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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

January 18, 2012
June 7, 2012
March 2010
January 2012   (final data collection date for primary outcome measure)
  • 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.

Same as current
Complete list of historical versions of study NCT01616316 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients
Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients: Prospective Randomized Study

Subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Thyroid Cancer
  • 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
  • Experimental: subfascial flap
    Intervention: Procedure: subfascial flap
  • Experimental: Subplatysmal flap
    Intervention: Procedure: subplatysmal flap
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
February 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • micropapillary thyroid cancer

Exclusion Criteria:

  • lateral neck lymph node metastasis
  • severe thyroiditis
  • goiter
  • reoperation
  • extrathyroidal extension
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01616316
2009-08-058
Yes
Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
June 2012

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