Evaluation of Compensatory Sweating After Unilateral Videothoracoscopic Sympathectomy of the Dominant Side or Sequential Bilateral Videothoracoscopic Sympathectomy: a Multicentric Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Change of sweating intensity
研究概览
简要总结
The standard treatment for palmar hyperhidrosis is bilateral sequential thoracic sympathectomy. High rates of compensatory sweating due to the surgical procedure are described in the literature. In the search for a reduction in this side effect, it is possible that unilateral sympathectomy in the dominant side obtains acceptable results and leads to less compensatory sweating with improvement of the quality of life. The aim of this study it to compare the intensity of compensatory sweating due to the standard treatment, that is, bilateral sequential videothoracoscopic sympathectomy in relation to unilateral thoracic sympathectomy on the dominant side.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index equal to or less than 28;
- •Exclusive palmar hyperhidrosis or palmar hyperhidrosis associated with axillary and / or plantar hyperhidrosis;
排除标准
- •Being sinister (or left-handed);
- •Craneo-f acial or generalized hyperhidrosis;
- •Coagulopathies;
- •Previous thoracic surgery;
- •Other comorbidities such as cardiological, metabolic, infectious or neoplastic diseases;
- •Pregnancy;
研究组 & 干预措施
Bilateral sympathectomy
Bilateral sequential (one surgical procedure) videothoracoscopic R4 sympathectomy
干预措施: Bilateral sequential sympathectomy (Procedure)
Unilateral sympathectomy
Unilateral videothoracoscopic R4 sympathectomy on the right (dominant) side
干预措施: Unilateral sympathectomy (Procedure)
Contralateral sympathectomy
Unilateral videothoracoscopic R4 sympathectomy on the left (contralateral) side
干预措施: Contralateral sympathectomy (Procedure)
结局指标
主要结局
Change of sweating intensity
时间窗: Change from baseline sweating to 6 months after surgery
To utilize the HDSS questionnaire to assessment of sweating intensity change in patients with palmar hyperhidrosis treated by bilateral sequential thoracic sympathectomy
次要结局
- Change of sweating intensity(Change from baseline sweating to 6 months after surgery)
- Change of sweating intensity(Change from baseline sweating to 6 months after sympathectomy)
研究者
Miguel L. Tedde
Thoracic surgeon
University of Sao Paulo