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A Randomized Control Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy in the Low Risk Population: A Report from the EDGE Consortium
Annah J. Vollstedt, MD1, Seth K. Bechis, MD2, Joel E. Abbott, DO2, Ben H. Chew, MD3, Nciole L. Miller, MD4, Amy E. Krambeck, MD5, Mitchell R. Humphreys, MD6, Manoj Monga, MD7, Roger L. Sur, MD2, Vernon M. Pais, Jr., MD1.
1Dartmouth Hitchcock Medical Center, Lebanon, NH, USA, 2University of California, San Diego, San Diego, CA, USA, 3The Ohio State University Wexner Medical Center, Columbus, OH, USA, 4Vanderbilt University Medical Center, Nashville, TN, USA, 5Indiana Univerisity, Indianapolis, IN, USA, 6Mayo Clinic, Phoenix, AZ, USA, 7Cleveland Clinic, Cleveland, OH, USA.
Single institution studies have suggested possible benefit of a week of pre-operative antibiotics prior to percutaneous nephrolithotomy (PNL). Yet prior studies are limited by lower methodology (Level IIa)1, including heterogeneous populations2, or utilizing quasi-sepsis definitions2. Other than the recommended peri-operative dose of IV antibiotics <24 hours per AUA Best Practice Statement, the duration/benefit of pre-operative antibiotics remains unclear. We sought to perform a rigorous (adhering to CONSORT guidelines) multi-institutional trial assessing utility of pre-operative PNL antibiotics for patients at low risk of infectious complications.
We performed a randomized controlled trial (RCT) coordinated across 7 academic stone centers for low risk PNL patients. Low risk patients were defined as those with negative urine cultures and under no antibiotic treatment course within 14 days of procedure, and without any urinary drains (catheters, stents, nephrostomy tubes). Patients randomized to the intervention arm received nitrofurantoin 100 mg twice daily for 7 days preceding surgery. All enrolled patients received standard preoperative dose of ampicillin (vancomycin if allergic) and gentamicin (ceftriaxone if eGFR<60 or allergic). PNL was performed per the usual practice of each treating surgeon. Baseline patient and stone characteristics were recorded. Perioperative infection related adverse events within the first 30-days were compared in both groups.
Thirty-four patients were randomized to each arm. Adverse events occurring within the first 30 days of procedure are reported in Table 1. The infection rate after PNL in the intervention arm was 17.6% (6/34) versus 11.8% (4/34), p=0.49. Two of the patients in the intervention arm with infectious complications needed readmission and two others required admission to the intensive care unit. Total length of hospital stay demonstrated no difference between the two groups (1.09 versus 1.47, p=0.2). There was no mortality reported during this study period.
There appears to be no advantage to providing one week of pre-operative oral antibiotics in patients at low risk for infectious complications. Less than 24 hours peri-operative antibiotics as per AUA Best Practice Statement appears sufficient. We continue to analyze this low risk group with a more robust data set, as well as analyze preoperative antibiotic benefit in other stratified risk groups.
Mariappan et al. BJU Int 2006
Kumar S. et al. Urol Res 2012
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