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

Phase 2

Completed

• Conditions: Thyroid Cancer
• Interventions: Procedure: subfascial flap; Procedure: subplatysmal flap

• Registration Number: NCT01616316
• Lead Sponsor: Samsung Medical Center

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2012-01
• Study First Submitted: 2012-01-18
• Study Completion: 2012-02
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-07
• Last Update Submitted: 2012-06-07
• Study First Posted: 2012-06-11
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• micropapillary thyroid cancer

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Exclusion Criteria

• lateral neck lymph node metastasis
• severe thyroiditis
• goiter
• reoperation
• extrathyroidal extension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subfascial flap	subfascial flap	-
Subplatysmal flap	subplatysmal flap	-

Primary Outcome Measures

Name	Time	Method
Dose subfascial approach make better result of swallowing function?	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?	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.

Secondary Outcome Measures

Name	Time	Method
The efficacy of subfascial approach in thyroid cancer	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.

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of