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

NCT07206992 | Not Yet Recruiting

• 1 other identifier: 2023-A01224-41
• Study Type: interventional
• Target: 894
• Locations: 1 country
• Sites: 1

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.

Conditions

Urologic Surgery

Keywords

Urologic Surgery Preoperative Antibiotic Therapy

Outcome Measures

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)

  One month

Study Arms (2)

Antibiotic therapy 24 hours

EXPERIMENTAL

Antibiotic therapy will start 24 hours before urological surgery

Drug: 24 hours antibiotics

Antibiotic therapy 48 hours

ACTIVE COMPARATOR

Antibiotic therapy will start 48 hours before urological surgery

Drug: 48 hours antibiotics

Interventions

24 hours antibiotics DRUG

Antibiotic therapy will start 24 hours before urological surgery

Antibiotic therapy 24 hours

48 hours antibiotics DRUG

Antibiotic therapy will start 48 hours before urological surgery

Antibiotic therapy 48 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé des Peupliers

Paris, 75013, France

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Dorian LEGRAVEREND, MD

CONTACT

+ 33 1 53 20 06 88; dorian.legraverend@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)