Clinical trial NCT05932121: Cross-sectional Case and Control Study on Quality of Life, Appearance and Functions in PTC Via Different Surgical Approach
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Papillary Thyroid Carcinoma
Thyroid Cancer
Keywords: Papillary thyroid carcinoma
Surgical approaches
Voice assessment
Swallowing assessment
Cosmetic outcomes
Quality of life
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All of the hospitalized patients of PTC with a definite pathological diagnosis who underwent thyroid lobectomy via trans-axillary approach and those who underwent thyroid lobectomy via open approach matched by age, gender and major operator with a ratio of 1: 1 from 2020 to 2023 in Peking Union Medical College Hospital.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cosmetic outcomes
timeFrame: up to 3 years after surgery
Secondary outcomes:
measure: Thyroid cancer specific postoperative quality of life
timeFrame: up to 3 years after surgery
measure: Voice outcomes
timeFrame: up to 3 years after surgery
measure: Swallowing function outcomes
timeFrame: up to 3 years after surgery
measure: Time to recurrence
timeFrame: up to 3 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Department of General Surgery, Peking Union Medical College Hospital
name: Quan Liao, M.D
role: STUDY_CHAIR
References: