A Randomized Controlled Trial of Preoperative Prophylactic Antibiotics for Percutaneous Nephrolithotomy in Moderate to High Infectious Risk Population: A Report from the EDGE Consortium

J Urol. 2021 May;205(5):1379-1386. doi: 10.1097/JU.0000000000001582. Epub 2020 Dec 28.


Purpose: Postoperative infectious related complications are not uncommon after percutaneous nephrolithotomy. Previously, we noted that 7 days of antibiotics did not decrease sepsis rates compared to just perioperative antibiotics in a low risk percutaneous nephrolithotomy population. This study aimed to compare the same regimens in individuals at moderate to high risk for sepsis undergoing percutaneous nephrolithotomy.

Materials and methods: Patients were prospectively randomized in this multi-institutional study to either 2 days or 7 days of preoperative antibiotics. Enrolled patients had stones requiring percutaneous nephrolithotomy and had either a positive preoperative urine culture or existing indwelling urinary drainage tube. Primary outcome was difference in sepsis rates between the groups. Secondary outcomes included rate of nonseptic bacteriuria, stone-free rate and length of stay.

Results: A total of 123 patients at 7 institutions were analyzed. There was no difference in sepsis rates between groups on univariate analysis. Similarly, there were no differences in nonseptic bacteriuria, stone-free rate and length of stay. On multivariate analysis, 2 days of antibiotics increased the risk of sepsis compared to 7 days of antibiotics (OR 3.1, 95% CI 1.1-8.9, p=0.031). Patients receiving antibiotics for 2 days had higher rates of staghorn calculus than the 7-day group (58% vs 32%, p=0.006) but post hoc subanalysis did not demonstrate increased sepsis in the staghorn only group.

Conclusions: Giving 7 days of preoperative antibiotics vs 2 days decreases the risk of sepsis in moderate to high risk percutaneous nephrolithotomy patients. Future guidelines should consider infectious risk stratification for percutaneous nephrolithotomy antibiotic recommendations.

Trial registration: ClinicalTrials.gov NCT02829060.

Keywords: anti-bacterial agents; nephrolithiasis; nephrolithotomy; percutaneous; sepsis; urolithiasis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibiotic Prophylaxis* / methods
  • Female
  • Humans
  • Kidney Calculi / surgery*
  • Male
  • Middle Aged
  • Nephrolithotomy, Percutaneous*
  • Postoperative Complications / epidemiology
  • Postoperative Complications / microbiology*
  • Postoperative Complications / prevention & control*
  • Prospective Studies
  • Risk Assessment
  • Sepsis / epidemiology
  • Sepsis / prevention & control*
  • Single-Blind Method
  • Time Factors
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT02829060