Comparative Study in Oral, Breast Approach and Open Thyroidectomy

• Conditions: Thyroid Neoplasms
• Interventions: Procedure: Thyroid Surgical Methods

• Registration Number: NCT03479801
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2018-02
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-25
• Last Update Submitted: 2018-03-25
• Study First Posted: 2018-03-27
• Last Update Posted: 2018-03-27
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic Thyroidectomy via Breast	Thyroid Surgical Methods	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)
Conventional Open	Thyroid Surgical Methods	Conventional open thyroidectomy group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection)
Transoral Endoscopic Surgery	Thyroid Surgical Methods	Transoral endoscopic thyroidectomy via vestibular approach group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection)

Primary Outcome Measures

Name	Time	Method
Quality of life assessment postoperatively	12 months after the surgery of thyroidectomy	Physicians Global Assessment to measure quality of life was performed, and the assessment form had been verified.

Secondary Outcome Measures

Name	Time	Method
Surgical Completeness of thyroidectomy postoperatively	12 months after the surgery of thyroidectomy	The rates (percentage) of surgical completeness (whether or not any thyroid associated tissues left by the examination of ultrasound and Iodine-131)
Cosmetic results of thyroidectomy postoperatively	12 months after the surgery of thyroidectomy	Visual Analog Score (1-10) for the cosmetic results (evaluated by patients) was been performed.
Surgical Complications of thyroidectomy postoperatively	12 months after the surgery of thyroidectomy	The rates (percentage) of surgical complications (transient or permanent Recurrent Laryngeal Nerve paralysis, transient or permanent hypoparathyroidism, Postoperative hemorrhage)

Trial Locations

Locations (1)

SAHZhejiangU; 🇨🇳 Hanzhou, Zhejiang, China