drugset / Trial / NCT05274672
Role of Prophylactic Postoperative Antibiotics in HoLEP
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to investigate whether prescribing a 3-day course of antibiotics after Holmium laser enucleation of the prostate (HoLEP) reduces the risk of urinary tract infection. The findings of this trial will have a major impact on clinical practice to either justify the prescription of antibiotics after HoLEP or give urologists more confidence in not prescribing antibiotics prophylactically after HoLEP.
Timeline
- Start
- 2023-03-01
- Primary completion
- 2025-02-20
- Completion
- 2025-02-20
Publications
- Background Tennyson LE, Averch TD. An Update on Fluoroquinolones: The Emergence of a Multisystem Toxicity Syndrome. Urol Pract. 2017 Sep;4(5):383-387. doi: 10.1016/j.urpr.2016.08.004. Epub 2016 Oct 24.
- Background Lightner DJ, Wymer K, Sanchez J, Kavoussi L. Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis. J Urol. 2020 Feb;203(2):351-356. doi: 10.1097/JU.0000000000000509. Epub 2019 Aug 23.
- Background Ivan SJ, Sindhwani P. Comparison of guideline recommendations for antimicrobial prophylaxis in urologic procedures: variability, lack of consensus, and contradictions. Int Urol Nephrol. 2018 Nov;50(11):1923-1937. doi: 10.1007/s11255-018-1971-1. Epub 2018 Aug 25.
- Background Das AK, Teplitsky S, Humphreys MR. Holmium laser enucleation of the prostate (HoLEP): a review and update. Can J Urol. 2019 Aug;26(4 Suppl 1):13-19.
- Background Ishikawa K, Maruyama T, Kusaka M, Shiroki R, Hoshinaga K. [The state of antimicrobial prophylaxis for holmium laser enucleation of the prostate : HoLEP and the results of a questionnaire survey]. Hinyokika Kiyo. 2011 Oct;57(10):539-43. Japanese.
- Background Davuluri M, Bernstein AP, Fram E, Watts KL. Variations in Perioperative Antibiotic Prescriptions Among Academic Urologists After Ambulatory Endoscopic Urologic Surgery: Impact on Infection Rates and Validation of 2019 Best Practice Statement. Urology. 2020 Dec;146:101-106. doi: 10.1016/j.urology.2020.07.049. Epub 2020 Aug 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CEPHALEXIN ANHYDROUS | Small molecule | — | — |
| Comparator | Ciprofloxacin | Small molecule | — | — |
| Comparator | Nitrofurantoin | Unknown | — | — |
| Comparator | trimethoprim-sulfamethoxazole | Unknown | — | — |