Comparison of Multiple-, Single- and Zero-dose of Ciprofloxacin Prophylaxis in Retrograde Intrarenal Surgery
Launched by GUOHUA ZENG · Dec 1, 2014
Trial Information
Current as of May 24, 2025
Unknown status
Keywords
ClinConnect Summary
PURPOSE:
To compare multiple-, single-, zero-dose antibiotic prophylaxis for retrograde intrarenal surgery (RIRS) and detect the ideal regimen to prevent systemic inflammatory response syndrome (SIRS).
METHODS:
An α error of 5% and a power of 80% were assumed to detect a 14.9% difference in rates of postoperative SIRS (5.1% for the antibiotic prophylaxis group and 20% for the control group) based on the historical data. According to sample size calculation formula for comparing rates between multiple independent samples, n=2λ/(2sin-1√Pmax-2sin-1√Pmin)2,the minimum sample sizes to detect ...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Decision to performed RIRS to treat the kidney stones
- • American society of Anesthesiology (ASA) score 1 and 2
- • Kidney stones of diameter \< 2.5 cm
- Exclusion Criteria:
- • Positive preoperative urine culture
- • Pyruria (\>10 white blood cells per high-power field)
- • Antibiotics treatment of UTI in the last 4 weeks
- • Immunocompromised
- • Diabetes mellitus
- • Allergy to quinolone
- • Existing ureteric stents
- • Turbid pelvic urine or purulent stone surface observed intraoperatively
- • Ureteral stricture, renal or urethral deformity
About Guohua Zeng
Guohua Zeng is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative trial designs and rigorous scientific methodologies. With a focus on enhancing therapeutic options across various medical fields, Guohua Zeng collaborates with leading researchers and healthcare professionals to ensure the highest standards of safety and efficacy in clinical studies. The sponsor is driven by a mission to translate pioneering research into tangible health solutions, fostering an environment of collaboration, integrity, and excellence in clinical trial management.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
Patients applied
Trial Officials
Guohua Zeng, PH.D and M.D
Study Chair
The First Affiliated Hospital of Guangzhou Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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