ThyroidectomyNCT04186715
Near Infrared Spectroscopy in Thyroidectomy
An observational study of Thyroidectomy and Near-infrared Spectroscopy, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Thyroidectomy operations have traditionally been performed as open surgery. However, the scarring that occurs in the patient leads to cosmetic problems, especially in young women. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy, Near-infrared Spectroscopy
- What is being tested?
- Near-infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2019to 1 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients applying to our Institute for thyroidectomy.
Who may be able to join
- ASA I-II
Who cannot join
- Patients with neck surgery.
- Patients who received radiotherapy to the neck region.
- Patients with cerebrovascular or neurological disease.
- Patients who underwent open surgery during the operation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Antalya Training and Research Hospital
Antalya, 07100
About this study
Official title: The Effect of Vestibular Transoral Endoscopic Thyroidectomy on Cerebral Regional Oxygen Saturation: Comparison With Open Thyroidectomy
Thyroidectomy operations have traditionally been performed as open surgery. However, the scarring that occurs in the patient leads to cosmetic problems, especially in young women. Today, as a result of the development of minimally invasive surgical techniques, the number of natural orifice transluminal endoscopic surgeries (NOTES) is increasing. Surgical scars are avoided by using natural pathways such as the mouth, urethra, vagina or anus. Transoral endoscopic thyroidectomy (TOETVA) with vestibular approach, a form of NOTES, was first performed in 2011. In this method, the operation is performed through three ports entered near the gingiva-buccal sulcus. TOETVA surgeries are performed with an insufflation pressure of 6 mmHg in the neck region. No studies are examining the effects of this pressure on the blood vessels in the neck region on the blood supply to the brain tissue. Therefore, the investigators aim to compare cases operated using open thyroidectomy or TOETVA method by measuring cerebral regional tissue saturation.
- Conditions
- Thyroidectomy, Near-infrared Spectroscopy
- Being tested
- Near-infrared spectroscopy
- Keywords
- TOETVA, Thyroidectomy, near-infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopyDevice
The Near-infrared spectroscopy probes will be placed in the frontal region.
| Study group | Role | What they receive |
|---|---|---|
| TOETVA | The demographic data of the patients undergoing TOETVA surgery will be recorded. Then, blood pressure, pulse pressure, pulse oximeter, end-tidal carbon dioxide, right and left cerebral regional oxygen values in the operation room will be recorded at certain intervals. It will also be recorded if complications develop. Receives: Device: Near-infrared spectroscopy | |
| Open thyroidectomy | The demographic data of the patients undergoing open thyroidectomy surgery will be recorded. Then, blood pressure, pulse pressure, pulse oximeter, end-tidal carbon dioxide, right and left cerebral regional oxygen values in the operation room will be recorded at certain intervals. It will also be recorded if complications develop. Receives: Device: Near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Measured: Before induction
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Measured: 10 minutes after induction
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Measured: 5 minutes after operation position
cerebral regional oxygen saturation in TOETVA
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Measured: 10 minutes after insufflation
cerebral regional oxygen saturation in TOETVA
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Measured: 10 minutes after desufflation
cerebral regional oxygen saturation in open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Measured: 10 minutes after platysma incision
cerebral regional oxygen saturation in open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Measured: 10 minutes after the closing of the platysma
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Measured: Through operation completion, an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start25 Oct 2019
- Primary completion25 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Erhan OZYURT, MD, Principal investigator, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186715
- Sponsor's protocol ID
- AntalyaEAH01
- Status last verified
- Nov 2019
- First submitted
- 26 Nov 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Transoral Endoscopic Thyroidectomy on Cerebral Regional Oxygen Saturation: Comparison With Open Thyroidectomy
- ClinicalTrials.gov ID
- NCT04186715
- Acronym / sponsor ID
- AntalyaEAH01
- Conditions
- Thyroidectomy, Near-infrared Spectroscopy
- Keywords
- TOETVA, Thyroidectomy, near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Dec 2019 (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.
Thyroidectomy operations have traditionally been performed as open surgery. However, the scarring that occurs in the patient leads to cosmetic problems, especially in young women. Today, as a result of the development of minimally invasive surgical techniques, the number of natural orifice transluminal endoscopic surgeries (NOTES) is increasing. Surgical scars are avoided by using natural pathways such as the mouth, urethra, vagina or anus. Transoral endoscopic thyroidectomy (TOETVA) with vestibular approach, a form of NOTES, was first performed in 2011. In this method, the operation is performed through three ports entered near the gingiva-buccal sulcus. TOETVA surgeries are performed with an insufflation pressure of 6 mmHg in the neck region. No studies are examining the effects of this pressure on the blood vessels in the neck region on the blood supply to the brain tissue. Therefore, the investigators aim to compare cases operated using open thyroidectomy or TOETVA method by measuring cerebral regional tissue saturation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOETVA | – | Device: Near-infrared spectroscopyThe demographic data of the patients undergoing TOETVA surgery will be recorded. Then, blood pressure, pulse pressure, pulse oximeter, end-tidal carbon dioxide, right and left cerebral regional oxygen values in the operation room will be recorded at certain intervals. It will also be recorded if complications develop. |
| Open thyroidectomy | – | Device: Near-infrared spectroscopyThe demographic data of the patients undergoing open thyroidectomy surgery will be recorded. Then, blood pressure, pulse pressure, pulse oximeter, end-tidal carbon dioxide, right and left cerebral regional oxygen values in the operation room will be recorded at certain intervals. It will also be recorded if complications develop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients applying to our Institute for thyroidectomy.
Key inclusion criteria (1 listed)
- ASA I-II
Key exclusion criteria (4 listed)
- Patients with neck surgery.
- Patients who received radiotherapy to the neck region.
- Patients with cerebrovascular or neurological disease.
- Patients who underwent open surgery during the operation.
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 |
|---|---|---|
| Near-infrared spectroscopyThe Near-infrared spectroscopy probes will be placed in the frontal region. | Device | Open thyroidectomy, TOETVA |
Primary outcome
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
Time frame: Before induction
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
Time frame: 10 minutes after induction
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
Time frame: 5 minutes after operation position
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
cerebral regional oxygen saturation in TOETVA
Time frame: 10 minutes after insufflation
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
cerebral regional oxygen saturation in TOETVA
Time frame: 10 minutes after desufflation
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
cerebral regional oxygen saturation in open thyroidectomy
Time frame: 10 minutes after platysma incision
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
cerebral regional oxygen saturation in open thyroidectomy
Time frame: 10 minutes after the closing of the platysma
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
Time frame: Through operation completion, an average of 4 hours
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
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 16 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Thyroidectomy
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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.
Erhan OZYURT, MD principal investigator
University of Health Sciences, Antalya Training and Research Hospital
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 Thyroidectomy and Near-infrared Spectroscopy, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 16 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 Turkey (Türkiye). 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?
cerebral regional oxygen saturation in TOETVA and open thyroidectomy (time frame: Before induction). The study lists 8 primary outcomes in all. 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 16 Feb 2021.