Thyroid CancerPhase 2/3NCT01616316
Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients
A Phase 2/3 study testing subfascial flap and subplatysmal flap in people with Thyroid Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- subfascial flap and subplatysmal flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Feb 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- micropapillary thyroid cancer
Who cannot join
- lateral neck lymph node metastasis
- severe thyroiditis
- goiter
- reoperation
- extrathyroidal extension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Thyroid Cancer
- Being tested
- subfascial flap, subplatysmal flap
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subfascial flapProcedure or surgery
Also called sub-strap muscle fascial flap approach
subfacial dissection to thyroid
subplatysmal flapProcedure or surgery
Also called subplatysmal mucle flap approach
subplatysmal approach to thyroid
| Study group | Role | What they receive |
|---|---|---|
| subfascial flap | Experimental | Not described Receives: Procedure: subfascial flap |
| Subplatysmal flap | Experimental | Not described Receives: Procedure: subplatysmal flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Until 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startMar 2010
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616316
- Sponsor's protocol ID
- 2009-08-058
- Status last verified
- Jun 2012
- First submitted
- 18 Jan 2012
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01616316
- Acronym / sponsor ID
- 2009-08-058
- Conditions
- Thyroid Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subfascial flap | Experimental | Procedure: subfascial flap |
| Subplatysmal flap | Experimental | Procedure: subplatysmal flap |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- micropapillary thyroid cancer
Key exclusion criteria (5 listed)
- lateral neck lymph node metastasis
- severe thyroiditis
- goiter
- reoperation
- extrathyroidal extension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subfascial flapAlso: sub-strap muscle fascial flap approachsubfacial dissection to thyroid | Procedure or surgery | subfascial flap |
| subplatysmal flapAlso: subplatysmal mucle flap approachsubplatysmal approach to thyroid | Procedure or surgery | Subplatysmal flap |
Primary outcome
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.
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.
1 secondary outcome
The efficacy of subfascial approach in thyroid cancer
Time frame: Until 1 year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing subfascial flap and subplatysmal flap in people with Thyroid Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose subfascial approach make better result of swallowing function? (time frame: Until 1 year follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.