Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis, Sohag University Hospital Experience
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing
研究概览
简要总结
The goal of this clinical trial is to examine the overall efficiency of Bilateral Thoracoscopic Sympathectomy on the permanent reduction of Primary focal hyperhidrosis of predilective parts of the body, palms, armpits, face, and soles.
详细描述
The aims of this study are:
- examine the efficiency of Bilateral Thoracoscopic Sympathectomy (BTS) with different levels of transection among the persons with the Primary focal Hyperhidrosis (PFH)
- examine the influence of BTS on cardio-pulmonary function tests in persons with PFH after the operation.
- examine the incidence, duration, and intensity of compensatory sweating after BTS among persons with PFH
- examine the incidence, duration, localization, and treatment of postoperative pain after BTS among persons with PFH.
- determine postoperative complications of BTS among persons with PFH
- examine the influence of BTS on quality of life among persons with PFH
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a. persons with confirmed and estimated Primary Focal Hyperhidrosis accepted to participate in this investigation, fulfilling pre and postoperative questionnaires about BTS effects and quality of life after the operation
- •b. Satisfactory CardioPulmonary Function
排除标准
- •previous thoracic surgical procedures, rib fractures, massive pneumonias, or pleural empyema
- •Secondary Hyperhidrosis
结局指标
主要结局
Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing
时间窗: Immediately After surgery
Participants will be assessed using the HDSS and gravimetric sweat testing. A reduction of ≥ 2 points in HDSS score or a ≥ 50% reduction in sweat production will be considered a successful outcome. Data will be aggregated as the proportion of participants achieving these reductions.
次要结局
- Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI)(From baseline to 3 months post-operation.)
- Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS)(From 1 day post-operation to 1 month post-operation.)
- Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)(From baseline to 3 months post-operation.)
研究者
Mohamed Ashraf Mokhtar
Resident physician, Cardiothoracic Surgery department
Sohag University