Near Infrared Spectroscopy in Thyroidectomy

The Effect of Vestibular Transoral Endoscopic Thyroidectomy on Cerebral Regional Oxygen Saturation: Comparison With Open Thyroidectomy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04186715

Enrollment

Registered

2019-12-05

Start date

2019-10-25

Completion date

2020-12-01

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Near-infrared Spectroscopy, Thyroidectomy

Keywords

TOETVA, Thyroidectomy, near-infrared spectroscopy

Brief 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. 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.

Interventions

DEVICENear-infrared spectroscopy

The Near-infrared spectroscopy probes will be placed in the frontal region.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ASA I-II

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
cerebral regional oxygen saturation in TOETVA and open thyroidectomy	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	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 open thyroidectomy	10 minutes after platysma incision	The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026