Back to resultsEfficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients
Primary Purpose
Thyroid Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
subfascial flap
subplatysmal flap
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer
Eligibility Criteria
Inclusion Criteria:
- micropapillary thyroid cancer
Exclusion Criteria:
- lateral neck lymph node metastasis
- severe thyroiditis
- goiter
- reoperation
- extrathyroidal extension
Sites / Locations
- Samsung medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
subfascial flap
Subplatysmal flap
Arm Description
Outcomes
Primary Outcome Measures
Dose subfascial approach make better result of swallowing function?
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?
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01616316
Brief Title
Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients
Official Title
Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients: Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subfascial flap
Arm Type
Experimental
Arm Title
Subplatysmal flap
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
subfascial flap
Other Intervention Name(s)
sub-strap muscle fascial flap approach
Intervention Description
subfacial dissection to thyroid
Intervention Type
Procedure
Intervention Name(s)
subplatysmal flap
Other Intervention Name(s)
subplatysmal mucle flap approach
Intervention Description
subplatysmal approach to thyroid
Primary Outcome Measure Information:
Title
Dose subfascial approach make better result of swallowing function?
Description
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.
Time Frame
Until 1 year follow up
Title
Dose subfascial approach make better result of voice symptom?
Description
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.
Time Frame
Until 1 year follow up
Secondary Outcome Measure Information:
Title
The efficacy of subfascial approach in thyroid cancer
Description
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.
Time Frame
Until 1 year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
micropapillary thyroid cancer
Exclusion Criteria:
lateral neck lymph node metastasis
severe thyroiditis
goiter
reoperation
extrathyroidal extension
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients
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