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

NCT06037174 | Unknown

• 1 other identifier: SYSKY-2023-472-01
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Keywords

thyroid cancer; quality of life; minimally invasive; surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• voice handicap index

  baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery

• scores of the surgical scar

  1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery

• level of thyroglobulin

  baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery

• level of calcium

  baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery

• operation duration

  Intraoperative

Study Arms (2)

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

traditional open surgery

undergoing thyroidectomy with tradition open surgery

Procedure: Conventional Open Surgery

Interventions

minimally invasive procedure 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)

minimally invasive surgery

Conventional Open Surgery PROCEDURE

Conventional Open Surgery

traditional open surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hopsital

Guangzhou, Guangdong, 510289, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

thyroid function test, thyroglobin, etc.

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Xiaoming Huang

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Xiaoming Huang, Professor

CONTACT

13602808820; hxming@mail.sysu.edu.cn

Peiliang Lin, Doctor

CONTACT

18520393810; linpliang3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Director

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: September 14, 2023
• Study Start: September 15, 2023
• Primary Completion: October 10, 2024
• Study Completion: September 10, 2025
• Last Updated: October 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)