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Clinical Trials/NCT03479801
NCT03479801
Unknown
Not Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country150 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid Neoplasms
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
150
Locations
1
Primary Endpoint
Quality of life assessment postoperatively
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 31, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Quality of life assessment postoperatively

Time Frame: 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 Outcomes

  • Surgical Completeness of thyroidectomy postoperatively(12 months after the surgery of thyroidectomy)
  • Cosmetic results of thyroidectomy postoperatively(12 months after the surgery of thyroidectomy)
  • Surgical Complications of thyroidectomy postoperatively(12 months after the surgery of thyroidectomy)

Study Sites (1)

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