Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Quality of Life Between Patients With Early Differentiated Thyroid Cancer Undergoing Minimally Invasive and Open Surgery: A Prospective Cohort Study

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Procedure: minimally invasive procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| minimally invasive surgery<br>undergoing thyroidectomy with endoscopy-assisted subclavian approach, robot-assisted transaxillary approach, robot-assisted transoral approach, robot-assisted retroauricular approach, etc. | Procedure: minimally invasive procedure<br>* different minimally invasive approach to complete thyroidectomy, including endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach (not leaving scar on the neck)<br>|
| traditional open surgery<br>undergoing thyroidectomy with tradition open surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid cancer, quality of life, minimally invasive, surgery