Clinical Trials Directory

Trials / Completed

CompletedNCT03239769

Compare the Aesthetic Effect of Different Thyroidectomies

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Peking University Cancer Hospital & Institute · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREthyroidectomyThyroidectomies 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).

Timeline

Start date
2012-06-01
Primary completion
2015-06-01
Completion
2015-06-01
First posted
2017-08-04
Last updated
2017-08-09

Source: ClinicalTrials.gov record NCT03239769. Inclusion in this directory is not an endorsement.