Systemic inflammatory response syndrome after flexible ureteroscopic lithotripsy: a study of risk factors.
Wen Zhong, Gioacchino Leto, Liang Wang...
https://pubmed.ncbi.nlm.nih.gov/24999535/Actively Recruiting
Led by Hitit University · Updated on 2026-06-24
180
Participants Needed
2
Research Sites
12 weeks
Total Duration
Researchers are evaluating ways to reduce infections after retrograde intrarenal surgery RIRS, a common minimally invasive treatment for kidney stones up to 20 mm. This trial examines the effects of gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath on postoperative complications such as fever, systemic inflammatory response syndrome SIRS, and sepsis. The study uses a 2x2 factorial design to assess the independent and combined benefits of these two interventions, which target bacterial contamination and elevated intrarenal pressure, respectively. Participants will undergo RIRS under general anesthesia. The study compares four groups standard saline irrigation with a standard ureteral sheath gentamicin added to irrigation fluid with a standard sheath suction-enabled ureteral sheath with standard irrigation and both gentamicin irrigation and suction sheath together. Gentamicin is locally added to irrigation fluid at a dose of 80 mg per 3 L saline bag, while suction-assisted sheaths aim to improve fluid drainage and reduce pressure during the procedure. Stone fragmentation is performed with a holmiumYAG laser, and a ureteral stent is placed afterward. During the study, participants are monitored for infectious outcomes within 48 hours after surgery, including fever, SIRS, and sepsis. Additional assessments include stone-free rates at 4 weeks and changes in blood and urine tests. The trial collects data on urine and blood cultures, white blood cell counts, and kidney function markers. These measures help determine the effects of the interventions on postoperative infection risks and surgical success over the course of follow-up.
CONDITIONS
Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS
M
MUSTAFA SERDAR ÇAĞLAYAN
A
AHMET TAŞCI
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Hitit University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure day with postoperative monitoring
Participants undergo retrograde intrarenal surgery using one of four approaches involving standard or gentamicin irrigation and standard or suction-enabled ureteral access sheaths under general anesthesia.
1 surgery visit and several postoperative assessments within 48 hours
Duration - 4 weeks
Participants are assessed for postoperative infectious complications and stone-free status through clinical evaluations and laboratory tests up to 4 weeks after surgery.
Follow-up visits and tests at 48 hours and 4 weeks after surgery
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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https://pubmed.ncbi.nlm.nih.gov/33752442/Hitit University
Lead Sponsor