Compare the Aesthetic Effect of Different Thyroidectomies

Differentiated Thyroid Carcinoma (DTC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239769
• Other study ID #: XMa-001
• Status: Completed
• Phase: N/A
• First received: August 1, 2017
• Last updated: August 7, 2017
• Start date: June 1, 2012
• Est. completion date: June 1, 2015

Study information

• Verified date: August 2017
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2015
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Differentiated Thyroid Carcinoma (DTC)
• Thyroid Neoplasms

Intervention

Procedure:
• thyroidectomy
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months post-operation
Secondary	Scar length	Using ruler to measure the length of the scar, accuracy to millimeter	12 months post-operation
Secondary	Operation time	From incision to suture completed (record the duration from start of operation to the end of operation)	Day 1 (on the day of operation)
Secondary	Blood loss	Blood loss from incision to suture completed (record the blood loss from start of operation to the end of operation)	Day 1 (on the day of operation)
Secondary	Amount of drainage	Record the amount of the drainage from end of surgical procedure to extubation of drainage	till extubation, an average of 48 hours post-operation
Secondary	Duration of drainage	Record the duration (days) of the drainage, from end of surgical procedure to extubation of drainage	till extubation, an average of 48 hours post-operation
Secondary	Number of CLND	Record the number of central lymph nodes	up to 2 weeks post-operation