REINFORCE – Reducing infection-related readmissions following cystectomy. A multicentre randomised clinical trial testing superiority of individualised targeted antibiotic prophylaxis over empiric prophylaxis at ureteral stent removal to reduce infection-related readmissions following cystectomy.

Conditions

Bacterial infection

Brief summary

90-day infection-related hospital readmission rate

Detailed description

Timing of ureteral stent removal and type of antimicrobial prophylaxis administered at ureteral stent removal, All-cause readmissions within 30 and 90 days after surgery, including main cause, timing, duration, microbiological tests, and antimicrobial treatment, Postoperative complications within 30 and 90 days of surgery using the Clavien-Dindo classification score, Days-alive-and-out-of-hospital (DAOH) at POD 30 and 90, Quality-of-life using the EORTC QLQ-C30 and QLQ-BLM30 questionnaires filled out preoperatively and on POD 90, Microbiological findings and antimicrobial susceptibility analyses in pre- and postoperative microbiological samples

Vejlgaard M, Stroomberg HV, Ynddal MS, Moser C, Joensen UN, Røder A.

2025-07-28

10.1186/s13063-025-08981-w

Interventions

DRUGtbl flm

DRUGNitrofurantoin 50 mg tablets

DRUGPivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets

DRUGTrimopan

DRUGfilmovertrukne tabletter

DRUGFluconazole 200 mg Capsules

DRUGAmoxicillin 500 mg film-coated tablets

DRUGCiprofloxacin 500 mg

DRUGfilm coated tablets

DRUGSulfametoxazol med trimetoprim SAD

DRUGtabletter

DRUGBioclavid 500 mg/125 mg filmdragerade tabletter

DRUGZinnat 500 mg

DRUGLinezolid Teva 600 mg filmdragerade tabletter

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
90-day infection-related hospital readmission rate	—

Secondary

Measure	Time frame
Timing of ureteral stent removal and type of antimicrobial prophylaxis administered at ureteral stent removal, All-cause readmissions within 30 and 90 days after surgery, including main cause, timing, duration, microbiological tests, and antimicrobial treatment, Postoperative complications within 30 and 90 days of surgery using the Clavien-Dindo classification score, Days-alive-and-out-of-hospital (DAOH) at POD 30 and 90, Quality-of-life using the EORTC QLQ-C30 and QLQ-BLM30 questionnaires filled out preoperatively and on POD 90, Microbiological findings and antimicrobial susceptibility analyses in pre- and postoperative microbiological samples	—

Measure

Time frame

Timing of ureteral stent removal and type of antimicrobial prophylaxis administered at ureteral stent removal, All-cause readmissions within 30 and 90 days after surgery, including main cause, timing, duration, microbiological tests, and antimicrobial treatment, Postoperative complications within 30 and 90 days of surgery using the Clavien-Dindo classification score, Days-alive-and-out-of-hospital (DAOH) at POD 30 and 90, Quality-of-life using the EORTC QLQ-C30 and QLQ-BLM30 questionnaires filled out preoperatively and on POD 90, Microbiological findings and antimicrobial susceptibility analyses in pre- and postoperative microbiological samples

—

Countries

Denmark

Outcome results

None listed