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Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865006
Recruitment Status : Unknown
Verified May 2013 by Server Sezgin Uludag, Istanbul University.
Recruitment status was:  Recruiting
First Posted : May 30, 2013
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Server Sezgin Uludag, Istanbul University

Brief Summary:
The purpose of this study is to compare effect of sutureless thyroidectomy with vessel closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric evaluation.

Condition or disease
Phoniatric Evaluation of Total Thyroidectomy

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture
Study Start Date : May 2013
Estimated Primary Completion Date : April 2014

Group/Cohort
Ligasure LF1212
Ultracision
Conventional



Primary Outcome Measures :
  1. Voice quality change in relation with operative technique [ Time Frame: Postoperative 1st week and 2nd month ]
    Voice quality change between postoperative 1st week and 2nd month in relation with operative technique (either sutureless (with Ligasure or Ultracision) or conventional technique) via Voice handicap index, videolaryngostroboscope, CSL MDVP advanced software, and Glottography.


Secondary Outcome Measures :
  1. Voice quality change in relation with histopathology. [ Time Frame: 1st week and 2nd month ]
    Voice quality change between postoperative 1st week and 2nd month in relation with histopathology via Voice handicap index, videolaryngostroboscope, CSL MDVP advanced software, and Glottography.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent to total thyroidectomy.
Criteria

Exclusion Criteria:

  • Pre-operative voice problems
  • Pre-operative vocal cord paralysis
  • Singers and teachers
  • Pre-operative known advanced stage malignity
  • Previously operated for thyroid diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865006


Contacts
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Contact: Server Sezgin ULUDAG, MD +905334933676 sszgn.uludag@gmail.com

Locations
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Turkey
Istanbul University Cerrahpasa Medical Faculty Department of General Surgery Recruiting
Istanbul, Turkey, 34098
Contact: Server Sezgin ULUDAĞ, MD    +905334933676    sszgn.uludag@gmail.com   
Principal Investigator: Server Sezgin ULUDAG, MD         
Sponsors and Collaborators
Istanbul University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Server Sezgin Uludag, Resident, Istanbul University
ClinicalTrials.gov Identifier: NCT01865006    
Other Study ID Numbers: IUCTF-2013-01
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013