Clinical trial NCT03239769: 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
Overall status: COMPLETED
Phase: NA
Conditions: Differentiated Thyroid Carcinoma (DTC)
Keywords: Thyroid surgery
Thyroidectomy
Minimally invasive access
Aesthetic principle
POSAS
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 12 months post-operation
Secondary outcomes:
measure: Scar length
timeFrame: 12 months post-operation
measure: Operation time
timeFrame: Day 1 (on the day of operation)
measure: Blood loss
timeFrame: Day 1 (on the day of operation)
measure: Amount of drainage
timeFrame: till extubation, an average of 48 hours post-operation
measure: Duration of drainage
timeFrame: till extubation, an average of 48 hours post-operation
measure: Number of CLND
timeFrame: up to 2 weeks post-operation
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Xiao Ma, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.