NCT05315219

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable quality-of-life

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

4 years

First QC Date

March 30, 2022

Last Update Submit

March 30, 2022

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    measured by THYCA-QoL questionaire

    5 years

Study Arms (2)

Endoscopic Thyroidectomy Bilateral Areola Approach

EXPERIMENTAL
Procedure: Endoscopic Thyroidectomy Bilateral Areola Approach

Open Thyroidectomy

NO INTERVENTION

Interventions

Endoscopic Thyroidectomy Bilateral Areola ApproachPROCEDURE

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.

Endoscopic Thyroidectomy Bilateral Areola Approach

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 7, 2022

Study Start

January 1, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

April 7, 2022

Record last verified: 2022-03