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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

Abstract: PD35-03
Sources of Funding: None. Registered under ClinicalTrials.gov ID NCT02384200

Introduction

Single institution studies have suggested possible benefit of a week of preoperative 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 preoperative antibiotics remains unclear. We sought to perform a rigorous (adhering to CONSORT guidelines) multi-institutional trial assessing utility of preoperative PNL antibiotics for patients at low risk of infectious complications.

Methods

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.

Results

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.

Conclusions

There appears to be no advantage to providing one week of preoperative 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. _x000D_ _x000D_ 1. Mariappan et al. BJU Int 2006_x000D_ 2. Kumar et al. Urol Res 2012_x000D_

Funding

None. Registered under ClinicalTrials.gov ID NCT02384200

Authors
Seth Bechis
Joel Abbott
Ben Chew
Nicole Miller
Amy Krambeck
Mitchell Humphreys
Vernon Pais, Jr
Manoj Monga
Roger Sur
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