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Near Infrared Spectroscopy in Thyroidectomy

A

Antalya Training and Research Hospital

Status

Completed

Conditions

Near-infrared Spectroscopy
Thyroidectomy

Treatments

Device: Near-infrared spectroscopy

Study type

Observational

Funder types

Other

Identifiers

NCT04186715
AntalyaEAH01

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

40 participants in 2 patient groups

TOETVA
Description:
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.
Treatment:
Device: Near-infrared spectroscopy
Open thyroidectomy
Description:
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.
Treatment:
Device: Near-infrared spectroscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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