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Differentiated Thyroid Carcinoma (DTC)NCT03239769

Compare the Aesthetic Effect of Different Thyroidectomies

A study testing thyroidectomy in people with Differentiated Thyroid Carcinoma (DTC), run by Peking University Cancer Hospital & Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

One hundred twenty female patients who underwent thyroidectomy were evenly distributed into three groups: conventional access (CA), aesthetic principles access (APA) and minimally invasive access (MIA). The Patient and Observer Scar Assessment Scale (POSAS) was used as the assessment tool for the linear scar. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Differentiated Thyroid Carcinoma (DTC)
What is being tested?
thyroidectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
1 Jun 2012to 1 Jun 2015
Phase
Interventional
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with DTC through preoperative fine needle aspiration biopsy pathology.
  • DTC staging was T1N0M0 or T1N1M0.
  • Female
  • Age over 18 years
  • Subjects who fully understand the study process, participate voluntarily

Who cannot join

  • Patients with other medical diseases, such as diabetes or obesity, a smoking history, a keloid tendency, a history of radiotherapy to the head and neck, or with incomplete information.

About this study

Official title: A Study to Evaluate and Compare the Surgical Outcomes, Aesthetic Effects and Incision Length of Different Access Procedures in Patients With DTC

One hundred twenty female patients who underwent thyroidectomy were evenly distributed into three groups: conventional access (CA), aesthetic principles access (APA) and minimally invasive access (MIA). The Patient and Observer Scar Assessment Scale (POSAS) was used as the assessment tool for the linear scar. After one year follow-up, the cosmetic outcomes were assessed.

Read the detailed description

A prospective study in patients with DTC at the Department of Head and Neck Surgery at Perking University Cancer Hospital (also called Beijing Cancer hospital). A total of 120 female patients who underwent surgical treatment for DTC were enrolled in the study from June 2012 to June 2014. All patients were diagnosed with DTC through preoperative fine needle aspiration biopsy pathology. These patients were individually randomly assigned (1:1:1 ratio) into the conventional access group (CA), the aesthetic principles access group (APA) or the minimally invasive access group (MIA). Lobectomy plus ipsilateral central lymph node dissection (CLND) was adopted in each patient. DTC staging was T1N0M0 or T1N1M0. The investigators retrieved the patients' information, including age, incision length, incision closure procedure, incidence of complications, and cosmetic assessment from patients' medical records. Patients with other medical diseases, such as diabetes or obesity, a smoking history, a keloid tendency, a history of radiotherapy to the head and neck, or with incomplete information, were excluded. RLN function was evaluated by electronic fiber laryngoscopy 6 months postoperatively. The follow-up time was 12.3 months. The research was reviewed and approved by the Ethics Committee of Peking University Cancer Hospital, and informed consent was obtained from all patients to publish the information/image(s) in an online open-access publication. The study was open-label with no blinding of patients, clinicians, or research staff.

Being tested
thyroidectomy
Keywords
Thyroid surgery, Thyroidectomy, Minimally invasive access, Aesthetic principle, POSAS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thyroidectomyProcedure or surgery

    Thyroidectomies have different approaches. The aim of this study was to evaluate and compare the aesthetic effects of different access procedures in patients with differentiated thyroid carcinoma (DTC).

Study groups in NCT03239769
Study groupRoleWhat they receive
conventional access group (CA)Active comparatorA 4- to 5-cm incision was created, subplatysmal flaps were raised, and the strap muscles were mobilized. Then, the superior pole of the thyroid gland was exposed and the gland was delivered through the surgical incision, and the thyroid isthmus was divided. Finally, CLND was performed. The strap muscles were re-approximated with No.1 silk suture. The full-thickness skin was closed with interrupted monofilament.
Receives: Procedure: thyroidectomy
aesthetic principles access group (APA)ExperimentalThe key difference focused on the disposal incision using aesthetic principles, which are depicted below. The incision was protected by Vaseline ointment. Excessive skin traction was avoided to prevent the injury on the skin edge. Bleeding was stanched with a low-power bipolar coagulation device. The surgical field does not have to be pulled in every direction to show the full operation field. The cervical linea alba was closed by continuous sutures with 3-0 absorbable Vicryl sutures. Interrupted sutures of 4-0 Vicryl were used to re-approximate the subcutaneous tissues. The epidermis was fixed with 3M steri-strip elastic skin closures rather than skin sutures.
Receives: Procedure: thyroidectomy
minimally invasive access group (MIA)ExperimentalWith the MIA approach, a shorter incision of between 3 and 4 cm was created. The procedure used the Harmonic scalpel as an auxiliary device. First, the isthmus was divided. Second, the lower pole of the thyroid was dissected from the adipose tissue, and the inferior thyroid vessels were divided close to the thyroid gland for mobilization. The RLN and parathyroid glands were carefully dissected. Third, the superior pole of the thyroid gland was disconnected. Finally, CLND was performed. The closure procedure for the incision was similar to that for APA.
Receives: Procedure: thyroidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient and Observer Scar Assessment Scale (POSAS)

    The POSAS scale is a reliable and feasible tool for linear scar evaluation. The POSAS included the observer scale and the patient scale. The Observer Scar Assessment Scale (OSAS) score was obtained by the same observer; this scale includes 5 items graded on a 10-point scale with 1 indicating normal skin and 10 indicating the worst scar imaginable. A summary score of 5 indicates normal skin, and a summary score of 50 is the worst possible scar result. The Patient Scar Assessment Scale (PSAS) consists of 6 items. All items are graded by the patient on a 10-point scale; a summary score of 6 to 60 represents the range from normal skin to the worst imaginable scar. After scoring the items, the observer and the patients rated the overall scar appearance on a visual analogue scale corresponding to a 10-point scale.

    Measured: 12 months post-operation

Secondary outcomes (6)

  1. Scar length

    Using ruler to measure the length of the scar, accuracy to millimeter

    Measured: 12 months post-operation

  2. Operation time

    From incision to suture completed (record the duration from start of operation to the end of operation)

    Measured: Day 1 (on the day of operation)

  3. Blood loss

    Blood loss from incision to suture completed (record the blood loss from start of operation to the end of operation)

    Measured: Day 1 (on the day of operation)

  4. Amount of drainage

    Record the amount of the drainage from end of surgical procedure to extubation of drainage

    Measured: till extubation, an average of 48 hours post-operation

  5. Duration of drainage

    Record the duration (days) of the drainage, from end of surgical procedure to extubation of drainage

    Measured: till extubation, an average of 48 hours post-operation

  6. Number of CLND

    Record the number of central lymph nodes

    Measured: up to 2 weeks post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2017
  2. Study start1 Jun 2012
  3. Primary completion1 Jun 2015
  4. Study completion1 Jun 2015

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
These patients were individually randomly assigned (1:1:1 ratio) into the conventional access group (CA), the aesthetic principles access group (APA) or the minimally invasive access group (MIA).
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03239769
Sponsor's protocol ID
XMa-001
Status last verified
Aug 2017
First submitted
1 Aug 2017
Last updated
9 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ma X, Xia QJ, Li G, Wang TX, Li Q. Aesthetic principles access thyroidectomy produces the best cosmetic outcomes as assessed using the patient and observer scar assessment scale. BMC Cancer. 2017 Sep 18;17(1):654. doi: 10.1186/s12885-017-3645-2.

    PubMed 28923027

Questions about this trial

What is this clinical trial studying?

A study testing thyroidectomy in people with Differentiated Thyroid Carcinoma (DTC), run by Peking University Cancer Hospital & Institute.

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 5 inclusion and 1 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 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

Patient and Observer Scar Assessment Scale (POSAS) (time frame: 12 months post-operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03239769, which also lists 1 linked publication.

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 9 Aug 2017.

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