Comparison of Transoral Endoscopic Thyroidectomy Vestibular Approach and Open Conventional Thyroidectomy for Inflammatory Responses, Pain and Patient Satisfaction: A Prospective Study
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
- Evaluate the TOETVA and Open Conventional Thyroidectomy Techniques in Terms of Postoperative Inflammatory Response by CRP (C-reactive protein)
研究概览
简要总结
Introduction-Objective:
The application of transoral endoscopic thyroidectomy vestibular approach (TOETVA) is gradually increasing recently. However, it is not clear whether TOETVA is a true minimally invasive thyroidectomy compared to open conventional thyroidectomy.
In this study, we aimed to evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response, pain and patient satisfaction.
Material and Method:
In this prospective study, 40 female patients between the ages of 18-65 were divided into 2 groups of 20 patients: TOETVA: 20 patients, open thyroidectomy: 20 patients. Operation time, inflammatory response with IL-6, white blood cell (WBC) and C-reactive protein (CRP), postoperative pain, postoperative complications and patient satisfaction were evaluated in both groups.
详细描述
The application of transoral endoscopic thyroidectomy vestibular approach (TOETVA) is gradually increasing recently. However, it is not clear whether TOETVA is a true minimally invasive thyroidectomy compared to open conventional thyroidectomy.
In this study, we aimed to evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response, pain and patient satisfaction.
This non-randomized prospective clinical study was performed in our clinic between September 2019 and January 2020 with the approval of the Sisli Hamidiye Etfal Training and Research Hospital Ethics Committee (Ethics committee date: 19/03/2019, number: 2313).
In the study, it was planned to form 2 groups with 20 patients in each, performing conventional open thyroidectomy (OTG) (Group 1) or transoral endoscopic thyroidectomy vestibular approach (TOETVA) (TTG) (Group 2). All patients who agreed to participate in the study were informed about both surgical techniques and complications, and their written consent was obtained. Patients took part in Group 1 or Group 2 according to their own preferences.
During this study, 43 patients underwent thyroidectomy. Patients who did not comply with the study criteria were excluded from the study. 43 female patients were selected from these patients who were eligible for the study. Of these patients, 3 patients who were converted to open surgery in the TTG group were excluded from the study, and a total of 40 patients were included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be aged 18 to 65 years
- •Benign thyroid disease, with FNAB results Bethesda 3,4 or below 1 cm + Bethesda V, VI
- •Thyroid volume less than 50 cm3
- •Largest nodule diameter must be less than 4 cm
- •No previous neck, chin and oral surgery
- •No vocal cord paralysis for any reason
- •In the preoperative period, clinically euthyroid and laboratory results in the euthyroid state
- •Agreed to participate in the study were included in the study..
排除标准
- •Patients with a FNAB result of Bethesda V, VI over 1 cm,
- •Planning of central and/or lateral neck dissection due to thyroid cancer
- •Patients with thyroid volume greater than 50 cm3
- •Secondary intervention cases
- •Patients with accompanying hyperparathyroidism
- •Patients with preoperative vocal cord paralysis (VCP)
- •Patients with ASA score III and IV
- •Patients who were started with TOETVA and converted to the conventional method intraoperatively
结局指标
主要结局
Evaluate the TOETVA and Open Conventional Thyroidectomy Techniques in Terms of Postoperative Inflammatory Response by CRP (C-reactive protein)
时间窗: 4 days
To evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response; CRP (C-reactive protein) levels were measured in all patients for evaluating the inflammatory response at preoperative, postoperative second hour, first day and second day.
Evaluate the TOETVA and Open Conventional Thyroidectomy Techniques in Terms of Postoperative Inflammatory Response by WBC (white blood cells)
时间窗: 4 days
To evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response; WBC (white blood cells) levels were measured in all patients for evaluating the inflammatory response at preoperative, postoperative second hour, first day and second day.
Evaluate the TOETVA and Open Conventional Thyroidectomy Techniques in Terms of Postoperative Inflammatory Response by IL-6 (Interleukin 6)
时间窗: 4 days
To evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response; IL-6 (Interleukin 6) levels were measured in all patients for evaluating the inflammatory response at preoperative, postoperative second hour, first day and second day.
Evaluate the Postoperative Pain after TOETVA and Open Conventional Thyroidectomy Techniques Assessed by the Visual Analogue Scale
时间窗: 4 days
Pain intensity of the patients was evaluated with the Visual Analogue Scale (VAS) score (0 to 10) on the 2nd and 12th hour, 1st and 2nd days postoperatively. Lower lip, lower chin and anterior neck area pain were evaluated separately with VAS score. VAS scores were determined by patients by marking the intensity of pain on the ruler, which was marked as 0 for the absence of pain and as 10 for the most severe pain sensation.
Comparison of Postoperative Patient Satisfaction Between Conventional Thyroidectomy and TOETVA
时间窗: 1 month
Patient satisfaction was evaluated on postoperative 15th and 30th days in both groups. Patients were asked to evaluate and score the operation in general and in terms of cosmesis (1: bad and 4: very good). In addition, the patients were asked which surgery (TOETVA or conventional thyroidectomy) they would prefer if they would have the operation again.
次要结局
未报告次要终点
研究者
MUnlu
Principal Investigator
Başakşehir Çam & Sakura City Hospital