NCT05392634

Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery

Рrospective Multicenter Randomized 3 Phase Study Evaluating the Role of Prolonged Antibiotic Prophylaxis as a Measure to Reduce the Incidence of Postoperative Complications After Radical Cystectomy With ERAS Protocol

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: N.N. Petrov National Medical Research Center of Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Meropenem 1000 mg	Group B: prolonged antibiotic prophylaxis \>72 hours (5 days) from the moment of the skin incision in accordance with the selected clinic drug + correction of the appointment based on clinical events after 5 days.
DRUG	Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg	Group A: antibiotic prophylaxis within 24 hours from the moment of skin incision according to local clinical practice;

Timeline

• Start date: 2022-02-02
• Primary completion: 2023-02-02
• Completion: 2023-11-01
• First posted: 2022-05-26
• Last updated: 2022-05-31

Locations

1 site across 1 country: Russia