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NCT Number: NCT01616316

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

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

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Samsung medical center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • micropapillary thyroid cancer

Exclusion criteria

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

Treatment and study plan

subfascial flap

Procedure

subfacial dissection to thyroid

Other names: sub-strap muscle fascial flap approach

subplatysmal flap

Procedure

subplatysmal approach to thyroid

Other names: subplatysmal mucle flap approach

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 11, 2012
Registry last updated
Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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