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Title: | A randomized trial regarding antimicrobial prophylaxis (AMP) in transurethral resection of bladder tumor (TURB) | Authors: | BATEN, Evert Van der Aa, F. GOETHUYS, Hans Slabbert, K. ARIJS, Ingrid VAN RENTERGHEM, Koenraad |
Issue Date: | 2021 | Publisher: | SPRINGER | Source: | World Journal of Urology, 39 (10), p. 3839-3844 | Abstract: | Purpose To determine whether omitting antimicrobial prophylaxis (AMP) in TURB is safe in patients undergoing TURB without an indwelling pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture. Materials and methods A multi-centered randomized controlled trial (RCT) from 17-09-2017 to 31-12-2019 in 5 hospitals. Patients with a pre-operative indwelling catheter/DJ-stent or nephrostomy and a positive pre-operative urinary culture (> 10(4) uropathogens/mL) were excluded. Post-operative fever was defined as body temperature >= 38.3 degrees C. A non-inferiority design with a 6% noninferiority margin and null hypothesis (H0) that the infection risk is at least 6% higher in the experimental (E) than in the control (C) group; H0: C (AMP-group) - E (no AMP-group) >= Delta (6% noninferiority margin). A multivariable, logistic regression was performed for AMP and post-TURB fever with covariates: tumor size and (clot-) retention. The R Project(R) for statistical computing was used for statistical analysis and a p value of 0.05 was considered as statistically significant. Results 459 Patients were included and 202/459 (44.1%) received AMP vs 257/459 (55.9%) without AMP. Fever occurred in 6/202 [2.9%; 95% CI (1.2-6.6%)] patients with AMP vs 8/257 [3.1%; 95% CI (1.5%-6.1%)] without AMP (p = 0.44). Multivariable, logistic regression showed no significant harm in omitting AMP when controlled for (clot-)retention and tumor size (p = 0.85) and an adjusted risk difference in developing post-TURB fever of 0.0016; 95% CI [- 0.029; 0.032]. Conclusion Our data suggest the safety of omitting AMP in patients undergoing TURB without an indwelling, pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture. | Notes: | Baten, E (corresponding author), Associatie Urol Hageland, Kapellekensweg 10, Kessel Lo, Belgium.; Baten, E (corresponding author), Univ Hasselt, Martelarenlaan 45, B-3050 Hasselt, Belgium. Evert.baten@gmail.com |
Other: | Baten, E (corresponding author), Associatie Urol Hageland, Kapellekensweg 10, Kessel Lo, Belgium ; Univ Hasselt, Martelarenlaan 45, B-3050 Hasselt, Belgium. Evert.baten@gmail.com | Keywords: | TURB;AMP;Microbial resistance;RCT;Fever;Antimicrobial stewardship | Document URI: | http://hdl.handle.net/1942/34079 | ISSN: | 0724-4983 | e-ISSN: | 1433-8726 | DOI: | 10.1007/s00345-021-03694-6 | ISI #: | WOS:000639060800002 | Rights: | The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2021 | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2022 |
Appears in Collections: | Research publications |
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