Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05932121 |
Other study ID # |
K4107-K23C1755 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.