Thyroid NoduleNCT03031639
Khon Kaen University's Thyroidectomy Registry
An observational study of Thyroid Nodule and Thyroid Neoplasms, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This registry tries to collect the outcomes including quality of life and complication for both endoscopic and conventional thyroidectomy methods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Nodule, Thyroid Neoplasms, Thyroid Cancer
- What is being tested?
- Endoscopic approach thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteThailand
- Study dates
- 13 Jan 2017to 12 Jan 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who underwent thyroidectomy at Khon Kaen University
Who may be able to join
- The patients who underwent thyroidectomy at Khon Kaen University
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Otolaryngology, Khonkaen University
Muang, Khonkaen, 40002
About this study
The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This registry tries to collect the outcomes including quality of life and complication for both endoscopic and conventional thyroidectomy methods.
- Conditions
- Thyroid Nodule, Thyroid Neoplasms, Thyroid Cancer
- Being tested
- Endoscopic approach thyroidectomy
- Keywords
- endoscopic, thyroidectomy
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic approach thyroidectomyProcedure or surgery
Thyroid surgery using endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic | This group is the patients who underwent endoscopic approaches thyroidectomy. Receives: Procedure: Endoscopic approach thyroidectomy | |
| Conventional | This group is the patients who underwent conventional approach thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of QOL Score at 6 months
Validated quality of life score(SF-36) will be measure at baseline and 6 months
Measured: 6 months
Secondary outcomes (2)
Change of the symptoms score
The questionnaire for pain, numbness, voice, swallowing and neck movement function will be given and the patient needs to rate from 0 to 10.
Measured: At 2, 6, 12, and 24 weeks after surgery
Complication rate
Complications after surgery
Measured: At 2, 6, 12, and 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start13 Jan 2017
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patorn Piromchai, Khon Kaen University
- Investigators
- Patorn Piromchai, MD, MSc, PhD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031639
- Sponsor's protocol ID
- HE591517
- Status last verified
- Feb 2021
- First submitted
- 20 Jan 2017
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord. 2008 Mar 20;8:1. doi: 10.1186/1472-6815-8-1.
PubMed 18366712Piromchai P, Wijakkanalan P, Teeramatwanich W, Kasemsiri P, Laohasiriwong S, Ratanaanekchai T. Postauricular-submental approach endoscopic thyroidectomy. Clin Otolaryngol. 2018 Apr;43(2):767-769. doi: 10.1111/coa.12791. Epub 2016 Nov 27. No abstract available.
PubMed 27860271
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Khon Kaen University's Thyroidectomy Registry
- ClinicalTrials.gov ID
- NCT03031639
- Acronym / sponsor ID
- HE591517
- Conditions
- Thyroid Nodule, Thyroid Neoplasms, Thyroid Cancer
- Keywords
- endoscopic, thyroidectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This registry tries to collect the outcomes including quality of life and complication for both endoscopic and conventional thyroidectomy methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic | – | Procedure: Endoscopic approach thyroidectomyThis group is the patients who underwent endoscopic approaches thyroidectomy. |
| Conventional | – | –This group is the patients who underwent conventional approach thyroidectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who underwent thyroidectomy at Khon Kaen University
Key inclusion criteria (1 listed)
- The patients who underwent thyroidectomy at Khon Kaen University
Key exclusion criteria (1 listed)
- None
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 approach thyroidectomyThyroid surgery using endoscopy. | Procedure or surgery | Endoscopic |
Primary outcome
Change from Baseline of QOL Score at 6 months
Time frame: 6 months
Validated quality of life score(SF-36) will be measure at baseline and 6 months
2 secondary outcomes
Change of the symptoms score
Time frame: At 2, 6, 12, and 24 weeks after surgery
Complication rate
Time frame: At 2, 6, 12, and 24 weeks after surgery
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 18 Feb 2021.
- Background: PubMed 18366712Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord. 2008 Mar 20;8:1. doi: 10.1186/1472-6815-8-1.
- Results publication: PubMed 27860271Piromchai P, Wijakkanalan P, Teeramatwanich W, Kasemsiri P, Laohasiriwong S, Ratanaanekchai T. Postauricular-submental approach endoscopic thyroidectomy. Clin Otolaryngol. 2018 Apr;43(2):767-769. doi: 10.1111/coa.12791. Epub 2016 Nov 27. No abstract available.
- Individual participant dataSharing planned: No
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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.
Patorn Piromchai, MD, MSc, PhD principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule and Thyroid Neoplasms, run by Khon Kaen University at 1 site in Thailand.
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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from Baseline of QOL Score at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031639, which also lists 2 linked publications.
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 18 Feb 2021; AzTrials last refreshed its copy on 3 Nov 2026.