Thyroid NeoplasmsNCT03479801
Comparative Study in Oral, Breast Approach and Open Thyroidectomy
An observational study of Thyroid Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Thyroid Surgical Methods
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SAHZhejiangU
Hanzhou, Zhejiang, 310009
Xing Yu, MD., +86-13732207545, yx6808@163.com
About this study
Official title: Comparative Study of Surgical Results in Endoscopic Thyroidectomy Via Oral Approach, Via Breast Approach and Conventional Open Thyroidectomy
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.
Read the 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.
- Conditions
- Thyroid Neoplasms
- Being tested
- Thyroid Surgical Methods
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid Surgical MethodsProcedure or surgery
Different methods of thyroid surgery, including conventional open thyroidectomy, transoral endoscopic thyroidectomy via vestibular approach, and endoscopic thyroidectomy via breast approach.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Open | Conventional open thyroidectomy group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection) Receives: Procedure: Thyroid Surgical Methods | |
| 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) Receives: Procedure: Thyroid Surgical Methods | |
| 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) Receives: Procedure: Thyroid Surgical Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment postoperatively
Physicians Global Assessment to measure quality of life was performed, and the assessment form had been verified.
Measured: 12 months after the surgery of thyroidectomy
Secondary outcomes (3)
Cosmetic results of thyroidectomy postoperatively
Visual Analog Score (1-10) for the cosmetic results (evaluated by patients) was been performed.
Measured: 12 months after the surgery of thyroidectomy
Surgical Complications of thyroidectomy postoperatively
The rates (percentage) of surgical complications (transient or permanent Recurrent Laryngeal Nerve paralysis, transient or permanent hypoparathyroidism, Postoperative hemorrhage)
Measured: 12 months after the surgery of thyroidectomy
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)
Measured: 12 months after the surgery of thyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianan Wang, MD., Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479801
- Sponsor's protocol ID
- 87783760
- Status last verified
- Feb 2018
- First submitted
- 15 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants who had studied endoscopic thyroid surgeries in our department would be introduced.
Publications
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.
PubMed 27585396Zhu 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;112(4):9958-74. doi: 10.1097/JS9.0000000000004578. Online ahead of print.
PubMed 41417934
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Surgical Results in Endoscopic Thyroidectomy Via Oral Approach, Via Breast Approach and Conventional Open Thyroidectomy
- ClinicalTrials.gov ID
- NCT03479801
- Acronym / sponsor ID
- 87783760
- Conditions
- Thyroid Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Open | – | Procedure: Thyroid Surgical MethodsConventional open thyroidectomy group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection) |
| Transoral Endoscopic Surgery | – | Procedure: Thyroid Surgical MethodsTransoral 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 | – | Procedure: Thyroid Surgical MethodsEndoscopic thyroidectomy via breast approach or bilateral areola approach group (thyroid neoplasms patients who underwent conventional thyroidectomy procedure with or without postoperative central node dissection) |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid Surgical MethodsDifferent methods of thyroid surgery, including conventional open thyroidectomy, transoral endoscopic thyroidectomy via vestibular approach, and endoscopic thyroidectomy via breast approach. | Procedure or surgery | Conventional Open, Endoscopic Thyroidectomy via Breast, Transoral Endoscopic Surgery |
Primary outcome
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.
3 secondary outcomes
Cosmetic results of thyroidectomy postoperatively
Time frame: 12 months after the surgery of thyroidectomy
Surgical Complications of thyroidectomy postoperatively
Time frame: 12 months after the surgery of thyroidectomy
Surgical Completeness of thyroidectomy postoperatively
Time frame: 12 months after the surgery of thyroidectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Results publication: PubMed 27585396Wang 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.
- Derived from this study: PubMed 41417934Zhu 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;112(4):9958-74. doi: 10.1097/JS9.0000000000004578. Online ahead of print.
- The links of reference which is related with this studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Participants who had studied endoscopic thyroid surgeries in our department would be introduced.
Related trials for Thyroid Neoplasms
Not yet recruitingPhase 1/2
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Studies on Tumors of the Thyroid
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianan Wang, MD. study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Wang, MD. (+86-15867119955, yuxing@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessment postoperatively (time frame: 12 months after the surgery of thyroidectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479801, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.