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NCT Number: NCT03239769

Compare the Aesthetic Effect of Different Thyroidectomies

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.

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Key information

Conditions

Differentiated Thyroid Carcinoma (DTC)

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thyroidectomy

Procedure

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 outcomes

  1. Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 12 months post-operation

    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 outcomes

  1. Scar length

    Time frame: 12 months post-operation

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

  2. Operation time

    Time frame: Day 1 (on the day of operation)

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

  3. Blood loss

    Time frame: Day 1 (on the day of operation)

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

  4. Amount of drainage

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

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

  5. Duration of drainage

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

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

  6. Number of CLND

    Time frame: up to 2 weeks post-operation

    Record the number of central lymph nodes

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 4, 2017
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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