Enhanced Versus Extended Preoperative Antibiotic Prophylaxis Regimens for Retrograde Intrarenal Surgery in High Infectious Risk Patients: Randomized Controlled Trial

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

In the available literature, we lack the risk categorization of infectious complications after RIRS with subsequent recommendation as regard to AP in different risk patients. Therefore we are planning to investigate the optimal protocol for AP prior to RIRS in high-risk population through comparing the enhanced regimen (2days) vs. the extended regimen (7 days) in a randomized controlled trial (RCT).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University

Criteria

Inclusion Criteria:

• Ability to give informed consent.

• Age ≥18 years.

• Renal stone <20 mm in which RIRS is recommended.

• High susceptibility of post-procedural infectious complications by one or more of the followings: - Positive preoperative urine culture within 12 weeks of the planned intervention. -Indwelling ureteral stents for more than 4 weeks. -Diabetes mellitus.

Exclusion Criteria:

• Solitary kidney.

• Chronic kidney disease.

• Pregnant.

• Have received antibiotics within 7 days prior to enrollment.