Near Infrared Spectroscopy in Thyroidectomy

Completed

• Conditions: Near-infrared Spectroscopy; Thyroidectomy

• Registration Number: NCT04186715
• Lead Sponsor: Antalya Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-25
• Status Verified: 2019-11
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-05
• Primary Completion: 2020-11-25
• Study Completion: 2020-12-01
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cerebral regional oxygen saturation in TOETVA	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	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	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.

Trial Locations

Locations (1)

University of Health Sciences, Antalya Training and Research Hospital; 🇹🇷 Antalya, Turkey