A Prospective Investigation Using the Expired Breath Ethanol Test

NCT02304549 | Completed

• 1 other identifier: CTU 14.012
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years.In cases with moderate to severe lower urinary tract symptoms (LUTS) monopolar transurethral resection of the prostate (TUR-P) is the standard treatment. Especially in frail patients, conventional TUR-P is associated with relevant and potentially deleterious complications, e.g. TUR syndrome. Using isotonic saline, like in bipolar TUR-P and transurethral laser vaporization (TUV-P), TUR syndrome can be prevented. The short-term complication rate with the Thulium laser is similar to the rate described after vaporisation with other laser systems18-23 and less than that with TUR-P. Despite recent publications on the safety and complications with Thulium vaporisation of the prostate, to the investigators knowledge, until now, no prospective trial has directly assessed, whether absorption of irrigation fluid occurs and to what extent in Thulium Laser vaporisation of the prostate. The investigators therefore aim to investigate if absorption of irrigation fluid occurs during Thulium Laser vaporisation of the prostate by expired breath ethanol test.

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

• Absorption volume of irrigation fluid during the Thulium laser TUV-P

  shortly after Thulium laser TUV-P

Secondary Outcomes (11)

• Duration of surgery

  at time of start and of end of surgery

• Does absorption of irrigation fluid occur?

  at time of surgery

• Assessment of bleeding and relevant intraoperative events (capsular perforation, injury to prostatic sinuses or deep bladder neck incision) by the surgeon

  at time of surgery

• Amount of laser energy used intraoperatively (kilojoules)

  at time of end of surgery

• Pre- to postoperative changes in serum biochemical and haematological variables (creatinin, sodium, potassium, chloride), venous pH, haemoglobin

  30 min after intervention

Other Outcomes (2)

• Adverse events categorised according to the NCI-CTAE in grade 1 to 5

  week 12

• Grading of complications according to Clavien classification

  week 12

Study Arms (1)

patients with BPH undergoing TUV-P

patients with Benign Prostatic Hyperplasia undergoing TUV-P

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with benign prostatic hyperplasia undergoing TUV-P

You may qualify if:

• Men older than 40
• Patient must be a candidate for TUV-P
• Refractory to medical therapy or patient is not willing to consider (further) medical treatment
• Written informed consent

You may not qualify if:

• Mild symptoms (IPSS \<8)
• Urethral stenosis
• Bladder diverticulum (\>100ml)
• Former alcoholic or chronic liver disease
• Alcohol consumption 24h before operation

Sponsors & Collaborators

• Daniel Stephan Engeler: lead

Study Sites (1)

Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Publications (1)

• Mordasini L, Abt D, Mullhaupt G, Engeler DS, Luthi A, Schmid HP, Schwab C. Is absorption of irrigation fluid a problem in Thulium laser vaporization of the prostate? A prospective investigation using the expired breath ethanol test. BMC Urol. 2015 Apr 24;15:35. doi: 10.1186/s12894-015-0029-2.

  PMID: 25903582 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Daniel Engeler, MD

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: December 2, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

CH (1)