Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| minimally invasive surgery undergoing thyroidectomy with endoscopy-assisted subclavian approach, robot-assisted transaxillary approach, robot-assisted transoral approach, robot-assisted retroauricular approach, etc. |
Procedure: minimally 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)
|
| traditional open surgery undergoing thyroidectomy with tradition open surgery |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- 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
- blood loss [up to 1 week after surgery]
blood loss during operation
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years and < 70 years;
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Biopsy or surgical pathology indicated differentiated thyroid carcinoma (papillary thyroid carcinoma, follicular carcinoma);
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stage T1T3a, N0N1a, M0;
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Ability to read and write Chinese;
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Willingness to follow up.
Exclusion Criteria:
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Age < 18 years old or ≥70 years old;
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Biopsy or surgical pathology indicated medullary carcinoma or anaplastic thyroid carcinoma;
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Aggressive histology: tall cell, columnar cell, hobnail variant, etc.
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Mixed with medullary carcinoma or anaplastic thyroid carcinoma;
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High risk of recurrence (according to ATA guideline);
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Lateral cervical lymph node metastasis or distant metastasis;
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Suffer from other malignant tumors;
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History of thyroid surgery or cervical lymph node dissection;
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Cognition or behavior impairment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen Memorial Hopsital | Guangzhou | Guangdong | China | 510289 |
Sponsors and Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
- Study Director: Xiaoming Huang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SYSKY-2023-472-01