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

Not Applicable

Not yet recruiting

• Conditions: Urologic Surgery
• Interventions: Drug: 24 hours antibiotics; Drug: 48 hours antibiotics

• Registration Number: NCT07206992
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2025-11-01
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 894

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic therapy 24 hours	24 hours antibiotics	Antibiotic therapy will start 24 hours before urological surgery
Antibiotic therapy 48 hours	48 hours antibiotics	Antibiotic therapy will start 48 hours before urological surgery

Primary Outcome Measures

Name	Time	Method
Post-operative infectious complications.	One month	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)

Trial Locations

Locations (1)

Hôpital Privé des Peupliers; 🇫🇷 Paris, France