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Not yet recruiting NCT07206992

Assessment of a 24-hour Preoperative Course of Antibiotic Therapy for Endoscopic Urological Surgery in Case of Positive Urine Culture

No phase Interventional Urologic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 24 hours antibiotics, 48 hours antibiotics.
Who it may be relevant to
Registry conditions: Urologic Surgery. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Endourology poses the problem of post-operative infections. The need to obtain a negative urine culture prior to surgery is accepted, and the effectiveness of this measure in reducing the risk of post-operative infection has been proven. Current French recommendations are unanimous in favour of preventive treatment for asymptomatic bacteriuria (positive urine culture) prior to urological procedures involving contact with urine. These same recommendations specify that treatment should be brief, with a preoperative course of antibiotics lasting 48 hours. However, the scientific literature on the subject does not provide an answer to the question of whether 48 hours is the optimal duration of preoperative antibiotic treatment to avoid the risk of postoperative infection. In this context, it is interesting to evaluate a duration of preoperative antibiotic therapy limited to 24 hours, as no study can confirm that 24 hours of treatment is insufficient to prevent post-operative infection.

Detailed description

Endourology poses the problem of post-operative infections. The need to obtain a negative urine culture prior to surgery is accepted, and the effectiveness of this measure in reducing the risk of post-operative infection has been proven.

Current French recommendations are unanimous in favour of preventive treatment for asymptomatic bacteriuria (positive urine culture) prior to urological procedures involving contact with urine. These same recommendations specify that treatment should be brief, with a preoperative course of antibiotics lasting 48 hours.

However, the scientific literature on the subject does not provide an answer to the question of whether 48 hours is the optimal duration of preoperative antibiotic treatment to avoid the risk of postoperative infection. Studies have shown that a single parenteral administration of antibiotics in the context of asymptomatic bacteriuria prior to urological surgery is effective in preventing post-operative infection. Furthermore, in some practical situations related to the time taken for the laboratory to return urine culture results, preoperative antibiotic therapy has been limited to 24 hours without any infections developing.

In this context, it is interesting to evaluate a duration of preoperative antibiotic therapy limited to 24 hours, as no study can confirm that 24 hours of treatment is insufficient to prevent post-operative infection.

Interventions

  • Drug 24 hours antibiotics
    Antibiotic therapy will start 24 hours before urological surgery
  • Drug 48 hours antibiotics
    Antibiotic therapy will start 48 hours before urological surgery

Primary outcome measures

  • Post-operative infectious complications. [Time frame: One month]

Eligibility criteria

Inclusion criteria

  • Patients over 18 years of age
  • Patients scheduled for urological endoscopy for one of the following indications: endoscopic surgery of the upper urinary tract (diagnostic, for treatment of stones or ureteral strictures), endoscopic prostate surgery (with or without laser: enucleation, vaporisation, resection), endoscopic surgery of the bladder and urethra (particularly tumours, strictures and foreign bodies) and ureteral stent surgery
  • Patients with a positive preoperative urine culture (presence of bacteria at more than 103/mL)
  • Asymptomatic patients (no signs of urinary tract infection in particular)
  • Patients affiliated with or covered by a social security scheme
  • French-speaking patients who have signed an informed consent form

Exclusion criteria

  • Patient participating in another clinical trial
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Patient with an immune deficiency
  • Patient presenting symptoms of preoperative pyelonephritis (fever)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Hôpital Privé des Peupliers — Paris

Identifiers

NCT: NCT07206992 · 2023-A01224-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗