About this trial
This randomized controlled trial aims to compare the efficacy and safety of a Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus a standard ureteral access sheath during flexible ureterorenoscopy (FURS) in pediatric patients with renal stones less than 2 cm. The study will evaluate stone-free rates. operative time. intraoperative parameters. operative and postoperative complication and the need for any auxiliary procedures. Sixty pediatric patients will be randomly allocated into two equal groups and treated at the Urology Department, Tanta University.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients (age ≤ 18 years)
Patients with renal stones less than 2 cm
Indicated for flexible ureterorenoscopy
Fit for general anesthesia
Disqualifiers
Stones larger than 2 cm
Active urinary tract infection
Congenital urinary tract anomalies affecting access
Previous ureteral surgery affecting the ureter
Trial design
Parallel
Treatments tested in this trial
Standard Ureteral Access Sheath (Boston Scientific).
DeviceStandard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr)
Flexible and Navigable Suction UAS (ClearPetra).
DeviceSuction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end
Treatment groups
Trial outcomes
Primary outcomes
Stone-free rate (SFR)
Absence of residual fragments or presence of clinically insignificant residual fragments measuring \< 3 mm, assessed by postoperative CT scan.
Secondary outcomes
Operative time
Intraoperative visibility and ease of access
Intraoperative visibility and ease of access using scale (good-moderate-poor)
Intraoperative complications
Postoperative complications
Postoperative complications (according to Clavien-Dindo classification).
Sponsors and contacts
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