Cross-sectional Case and Control Study on Quality of Life, Appearance and Functions in PTC Via Different Surgical Approach

Thyroid Cancer Clinical Trial

Official title:

The Effect of Postoperative Quality of Life and Cosmetic Result Between PTC Patients Underwent Thyroid Lobectomy Via Different Surgical Approach, Trans-axillary Approach vs Open Approach: A Cross-sectional Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932121
• Other study ID #: K4107-K23C1755
• Status: Recruiting
• Start date: June 25, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2023
• Source: Peking Union Medical College Hospital
• Contact: Qiaofei Liu, M.D
• Phone: 8615201693370
• Email: qfliu[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational cross-sectional case-control study on the postoperative quality of life (5 aspects, general quality of life, thyroid specific quality of life, scar appearance, voice and swallowing functions) of papillary thyroid carcinoma (PTC) patients underwent thyroid lobectomy via different approach, open vs trans-axillary. The patients are recruited in Peking Union Medical College Hospital (PUMCH) from 2020 to 2023 and are evaluated by follow-up with both outpatient visits and questionnaires made up of 9 validated scales.

Description:

Thyroid carcinoma is the most common thyroid tumor with a rising incidence. By 2015, it has risen to the fourth most common tumor among all tumors in female. Papillary thyroid carcinoma (PTC), representing up to 80% of all thyroid carcinomas, mostly occurring in female between 30-50 years old, although it has an excellent long-term survival outcome, still it brings the patients concerns and complaints of the obvious scars left on their necks by operations via traditional open approach. Cosmetic approaches of thyroid surgery have been developing rapidly in the last two decades, through approaches including trans-axillary, transoral, and trans-breast-chest, thyroid operations are able to avoid leaving surgical scars on the necks and instead leaving them on other parts of bodies covering by clothes. However, concerns of this new emerging technique including its excision extent, surgical complication, clinical outcome, functional outcome and postoperative quality of life still remain unsolved. Well-matched, high quality-studies focused on functional outcomes, cosmetic outcomes, and quality of life with large samples are still missing.

This observational cross-sectional case-control study with follow-up on the postoperative quality of life, clinical outcomes, functional outcomes and cosmetic outcomes of PTC patients underwent thyroid lobectomy via different approach, open vs trans-axillary, aims on achieving comprehensive understanding on how different surgical approaches affect the quality of life, clinical outcomes and functional outcomes. Patients are recruited in PUMCH from 2020-2023 who underwent thyroid lobectomy and with a definite pathological diagnosis of PTC. Cases are defined as PTC patients who underwent thyroid lobectomy via trans-axillary approach. Controls are defined as PTC patients who underwent thyroid lobectomy via open approach. Controls are matched to cases with a 1:1 ratio according to gender, age, main operator.

The postoperative quality of life, functional outcomes will be evaluated by a questionnaire made up of 4 validated scales (EORTC thyroid cancer specific quality of life questionnaire (THY34-QoL); patient scar assessment questionnaire (PSAQ); voice handicap index questionnaire (VHI-10); Swallowing impairment score (SIS-6). Clinical outcomes will be evaluated by data collected both from inpatient medical records and outpatient follow-up medical records. To our knowledge, this is the largest PTC thyroid lobectomy via trans-axillary approach case-control study worldwide, the first study with the design of assigning control matched to cases by applying pre-matching score method in this field, and the first study to concentrate on both clinical outcomes and comprehensive postoperative quality of life including physical, functional, and cosmetic outcomes in PTC patients via different surgical approaches.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• PTC patients underwent thyroid lobectomy with pathological diagnosis of PTC after surgery

Exclusion Criteria:

• Refusal to participate; Patients with invalid or incomplete questionnaire results; Patients with another primary malignancy; Patients with severe immune disease or chronic disease accompanying with major organ failure.

Related Conditions & MeSH terms

• Papillary Thyroid Carcinoma
• Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Thyroid lobectomy via trans-axillary approach
Patient with PTC underwent thyroid lobectomy via trans-axillary approach
• Thyroid lobectomy via open approach
Patient with PTC underwent thyroid lobectomy via open approach

Locations

Country	Name	City	State
China	Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic outcomes	The primary outcome will be evaluated by scores of cosmetic outcomes of PTC patients underwent thyroid lobectomy via different surgical approach up to 3 years after surgery. The scores are evaluated by a follow-up questionnaire made up of cosmetic outcome via scale of PSAQ. Scores will be compared in case and control groups. Lower scores in PSAQ indicate poorer outcomes in this field.	up to 3 years after surgery
Secondary	Thyroid cancer specific postoperative quality of life	The thyroid cancer specific postoperative quality of life will be evaluated by scores of thyroid cancer specific quality of life of PTC patients underwent thyroid lobectomy via different surgical approach up to 3 years after surgery. The scores are evaluated by a follow-up questionnaire made up of EORTC THY34-QoL scale. Scores will be compared in case and control groups. Higher scores in EORTC THY34-QoL indicate better quality of life.	up to 3 years after surgery
Secondary	Voice outcomes	The voice outcomes will be evaluated by scores of voice outcomes of PTC patients underwent thyroid lobectomy via different surgical approach up to 3 years after surgery. The scores are evaluated by a follow-up questionnaire made up of VHI-10 scale. Scores will be compared in case and control groups. Lower scores in VHI-6 indicate poorer outcomes in this field.	up to 3 years after surgery
Secondary	Swallowing function outcomes	The swallowing function outcomes will be evaluated by scores of swallowing function outcome of PTC patients underwent thyroid lobectomy via different surgical approach up to 3 years after surgery. The scores are evaluated by a follow-up questionnaire made up of SIS-6 scale. Scores will be compared in case and control groups. Lower scores in SIS-6 indicate poorer outcomes in swallowing function.	up to 3 years after surgery
Secondary	Time to recurrence	The time from the surgery to the recurrence (from date of surgery until the date of first documented recurrence including local recurrence, lymph node recurrence and distant metastasis).	up to 3 years after surgery