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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01616316
Enrollment
86
Registered
2012-06-11
Start date
2010-03-31
Completion date
2012-02-29
Last updated
2012-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer

Brief summary

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

Interventions

PROCEDUREsubfascial flap

subfacial dissection to thyroid

PROCEDUREsubplatysmal flap

subplatysmal approach to thyroid

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* micropapillary thyroid cancer

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Dose subfascial approach make better result of swallowing function?Until 1 year follow upTo 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?Until 1 year follow upTo 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

MeasureTime frameDescription
The efficacy of subfascial approach in thyroid cancerUntil 1 year follow upTo 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026