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临床试验/NCT02429219
NCT02429219已完成不适用

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

University of Magdeburg1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

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

Active Comparator

Transurethral Resection of the Prostate in Saline irrigation with ethanol

干预措施: Saline Irrigation with Ethanol (Drug)

Photoselective vaporisation

Experimental

Photoselective vaporisation of the Prostate in Saline irrigation with ethanol

干预措施: Saline Irrigation with Ethanol (Drug)

Photoselective vaporisation

Experimental

Photoselective vaporisation of the Prostate in Saline irrigation with ethanol

干预措施: photoselective vaporisation of the prostate (Procedure)

Transurethral Resection

Active Comparator

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

发起方
University of Magdeburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johann J. Wendler, MD

Dr. med.

University of Magdeburg

研究点 (1)

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