The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis.
Participants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently given at Rigshospitalet, Copenhagen or (B) a conventional orally administered antibiotic prophylaxis targeting bacteria found in the urine postoperatively.
The investigators' hypothesis is that the targeted prophylactic antibiotic strategy will reduce the number of infection-related readmissions within 90 days of surgery compared to the standardised prophylaxis.
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
Previous severe allergic reaction to antimicrobial treatment
Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy
Parallel
Pivmecillinam
DrugOrally administered pivmecillinam 400mg
Pivmecillinam
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Amoxicillin clavulanic acid
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Amoxicillin
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Cefuroxime
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Ciprofloxacin
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Linezolid
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Nitrofurantoin
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Trimethoprim
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Sulfamethoxazole trimethoprim
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Fluconazole
DrugOrally administered targeted antimicrobial prophylaxis based on a urine culture.
Infection-related readmission rate
The rate of readmissions where the main cause of readmission is symptoms of infection.
Postoperative complications
Postoperative complications using the validated Clavien-Dindo classification score, ranging from 1-5 where 1-2 are minor complications and 3-5 are major complications.
Postoperative readmissions
All-cause postoperative readmissions, including the the main cause, timing, and duration.
Days alive and out of hospital
The number of days that the participants are alive and not admitted to the hospital.
Quality of life
Quality-of-life using the validated European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30). Results will be presented as scores ranging from 0-100 where high scores in the global health status and functional scales represent a better quality of life and high scores in the symptom scales represent a high level of symptomatology.
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