A Follow-up Study on Total Endoscopic Thyroidectomy Bilateral Areola Approach
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT05315219
Collaborator
(none)
295
2
48
Study Details
Study Description
Brief Summary
Endoscopic thyroidectomy bilateral areola approach (ETBAA) is one of the most widely applied approach in China, meanwhile its safety and effectiveness has been broadly discussed since being introduced. However, these studies are generally with small sample size and short follow-up duration. The lack of long-term follow-up on oncological outcomes makes it inaccurate to evaluate the effectiveness of ETBAA versus OT. Thus, in this study, we evaluated long-term QoL and outcomes of patients with PTC underwent thyroidectomy via ETBAA versus OT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
295 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Screening
Official Title:
A Follow-up Study on the Long-term Treatment Effect and Quality of Life of Thyroid Cancer After Total Endoscopic Thyroidectomy Bilateral Areola Approach
Actual Study Start Date
:
Jan 1, 2014
Actual Primary Completion Date
:
Dec 31, 2017
Actual Study Completion Date
:
Dec 31, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Endoscopic Thyroidectomy Bilateral Areola Approach
|
Procedure: Endoscopic Thyroidectomy Bilateral Areola Approach
The endoscopic thyroidectomy achieves better cosmetic effects than open thyroidectomy, and is one of the most widely applied approach in China, meanwhile its safety and effectiveness has been broadly discussed since being introduced.
|
| No Intervention: Open Thyroidectomy
|
Outcome Measures
Primary Outcome Measures
- Quality of life [5 years]
measured by THYCA-QoL questionaire
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
- Female patients under 55 years old; 2) no lateral cervical lymph node or distant metastasis were detected before the operation; 3) postoperative pathology confirmed the diagnosis of papillary thyroid carcinoma.
Exclusion Criteria:
-
- Previous history of thyroid surgery; 2) lateral cervical lymph node dissection in the operation; 3) past or current history of underlying diseases including hyperthyroidism, hypertension, diabetes, coagulation dysfunction.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05315219
Other Study ID Numbers:
- 2021-0439
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No