Prospective Study of Monitoring the Alcohol Concentration in Breathing Air During Transurethral Prostate Resection of Benign Prostate Hyperplasia (BPH) Assessing the Uptake of Irrigation Fluids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- last breath alcohol measurement
研究概览
简要总结
Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an ethanol-containing saline irrigating fluid, prospective detected by breath alcohol measurement.
详细描述
Aim was to evaluate the amount of absorbed saline irrigation fluid during transurethral therapy of benign prostatic hyperplasia (BPH). We want to differentiate two different methods of the surgical therapy: the TransUrethral Resection in Saline (TURiS) and the Photoselective Vaporisation of the Prostate (PVP). Both methods using saline irrigation. To measure the amount of absorbed saline irrigation fluid, we added pure Ethanol to the Irrigation fluid resulting in am 0,02% ethanol containing saline irrigation fluid. The conventional TransUrethral Resection of the Prostate (TUR) method is using electrolyte free irrigation. In the literature this method is well known for the occurence of the transurethral resection syndrome ("TUR syndrome"). This is caused by absorption of electrolyte-free irrigating fluid, followed by a hyponatraemic hyperhydration, and consists of symptoms from the circulatory and nervous Systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients in which a TURiS or PVP to be performed
排除标准
- •Alcoholics,
- •Patients with severe hepatic impairment,
- •Epilepsy,
- •Existing metabolic acidosis.
研究组 & 干预措施
Transurethral Resection
Transurethral Resection of the Prostate in Saline irrigation with ethanol
干预措施: Saline Irrigation with Ethanol (Drug)
Photoselective vaporisation
Photoselective vaporisation of the Prostate in Saline irrigation with ethanol
干预措施: Saline Irrigation with Ethanol (Drug)
Photoselective vaporisation
Photoselective vaporisation of the Prostate in Saline irrigation with ethanol
干预措施: photoselective vaporisation of the prostate (Procedure)
Transurethral Resection
Transurethral Resection of the Prostate in Saline irrigation with ethanol
干预措施: transurethral resection of the prostate (Procedure)
结局指标
主要结局
last breath alcohol measurement
时间窗: Every 10 minutes, the breath alcohol is measured to 2 hours after the operation. Of these unnoticed, the intervention (surgery) is carried out until the end. It's all about the detection; the patient's treatment does not change.
Measurement will be done using a breath Alcohol device (Alcomed 3011, Envitec-Wismar Inc., Germany). The unit will be mg/l.
次要结局
- Surgical abortion with significant Absorption of irrigation fluid(Surgery will be last on average 1 hour)
研究者
Johann J. Wendler, MD
Dr. med.
University of Magdeburg
