Clinical trial NCT04186715: Near Infrared Spectroscopy in Thyroidectomy
Official title: The Effect of Vestibular Transoral Endoscopic Thyroidectomy on Cerebral Regional Oxygen Saturation: Comparison With Open Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroidectomy
Near-infrared Spectroscopy
Keywords: TOETVA
Thyroidectomy
near-infrared spectroscopy
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients applying to our Institute for thyroidectomy.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: cerebral regional oxygen saturation in TOETVA and open thyroidectomy
timeFrame: Before induction
measure: cerebral regional oxygen saturation in TOETVA and open thyroidectomy
timeFrame: 10 minutes after induction
measure: cerebral regional oxygen saturation in TOETVA and open thyroidectomy
timeFrame: 5 minutes after operation position
measure: cerebral regional oxygen saturation in TOETVA
timeFrame: 10 minutes after insufflation
measure: cerebral regional oxygen saturation in TOETVA
timeFrame: 10 minutes after desufflation
measure: cerebral regional oxygen saturation in open thyroidectomy
timeFrame: 10 minutes after platysma incision
measure: cerebral regional oxygen saturation in open thyroidectomy
timeFrame: 10 minutes after the closing of the platysma
measure: cerebral regional oxygen saturation in TOETVA and open thyroidectomy
timeFrame: Through operation completion, an average of 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: University of Health Sciences, Antalya Training and Research Hospital
Study officials:
affiliation: University of Health Sciences, Antalya Training and Research Hospital
name: Erhan OZYURT, MD
role: PRINCIPAL_INVESTIGATOR
References: