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Completed

NCT Number: NCT04186715

Near Infrared Spectroscopy in 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.

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Key information

Conditions

Thyroidectomy Near-Infrared Spectroscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences, Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Near-infrared spectroscopy

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2019
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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