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

Thyroid Cancer Clinical Trial

Official title:

Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients: Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616316
• Other study ID #: 2009-08-058
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 18, 2012
• Last updated: June 7, 2012
• Start date: March 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• micropapillary thyroid cancer

Exclusion Criteria:

• lateral neck lymph node metastasis

• severe thyroiditis

• goiter

• reoperation

• extrathyroidal extension

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• subfascial flap
subfacial dissection to thyroid
• subplatysmal flap
subplatysmal approach to thyroid

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Until 1 year follow up	Yes
Primary	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.	Until 1 year follow up	Yes
Secondary	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.	Until 1 year follow up	Yes