edoc

Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial)

Speich, Benjamin and Bausch, Kathrin and Roth, Jan A. and Hemkens, Lars G. and Ewald, Hannah and Vogt, Deborah R. and Bruni, Nicole and Deuster, Stefanie and Seifert, Hans-H. and Widmer, Andreas F.. (2019) Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial). Trials, 20 (142). pp. 1-11.

Full text not available from this repository.

Official URL: https://edoc.unibas.ch/71496/

Downloads: Statistics Overview

Abstract

Transurethral resection of the prostate (TURP) and Greenlight laser vaporisation (GL) of the prostate are frequently performed urological procedures. For TURP, a single-dose antimicrobial prophylaxis (AP) is recommended to reduce postoperative urinary tract infections. So far, no international recommendations for AP have been established for GL. In a survey-based study in Switzerland, Germany and Austria, urologists reported routinely extending AP primarily for 3 days after both interventions. We therefore aim to determine whether single-dose AP with cotrimoxazole is non-inferior to 3-day AP with cotrimoxazole in patients undergoing TURP or GL of the prostate.; We will conduct an investigator-initiated, multicentre, randomised controlled trial. We plan to assess the non-inferiority of single-dose AP compared to 3-day AP. The primary outcome is the occurrence of clinically diagnosed symptomatic urinary tract infections which are treated with antimicrobial agents within 30 days after randomisation. The vast majority of collected outcomes will be assessed from routinely collected data. The sample size was estimated to be able to show the non-inferiority of single-dose AP compared to 3-day AP with at least 80% power (1 - β = 0.8) at a significance level of α = 5%, applying a 1:1 randomisation scheme. The non-inferiority margin was determined in order to preserve 70% of the effect of usual care on the primary outcome. For an assumed event rate of 9% in both treatment arms, this resulted in a non-inferiority margin of 4.4% (i.e. 13.4% to 9%). To prove non-inferiority, a total of 1574 patients should be recruited, in order to have 1416 evaluable patients. The study is supported by the Swiss National Science Foundation.; For AP in TURP and GL, there is a large gap between usual clinical practice and evidence-based guidelines. If single-dose AP proves non-inferior to prolonged AP, our study findings may help to reduce the duration of AP in daily routine-potentially reducing the risk of emerging resistance and complications related to AP.; Clinicaltrials.gov, NCT03633643 . Registered 16 August 2018.
Faculties and Departments:03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB
10 Zentrale universitäre Einrichtungen > Universitätsbibliothek
UniBasel Contributors:Ewald, Hannah
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:BioMed Central
ISSN:1468-6708
e-ISSN:1745-6215
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:19 Sep 2019 14:38
Deposited On:19 Sep 2019 14:38

Repository Staff Only: item control page