Thyroid Gland DiseaseNCT05396703
TOETVA Feasibility and Complications - Single Center First Experience
An observational study of Thyroid Gland Disease and Surgery, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
All participants who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center are observed for complications and feasibility of this surgery. Anonymised data relevant to the participants' condition will be used. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thyroid Gland Disease, Surgery
- What is being tested?
- TOETVA
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Oct 2019to 19 Jun 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach at the investigators' center.
Who may be able to join
- Patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center
Who cannot join
- Patients who did not undergo (or will not undergo) a TOETVA at the investigators' center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Complications After Transoral Endoscopic Thyroidectomy Via Vestibular Approach (TOETVA) - a Single-Center First Experience Case Series and Systematic Review
All participants who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center are observed for complications and feasibility of this surgery. Anonymised data relevant to the participants' condition will be used.
- Conditions
- Thyroid Gland Disease, Surgery
- Being tested
- TOETVA
- Keywords
- TOETVA, NOTES, Surgery, Endocrine, Thyroid, Case Series
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOETVAProcedure or surgery
Completed procedure.
| Study group | Role | What they receive |
|---|---|---|
| TOETVA | All patients who underwent a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center. Receives: Procedure: TOETVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications initial
Complications after performed surgery
Measured: Immediately postoperative (during hospitalization)
Complications before follow-up
Complications after performed surgery
Measured: If premature presentation occurs (admission after discharge and before follow-up consultation at 1 month after surgery)
Complications before follow-up
Complications after performed surgery
Measured: Data at first follow-up visit will be reported. First follow-up visit will be at (average) 1 month after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start22 Oct 2019
- Primary completion8 May 2022
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Gland DiseaseStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Kinet, MD, Principal investigator, Zuyderland MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396703
- Sponsor's protocol ID
- BWO Z2021024
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised patient sex, age, extent of resection, preoperative TSH values, TI-RADS classification, Bethesda classification, malignancy of lesion, and complications after surgery will be provided within the final manuscript.
Publications
Kinet S, van Weezelenburg MAS, Pijnenburg A, Stoot JHMB, van Bastelaar J. Feasibility and complications after transoral endoscopic thyroidectomy via vestibular approach (TOETVA) - a single-center first experience case series. Langenbecks Arch Surg. 2024 May 15;409(1):158. doi: 10.1007/s00423-024-03347-3.
PubMed 38748236
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Complications After Transoral Endoscopic Thyroidectomy Via Vestibular Approach (TOETVA) - a Single-Center First Experience Case Series and Systematic Review
- ClinicalTrials.gov ID
- NCT05396703
- Acronym / sponsor ID
- BWO Z2021024
- Conditions
- Thyroid Gland Disease, Surgery
- Keywords
- TOETVA, NOTES, Surgery, Endocrine, Thyroid, Case Series
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 31 May 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.
All participants who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center are observed for complications and feasibility of this surgery. Anonymised data relevant to the participants' condition will be used.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOETVA | – | Procedure: TOETVAAll patients who underwent a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach at the investigators' center.
Key inclusion criteria (1 listed)
- Patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center
Key exclusion criteria (1 listed)
- Patients who did not undergo (or will not undergo) a TOETVA at the investigators' center
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 |
|---|---|---|
| TOETVACompleted procedure. | Procedure or surgery | TOETVA |
Primary outcome
Complications initial
Time frame: Immediately postoperative (during hospitalization)
Complications after performed surgery
Complications before follow-up
Time frame: If premature presentation occurs (admission after discharge and before follow-up consultation at 1 month after surgery)
Complications after performed surgery
Complications before follow-up
Time frame: Data at first follow-up visit will be reported. First follow-up visit will be at (average) 1 month after discharge.
Complications after performed 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 6 Sep 2023.
- Derived from this study: PubMed 38748236Kinet S, van Weezelenburg MAS, Pijnenburg A, Stoot JHMB, van Bastelaar J. Feasibility and complications after transoral endoscopic thyroidectomy via vestibular approach (TOETVA) - a single-center first experience case series. Langenbecks Arch Surg. 2024 May 15;409(1):158. doi: 10.1007/s00423-024-03347-3.
- Individual participant dataSharing planned: Undecided. Anonymised patient sex, age, extent of resection, preoperative TSH values, TI-RADS classification, Bethesda classification, malignancy of lesion, and complications after surgery will be provided within the final manuscript.
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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.
Sam Kinet, MD principal investigator
Zuyderland MC
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 Gland Disease and Surgery, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 6 Sep 2023. 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 Netherlands. 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?
Complications initial (time frame: Immediately postoperative (during hospitalization)). The study lists 3 primary outcomes in all. 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 NCT05396703, which also lists 1 linked publication.
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 6 Sep 2023.