NCT01616316

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

January 18, 2012

Last Update Submit

June 7, 2012

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    Until 1 year follow up

  • 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.

    Until 1 year follow up

Secondary Outcomes (1)

  • The efficacy of subfascial approach in thyroid cancer

    Until 1 year follow up

Study Arms (2)

subfascial flap

EXPERIMENTAL
Procedure: subfascial flap

Subplatysmal flap

EXPERIMENTAL
Procedure: subplatysmal flap

Interventions

subfascial flapPROCEDURE

subfacial dissection to thyroid

Also known as: sub-strap muscle fascial flap approach
subfascial flap
subplatysmal flapPROCEDURE

subplatysmal approach to thyroid

Also known as: subplatysmal mucle flap approach
Subplatysmal flap

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • micropapillary thyroid cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

June 11, 2012

Study Start

March 1, 2010

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

June 11, 2012

Record last verified: 2012-06

Locations

KR(1)