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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 24 hours antibiotics

    Drug

    Antibiotic therapy will start 24 hours before urological surgery

  • 48 hours antibiotics

    Drug

    Antibiotic therapy will start 48 hours before urological surgery

Treatment groups

894 Participants
are divided into 2 treatment groups
Group A: Antibiotic therapy 24 hoursExperimental treatment 1 intervention
Group B: Antibiotic therapy 48 hoursActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative infectious complications.

Post-operative infectious complications will be assessed as %. Post-operative infection will be defined as: • A fever (T\>38°C) / hypothermia (T\<36°C) with no other cause other than urological, OR lower back pain, OR lower urinary tract symptoms that appeared or persisted at least 7 days after the procedure. AND • A positive urine culture (leukocyturia \>or= 10\^4/ml and positive urine culture \>10\^3 cfu/ml for a uropathogen)

Time frame
One month

Secondary outcomes

Other outcomes

Sponsors and contacts

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