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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037174
• Other study ID #: SYSKY-2023-472-01
• Status: Recruiting
• Start date: September 15, 2023
• Est. completion date: September 10, 2025

Study information

• Verified date: December 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Xiaoming Huang, Professor
• Phone: 13602808820
• Email: hxming[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: September 10, 2025
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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)

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hopsital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	operation duration	time for operation	Intraoperative
Secondary	blood loss	blood loss during operation	up to 1 week after surgery
Secondary	postoperative drainage	drainage volume after surgery	up to 1 week after surgery
Secondary	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
Secondary	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