MedTrace Logo

Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery

NCT05392634 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2022-05-31

No results posted yet for this study

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

Interventions

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;

Sponsors & Collaborators

  • The Foundation for Cancer Research Support (RakFond)

    collaborator UNKNOWN

  • N.N. Petrov National Medical Research Center of Oncology

    lead OTHER

Principal Investigators

  • Mariya Berkut, PhD · FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05392634 on ClinicalTrials.gov