<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/NCT04410601</url>
  </required_header>
  <id_info>
    <org_study_id>B.10.1.TKH.4.34.H.GP.0.01/173</org_study_id>
    <secondary_id>12.05.2020/173</secondary_id>
    <nct_id>NCT04410601</nct_id>
  </id_info>
  <brief_title>Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT</brief_title>
  <acronym>Dysphagia-TT</acronym>
  <official_title>Pre-and Post-operative Risk Factors Affecting the Incidence and Severity of Dysphagia Following Total Thyroidectomy: An International Multi-centric Prospective Randomized Controlled Clinical Trial (RCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The most common and feared complications of total thyroidectomy are vocal cord paralyses and&#xD;
      hypocalcemia. However, post-thyroidectomy dysphagia is not uncommon and has important&#xD;
      consequences on the quality of life (QoL). It should be taken seriously by all clinicians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dysphagia is a possible complication that can be observed in patients undergoing&#xD;
      thyroidectomy, and can be related to superior and inferior laryngeal nerves dysfunction, but&#xD;
      it usually appears after an uncomplicated surgical procedure. Aerodigestive symptoms, such as&#xD;
      discomfort, tightness, lump, foreign body, difficulty or pain during swallowin, can also&#xD;
      present before operation. If it appears or aggrevates after surgery, laryngeal nerve damage&#xD;
      (superior laryngeal nerve - SLN, or inferior laryngeal nerve - recurrent, RLN),&#xD;
      tracheo-malacia and postoperative fibrotic changes should be interrogated. However, in most&#xD;
      of the cases, an anatomic and/or physiologic defect in the oro-pharngeal region is not easy&#xD;
      to be detected. Therefore, a subjective feeling of dysphagia is more common.&#xD;
&#xD;
      Dysphagia has important consequences on the QoL in postoperative period, and should be&#xD;
      addressed by the primary surgeon/clinician, regardless of whether it is objective or&#xD;
      subjective.&#xD;
&#xD;
      The goal of the present study is to better understand the incidence of postoperative&#xD;
      dysphagia symptoms among patients who have undergone total thyroidectomy for benign or malign&#xD;
      thyroid disease. Besides, all possible risk factors (pre-intra-post-operative) are also going&#xD;
      to be evaluated in detail, and the efficacy of a 6-week dysphagia-rehabilitation programme&#xD;
      will also be employed and results will be shared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 14, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 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>
    <intervention_model_description>Dysphagia among patients who have undergone total hyroidectomy for benign/malign thyroid disease. The preoperative factors (demographics; co-morbidities such as diabetes, multiple sclerosis, Parkinson's; body mass index; routine ear-nose-throat-ENT consultation), operative factors (over-manipulation, injury to larynx/neural plexus, easy/hard tracheal intubation, closure of strap muscles/stay open) and postoperative evaluation 1-No dysphagia, 2-Dysphagia with at least one other complication (nerve injury, hypocalcemia), 3-Dysphagia without any other surgical complications; ENT&amp;neurology consultations, survey.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>THE STUDY IS OPEN TO ALL SURGICAL CLINICS OVER THE WORLD EAGER TO JOIN; EXCEL WITH FORMS TO BE FILLED ARE AVAILABLE, please contact the principle/co-investigators by phone/e-mail.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Dysphagia-Subjective Survey Form</measure>
    <time_frame>12 months</time_frame>
    <description>Subjective survey form to be filled- a self-evaluation questionnaire-to evaluate 'Change from baseline postoperative (po) day 1-3 to week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control.&#xD;
assessing common dysphagia symptoms- includes 6 items scored within a range of 0 (without swallowing alterations) to 24 (maximum swallowing dysfunction).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Dysphagia-Objective Functional Outcome Swallowing Score (FOSS)</measure>
    <time_frame>12 months</time_frame>
    <description>Objective survey form to be filled- a clinician-oriented questionnaire assessing the swallowing function objectively, from stage I (normal function) to stage V (no oral intake). To evaluate change in dysphagia from baseline po day 1-3 to .po week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Dysphagia- ENT Consultation</measure>
    <time_frame>12 months</time_frame>
    <description>Flexible fiberoptic laryngoscopy (any anatomic explanation for dysphagia? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Dysphagia- Neurology Consultation</measure>
    <time_frame>12 months</time_frame>
    <description>EMG-electromyography test (any anatomic and/or physiologic dysfunction? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Standard Dysphagia Rehabilitation</measure>
    <time_frame>12 weeks</time_frame>
    <description>6-week treatment, starting from po week 6, for all patients with dysphagia- ending at po week 12. Any improvement after 6-week treatment? evaluate at po week 12 and please answer: Any improvent in dysphagia symptom? -YES or NO?</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Dysphagia, Esophageal</condition>
  <condition>Dysphagia, Oral Phase</condition>
  <condition>Dysphagia Comes and Goes</condition>
  <condition>Thyroiditis</condition>
  <condition>Thyroid Cancer</condition>
  <condition>Thyroid Neoplasms</condition>
  <condition>Thyroid Goiter</condition>
  <condition>Thyroid Nodule (Benign)</condition>
  <arm_group>
    <arm_group_label>No dysphagia (after total thyroidectomy-TT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients s/p post-thyroidectomy without complication&#xD;
*will NOT be enrolled to standard dysphagia-rehabilitation treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dysphagia (with at least one more complication of TT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients s/p post-thyroidectomy with both dysphagia and other documented TT complication such as vocal cord paralysis/hypocalcemia/surgical site infection etc.&#xD;
*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dysphagia (the only complication after TT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients s/p post-thyroidectomy dysphagia only.&#xD;
*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total thyroidectomy</intervention_name>
    <description>DRT-diet modification, compensation strategies, oral motor exercises such as laryngeal elevation, masseters / tongue hold / exercise, bolus transition exercise; chin-down/up, head rotation, and other maneuvers with tactile stimulation.</description>
    <arm_group_label>Dysphagia (the only complication after TT)</arm_group_label>
    <arm_group_label>Dysphagia (with at least one more complication of TT)</arm_group_label>
    <arm_group_label>No dysphagia (after total thyroidectomy-TT)</arm_group_label>
    <other_name>Dysphagia rehabilitation treatment (DRT) programme</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre,&#xD;
             thyroid carcinoma)&#xD;
&#xD;
          -  Patients with total thyroidectomy (TT) indication&#xD;
&#xD;
          -  Patients over 17 year-old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without thyroid disease&#xD;
&#xD;
          -  Patients with thyroid disorder, but prepared for surgery other than TT&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Patients below 17 y/o&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sema YUKSEKDAG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instructor in General Surgery</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ethem UNAL, MD, PhD, ECFMG, IFSO &amp; Board CSS</last_name>
    <role>Study Chair</role>
    <affiliation>Assoc. Professor of General Surgery and Surgical Oncology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ethem UNAL, MD, PhD, USMLE, IFSO &amp; Board CSS</last_name>
    <phone>00 90 (216) 632 1818</phone>
    <phone_ext>1951</phone_ext>
    <email>drethemunal@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sema YUKSEKDAG, MD</last_name>
    <phone>00 90 (216) 632 1818</phone>
    <phone_ext>19511</phone_ext>
    <email>drsemayuksekdag@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Umraniye Education and Research Hospital, Health Sciences University</name>
      <address>
        <city>Istanbul</city>
        <zip>34764</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ethem UNAL, MD, PhD, ECFMG, IFSO &amp; Board CSS</last_name>
      <phone>00 90 (216) 632 1818</phone>
      <phone_ext>1951</phone_ext>
      <email>drethemunal@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sema YUKSEKDAG, MD</last_name>
      <phone>00 90 (216) 632 1818</phone>
      <phone_ext>1951</phone_ext>
      <email>drsemayuksekdag@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Kadir M YILDIRAK, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sema YUKSEKDAG, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://scholar.google.com.tr/citations?user=6bFlCZwAAAAJ&amp;hl=tr</url>
    <description>Ethem Unal, MD, PhD, ECFMG, IFSO, BCSS, Assoc. Professor of General Surgery &amp; Surgical Oncology, H-index:18 / i10-index:33</description>
  </link>
  <reference>
    <citation>Rihn JA, Kane J, Albert TJ, Vaccaro AR, Hilibrand AS. What is the incidence and severity of dysphagia after anterior cervical surgery? Clin Orthop Relat Res. 2011 Mar;469(3):658-65. doi: 10.1007/s11999-010-1731-8.</citation>
    <PMID>21140251</PMID>
  </reference>
  <reference>
    <citation>Hashemian M, Khorasani B, Tarameshlu M, Haghani H, Ghelichi L, Nakhostin Ansari N. Effects of Dysphagia Therapy on Swallowing Dysfunction after Total Thyroidectomy. Iran J Otorhinolaryngol. 2019 Nov;31(107):329-334. doi: 10.22038/ijorl.2019.36233.2193.</citation>
    <PMID>31857976</PMID>
  </reference>
  <reference>
    <citation>Exarchos ST, Lachanas VA, Tsiouvaka S, Tsea M, Hajiioannou JK, Skoulakis CE, Bizakis JG. The impact of perioperative dexamethasone on swallowing impairment score after thyroidectomy: a retrospective study of 118 total thyroidectomies. Clin Otolaryngol. 2016 Oct;41(5):615-8. doi: 10.1111/coa.12547. Epub 2016 Feb 8. No abstract available.</citation>
    <PMID>26434490</PMID>
  </reference>
  <reference>
    <citation>Shimizu M, Kobayashi T, Jimbo S, Senoo I, Ito H. Clinical evaluation of surgery for osteophyte-associated dysphagia using the functional outcome swallowing scale. PLoS One. 2018 Aug 1;13(8):e0201559. doi: 10.1371/journal.pone.0201559. eCollection 2018.</citation>
    <PMID>30067834</PMID>
  </reference>
  <results_reference>
    <citation>Scerrino G, Tudisca C, Bonventre S, Raspanti C, Picone D, Porrello C, Paladino NC, Vernuccio F, Cupido F, Cocorullo G, Lo Re G, Gulotta G. Swallowing disorders after thyroidectomy: What we know and where we are. A systematic review. Int J Surg. 2017 May;41 Suppl 1:S94-S102. doi: 10.1016/j.ijsu.2017.03.078.</citation>
    <PMID>28506421</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ethem Unal, M.D., PhD, Associate Prof of Surgery &amp; Surgic</investigator_full_name>
    <investigator_title>Associated Professor of General Surgery and Surgical Oncology</investigator_title>
  </responsible_party>
  <keyword>Thyroidectomy</keyword>
  <keyword>Total thyroidectomy</keyword>
  <keyword>Post-thyroidectomy</keyword>
  <keyword>Post-thyroidectomy dysphagia</keyword>
  <keyword>International</keyword>
  <keyword>Multi-centric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Goiter</mesh_term>
    <mesh_term>Thyroiditis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Excel documents including data (patient ID and protocol # will be shaded) available upon request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>6 months from the beginning (01.06.2020)</ipd_time_frame>
    <ipd_access_criteria>All surgical clinics/Investigators are WELCOME / INVITED to join this CONSORT-compatible RCT</ipd_access_criteria>
    <ipd_url>http://www.consort-statement.org/</ipd_url>
  </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/NCT04410601
org study id: B.10.1.TKH.4.34.H.GP.0.01/173
secondary id: 12.05.2020/173
nct id: NCT04410601
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The most common and feared complications of total thyroidectomy are vocal cord paralyses and
      hypocalcemia. However, post-thyroidectomy dysphagia is not uncommon and has important
      consequences on the quality of life (QoL). It should be taken seriously by all clinicians.
Dysphagia is a possible complication that can be observed in patients undergoing
      thyroidectomy, and can be related to superior and inferior laryngeal nerves dysfunction, but
      it usually appears after an uncomplicated surgical procedure. Aerodigestive symptoms, such as
      discomfort, tightness, lump, foreign body, difficulty or pain during swallowin, can also
      present before operation. If it appears or aggrevates after surgery, laryngeal nerve damage
      (superior laryngeal nerve - SLN, or inferior laryngeal nerve - recurrent, RLN),
      tracheo-malacia and postoperative fibrotic changes should be interrogated. However, in most
      of the cases, an anatomic and/or physiologic defect in the oro-pharngeal region is not easy
      to be detected. Therefore, a subjective feeling of dysphagia is more common.

      Dysphagia has important consequences on the QoL in postoperative period, and should be
      addressed by the primary surgeon/clinician, regardless of whether it is objective or
      subjective.

      The goal of the present study is to better understand the incidence of postoperative
      dysphagia symptoms among patients who have undergone total thyroidectomy for benign or malign
      thyroid disease. Besides, all possible risk factors (pre-intra-post-operative) are also going
      to be evaluated in detail, and the efficacy of a 6-week dysphagia-rehabilitation programme
      will also be employed and results will be shared.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Dysphagia among patients who have undergone total hyroidectomy for benign/malign thyroid disease. The preoperative factors (demographics; co-morbidities such as diabetes, multiple sclerosis, Parkinson's; body mass index; routine ear-nose-throat-ENT consultation), operative factors (over-manipulation, injury to larynx/neural plexus, easy/hard tracheal intubation, closure of strap muscles/stay open) and postoperative evaluation 1-No dysphagia, 2-Dysphagia with at least one other complication (nerve injury, hypocalcemia), 3-Dysphagia without any other surgical complications; ENT&neurology consultations, survey.
primary purpose: Diagnostic
masking: None (Open Label)
masking description: THE STUDY IS OPEN TO ALL SURGICAL CLINICS OVER THE WORLD EAGER TO JOIN; EXCEL WITH FORMS TO BE FILLED ARE AVAILABLE, please contact the principle/co-investigators by phone/e-mail.
measure: Evaluation of Dysphagia-Subjective Survey Form
time frame: 12 months
description: Subjective survey form to be filled- a self-evaluation questionnaire-to evaluate 'Change from baseline postoperative (po) day 1-3 to week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control.
assessing common dysphagia symptoms- includes 6 items scored within a range of 0 (without swallowing alterations) to 24 (maximum swallowing dysfunction).
measure: Evaluation of Dysphagia-Objective Functional Outcome Swallowing Score (FOSS)
time frame: 12 months
description: Objective survey form to be filled- a clinician-oriented questionnaire assessing the swallowing function objectively, from stage I (normal function) to stage V (no oral intake). To evaluate change in dysphagia from baseline po day 1-3 to .po week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control.
measure: Evaluation of Dysphagia- ENT Consultation
time frame: 12 months
description: Flexible fiberoptic laryngoscopy (any anatomic explanation for dysphagia? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).
measure: Evaluation of Dysphagia- Neurology Consultation
time frame: 12 months
description: EMG-electromyography test (any anatomic and/or physiologic dysfunction? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).
measure: Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)
time frame: 6 weeks
description: Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.
measure: Evaluation of Standard Dysphagia Rehabilitation
time frame: 12 weeks
description: 6-week treatment, starting from po week 6, for all patients with dysphagia- ending at po week 12. Any improvement after 6-week treatment? evaluate at po week 12 and please answer: Any improvent in dysphagia symptom? -YES or NO?
arm group label: No dysphagia (after total thyroidectomy-TT)
arm group type: Active Comparator
description: Patients s/p post-thyroidectomy without complication
*will NOT be enrolled to standard dysphagia-rehabilitation treatment
arm group label: Dysphagia (with at least one more complication of TT)
arm group type: Experimental
description: Patients s/p post-thyroidectomy with both dysphagia and other documented TT complication such as vocal cord paralysis/hypocalcemia/surgical site infection etc.
*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.
arm group label: Dysphagia (the only complication after TT)
arm group type: Experimental
description: Patients s/p post-thyroidectomy dysphagia only.
*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.
intervention type: Procedure
intervention name: Total thyroidectomy
description: DRT-diet modification, compensation strategies, oral motor exercises such as laryngeal elevation, masseters / tongue hold / exercise, bolus transition exercise; chin-down/up, head rotation, and other maneuvers with tactile stimulation.
arm group label: Dysphagia (the only complication after TT)
arm group label: Dysphagia (with at least one more complication of TT)
arm group label: No dysphagia (after total thyroidectomy-TT)
other name: Dysphagia rehabilitation treatment (DRT) programme
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Sema YUKSEKDAG, MD
role: Principal Investigator
affiliation: Instructor in General Surgery
last name: Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS
role: Study Chair
affiliation: Assoc. Professor of General Surgery and Surgical Oncology
last name: Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS
phone: 00 90 (216) 632 1818
phone ext: 1951
email: drethemunal@gmail.com
last name: Sema YUKSEKDAG, MD
phone: 00 90 (216) 632 1818
phone ext: 19511
email: drsemayuksekdag@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Turkey
url: https://scholar.google.com.tr/citations?user=6bFlCZwAAAAJ&hl=tr
description: Ethem Unal, MD, PhD, ECFMG, IFSO, BCSS, Assoc. Professor of General Surgery & Surgical Oncology, H-index:18 / i10-index:33
citation: Rihn JA, Kane J, Albert TJ, Vaccaro AR, Hilibrand AS. What is the incidence and severity of dysphagia after anterior cervical surgery? Clin Orthop Relat Res. 2011 Mar;469(3):658-65. doi: 10.1007/s11999-010-1731-8.
PMID: 21140251
citation: Hashemian M, Khorasani B, Tarameshlu M, Haghani H, Ghelichi L, Nakhostin Ansari N. Effects of Dysphagia Therapy on Swallowing Dysfunction after Total Thyroidectomy. Iran J Otorhinolaryngol. 2019 Nov;31(107):329-334. doi: 10.22038/ijorl.2019.36233.2193.
PMID: 31857976
citation: Exarchos ST, Lachanas VA, Tsiouvaka S, Tsea M, Hajiioannou JK, Skoulakis CE, Bizakis JG. The impact of perioperative dexamethasone on swallowing impairment score after thyroidectomy: a retrospective study of 118 total thyroidectomies. Clin Otolaryngol. 2016 Oct;41(5):615-8. doi: 10.1111/coa.12547. Epub 2016 Feb 8. No abstract available.
PMID: 26434490
citation: Shimizu M, Kobayashi T, Jimbo S, Senoo I, Ito H. Clinical evaluation of surgery for osteophyte-associated dysphagia using the functional outcome swallowing scale. PLoS One. 2018 Aug 1;13(8):e0201559. doi: 10.1371/journal.pone.0201559. eCollection 2018.
PMID: 30067834
citation: Scerrino G, Tudisca C, Bonventre S, Raspanti C, Picone D, Porrello C, Paladino NC, Vernuccio F, Cupido F, Cocorullo G, Lo Re G, Gulotta G. Swallowing disorders after thyroidectomy: What we know and where we are. A systematic review. Int J Surg. 2017 May;41 Suppl 1:S94-S102. doi: 10.1016/j.ijsu.2017.03.078.
PMID: 28506421
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
investigator title: Associated Professor of General Surgery and Surgical Oncology
mesh term: Thyroid Neoplasms
mesh term: Thyroid Nodule
mesh term: Deglutition Disorders
mesh term: Thyroid Diseases
mesh term: Goiter
mesh term: Thyroiditis
sharing ipd: Yes
ipd description: Excel documents including data (patient ID and protocol # will be shaded) available upon request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 6 months from the beginning (01.06.2020)
ipd access criteria: All surgical clinics/Investigators are WELCOME / INVITED to join this CONSORT-compatible RCT
ipd url: http://www.consort-statement.org/