REINFORCE – Reducing infection-related readmissions following cystectomy.

Phase 4

Recruiting

Brief Summary: The main objective of the study is to explore whether the use of targeted antibiotic prophylaxis can reduce infection-related readmissions following cystectomy compared to the current regimen given at ureteral stent removal.

Recruitment & Eligibility

Inclusion Criteria

Age at surgery ≥ 18 years

Ability to understand and sign an informed consent

Malignant or benign indication for undergoing cystectomy

Planned ileal conduit as urinary diversion

Exclusion Criteria

Previous severe allergic reaction to antimicrobial treatment

Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy

Primary Outcome Measures

Name	Time	Method
90-day infection-related hospital readmission rate		90-day infection-related hospital readmission rate

Secondary Outcome Measures

Name	Time	Method
Timing of ureteral stent removal and type of antimicrobial prophylaxis administered at ureteral stent removal		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		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		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		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		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		Microbiological findings and antimicrobial susceptibility analyses in pre- and postoperative microbiological samples

Locations (5): Odense University Hospital
🇩🇰
Odense C, Denmark
Aarhus University Hospital
🇩🇰
Aarhus, Denmark
Rigshospitalet
🇩🇰
Copenhagen Oe, Denmark
Aalborg University Hospital
🇩🇰
Aalborg, Denmark
Herlev Hospital
🇩🇰
Herlev, Denmark
Odense University Hospital
🇩🇰Odense C, Denmark
Lasse Bro
Site contact
29658392
lasse.bro@rsyd.dk