drugset / Trial / NCT05392634

Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery

NCT05392634

RandomizedParallel-groupOpen-labelPrevention

Summary

The current usage of antibiotic prophylaxis (AP) in radical cystectomy (RC) is aimed to reducing the incidence of surgical site infections and incidence of unnecessary prescribing of antibiotics. There are a huge number of different AP protocols according to Urological Associations. However, there is no convincing evidence to support variations and duration of AP which requires a randomized clinical trial on AP when performing variants of RC with uroderivation. Research hypothesis: The use of prolonged antibiotic prophylaxis (5 days), depending on the glomerular filtration rate, does not affect the incidence of postoperative complications.

Timeline

Start
2022-02-02
Primary completion
2023-02-02
Completion
2023-11-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified
Comparator Cefuroksim Unknown 1500 mg
Subject Meropenem Small molecule 1000 mg
Comparator clavulanic acid Small molecule