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

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: NCT01616316
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE January 18, 2012
First Posted Date  ICMJE June 11, 2012
Last Update Posted Date June 11, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients
Official Title  ICMJE Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients: Prospective Randomized Study
Brief Summary Subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Cancer
Intervention  ICMJE
  • Procedure: subfascial flap
    subfacial dissection to thyroid
    Other Name: sub-strap muscle fascial flap approach
  • Procedure: subplatysmal flap
    subplatysmal approach to thyroid
    Other Name: subplatysmal mucle flap approach
Study Arms  ICMJE
  • Experimental: subfascial flap
    Intervention: Procedure: subfascial flap
  • Experimental: Subplatysmal flap
    Intervention: Procedure: subplatysmal flap
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2012)
86
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • micropapillary thyroid cancer

Exclusion Criteria:

  • lateral neck lymph node metastasis
  • severe thyroiditis
  • goiter
  • reoperation
  • extrathyroidal extension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01616316
Other Study ID Numbers  ICMJE 2009-08-058
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP