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

NCT ID: NCT07206992

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 894 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-08-31

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.

Conditions

Urologic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Antibiotic therapy 24 hours

Antibiotic therapy will start 24 hours before urological surgery

Group Type: EXPERIMENTAL

24 hours antibiotics

Intervention Type: DRUG

Antibiotic therapy will start 24 hours before urological surgery

Antibiotic therapy 48 hours

Antibiotic therapy will start 48 hours before urological surgery

Group Type: ACTIVE_COMPARATOR

48 hours antibiotics

Intervention Type: DRUG

Antibiotic therapy will start 48 hours before urological surgery

Interventions

24 hours antibiotics

Antibiotic therapy will start 24 hours before urological surgery

Intervention Type: DRUG

48 hours antibiotics

Antibiotic therapy will start 48 hours before urological surgery

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé des Peupliers

Paris, , France

Countries

France

Central Contacts

Dorian LEGRAVEREND, MD

Role: CONTACT

dorian.legraverend@gmail.com

+ 33 1 53 20 06 88

Facility Contacts

Dorian LEGRAVEREND, MD

Role: primary

dorian.legraverend@gmail.com

+ 33 1 53 20 06 88

Other Identifiers

2023-A01224-41

Identifier Type: -

Identifier Source: org_study_id