Clinical trial NCT06037174: Comparison of Quality of Life in Patients with Differentiated Thyroid Carcinoma Undergoing Different Surgery
Official title: Comparison of Quality of Life Between Patients with Early Differentiated Thyroid Cancer Undergoing Minimally Invasive and Open Surgery: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Keywords: thyroid cancer
quality of life
minimally invasive
surgery
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of quality of life (SF-36)
timeFrame: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
measure: change of quality of life (Thyca-Qol)
timeFrame: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Secondary outcomes:
measure: voice handicap index
timeFrame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
measure: scores of the surgical scar
timeFrame: 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
measure: level of thyroglobulin
timeFrame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
measure: level of calcium
timeFrame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
measure: operation duration
timeFrame: Intraoperative
measure: blood loss
timeFrame: up to 1 week after surgery
measure: postoperative drainage
timeFrame: up to 1 week after surgery
measure: complications
timeFrame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
measure: satisfaction of the surgery
timeFrame: 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hopsital
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Xiaoming Huang
role: STUDY_DIRECTOR
References: