Near Infrared Spectroscopy in Thyroidectomy

NCT04186715 — Completed, 40 participants, Antalya Training and Research Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT04186715
Status	Completed
Study type	Observational
Enrollment	40 (Actual)
Sponsor	Antalya Training and Research Hospital (Other gov)
Conditions	Thyroidectomy, Near-infrared Spectroscopy
Interventions	Near-infrared spectroscopy (Device)
Dates	start 2019-10-25, primary completion 2020-11-25, completion 2020-12-01, first posted 2019-12-05, last updated 2021-02-16
Locations	1 site in Turkey (Türkiye)

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
TOETVA		Device: Near-infrared spectroscopy	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.
Open thyroidectomy		Device: Near-infrared spectroscopy	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.

Near-infrared spectroscopy (Device): The Near-infrared spectroscopy probes will be placed in the frontal region.

+Outcome measures

Primary outcomes

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 and open thyroidectomy [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 [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 [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 [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 [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 [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 [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
University of Health Sciences, Antalya Training and Research Hospital	Antalya	Turkey (Türkiye)

+Investigators

Erhan OZYURT, MD, Principal investigator, University of Health Sciences, Antalya Training and Research Hospital