Retrograde Intrarenal Surgery Low Risk Trial

NCT06741917 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 202405150MIND
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Retrograde Intrarenal Surgery; Renal Stones

Keywords

retrograde intrarenal surgery; Prophylactic antibiotics

Outcome Measures

Primary Outcomes (1)

• Post-operative sepsis

  Postoperative systemic inflammatory response syndrome within two weeks

  Postoperative two weeks

Study Arms (2)

Oral Levofloxacin

EXPERIMENTAL

Drug: Levofloxacin

Intravenous cefmetzole

ACTIVE COMPARATOR

Drug: Cefmetazole (drug)

Interventions

Levofloxacin DRUG

single dose of oral Levofloxacin (500mg/tab) before retrograde intrarenal surgery

Oral Levofloxacin

Cefmetazole (drug) DRUG

single dose of intravenous Cefmetazole (1000 mg)before retrograde intrarenal surgery

Intravenous cefmetzole

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Wollin DA, Joyce AD, Gupta M, Wong MYC, Laguna P, Gravas S, Gutierrez J, Cormio L, Wang K, Preminger GM. Antibiotic use and the prevention and management of infectious complications in stone disease. World J Urol. 2017 Sep;35(9):1369-1379. doi: 10.1007/s00345-017-2005-9. Epub 2017 Feb 3.

  PMID: 28160088 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Levofloxacin; Cefmetazole; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephamycins; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 19, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)