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
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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 ] [ 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.



Secondary Outcome Measures:
  • 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.



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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01616316

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

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01616316     History of Changes
Other Study ID Numbers: 2009-08-058
Study First Received: January 18, 2012
Last Updated: June 7, 2012
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014