Cargando…

Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial

Background: The best method of antimicrobial prophylaxis administration for surgical site infection (SSI) in transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB) remains controversial. The purpose of this study is to compare one-day a...

Descripción completa

Detalles Bibliográficos
Autores principales: Shigemura, Katsumi, Yamamichi, Fukashi, Nishimoto, Kento, Kitagawa, Koichi, Fujisawa, Masato
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6524744/
https://www.ncbi.nlm.nih.gov/pubmed/31143442
http://dx.doi.org/10.12688/f1000research.17660.2
_version_ 1783419606155657216
author Shigemura, Katsumi
Yamamichi, Fukashi
Nishimoto, Kento
Kitagawa, Koichi
Fujisawa, Masato
author_facet Shigemura, Katsumi
Yamamichi, Fukashi
Nishimoto, Kento
Kitagawa, Koichi
Fujisawa, Masato
author_sort Shigemura, Katsumi
collection PubMed
description Background: The best method of antimicrobial prophylaxis administration for surgical site infection (SSI) in transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB) remains controversial. The purpose of this study is to compare one-day and two-day cefazolin in a randomized 2 (nd)-phase study to help establish a protocol with a 95% confidence interval (CI) for SSI prevention. Methods: Patients undergoing HoLEP/TUEB for benign prostate hyperplasia without preoperative pyuria will be enrolled and randomized to receive prophylactic antibiotic administration for HoLEP/TUEB in two groups, 1-day (single dose) cefazolin and 2-day cefazolin. The primary endpoint is the occurrence rate of postoperative urinary tract infection or urogenital infection within 30 days after HoLEP/TUEB with a statistical 95% CI in comparison between those groups. Secondary outcomes include the kind of infectious disease and evidence of diagnosis, day of diagnosis of infectious disease, performance of urine or blood culture, detection of bacteria, treatments, duration of treatments, AEs other than surgical site infection, and drug-induced AEs. Discussion: The results of this study will provide evidence for defining the optimal duration of cefazolin prophylactic antibiotic administration for SSI. Trial registration: This study was registered in the University Hospital Medical Information Network-Clinical Trial Registry ( UMIN000027955) based on recommendations from the International Committee of Medical Journal Editors (ICMJE) on July 1 (st) 2017.
format Online
Article
Text
id pubmed-6524744
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher F1000 Research Limited
record_format MEDLINE/PubMed
spelling pubmed-65247442019-05-28 Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial Shigemura, Katsumi Yamamichi, Fukashi Nishimoto, Kento Kitagawa, Koichi Fujisawa, Masato F1000Res Study Protocol Background: The best method of antimicrobial prophylaxis administration for surgical site infection (SSI) in transurethral holmium laser resection and enucleation of the prostate (HoLEP)/bipolar transurethral enucleation (TUEB) remains controversial. The purpose of this study is to compare one-day and two-day cefazolin in a randomized 2 (nd)-phase study to help establish a protocol with a 95% confidence interval (CI) for SSI prevention. Methods: Patients undergoing HoLEP/TUEB for benign prostate hyperplasia without preoperative pyuria will be enrolled and randomized to receive prophylactic antibiotic administration for HoLEP/TUEB in two groups, 1-day (single dose) cefazolin and 2-day cefazolin. The primary endpoint is the occurrence rate of postoperative urinary tract infection or urogenital infection within 30 days after HoLEP/TUEB with a statistical 95% CI in comparison between those groups. Secondary outcomes include the kind of infectious disease and evidence of diagnosis, day of diagnosis of infectious disease, performance of urine or blood culture, detection of bacteria, treatments, duration of treatments, AEs other than surgical site infection, and drug-induced AEs. Discussion: The results of this study will provide evidence for defining the optimal duration of cefazolin prophylactic antibiotic administration for SSI. Trial registration: This study was registered in the University Hospital Medical Information Network-Clinical Trial Registry ( UMIN000027955) based on recommendations from the International Committee of Medical Journal Editors (ICMJE) on July 1 (st) 2017. F1000 Research Limited 2019-05-09 /pmc/articles/PMC6524744/ /pubmed/31143442 http://dx.doi.org/10.12688/f1000research.17660.2 Text en Copyright: © 2019 Shigemura K et al. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Shigemura, Katsumi
Yamamichi, Fukashi
Nishimoto, Kento
Kitagawa, Koichi
Fujisawa, Masato
Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial
title Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial
title_full Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial
title_fullStr Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial
title_full_unstemmed Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial
title_short Protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial
title_sort protocol for a comparison study of 1-day (single dose) versus 2-day prophylactic antibiotic administration in holmium laser enucleation of the prostate (holep): a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6524744/
https://www.ncbi.nlm.nih.gov/pubmed/31143442
http://dx.doi.org/10.12688/f1000research.17660.2
work_keys_str_mv AT shigemurakatsumi protocolforacomparisonstudyof1daysingledoseversus2dayprophylacticantibioticadministrationinholmiumlaserenucleationoftheprostateholeparandomizedcontrolledtrial
AT yamamichifukashi protocolforacomparisonstudyof1daysingledoseversus2dayprophylacticantibioticadministrationinholmiumlaserenucleationoftheprostateholeparandomizedcontrolledtrial
AT nishimotokento protocolforacomparisonstudyof1daysingledoseversus2dayprophylacticantibioticadministrationinholmiumlaserenucleationoftheprostateholeparandomizedcontrolledtrial
AT kitagawakoichi protocolforacomparisonstudyof1daysingledoseversus2dayprophylacticantibioticadministrationinholmiumlaserenucleationoftheprostateholeparandomizedcontrolledtrial
AT fujisawamasato protocolforacomparisonstudyof1daysingledoseversus2dayprophylacticantibioticadministrationinholmiumlaserenucleationoftheprostateholeparandomizedcontrolledtrial