Retrograde Intrarenal Surgery Low Risk Trial

Phase 4

• Conditions: Retrograde Intrarenal Surgery; Renal Stones
• Interventions: Drug: Levofloxacin; Drug: Cefmetazole (drug)

• Registration Number: NCT06741917
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

In the treatment of kidney stones and upper ureteral stones, flexible ureteroscopic lithotripsy has become the mainstream choice due to its minimally invasive nature and high safety. However, there is still no universal consensus on the use of prophylactic antibiotics before surgery. Taiwan, located in the subtropical region, is one of the areas in the world with a high incidence of urinary tract stones. Currently, there are no established guidelines for the use of prophylactic antibiotics before flexible ureteroscopic lithotripsy in Taiwan. This study aims to evaluate the differences between single-dose, different types of prophylactic antibiotics in generally healthy adult patients undergoing flexible ureteroscopic lithotripsy.

Detailed Description

This study focuses on flexible ureteroscopic lithotripsy, a procedure commonly used to treat kidney stones and stones in the upper part of the ureter. This surgery is popular because it is minimally invasive and considered very safe. However, there is no clear agreement on whether or which antibiotics should be given to patients before the surgery to prevent infections.

Taiwan is one of the regions in the world with a high rate of urinary tract stones, and because of this, it is especially important to ensure that the best practices are followed to prevent infections during and after the surgery. Currently, there are no official guidelines in Taiwan on which antibiotics should be used before flexible ureteroscopic lithotripsy.

This study aims to compare different types of single-dose antibiotics given before the surgery to see if one is more effective than others in preventing infections. By looking at how different antibiotics perform, the study hopes to provide clearer guidance for doctors in choosing the best antibiotic treatment for patients, ultimately improving patient care and reducing the risk of infections after surgery.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-12-04
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-15
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Stone diameter < 3 cm or stone area < 900 mm2
• Preoperative(2 weeks) negative urine culture
• No active symptoms , including fever, dysuria, urinary frequency, urgency)
• Urinalysis WBC < 10/HPF

Exclusion Criteria

• Immunocompromised
• Poor control Diabetes mellitus
• Allergy to antibiotics
• Ureteric stents or Foley catheter present
• Ureteric stricture
• Renal or urethral deformity
• Antibiotic treatment for urinary tract infection in the preceding 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Levofloxacin	Levofloxacin	-
Intravenous cefmetzole	Cefmetazole (drug)	-

Primary Outcome Measures

Name	Time	Method
Post-operative sepsis	Postoperative two weeks	Postoperative systemic inflammatory response syndrome within two weeks

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan