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Compare the Aesthetic Effect of Different Thyroidectomies

Primary Purpose

Differentiated Thyroid Carcinoma (DTC)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thyroidectomy
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Differentiated Thyroid Carcinoma (DTC) focused on measuring Thyroid surgery, Thyroidectomy, Minimally invasive access, Aesthetic principle, POSAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    conventional access group (CA)

    aesthetic principles access group (APA)

    minimally invasive access group (MIA)

    Arm Description

    A 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.

    The 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.

    With 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Scar length
    Using ruler to measure the length of the scar, accuracy to millimeter
    Operation time
    From incision to suture completed (record the duration from start of operation to the end of operation)
    Blood loss
    Blood loss from incision to suture completed (record the blood loss from start of operation to the end of operation)
    Amount of drainage
    Record the amount of the drainage from end of surgical procedure to extubation of drainage
    Duration of drainage
    Record the duration (days) of the drainage, from end of surgical procedure to extubation of drainage
    Number of CLND
    Record the number of central lymph nodes

    Full Information

    First Posted
    August 1, 2017
    Last Updated
    August 7, 2017
    Sponsor
    Peking University Cancer Hospital & Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03239769
    Brief Title
    Compare the Aesthetic Effect of Different Thyroidectomies
    Official Title
    A Study to Evaluate and Compare the Surgical Outcomes, Aesthetic Effects and Incision Length of Different Access Procedures in Patients With DTC
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2012 (Actual)
    Primary Completion Date
    June 1, 2015 (Actual)
    Study Completion Date
    June 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Cancer Hospital & Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. After one year follow-up, the cosmetic outcomes were assessed.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Differentiated Thyroid Carcinoma (DTC)
    Keywords
    Thyroid surgery, Thyroidectomy, Minimally invasive access, Aesthetic principle, POSAS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    conventional access group (CA)
    Arm Type
    Active Comparator
    Arm Description
    A 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.
    Arm Title
    aesthetic principles access group (APA)
    Arm Type
    Experimental
    Arm Description
    The 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.
    Arm Title
    minimally invasive access group (MIA)
    Arm Type
    Experimental
    Arm Description
    With 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    thyroidectomy
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Patient and Observer Scar Assessment Scale (POSAS)
    Description
    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.
    Time Frame
    12 months post-operation
    Secondary Outcome Measure Information:
    Title
    Scar length
    Description
    Using ruler to measure the length of the scar, accuracy to millimeter
    Time Frame
    12 months post-operation
    Title
    Operation time
    Description
    From incision to suture completed (record the duration from start of operation to the end of operation)
    Time Frame
    Day 1 (on the day of operation)
    Title
    Blood loss
    Description
    Blood loss from incision to suture completed (record the blood loss from start of operation to the end of operation)
    Time Frame
    Day 1 (on the day of operation)
    Title
    Amount of drainage
    Description
    Record the amount of the drainage from end of surgical procedure to extubation of drainage
    Time Frame
    till extubation, an average of 48 hours post-operation
    Title
    Duration of drainage
    Description
    Record the duration (days) of the drainage, from end of surgical procedure to extubation of drainage
    Time Frame
    till extubation, an average of 48 hours post-operation
    Title
    Number of CLND
    Description
    Record the number of central lymph nodes
    Time Frame
    up to 2 weeks post-operation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiao Ma, Doctor
    Organizational Affiliation
    Peking University Cancer Hospital & Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28923027
    Citation
    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.
    Results Reference
    derived

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