Comparative Study in Oral, Breast Approach and Open Thyroidectomy

NCT ID: NCT03479801

Last Updated: 2018-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Thyroid Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional Open

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

Thyroid Surgical Methods

Intervention Type PROCEDURE

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

Transoral Endoscopic Surgery

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

Thyroid Surgical Methods

Intervention Type PROCEDURE

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

Endoscopic Thyroidectomy via Breast

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)

Thyroid Surgical Methods

Intervention Type PROCEDURE

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

Interventions

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Thyroid Surgical Methods

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianan Wang, MD.

Role: STUDY_DIRECTOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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SAHZhejiangU

Hanzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong Wang, MD.

Role: CONTACT

+86-15867119955

Xing Yu, MD.

Role: CONTACT

+86-13732207545

Facility Contacts

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Xing Yu, MD.

Role: primary

+86-13732207545

References

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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. doi: 10.1089/lap.2016.0291. Epub 2016 Sep 1.

Reference Type RESULT
PMID: 27585396 (View on PubMed)

Other Identifiers

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87783760

Identifier Type: -

Identifier Source: org_study_id

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