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Comparative Study in Oral, Breast Approach and Open Thyroidectomy

Comparative Study of Surgical Results in Endoscopic Thyroidectomy Via Oral Approach, Via Breast Approach and Conventional Open Thyroidectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03479801
Enrollment
150
Registered
2018-03-27
Start date
2017-01-01
Completion date
2018-12-31
Last updated
2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Neoplasms

Brief summary

Purpose: Total endoscopic thyroidectomy including oral approach and breast approach has excellent cosmetic and several functional results. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. The procedure of total endoscopic thyroidectomy by breast approach only left three incisions, while by oral approach did not leave any incisions in the body surface, which is scarless in the neck, involved with a higher cosmetic result. However, the long-term property evaluation of total endoscopic thyroidectomy was not confirmed. The purpose of our study was to evaluate the surgical results of total endoscopic thyroidectomy (transoral approach and breast approach) versus conventional open thyroidectomy.

Detailed description

Purpose: Total endoscopic thyroidectomy including oral approach and breast approach has excellent cosmetic and several functional results. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Transoral endoscopic thyroidectomy via vestibular approach (TOETVA) and endoscopic thyroidectomy via breast approach were routinely performed in our institute. The procedures of total endoscopic thyroidectomy by breast approach only left three incisions, while by oral approach did not leave any incisions in the body surface, which is scarless in the neck, involved with a higher cosmetic result. However, the comprehensive comparison between transoral approach, breast approach and conventional open method was not confirmed. The purpose of our study was to evaluate the surgical results of total endoscopic thyroidectomy (transoral approach and breast approach) versus conventional open thyroidectomy.

Interventions

PROCEDUREThyroid Surgical Methods

Different methods of thyroid surgery, including conventional open thyroidectomy, transoral endoscopic thyroidectomy via vestibular approach, and endoscopic thyroidectomy via breast approach.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

1. Age: 15\ 55 years old; 2. Type: Differentiated thyroid carcinoma, diameter ≤ 2cm, cN0 or cN1a, M0; 3. Thyroid lobe was less than the second degree enlargement; 4. Thyroid benign goiter, and the diameter ≤ 6cm

Exclusion criteria

1. Combine the surgical history of mandibular, oral, facial, or neck; 2. It was shown by preoperative radiological examination that the thyroid cancer has local invasion, N1b, or distant metastasis. 3. Thyroid lobe was more than the third degree enlargement 4. Any medical history that probably interfere the test results or increase the disease risks 5. The patient's compliance is not very well, and cannot work as the doctors asked

Design outcomes

Primary

MeasureTime frameDescription
Quality of life assessment postoperatively12 months after the surgery of thyroidectomyPhysicians Global Assessment to measure quality of life was performed, and the assessment form had been verified.

Secondary

MeasureTime frameDescription
Cosmetic results of thyroidectomy postoperatively12 months after the surgery of thyroidectomyVisual Analog Score (1-10) for the cosmetic results (evaluated by patients) was been performed.
Surgical Complications of thyroidectomy postoperatively12 months after the surgery of thyroidectomyThe rates (percentage) of surgical complications (transient or permanent Recurrent Laryngeal Nerve paralysis, transient or permanent hypoparathyroidism, Postoperative hemorrhage)
Surgical Completeness of thyroidectomy postoperatively12 months after the surgery of thyroidectomyThe rates (percentage) of surgical completeness (whether or not any thyroid associated tissues left by the examination of ultrasound and Iodine-131)

Countries

China

Contacts

Primary ContactYong Wang, MD.
yuxing@zju.edu.cn+86-15867119955
Backup ContactXing Yu, MD.
yx6808@163.com+86-13732207545

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026