Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Successful resection of bladder tumor
研究概览
简要总结
This is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve.
One of the major safety issues with transurethral resection is bladder perforation as a consequence of obturator nerve stimulation followed by muscle contraction of. This is mostly a risk of resection of lateral bladder wall tumors near the course of the obturator nerve. It has been advocated that bipolar may be superior to monopolar resection, based on its different electrical properties. This is an important safety aspect for the patient.
Main study question: In patients with lateral wall urinary bladder tumors, is bipolar superior to monopolar transurethral electroresection regarding risk of stimulation of the obturator nerve without preoperative nerve block?
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neoplasms of the lateral wall of the urinary bladder (laterally to the corresponding ostium)
- •operability given based on general medical condition
- •informed consent
排除标准
- •antiplatelet drugs stopped <7days (except acetylsalicylate <= 100mg p.o. qd)
- •prothrombine time <70%
- •age <18 years
- •patronized Patients
- •pregnancy
- •severe poor medical condition
研究组 & 干预措施
Bipolar transurethral resection
干预措施: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius) (Device)
Monopolar transurethral resection
干预措施: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole) (Device)
结局指标
主要结局
Successful resection of bladder tumor
时间窗: Intraoperative
Successful resection of the neoplasm without relevant stimulation of the obturator nerve and consecutive contraction of the ipsilateral adductor muscles
次要结局
- Complications(3 months)
研究者
Daniel Stephan Engeler
Leitender Arzt, Klinik für Urologie
Cantonal Hospital of St. Gallen