Near Infrared Spectroscopy in Thyroidectomy

Overview

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.

Full Title of Study: “The Effect of Vestibular Transoral Endoscopic Thyroidectomy on Cerebral Regional Oxygen Saturation: Comparison With Open Thyroidectomy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 25, 2020

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Antalya Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Erhan OZYURT, MD, Principal Investigator, University of Health Sciences, Antalya Training and Research Hospital

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