Comparative Study in Oral, Breast Approach and Open Thyroidectomy
Comparative Study of Surgical Results in Endoscopic Thyroidectomy Via Oral Approach, Via Breast Approach and Conventional Open Thyroidectomy
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMarch 27, 2018
February 1, 2018
2 years
March 15, 2018
March 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Cosmetic results of thyroidectomy postoperatively
12 months after the surgery of thyroidectomy
Surgical Complications of thyroidectomy postoperatively
12 months after the surgery of thyroidectomy
Surgical Completeness of thyroidectomy postoperatively
12 months after the surgery of thyroidectomy
Study Arms (3)
Conventional Open
Conventional open thyroidectomy group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection)
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)
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)
Interventions
Different methods of thyroid surgery, including conventional open thyroidectomy, transoral endoscopic thyroidectomy via vestibular approach, and endoscopic thyroidectomy via breast approach.
Eligibility Criteria
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts about the eligibility criteria. Patients will be introduced the general information of different surgical methods, and the clinical studies.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SAHZhejiangU
Hanzhou, Zhejiang, 310009, China
Related Publications (2)
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.
PMID: 27585396RESULTZhu R, Yue N, Hong Y, Ye Q, Han Z, Luo Z, Xie C, Yan H, Yu X. Ectopic parathyroid adenomas in primary hyperparathyroidism: anatomical classifications, localization strategies, and case series. Int J Surg. 2026 Jan 12. doi: 10.1097/JS9.0000000000004578. Online ahead of print.
PMID: 41417934DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jianan Wang, MD.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2018
First Posted
March 27, 2018
Study Start
January 1, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
March 27, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share
Participants who had studied endoscopic thyroid surgeries in our department would be introduced.