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CompletedNCT01616316Updated Jun 11, 2012

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

A Phase 2/3 interventional study of subfascial flap and subplatysmal flap in Thyroid Cancer, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-11.

Sponsored by Samsung Medical Center · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Thyroid Cancer

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03

In context

Thyroid Diseases

967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.

This study's enrollment of 86 is above the median of 60 across 544 interventional studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • micropapillary thyroid cancer

Exclusion criteria

Exclusion Criteria:

  • lateral neck lymph node metastasis
  • severe thyroiditis
  • goiter
  • reoperation
  • extrathyroidal extension
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    subfascial flap

    Procedure: subfascial flap

  • Experimental
    Subplatysmal flap

    Procedure: subplatysmal flap

Interventions

  • Proceduresubfascial flap

    subfacial dissection to thyroid

    Also known as: sub-strap muscle fascial flap approach

  • Proceduresubplatysmal flap

    subplatysmal approach to thyroid

    Also known as: subplatysmal mucle flap approach

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Until 1 year follow up

  2. 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.

    Time frame: Until 1 year follow up

Secondary outcomes

  1. 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.

    Time frame: Until 1 year follow up

07

Study locations

1 site
  • Samsung medical center
    Seoul, 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01616316
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Jun 11, 2012
Start date
Mar 2010
Primary completion
Jan 2012
Completion
Feb 2012
Last update
Jun 11, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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