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Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate (SATURN-P)

Primary Purpose

Benign Prostatic Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Saline Irrigation with Ethanol
transurethral resection of the prostate
photoselective vaporisation of the prostate
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hypertrophy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in which a TURiS or PVP to be performed

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Transurethral Resection

Photoselective vaporisation

Arm Description

Transurethral Resection of the Prostate in Saline irrigation with ethanol

Photoselective vaporisation of the Prostate in Saline irrigation with ethanol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical abortion with significant Absorption of irrigation fluid
If a significant amount if Irrigation fluid is absorbed (>1,5l), the procedure will be aborted

Full Information

First Posted
February 19, 2015
Last Updated
April 28, 2015
Sponsor
University of Magdeburg
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1. Study Identification

Unique Protocol Identification Number
NCT02429219
Brief Title
Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate
Acronym
SATURN-P
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Magdeburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transurethral Resection
Arm Type
Active Comparator
Arm Description
Transurethral Resection of the Prostate in Saline irrigation with ethanol
Arm Title
Photoselective vaporisation
Arm Type
Experimental
Arm Description
Photoselective vaporisation of the Prostate in Saline irrigation with ethanol
Intervention Type
Drug
Intervention Name(s)
Saline Irrigation with Ethanol
Other Intervention Name(s)
ethanol containinge saline irrigation fluid
Intervention Description
Saline Irrigation with Ethanol (alcohol)
Intervention Type
Procedure
Intervention Name(s)
transurethral resection of the prostate
Other Intervention Name(s)
TURP
Intervention Description
transurethral electro-resection of the prostate (TURP)
Intervention Type
Procedure
Intervention Name(s)
photoselective vaporisation of the prostate
Other Intervention Name(s)
PVP
Intervention Description
photoselective laser-vaporisation of the prostate (PVP)
Primary Outcome Measure Information:
Title
last breath alcohol measurement
Description
Measurement will be done using a breath Alcohol device (Alcomed 3011, Envitec-Wismar Inc., Germany). The unit will be mg/l.
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.
Secondary Outcome Measure Information:
Title
Surgical abortion with significant Absorption of irrigation fluid
Description
If a significant amount if Irrigation fluid is absorbed (>1,5l), the procedure will be aborted
Time Frame
Surgery will be last on average 1 hour

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in which a TURiS or PVP to be performed Exclusion Criteria: Alcoholics, Patients with severe hepatic impairment, Epilepsy, Existing metabolic acidosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Porsch, MD
Organizational Affiliation
Urologic Faculty University Magdeburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25108273
Citation
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.
Results Reference
result

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

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