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The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Early differentiated thyroid cancer has a good prognosis, and surgery is the main treatment. Traditional open surgery would leave a scar on the neck. However, emerging minimally invasive procedures can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.
This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing different surgery. The quality of life, voice, scar would be assessed by authoritative questionaires or scales. We hope to demonstrate that minimally invasive surgery is better than traditional open surgery in order to provide reliable evidence for clinical practice.
The incidence of thyroid cancer has increased rapidly in recent years, especially in women. Differentiated thyroid cancer takes the largest proportion in thyroid cancer, but it has a good prognosis. For early differentiated thyroid cancer, surgery is the main treatment. Traditional open surgery would leave a scar on the neck, which is especially troublesome for female patients. However, emerging minimally invasive procedures, such as endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach, etc., can avoid the scar on the neck, resulting in better aesthetic effect, which would have an impact on the quality of life of patients to a certain degree.
This study intend to follow up patients regularly with early differentiated thyroid cancer undergoing surgery according to a prospective cohort design. The evaluation questionnaires including quality of life, voice and scar would be completed to demonstrate that minimally invasive surgery is better than traditional open surgery not only in the way of effectiveness, but also in the quality of life. We hope to provide reliable evidence for clinical practice by this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minimally invasive surgery | undergoing thyroidectomy with endoscopy-assisted subclavian approach, robot-assisted transaxillary approach, robot-assisted transoral approach, robot-assisted retroauricular approach, etc. |
| |
| traditional open surgery | undergoing thyroidectomy with tradition open surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minimally invasive procedure | Procedure | different minimally invasive approach to complete thyroidectomy, including endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach (not leaving scar on the neck) |
| Measure | Description | Time Frame |
|---|---|---|
| change of quality of life (SF-36) | change of the scores of the SF-36(36-item Short-Form)questionaire | baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery |
| change of quality of life (Thyca-Qol) | change of the scores of the Thyca-Qol(Thyroid Cancer-specific Quality of Life) questionaire | baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| voice handicap index | assessment of quality of voice | baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery |
| scores of the surgical scar | scores of the questionaires (POSAS) about scar |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoming Huang, Professor | Contact | 13602808820 | hxming@mail.sysu.edu.cn | |
| Peiliang Lin, Doctor | Contact | 18520393810 | linpliang3@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoming Huang | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hopsital | Recruiting | Guangzhou | Guangdong | 510289 | China |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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thyroid function test, thyroglobin, etc.
| Conventional Open Surgery | Procedure | Conventional Open Surgery |
|
| 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery |
| level of thyroglobulin | an indicator to monitor tumor residual or recurrence | baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery |
| level of calcium | to indicate whether the patient have hypocalcemia | baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery |
| operation duration | time for operation | Intraoperative |
| blood loss | blood loss during operation | up to 1 week after surgery |
| postoperative drainage | drainage volume after surgery | up to 1 week after surgery |
| complications | complication events after surgery, e.g. hoarseness, hypocalcemia, hemorrhage, seroma | baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery |
| satisfaction of the surgery | Visual Analog Score for satisfaction | 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |