Ahmed M Elshal1, Ahmed M Atwa2, Ahmed R El-Nahas2, Mohamed A El-Ghar3, Asaad Gaber4, Essam Elsawy4, Abdelwahab Hashem2, Yasser Farag4, Hashim Farg3, Ali Elsorougy3, Mohamed Fouda3, Hossam Nabeeh2, Ahmed Mosbah2. 1. Prostate Unit, Urology Department, Urology and Nephrology Center, Mansoura University, El Gomhoria Street, Mansoura, DK, 35516, Egypt. elshalam@hotmail.com. 2. Prostate Unit, Urology Department, Urology and Nephrology Center, Mansoura University, El Gomhoria Street, Mansoura, DK, 35516, Egypt. 3. Radiology Department, Urology and Nephrology Center, Mansoura University, Mansoura, DK, Egypt. 4. Microbiology Department, Urology and Nephrology Center, Mansoura University, Mansoura, DK, Egypt.
Abstract
PURPOSE: To compare the efficacy of three chemoprophylaxis approaches in prevention of post-transrectal biopsy infectious complications (TBICs). METHODS: Patients were randomly assigned to receive ciprofloxacin 3 days 500 mg B.I.D 3 days starting the night prior to biopsy (standard prophylaxis), augmented prophylaxis using ciprofloxacin and single preprocedure shot of 160 mg gentamicin IM (augmented prophylaxis) and rectal swab culture-based prophylaxis (targeted prophylaxis). Patients were assessed 2 weeks prior to biopsy, at biopsy and 2 weeks after. Primary end point was occurrence of post-TBICs that included simple UTI, febrile UTI or sepsis. Secondary end points were post-biopsy change in the inflammatory markers (TLC, ESR and CRP), unplanned visits, hospitalization and occurrence of fluoroquinolones resistance (FQ-R; bacterial growth on MacConkey agar plate with 10 μg/ml ciprofloxacin) in the fecal carriage of screened men. RESULTS: Between April/2015 and January/2017, standard, augmented and targeted prophylaxes were given to 163, 166 and 167 patients, respectively. Post-TBICs were reported in 43 (26%), 13 (7.8%) and 34 (20.3%) patients following standard, augmented and targeted prophylaxes protocols, respectively (P = 0.000). Post-TBICs included UTI in 23 (4.6%), febrile UTI in 41 (8.2%) and sepsis in 26 (5.2%) patients. Significantly lower number of post-biopsy positive urine culture was depicted in the augmented group (P = 0.000). The number of biopsy cores was statistically different in the three groups (P = 0.004). On multivariate analysis, augmented prophylaxis had independently lower post-TBICs (OR 0.2, 95% CI 0.1-0.4, P = 0.000) when compared with the other two groups regardless of the number of biopsy cores taken (OR 1.07, 95% CI 0.95-1.17, P = 0.229). Post-biopsy hospitalization was needed in four (2%), one (0.6%) and ten (6%) patients following standard, augmented and targeted prophylaxes, respectively (P = 0.014). However, sepsis-related hospitalization was not statistically different. Post-biopsy changes in the inflammatory markers were significantly less in augmented prophylaxis (P < 0.05). FQ-R was depicted in 139 (83.2%) of the screened men. CONCLUSION: Augmented prophylaxis with single-dose gentamicin is an effective and practical approach. Targeted prophylaxis might be reserved for cases with contraindication to gentamicin.
RCT Entities:
PURPOSE: To compare the efficacy of three chemoprophylaxis approaches in prevention of post-transrectal biopsy infectious complications (TBICs). METHODS:Patients were randomly assigned to receive ciprofloxacin 3 days 500 mg B.I.D 3 days starting the night prior to biopsy (standard prophylaxis), augmented prophylaxis using ciprofloxacin and single preprocedure shot of 160 mg gentamicin IM (augmented prophylaxis) and rectal swab culture-based prophylaxis (targeted prophylaxis). Patients were assessed 2 weeks prior to biopsy, at biopsy and 2 weeks after. Primary end point was occurrence of post-TBICs that included simple UTI, febrile UTI or sepsis. Secondary end points were post-biopsy change in the inflammatory markers (TLC, ESR and CRP), unplanned visits, hospitalization and occurrence of fluoroquinolones resistance (FQ-R; bacterial growth on MacConkey agar plate with 10 μg/ml ciprofloxacin) in the fecal carriage of screened men. RESULTS: Between April/2015 and January/2017, standard, augmented and targeted prophylaxes were given to 163, 166 and 167 patients, respectively. Post-TBICs were reported in 43 (26%), 13 (7.8%) and 34 (20.3%) patients following standard, augmented and targeted prophylaxes protocols, respectively (P = 0.000). Post-TBICs included UTI in 23 (4.6%), febrile UTI in 41 (8.2%) and sepsis in 26 (5.2%) patients. Significantly lower number of post-biopsy positive urine culture was depicted in the augmented group (P = 0.000). The number of biopsy cores was statistically different in the three groups (P = 0.004). On multivariate analysis, augmented prophylaxis had independently lower post-TBICs (OR 0.2, 95% CI 0.1-0.4, P = 0.000) when compared with the other two groups regardless of the number of biopsy cores taken (OR 1.07, 95% CI 0.95-1.17, P = 0.229). Post-biopsy hospitalization was needed in four (2%), one (0.6%) and ten (6%) patients following standard, augmented and targeted prophylaxes, respectively (P = 0.014). However, sepsis-related hospitalization was not statistically different. Post-biopsy changes in the inflammatory markers were significantly less in augmented prophylaxis (P < 0.05). FQ-R was depicted in 139 (83.2%) of the screened men. CONCLUSION: Augmented prophylaxis with single-dose gentamicin is an effective and practical approach. Targeted prophylaxis might be reserved for cases with contraindication to gentamicin.
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