Retrograde Intrarenal Surgery Low Risk Trial
- Conditions
- Interventions
- 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...
- 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...
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan