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:

MedlinePlus related topics: Cancer Thyroid Cancer Thyroid Diseases

Drug Information available for: Thyroid

U.S. FDA Resources

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616316

Locations

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 Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site

Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013