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

Last updated: October 1, 2024
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thyroid Cancer

Treatment

minimally invasive procedure

Conventional Open Surgery

Clinical Study ID

NCT06037174
SYSKY-2023-472-01
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years and < 70 years;

  • Biopsy or surgical pathology indicated differentiated thyroid carcinoma (papillarythyroid carcinoma, follicular carcinoma);

  • stage T1T3a, N0N1a, M0;

  • Ability to read and write Chinese;

  • Willingness to follow up.

Exclusion

Exclusion Criteria:

  • Age < 18 years old or ≥70 years old;

  • Biopsy or surgical pathology indicated medullary carcinoma or anaplastic thyroidcarcinoma;

  • 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

Total Participants: 230
Treatment Group(s): 2
Primary Treatment: minimally invasive procedure
Phase:
Study Start date:
September 15, 2023
Estimated Completion Date:
September 10, 2025

Study 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.

Connect with a study center

  • Sun Yat-sen Memorial Hopsital

    Guangzhou, Guangdong 510289
    China

    Active - Recruiting

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