Comparative Study in Oral, Breast Approach and Open Thyroidectomy

Thyroid Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479801
• Other study ID #: 87783760
• Status: Recruiting
• First received: March 15, 2018
• Last updated: March 25, 2018
• Start date: January 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yong Wang, MD.
• Phone: +86-15867119955
• Email: yuxing[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Neoplasms

Intervention

Procedure:
• Thyroid Surgical Methods
Different methods of thyroid surgery, including conventional open thyroidectomy, transoral endoscopic thyroidectomy via vestibular approach, and endoscopic thyroidectomy via breast approach.

Locations

Country	Name	City	State
China	SAHZhejiangU	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang Y, Yu X, Wang P, Miao C, Xie Q, Yan H, Zhao Q, Zhang M, Xiang C. Implementation of Intraoperative Neuromonitoring for Transoral Endoscopic Thyroid Surgery: A Preliminary Report. J Laparoendosc Adv Surg Tech A. 2016 Dec;26(12):965-971. Epub 2016 Sep 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessment postoperatively	Physicians Global Assessment to measure quality of life was performed, and the assessment form had been verified.	12 months after the surgery of thyroidectomy
Secondary	Cosmetic results of thyroidectomy postoperatively	Visual Analog Score (1-10) for the cosmetic results (evaluated by patients) was been performed.	12 months after the surgery of thyroidectomy
Secondary	Surgical Complications of thyroidectomy postoperatively	The rates (percentage) of surgical complications (transient or permanent Recurrent Laryngeal Nerve paralysis, transient or permanent hypoparathyroidism, Postoperative hemorrhage)	12 months after the surgery of thyroidectomy
Secondary	Surgical Completeness of thyroidectomy postoperatively	The rates (percentage) of surgical completeness (whether or not any thyroid associated tissues left by the examination of ultrasound and Iodine-131)	12 months after the surgery of thyroidectomy

External Links

•   The links of reference which is related with this study