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临床试验/NCT04186715
NCT04186715已完成不适用

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

Antalya Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
cerebral regional oxygen saturation in TOETVA

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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.

结局指标

主要结局

cerebral regional oxygen saturation in TOETVA

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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