Quality of LifeNCT05315219
A Follow-up Study on Total Endoscopic Thyroidectomy Bilateral Areola Approach
A study testing Endoscopic Thyroidectomy Bilateral Areola Approach in people with Quality of Life, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Quality of Life
- What is being tested?
- Endoscopic Thyroidectomy Bilateral Areola Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1) 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.
Who cannot join
- 1) 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.
About this study
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
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.
- Conditions
- Quality of Life
- Being tested
- Endoscopic Thyroidectomy Bilateral Areola Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Thyroidectomy Bilateral Areola ApproachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Thyroidectomy Bilateral Areola Approach | Experimental | Not described Receives: Procedure: Endoscopic Thyroidectomy Bilateral Areola Approach |
| Open Thyroidectomy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
measured by THYCA-QoL questionaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315219
- Sponsor's protocol ID
- 2021-0439
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05315219
- Acronym / sponsor ID
- 2021-0439
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Thyroidectomy Bilateral Areola Approach | Experimental | Procedure: Endoscopic Thyroidectomy Bilateral Areola Approach |
| Open Thyroidectomy | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) 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.
Key exclusion criteria (1 listed)
- 1) 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Thyroidectomy Bilateral Areola ApproachThe 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. | Procedure or surgery | Endoscopic Thyroidectomy Bilateral Areola Approach |
Primary outcome
Quality of life
Time frame: 5 years
measured by THYCA-QoL questionaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Thyroidectomy Bilateral Areola Approach in people with Quality of Life, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.