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

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer
• Intervention / Treatment: Procedure: subfascial flap; Procedure: subplatysmal flap

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• micropapillary thyroid cancer

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: subfascial flap	Procedure: subfascial flap; subfacial dissection to thyroid; Other Names: sub-strap muscle fascial flap approach
EXPERIMENTAL: Subplatysmal flap	Procedure: subplatysmal flap; subplatysmal approach to thyroid; Other Names: subplatysmal mucle flap approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (ESTIMATE): June 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 11, 2012
• Last Update Submitted That Met QC Criteria: June 7, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: 2009-08-058