Comparative Study in Oral, Breast Approach and Open Thyroidectomy

Zhejiang University

Status: Unknown

Conditions: Thyroid Neoplasms

Treatments: Procedure: Thyroid Surgical Methods

Study type: Observational

Funder types: Other

Identifiers

NCT03479801

87783760

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 15 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

Conventional Open

Description:

Conventional open thyroidectomy group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection)

Treatment:

Procedure: Thyroid Surgical Methods

Transoral Endoscopic Surgery

Description:

Transoral endoscopic thyroidectomy via vestibular approach group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection)

Treatment:

Procedure: Thyroid Surgical Methods

Endoscopic Thyroidectomy via Breast

Description:

Endoscopic thyroidectomy via breast approach or bilateral areola approach group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection)

Treatment:

Procedure: Thyroid Surgical Methods