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.
Pediatric urolithiasis is an increasingly recognized condition associated with substantial morbidity and recurrence risk. Flexible ureterorenoscopy has become an established minimally invasive treatment option for renal stones smaller than 2 cm. The use of ureteral access sheaths facilitates repeated upper urinary tract access and may improve operative efficiency; however, concerns regarding ureteral trauma remain. Recently developed suction-assisted ureteral access sheaths have been introduced to improve visibility, facilitate fragment evacuation, and reduce intrarenal pressure. Although promising results have been reported in adults, evidence in pediatric patients remains limited. This prospective randomized controlled trial will compare a standard ureteral access sheath with a Flexible and Navigable Suction Ureteral Access Sheath (FANS) in pediatric patients undergoing flexible ureterorenoscopy for renal stones less than 2 cm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr)
Suction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end
Tanta University
Tanta, Gharbia Governorate, Egypt
Stone-free rate (SFR)
Absence of residual fragments or presence of clinically insignificant residual fragments measuring \< 3 mm, assessed by postoperative CT scan.
Time frame: 1 month postoperatively
Operative time
Time frame: Intraoperatively . from insertion of sheath
Intraoperative visibility and ease of access
Intraoperative visibility and ease of access using scale (good-moderate-poor)
Time frame: intraoperatively
Intraoperative complications
Time frame: intraoperatively
Postoperative complications
Postoperative complications (according to Clavien-Dindo classification).
Time frame: up to 30 days postoperatively
Need for auxiliary procedures.
This outcome measure will evaluate the requirement for additional interventions to achieve complete stone clearance or manage residual fragments. It will be assessed by recording the percentage of participants who require any secondary or ancillary surgical procedures (such as second-stage ureterorenoscopy, shock wave lithotripsy, or temporary stenting) within 30 days postoperatively
Time frame: up to 30 days postoperatively
Length of hospital stay.
The duration of hospitalization will be calculated in days, from the date of the participant's admission/surgery until the actual date of discharge from the hospital
Time frame: From the day of surgery up to hospital discharge (estimated average of 3 days)
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