellamigliavacca@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Raphaella Migliavacca</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90480030</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raphaella Migliavacca, MsC</last_name>
      <phone>555133598249</phone>
      <email>raphaellamigliavacca@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Michelle Lavinsky-Wolff, PhD</last_name>
      <phone>555133598249</phone>
      <email>mlavinsky@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 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>Nasal Obstruction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04499469
org study id: 91672218400005327
nct id: NCT04499469
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nasal obstruction is one of the majors concerns in reduction rhinoseptoplasty, because it
      affects quality of life and surgical outcomes. Is the association of middle third grafts with
      reduction rhinoseptoplasty responsible for an increase in quality of life related to nasal
      obstruction when compared to reduction rhinoseptoplasty without the placement of these
      grafts?
Reduction rhinoplasty and rhinoseptoplasty are among the most accomplished aesthetic
      procedures in Plastic Surgery and Otorhinolaryngology. Nasal obstruction is one of the majors
      concerns in this procedures, because it affects quality of life and surgical outcomes. Nasal
      surgeons have paid much attention to nasal valve area to prevent nasal obstruction and some
      assert reconstruction of the middle vault after dorsal reduction with grafts. The gold
      standard for middle vault reconstruction after dorsal reduction has been the spreader graft,
      first advocated by Sheen. Studies in surgical techniques for the treatment of nasal valve
      collapse focus much more in techniques than in evidence of its efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Nasal Obstruction Symptom Evaluation Scale (NOSE)
time frame: 180 postoperative days
description: The NOSE will be used to measure the quality of life related to nasal obstruction. It is a validated instrument specifically designed for use in patients with nasal obstruction. According to this scale patients are asked to evaluate difficulty breathing in a general way and specifically the difficulty in breathing through the nose, breathing during sleep, and severity of their nasal congestion. The severity of the symptoms is recorded on a scale of 0 to 4, with 0 being the absence of a problem and 4 being a serious problem. The possible scores range from 0 to 20 and the higher scores indicate a higher degree of nasal obstruction. The sum of the scores is multiplied by 5 so as to obtain a final score ranging from 0 to 100, with higher values associated with poorer quality of life.
The scale will be applied at the base line and at 30, 90 and 180 postoperative days.
measure: Rhinoplasty Outcome Evaluation (ROE) Scale
time frame: 180 postoperative days
description: The ROE scale is a questionnaire, designed for the evaluation of rhinoplasty results. This instrument is composed of six questions that assess three domains of quality of life: physical, mental / emotional and social. Each question is scored on a scale of 0 to 4 and converted to a total score of 0 to 100, dividing the value by 24 and multiplying by 100. A score above 85 is considered excellent and generally means that the patient is very satisfied. However, the comparison of pre and postoperative values usually provide the most relevant information. Patients will be asked to respond to this scale in the base line and at 30, 90 and 180 postoperative days.
measure: Visual Analogue Scale - Nasal Obstruction
time frame: 180 postoperative days
description: Patients will be asked to complete an analogue-visual scale indicating the degree of nasal obstruction, with the instrument Visual Analogue Scale (VAS). The VAS for nasal obstruction has 100 mm and this scale will be converted into a scale ranging from 0 to 100, and the value "0" represents no nasal obstruction and the value "100" correspond to the highest nasal obstruction level possible. The scale will be applied in the base line as well as in the 30,90 and 180 postoperative days.
measure: Clinical Diagnosis of Allergic Rhinitis
time frame: Base line and 180 postoperative days
description: A questionnaire of symptoms and intensity based in Allergic Rhinitis and its Impact on Asthma (ARIA) recommendations and treatment of Allergic Rhinitis is applied in the base line and 30, 90 and 180 postoperative days
measure: Complications
time frame: 7 until 180 postoperative days
description: The protocol includes data such as bleeding, signs of graft detachment, presence of crusts, residual septal deviation, synechiae and septal perforation to be to be evaluated on the 7th, 30th, 90th and 180th postoperative days
measure: Anterior Rhinoscopy and Nasal Endoscopy
time frame: Base line and 180 postoperative days
description: All patients will be submitted to anterior rhinoscopy and nasal endoscopy using a 0 degree rigid nasal endoscope. The septal deviation will be classified considering the side of maximum deviation (right / left), the severity of the obstruction caused by the septal deviation (<25% of obstruction, 25-50% of obstruction, 50-75% of obstruction;> 75% of obstruction) and the location of the point of greatest deviation based on the classification of the five Cottle areas.
The evaluation of this outcome will be performed in the preoperative consultation, 30, 90 and 180 after the surgery.
arm group label: Spreader Graft
arm group type: Experimental
description: Placement and attachment with 5.0 polydioxanone (PDS) suture 2 grafts in the middle third of the nose
arm group label: Without Spreader Graft
arm group type: No Intervention
description: No engraftment in the middle third
intervention type: Procedure
intervention name: Spreader Graft
description: To place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose
arm group label: Spreader Graft
other name: Middle Third Grafts
criteria: 
gender: All
minimum age: 14 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michelle Lavinsky-Wolff, PhD
role: Study Director
affiliation: Federal University of Health Science of Porto Alegre
last name: Michelle Lavinsky-Wolff, PhD
phone: 555133598249
email: mlavinsky@gmail.com
last name: Raphaella Migliavacca, MsC
phone: 555133598249
email: raphaellamigliavacca@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Sponsor
mesh term: Nasal Obstruction
sharing ipd: Undecided