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Completed

NCT Number: NCT02429219

Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate

Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an ethanol-containing saline irrigating fluid, prospective detected by breath alcohol measurement.

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Key information

Conditions

Benign Prostatic Hypertrophy Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology University Hospital Otto-von-Guericke-University Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients in which a TURiS or PVP to be performed

Exclusion criteria

  • Alcoholics,
  • Patients with severe hepatic impairment,
  • Epilepsy,
  • Existing metabolic acidosis.

Treatment and study plan

Saline Irrigation with Ethanol

Drug

Saline Irrigation with Ethanol (alcohol)

Other names: ethanol containinge saline irrigation fluid

transurethral resection of the prostate

Procedure

transurethral electro-resection of the prostate (TURP)

Other names: TURP

photoselective vaporisation of the prostate

Procedure

photoselective laser-vaporisation of the prostate (PVP)

Other names: PVP

Primary outcomes

  1. last breath alcohol measurement

    Time frame: 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.

Secondary outcomes

  1. Surgical abortion with significant Absorption of irrigation fluid

    Time frame: Surgery will be last on average 1 hour

    If a significant amount if Irrigation fluid is absorbed (>1,5l), the procedure will be aborted

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Registry information

Official study title

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

Acronym: SATURN-P

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2015
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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