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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01616316

First received: January 18, 2012

Last updated: June 7, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 18, 2012
Last Updated Date	June 7, 2012
Start Date ^ICMJE	March 2010
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 ] [ Designated as safety issue: Yes ] 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 ] [ Designated as safety issue: Yes ] 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	Complete list of historical versions of study NCT01616316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 7, 2012)	The efficacy of subfascial approach in thyroid cancer [ Time Frame: Until 1 year follow up ] [ Designated as safety issue: Yes ] 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 Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) 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 Arm (s)	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
Enrollment ^ICMJE	86
Completion Date	February 2012
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
Gender	Both
Ages	20 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01616316
Other Study ID Numbers ^ICMJE	2009-08-058
Has Data Monitoring Committee	Yes
Responsible Party	Samsung Medical Center
Study Sponsor ^ICMJE	Samsung Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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

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