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Enrolling by Invitation

NCT Number: NCT06741917

Retrograde Intrarenal Surgery Low Risk Trial

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levofloxacin

Drug

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

Cefmetazole (drug)

Drug

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

Primary outcomes

  1. Post-operative sepsis

    Time frame: Postoperative two weeks

    Postoperative systemic inflammatory response syndrome within two weeks

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Comparison of the Post-operative Infection by Using Different Type Prophylactic Antibiotics in Low Risk Patients Who Underwent Retrograde Intrarenal Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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