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Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01616316
First Posted: June 11, 2012
Last Update Posted: June 11, 2012
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.
Information provided by (Responsible Party):
Samsung Medical Center
  Purpose
Subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients

Condition Intervention Phase
Thyroid Cancer Procedure: subfascial flap Procedure: subplatysmal flap Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients: Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Dose subfascial approach make better result of swallowing function? [ Time Frame: Until 1 year follow up ]

    To see the effect of subfascial approach for postthyroidectomy swallowing symptom , we will compare the swallowing function between group I(subfascial approach) and group II(subplatysmal approach) after completion of study(after 1 year f/u).

    To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.


  • Dose subfascial approach make better result of voice symptom? [ Time Frame: Until 1 year follow up ]

    To see the effect of subfascial approach for postthyroidectomy voice function, we will compare the voice function(e.g. hoarseness) between group I(subfascial approach) and group II(subplatysmal approach) after completion of study(after 1 year f/u).

    To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.



Secondary Outcome Measures:
  • The efficacy of subfascial approach in thyroid cancer [ Time Frame: Until 1 year follow up ]

    To see the effect of subfascial approach for postthyroidectomy sensory symptom on neck, we will compare the sensory function and between group I(subfascial approach) and group II(subplatysmal approach) after completion of study(after 1 year f/u).

    To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.



Enrollment: 86
Study Start Date: March 2010
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: subfascial flap Procedure: subfascial flap
subfacial dissection to thyroid
Other Name: sub-strap muscle fascial flap approach
Experimental: Subplatysmal flap Procedure: subplatysmal flap
subplatysmal approach to thyroid
Other Name: subplatysmal mucle flap approach

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • micropapillary thyroid cancer

Exclusion Criteria:

  • lateral neck lymph node metastasis
  • severe thyroiditis
  • goiter
  • reoperation
  • extrathyroidal extension
  Contacts and Locations
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): NCT01616316


Locations
Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01616316     History of Changes
Other Study ID Numbers: 2009-08-058
First Submitted: January 18, 2012
First Posted: June 11, 2012
Last Update Posted: June 11, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms