Comparison of Quality of Life in Patients with Differentiated Thyroid Carcinoma Undergoing Different Surgery
- Conditions
- Thyroid Cancer
- Interventions
- Procedure: minimally invasive procedureProcedure: Conventional Open Surgery
- Registration Number
- NCT06037174
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 230
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description minimally invasive surgery minimally invasive procedure undergoing thyroidectomy with endoscopy-assisted subclavian approach, robot-assisted transaxillary approach, robot-assisted transoral approach, robot-assisted retroauricular approach, etc. traditional open surgery Conventional Open Surgery undergoing thyroidectomy with tradition open surgery
- Primary Outcome Measures
Name Time Method 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
Name Time Method operation duration Intraoperative time for operation
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
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
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
postoperative drainage up to 1 week after surgery drainage volume after surgery
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
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
blood loss up to 1 week after surgery blood loss during operation
Trial Locations
- Locations (1)
Sun Yat-sen Memorial Hopsital
🇨🇳Guangzhou, Guangdong, China