Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy During Total Laparoscopic Hysterectomy in Terms of Surgical Smoke and Lateral Thermal Damage: a Randomized Controlled Trial (ULMOST Trial)
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
- 2
- 主要终点
- Degree of surgical smoke obstructing vision
研究概览
简要总结
The aim of this randomized trial was to compare the degree of surgical smoke obstructing vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in colpotomy during total laparoscopic hysterectomy.
详细描述
According to previous studies performed in porcine and bovine tissues, ultrasonic energy based surgical devices (ESDs) created less surgical smoke, involved less visual obstruction, and produced less lateral thermal damage than monopolar ESDs. However, there was no study comparing ultrasonic ESD and monopolar ESD in laparoscopic colpotomy in terms of surgical smoke and lateral thermal damage. Therefore, the aim of this randomized trial was to compare the degree of surgical smoke obstructing vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in colpotomy during total laparoscopic hysterectomy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with gynecologic diseases, such as uterine myoma, adenomyosis, and ovarian tumor;
- •women who were planning to undergo TLH;
- •women between 19 and 75 years of age.
排除标准
- •women with any suggestion of malignant cervical or vaginal pathologies
- •women with uncontrolled medical comorbidities or psychiatric illness, which could affect follow-up and/or compliance
- •women who refused to participate or give consent to the procedures.
结局指标
主要结局
Degree of surgical smoke obstructing vision
时间窗: Day of surgery
The degree of surgical smoke obstructing laparoscopic view was assessed by an independent, blinded, gynecologic surgeon who reviewed videotapes of each patient's laparoscopic colpotomy procedure using a 5-point Likert scale (1 = very clear; 2 = quite clear; 3 =somewhat smoky; 4 = quite smoky; and 5 = extremely smoky), and a higher score indicates a worse visuality
Degree of lateral thermal damage
时间窗: Day of surgery
Using a light microscope, the width of lateral thermal damage was measured from the point of instrument application to the margins of unchanged nearby tissue
次要结局
未报告次要终点
研究者
Taejong Song
Professor
Kangbuk Samsung Hospital