Comparison of Flexible & Navigable Suction Ureteral Access Sheath vs. Antegrade Suction in Retrograde Flexible Ureteroscopy for Lower Calyceal Stones

Not Applicable

Not yet recruiting

• Conditions: Nephrolithiasis; Urolithiasis; Endourology

• Registration Number: NCT06889051
• Lead Sponsor: Benha University

Brief Summary

This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. The study evaluates Flexible \& Navigable Suction Ureteral Access Sheath (FANS) versus Antegrade Suction (via percutaneous access) in improving stone-free rates (SFR), reducing operative time, and minimizing complications such as bleeding, ureteral injury, and infection. A total of 120 adult patients will be randomized into two groups, undergoing either flexible ureteroscopy (FURS) with Flexible \& Navigable Suction Ureteral Access Sheath (FANS) or flexible ureteroscopy (FURS) with antegrade suction, at Banha University Faculty of Medicine.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-15
• Study First Submitted QC: 2025-03-15
• Last Update Submitted: 2025-03-15
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-03-30
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Adult patients (≥18 years old)
• Patients diagnosed with renal stones (1.5-2 cm) confirmed by non-contrast computed tomography (NCCT)
• Patients undergoing flexible ureteroscopy (FURS) as the primary treatment approach
• Patients with no active urinary tract infection (UTI) at baseline
• Patients who provide written informed consent

Exclusion Criteria

• Patients with anatomical anomalies (e.g., horseshoe kidney, PUJ obstruction)
• Patients with a single functioning kidney
• Pregnant women
• Patients with a history of urological malignancy
• Patients with active bleeding disorders or those on anticoagulant therapy that cannot be safely discontinued
• Patients at high risk for anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stone-Free Rate (SFR)	1 Month Postoperative	The stone-free rate (SFR) will be assessed one month postoperatively using non-contrast computed tomography (NCCT) to determine the presence or absence of residual stone fragments ≥4 mm. A higher SFR indicates better effectiveness of the intervention.

Secondary Outcome Measures

Name	Time	Method
Operative Time	During Surgery	The total operative time will be recorded from the initial endoscopic access to procedure completion. This includes access sheath insertion, ureteroscopy, lithotripsy, and final stone evacuation. A shorter operative time is indicative of a more efficient technique.
Intraoperative Bleeding Requiring Intervention	During Surgery	The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.
Ureteral Injury	During Surgery	The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.
Postoperative Hematuria	Within 7 Days Postoperative	The presence of postoperative hematuria (macroscopic bleeding) will be assessed. It will be classified as mild (self-limited), moderate (requiring irrigation), or severe (requiring intervention such as transfusion or embolization).
Postoperative Urosepsis	Within 7 Days Postoperative	The incidence of postoperative urosepsis, defined as systemic inflammatory response syndrome (SIRS) with a positive urine culture and clinical deterioration requiring IV antibiotics or ICU admission, will be recorded.