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

June 7, 2012 updated by: Samsung Medical Center

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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?
Time Frame: 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.
Until 1 year follow up
Dose subfascial approach make better result of voice symptom?
Time Frame: 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.
Until 1 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of subfascial approach in thyroid cancer
Time Frame: 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.
Until 1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 2009-08-058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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