Near Infrared Spectroscopy in Thyroidectomy

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.

Study Overview

• Status: Completed
• Conditions: Thyroidectomy; Near-infrared Spectroscopy
• Intervention / Treatment: Device: Near-infrared spectroscopy

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07100
    • University of Health Sciences, Antalya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients applying to our Institute for thyroidectomy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Near-infrared spectroscopy; The Near-infrared spectroscopy probes will be placed in the frontal region.
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.	Device: Near-infrared spectroscopy; The Near-infrared spectroscopy probes will be placed in the frontal region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Through operation completion, an average of 4 hours

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Principal Investigator: Erhan OZYURT, MD, University of Health Sciences, Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2019
• Primary Completion (ACTUAL): November 25, 2020
• Study Completion (ACTUAL): December 1, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (ACTUAL): December 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: near-infrared spectroscopy; Thyroidectomy; TOETVA
• Other Study ID Numbers: AntalyaEAH01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No