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 [version 2; peer review: 2 approved]

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 2nd-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 1st 2017

A Clinical Trial Evaluating the Usefulness of Tailored Antimicrobial Prophylaxis Using Rectal-culture Screening Media Prior to Transrectal Prostate Biopsy: A Multicenter, Randomized Controlled Trial

The aim of this report is to introduce an on-going, multicenter, randomized controlled trial to evaluate whether tailored antimicrobial prophylaxis guided by rectal culture screening prevents acute bacterial prostatitis following transrectal prostate biopsy (TRPB). Patients will be randomized into an intervention or non-intervention group; tazobactam-piperacillin or levofloxacin will be prophylactically administered according to the results of rectal culture prior to TRPB in the intervention group whereas levofloxacin will be routinely given in the non-intervention group. The primary endpoint is the occurrence rate of acute bacterial prostatitis after TRPB. Recruitment begins in April, 2021 and the target total sample size is 5,100 participants

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

Protocol for a comparison study of 1-day versus 2-day prophylactic antibiotic administration in Holmium Laser enucleation of the prostate (HoLEP): a randomized controlled trial Shigemura K, Yamamichi F, Nishimoto K, Kitagawa K and Fujisawa

Efficacy of Combining Flexible and Rigid Ureteroscopy for Transurethral Lithotripsy

Transurethral lithotripsy (TUL) is a common procedure in urology. However, controversy persists about how to deal with stones pushed up into kidney from the ureter during the procedure of TUL. This study investigated the efficacy of combining flexible ureteroscopy and rigid ureteroscopy for pushed-up stones into kidney during TUL. Fotry-one patients underwent TUL by a single surgeon from July 2007 to May 2009. Eight cases resulted in pushed-up stones during operation or involved existing kidney stones. We used a Zero-tipR or Litho Catch BasketR catheter and a flexible ureteroscope to carry these stones in kidney down into the ureter where the rigid ureteroscope could then reach and handle the stone for lithotripsy or being taken away. A LithoclastR system was used for lithotripsy. Five cases involved stones pushed up during surgery and 3 cases involved stones already in the kidney in detail. We pulled the stones down into the ureter in all cases and successfully completed lithotripsy or removed the stone, thus avoiding the performance of additional extracorporeal shock wave lithotripsy (ESWL). In conclusions, combined use of flexible ureteroscopy and rigid ureteroscopy for upper urinary tract stones pushed up into the kidney during TUL or renal stones could be useful for avoiding additional ESWL

難治性精巣腫瘍に対する末梢血幹細胞移植併用大量抗癌化学療法時の感染予防に関する検討

The side effects of high-dose anti-cancer drug chemotherapy with peripheral blood stem cell transplantation (PBCST) for the treatment of intractable testicular tumor are very serious. In particular, agranulocytosis in bone marrow suppression may be life threatening. In this study, we examined opportunistic infectious diseases and preventive counter measures in the compromised conditions of anti-cancer drug chemotherapy. The patients underwent anti-cancer drug chemotherapy with PBCST for the treatment of intractable testicular tumors at Kobe University Hospital from September 1996 to September 2002. The high-dose chemotherapy regimen consisted of total doses per course of 1, 250 mg/m2 carboplatin, 1, 500 mg/m2 etoposide, and 7, 500 mg/m2 ifosfamide. Twenty-four men (median age, 30 years; range, 18-70 years) received 50 courses of chemotherapy in total. The nadir of peripheral leukocyte counts was less than 1, 000/mm3 in all courses, and the mean period was for 7.1 days. None of these patients developed critical sepsis leading to disseminated intravascular coagulation or treatment-related death. Our detailed data show that we can perform high-dose anti-cancer drug chemotherapy with PBSCT for intractable testicular tumors without serious infectious complications if we take sufficient preventive countermeasures for infectious diseases.難治性精巣腫瘍に対する末梢血幹細胞移植併用大量抗癌化学療法の副作用はとても重篤である.とくに骨髄抑制における無顆粒球症は時に患者を死に至らしめることもある.今回われわれは抗癌剤投与による免疫力低下状態における日和見感染症とその予防策について検討した.対象は1996年9月から2002年9月までの期間に神戸大学医学部付属病院において難治性精巣腫瘍にて末梢血幹細胞移植併用大量抗癌化学療法を施行した患者である.大量抗癌化学療法のregimenはtotal doseで1コースあたり1, 250mg/m2 carboplatin, 1, 500mg/m2 etoposide, 7, 500mg/m2 ifosfamideを用いた.計24人, のべ50コースの当療法が行われ, 患者の年齢は中間値30歳, 範囲は18歳から70歳であった.全50コースにおいて, 末梢白血球数のnadirは1, 000/mm3以下となり, その平均期間は7.1日間であった.播種性血管内凝固を起こした重篤敗血症症例や治療関連死は認めなかった.当データにより難治性精巣腫瘍に対する末梢血幹細胞移植併用大量抗癌化学療法は十分な感染症に対する予防策がとられれば, 重篤な感染性合併症なく施行しうることが示された(著者抄録

Limited Hydration May Reduce Intraoperative Blood Loss in Retropubic Radical Prostatectomy

Retropubic radical prostatectomy (RRP) may involve major intraoperative blood loss. This study focuses on how limited intraoperative hydration, especially in the early part of the surgery, affects the total blood loss. Fifteen prostate cancer patients were enrolled in this study in which the RRPs were performed by a single surgeon with limited (no more than 1500 ml as a rule) intraoperative hydration in the first 2 hours of the surgery when ligation of intrapelvic lymph node, dorsal vein complex (DVC), neurovascular bundle (NVB) and cut of urethra are assumed to be finished, and were compared with the control group in which no intervention of hydration was undertaken. Intervention group (n=15) had significantly less intraoperative blood loss (p<0.05) compared with control group even though blood pressure at the first 2 hours was not significantly different. Limited hydration did not cause apparent adverse events resulted from dehydration. In conclusion, limited hydration especially in the first half of operation may reduce intraoperative blood loss without any side effects of dehydration. This study could help to establish detailed guidelines for hydration methods for less blood loss during RRP