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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer
• Intervention / Treatment: Procedure: minimally invasive procedure; Procedure: Conventional Open Surgery

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 Type: Observational
• Enrollment (Estimated): 230

Contacts and Locations

• Study Contact: Name: Xiaoming Huang, Professor; Phone Number: 13602808820; Email: hxming@mail.sysu.edu.cn
• Study Contact Backup: Name: Peiliang Lin, Doctor; Phone Number: 18520393810; Email: linpliang3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510289
      • Recruiting
      • Sun Yat-sen Memorial Hopsital
      • Contact: Xiaoming Huang, Professor; Phone Number: 13602808820; Email: hxming@mail.sysu.edu.cn
      • Contact: Peiliang Lin, Doctor; Phone Number: 18520393810; Email: linpliang3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

primary care clinic

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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	Procedure: Conventional Open Surgery; Conventional Open Surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): October 10, 2024
• Study Completion (Estimated): September 10, 2025

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; surgery; thyroid cancer; minimally invasive
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: SYSKY-2023-472-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No