Thyroid Cancer
Conditions
Keywords
thyroid cancer, quality of life, minimally invasive, surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREminimally invasive 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)
PROCEDUREConventional Open Surgery
Conventional Open Surgery
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years and \< 70 years; * Biopsy or surgical pathology indicated differentiated thyroid carcinoma (papillary thyroid carcinoma, follicular carcinoma); * stage T1\ T3a, N0\ N1a, M0; * Ability to read and write Chinese; * Willingness to follow up.
Exclusion criteria
* Age \< 18 years old or ≥70 years old; * Biopsy or surgical pathology indicated medullary carcinoma or anaplastic thyroid carcinoma; * Aggressive histology: tall cell, columnar cell, hobnail variant, etc. * Mixed with medullary carcinoma or anaplastic thyroid carcinoma; * High risk of recurrence (according to ATA guideline); * Lateral cervical lymph node metastasis or distant metastasis; * Suffer from other malignant tumors; * History of thyroid surgery or cervical lymph node dissection; * Cognition or behavior impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of quality of life (SF-36) | baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery | change of the scores of the SF-36（36-item Short-Form）questionaire |
| change of quality of life (Thyca-Qol) | baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery | change of the scores of the Thyca-Qol（Thyroid Cancer-specific Quality of Life） questionaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| level of thyroglobulin | baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery | an indicator to monitor tumor residual or recurrence |
| level of calcium | baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery | to indicate whether the patient have hypocalcemia |
| operation duration | Intraoperative | time for operation |
| voice handicap index | baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery | assessment of quality of voice |
| postoperative drainage | up to 1 week after surgery | drainage volume after surgery |
| complications | baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery | complication events after surgery, e.g. hoarseness, hypocalcemia, hemorrhage, seroma |
| satisfaction of the surgery | 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery | Visual Analog Score for satisfaction |
| blood loss | up to 1 week after surgery | blood loss during operation |
| scores of the surgical scar | 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery | scores of the questionaires (POSAS) about scar |
Countries
China
Contacts
Primary ContactXiaoming Huang, Professor
Backup ContactPeiliang Lin, Doctor
Outcome results
None listed