Compare the Aesthetic Effect of Different Thyroidectomies

NCT ID: NCT03239769

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-01
• Study Completion Date: 2015-06-01

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.

Conditions

Differentiated Thyroid Carcinoma (DTC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional access group (CA)

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.

Group Type: ACTIVE_COMPARATOR

thyroidectomy

Intervention Type: 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).

aesthetic principles access group (APA)

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.

Group Type: EXPERIMENTAL

thyroidectomy

Intervention Type: 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).

minimally invasive access group (MIA)

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.

Group Type: EXPERIMENTAL

thyroidectomy

Intervention Type: 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).

Interventions

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).

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Xiao Ma

Associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao Ma, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

References

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.

Reference Type: DERIVED

PMID: 28923027 (View on PubMed)

Other Identifiers

XMa-001

Identifier Type: -

Identifier Source: org_study_id