<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/NCT03294421</url>
  </required_header>
  <id_info>
    <org_study_id>50571215.0.0000.5327</org_study_id>
    <nct_id>NCT03294421</nct_id>
  </id_info>
  <brief_title>Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy</brief_title>
  <official_title>Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy</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>
      Chronic otitis media is a prevalent medical condition, leading to important impact in the&#xD;
      lives of the individuals with this condition, and a great amount of patients may need&#xD;
      surgical intervention. The main objectives of the surgery in these cases are to restore the&#xD;
      anatomy of the middle ear, to improve hearing and to remove the infection to avoid further&#xD;
      complications. Still, chronic otitis media with cholesteatoma presents high rates of&#xD;
      recurrence and residual symptoms after surgery.&#xD;
&#xD;
      The standard technique used for treatment of chronic otitis media is microsurgery.&#xD;
      Nonetheless, with the development of new technologies that use endoscopy, it is now possible&#xD;
      to use endoscopic surgery to improve the visualization of the cholesteatoma and ear&#xD;
      structures by combining both techniques.&#xD;
&#xD;
      This study will evaluate the efficacy of the combined access surgery technique, which is&#xD;
      microsurgery combined with endoscopy, for closed tympanomastoidectomy in patients with&#xD;
      cholesteatoma. Furthermore, the study aims to compare the results of the combined access&#xD;
      technique and the standard technique by randomizing the patients in two groups: one group&#xD;
      will receive tympanomastoidectomy by standard technique and the other group will receive&#xD;
      combined technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with cholesteatoma and medical indication of closed tympanomastoidectomy will be&#xD;
      randomized into two groups. In the first group, microsurgical tympanomastoidectomy will be&#xD;
      performed; while combined technique will be performed in the other group. The combined&#xD;
      technique improves the visualization of the middle ear canal and the mastoid. Herewith, the&#xD;
      best visualization of the surgical site facilitates the full removal of the cholesteatoma. In&#xD;
      addition to that, the combined technique is less invasive than the standard one, since less&#xD;
      bone debridement is required to access the surgical site.&#xD;
&#xD;
      The outcomes of the study will be evaluated through follow up medical appointments and exams.&#xD;
      The patients will be followed by monthly medical appointments with otoscopic evaluations for&#xD;
      diagnose of possible recurrence of the disease or residual cholesteatoma. Also, audiometry&#xD;
      exams will be performed in the third, sixth and twelfth months. Image exams such as nuclear&#xD;
      magnetic resonance may be performed at the end of this period to evaluate relapse of the&#xD;
      disease if the otoscopic evaluation is inconclusive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 7, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence of cholesteatoma.</measure>
    <time_frame>12 months post intervention.</time_frame>
    <description>Recurrence of cholesteatoma, which is defined as development of new disease in the same ear (not related with the previous cholesteatoma), will be evaluated through second look surgery or nuclear magnetic resonance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Residual cholesteatoma</measure>
    <time_frame>12 months post intervention.</time_frame>
    <description>Presence of residual cholesteatoma, which is defined as disease that was not fully removed in the first intervention, will be evaluated through second look surgery or nuclear magnetic resonance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hearing outcomes</measure>
    <time_frame>3 months post intervention.</time_frame>
    <description>Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: Pure tone average (PTA) 500.000 Hz to 2.000 Hz and air bone gap) after three months after surgery and compared with the audiometry exam made before the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing outcomes</measure>
    <time_frame>6 months post intervention.</time_frame>
    <description>Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: PTA 500.000 Hz to 2.000 Hz and air bone gap) after six months after surgery and compared with the audiometry exam made before the surgery and the audiometry exam made three months after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing outcomes</measure>
    <time_frame>12 months post intervention.</time_frame>
    <description>Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: PTA 500.000 Hz to 2.000 Hz and air bone gap) after twelve months after surgery and compared with the audiometry exam made before the surgery and the audiometry exams made three and six months after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of procedure</measure>
    <time_frame>measured in minutes from the surgical incision until the suture of the skin.</time_frame>
    <description>Compares the length of the closed tympanomastoidectomy with standard technique and the combined access tympanomastoidectomy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Cholesteatoma</condition>
  <condition>Chronic Otitis Media</condition>
  <arm_group>
    <arm_group_label>standard closed tympanomastoidectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group it will be performed the standard technique for closed tympanomastoidectomy, in which a surgical microscope is used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>combined access tympanomastoidectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group a closed tympanomastoidectomy with combined access will be performed. This technique combines the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>combined access tympanomastoidectomy</intervention_name>
    <description>Trans canal surgery with the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation allowing better visualization and removal of the cholesteatoma before mastoid debridement. In this surgery, mastoid debridement is conducted only if there was no full endoscopic removal of the cholesteatoma. The other procedures of this type of surgery are similar to the standard tympanomastoidectomy technique.</description>
    <arm_group_label>combined access tympanomastoidectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>standard closed tympanomastoidectomy</intervention_name>
    <description>Supine position and general anesthesia with orotracheal intubation&#xD;
Antisepsis and placing of sterile fields&#xD;
Local anesthesia of the external auditory canal with lidocaine 2% and adrenaline 1:100. 000 UI&#xD;
Retroauricular incision&#xD;
Removal of the temporal muscle fascia&#xD;
Elevation of the surgical flap of the tympanic meatus&#xD;
Visualization and exploration of the cholesteatoma&#xD;
Exploration of the ossicular chain&#xD;
Mastoid debridement&#xD;
Conservation of the upper posterior wall of the auditory conduct&#xD;
Removal of the cholesteatoma&#xD;
Tympanoplasty with the temporal fascia&#xD;
Retroauricular suture with vycril 3.0 and mononylon 4.0</description>
    <arm_group_label>standard closed tympanomastoidectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cholesteatoma with indication for closed tympanomastoidectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with malformation of the temporal bone or previous surgery in the ear&#xD;
             eligible for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sady S Da costa</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mauricio LS Da silva</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de clínicas de porto alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Paparella MM. Current concepts in otitis media. Henry Ford Hosp Med J. 1983;31(1):30-6. No abstract available.</citation>
    <PMID>6863004</PMID>
  </reference>
  <reference>
    <citation>Ghaffar S, Ikram M, Zia S, Raza A. Incorporating the endoscope into middle ear surgery. Ear Nose Throat J. 2006 Sep;85(9):593-6.</citation>
    <PMID>17044426</PMID>
  </reference>
  <reference>
    <citation>Lima Tde O, Araujo TF, Soares LC, Testa JR. The impact of endoscopy on the treatment of cholesteatomas. Braz J Otorhinolaryngol. 2013 Aug;79(4):505-11. doi: 10.5935/1808-8694.20130090.</citation>
    <PMID>23929154</PMID>
  </reference>
  <reference>
    <citation>Badr-El-Dine M, James AL, Panetti G, Marchioni D, Presutti L, Nogueira JF. Instrumentation and technologies in endoscopic ear surgery. Otolaryngol Clin North Am. 2013 Apr;46(2):211-25. doi: 10.1016/j.otc.2012.10.005.</citation>
    <PMID>23566907</PMID>
  </reference>
  <reference>
    <citation>Marchioni D, Soloperto D, Rubini A, Villari D, Genovese E, Artioli F, Presutti L. Endoscopic exclusive transcanal approach to the tympanic cavity cholesteatoma in pediatric patients: our experience. Int J Pediatr Otorhinolaryngol. 2015 Mar;79(3):316-22. doi: 10.1016/j.ijporl.2014.12.008. Epub 2015 Jan 7.</citation>
    <PMID>25631934</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>September 4, 2020</last_update_submitted>
  <last_update_submitted_qc>September 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 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>Otitis Media</mesh_term>
    <mesh_term>Cholesteatoma</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/NCT03294421
org study id: 50571215.0.0000.5327
nct id: NCT03294421
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic otitis media is a prevalent medical condition, leading to important impact in the
      lives of the individuals with this condition, and a great amount of patients may need
      surgical intervention. The main objectives of the surgery in these cases are to restore the
      anatomy of the middle ear, to improve hearing and to remove the infection to avoid further
      complications. Still, chronic otitis media with cholesteatoma presents high rates of
      recurrence and residual symptoms after surgery.

      The standard technique used for treatment of chronic otitis media is microsurgery.
      Nonetheless, with the development of new technologies that use endoscopy, it is now possible
      to use endoscopic surgery to improve the visualization of the cholesteatoma and ear
      structures by combining both techniques.

      This study will evaluate the efficacy of the combined access surgery technique, which is
      microsurgery combined with endoscopy, for closed tympanomastoidectomy in patients with
      cholesteatoma. Furthermore, the study aims to compare the results of the combined access
      technique and the standard technique by randomizing the patients in two groups: one group
      will receive tympanomastoidectomy by standard technique and the other group will receive
      combined technique.
Patients with cholesteatoma and medical indication of closed tympanomastoidectomy will be
      randomized into two groups. In the first group, microsurgical tympanomastoidectomy will be
      performed; while combined technique will be performed in the other group. The combined
      technique improves the visualization of the middle ear canal and the mastoid. Herewith, the
      best visualization of the surgical site facilitates the full removal of the cholesteatoma. In
      addition to that, the combined technique is less invasive than the standard one, since less
      bone debridement is required to access the surgical site.

      The outcomes of the study will be evaluated through follow up medical appointments and exams.
      The patients will be followed by monthly medical appointments with otoscopic evaluations for
      diagnose of possible recurrence of the disease or residual cholesteatoma. Also, audiometry
      exams will be performed in the third, sixth and twelfth months. Image exams such as nuclear
      magnetic resonance may be performed at the end of this period to evaluate relapse of the
      disease if the otoscopic evaluation is inconclusive.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence of cholesteatoma.
time frame: 12 months post intervention.
description: Recurrence of cholesteatoma, which is defined as development of new disease in the same ear (not related with the previous cholesteatoma), will be evaluated through second look surgery or nuclear magnetic resonance.
measure: Residual cholesteatoma
time frame: 12 months post intervention.
description: Presence of residual cholesteatoma, which is defined as disease that was not fully removed in the first intervention, will be evaluated through second look surgery or nuclear magnetic resonance.
measure: Hearing outcomes
time frame: 3 months post intervention.
description: Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: Pure tone average (PTA) 500.000 Hz to 2.000 Hz and air bone gap) after three months after surgery and compared with the audiometry exam made before the surgery.
measure: Hearing outcomes
time frame: 6 months post intervention.
description: Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: PTA 500.000 Hz to 2.000 Hz and air bone gap) after six months after surgery and compared with the audiometry exam made before the surgery and the audiometry exam made three months after surgery.
measure: Hearing outcomes
time frame: 12 months post intervention.
description: Hearing outcomes will be measured through audiometry exams (parameters that will be analyzed in the exam: PTA 500.000 Hz to 2.000 Hz and air bone gap) after twelve months after surgery and compared with the audiometry exam made before the surgery and the audiometry exams made three and six months after surgery.
measure: Length of procedure
time frame: measured in minutes from the surgical incision until the suture of the skin.
description: Compares the length of the closed tympanomastoidectomy with standard technique and the combined access tympanomastoidectomy.
arm group label: standard closed tympanomastoidectomy
arm group type: Active Comparator
description: In this group it will be performed the standard technique for closed tympanomastoidectomy, in which a surgical microscope is used.
arm group label: combined access tympanomastoidectomy
arm group type: Experimental
description: In this group a closed tympanomastoidectomy with combined access will be performed. This technique combines the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation.
intervention type: Procedure
intervention name: combined access tympanomastoidectomy
description: Trans canal surgery with the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation allowing better visualization and removal of the cholesteatoma before mastoid debridement. In this surgery, mastoid debridement is conducted only if there was no full endoscopic removal of the cholesteatoma. The other procedures of this type of surgery are similar to the standard tympanomastoidectomy technique.
arm group label: combined access tympanomastoidectomy
intervention type: Procedure
intervention name: standard closed tympanomastoidectomy
description: Supine position and general anesthesia with orotracheal intubation
Antisepsis and placing of sterile fields
Local anesthesia of the external auditory canal with lidocaine 2% and adrenaline 1:100. 000 UI
Retroauricular incision
Removal of the temporal muscle fascia
Elevation of the surgical flap of the tympanic meatus
Visualization and exploration of the cholesteatoma
Exploration of the ossicular chain
Mastoid debridement
Conservation of the upper posterior wall of the auditory conduct
Removal of the cholesteatoma
Tympanoplasty with the temporal fascia
Retroauricular suture with vycril 3.0 and mononylon 4.0
arm group label: standard closed tympanomastoidectomy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sady S Da costa
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
last name: Mauricio LS Da silva
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
country: Brazil
citation: Paparella MM. Current concepts in otitis media. Henry Ford Hosp Med J. 1983;31(1):30-6. No abstract available.
PMID: 6863004
citation: Ghaffar S, Ikram M, Zia S, Raza A. Incorporating the endoscope into middle ear surgery. Ear Nose Throat J. 2006 Sep;85(9):593-6.
PMID: 17044426
citation: Lima Tde O, Araujo TF, Soares LC, Testa JR. The impact of endoscopy on the treatment of cholesteatomas. Braz J Otorhinolaryngol. 2013 Aug;79(4):505-11. doi: 10.5935/1808-8694.20130090.
PMID: 23929154
citation: Badr-El-Dine M, James AL, Panetti G, Marchioni D, Presutti L, Nogueira JF. Instrumentation and technologies in endoscopic ear surgery. Otolaryngol Clin North Am. 2013 Apr;46(2):211-25. doi: 10.1016/j.otc.2012.10.005.
PMID: 23566907
citation: Marchioni D, Soloperto D, Rubini A, Villari D, Genovese E, Artioli F, Presutti L. Endoscopic exclusive transcanal approach to the tympanic cavity cholesteatoma in pediatric patients: our experience. Int J Pediatr Otorhinolaryngol. 2015 Mar;79(3):316-22. doi: 10.1016/j.ijporl.2014.12.008. Epub 2015 Jan 7.
PMID: 25631934
responsible party type: Sponsor
mesh term: Otitis Media
mesh term: Cholesteatoma
sharing ipd: No