Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate
SATURN-P
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
1 other identifier
interventional
60
1 country
1
Brief Summary
Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an ethanol-containing saline irrigating fluid, prospective detected by breath alcohol measurement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 19, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedApril 29, 2015
April 1, 2015
1.3 years
February 19, 2015
April 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
last breath alcohol measurement
Measurement will be done using a breath Alcohol device (Alcomed 3011, Envitec-Wismar Inc., Germany). The unit will be mg/l.
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.
Secondary Outcomes (1)
Surgical abortion with significant Absorption of irrigation fluid
Surgery will be last on average 1 hour
Study Arms (2)
Transurethral Resection
ACTIVE COMPARATORTransurethral Resection of the Prostate in Saline irrigation with ethanol
Photoselective vaporisation
EXPERIMENTALPhotoselective vaporisation of the Prostate in Saline irrigation with ethanol
Interventions
Saline Irrigation with Ethanol (alcohol)
transurethral electro-resection of the prostate (TURP)
photoselective laser-vaporisation of the prostate (PVP)
Eligibility Criteria
You may qualify if:
- Patients in which a TURiS or PVP to be performed
You may not qualify if:
- Alcoholics,
- Patients with severe hepatic impairment,
- Epilepsy,
- Existing metabolic acidosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
Related Publications (1)
Hermanns T, Grossmann NC, Wettstein MS, Fankhauser CD, Capol JC, Poyet C, Hefermehl LJ, Zimmermann M, Sulser T, Muller A. Absorption of irrigation fluid occurs frequently during high power 532 nm laser vaporization of the prostate. J Urol. 2015 Jan;193(1):211-6. doi: 10.1016/j.juro.2014.07.117. Epub 2014 Aug 7.
PMID: 25108273RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus Porsch, MD
Urologic Faculty University Magdeburg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med.
Study Record Dates
First Submitted
February 19, 2015
First Posted
April 29, 2015
Study Start
November 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 29, 2015
Record last verified: 2015-04