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Clinical Trials/NCT04186715
NCT04186715
Completed
Not Applicable

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

Antalya Training and Research Hospital1 site in 1 country40 target enrollmentOctober 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroidectomy
Sponsor
Antalya Training and Research Hospital
Enrollment
40
Locations
1
Primary Endpoint
cerebral regional oxygen saturation in TOETVA
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 25, 2019
End Date
December 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Antalya Training and Research Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

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 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.

Study Sites (1)

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