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

Sun Yat-sen University

Status: Enrolling

Conditions: Thyroid Cancer

Treatments: Procedure: minimally invasive procedure; Procedure: Conventional Open Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06037174

SYSKY-2023-472-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

230 participants in 2 patient groups

minimally invasive surgery

Description:

undergoing thyroidectomy with endoscopy-assisted subclavian approach, robot-assisted transaxillary approach, robot-assisted transoral approach, robot-assisted retroauricular approach, etc.

Treatment:

Procedure: minimally invasive procedure

traditional open surgery

Description:

undergoing thyroidectomy with tradition open surgery

Treatment:

Procedure: Conventional Open Surgery