Comparison Study Between Using Retrograde Flexible Ureteroscopy With Flexible & Navigable Suction Ureteral Access Sheath Versus Retrograde Flexible Ureteroscopy With Antegrade Suction in Lower Calyceal Stone: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Benha University
- Enrollment
- 120
- Primary Endpoint
- Stone-Free Rate (SFR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
This is an open-label trial with no masking, as both the surgeon and patient will be aware of the assigned intervention.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group
Patients in this group will undergo retrograde flexible ureteroscopy (FURS) with the Flexible & Navigable Suction Ureteral Access Sheath (FANS). The FANS facilitates continuous suctioning, improving stone fragment evacuation, reducing intrarenal pressure, and optimizing stone-free rates (SFR).
Intervention: Flexible & Navigable Suction Ureteral Access Sheath (FANS) (Procedure)
Antegrade Suction with Flexible Ureteroscopy (FURS) Group
Patients in this group will undergo retrograde flexible ureteroscopy (FURS) with antegrade suction, using a percutaneous nephrostomy (PCN) access for suctioning from the kidney during the procedure. This method aims to enhance stone fragment clearance and reduce intrarenal pressure without using a ureteral access sheath.
Intervention: Antegrade Suction via Percutaneous Nephrostomy (Procedure)
Outcomes
Primary Outcomes
Stone-Free Rate (SFR)
Time Frame: 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 Outcomes
- Operative Time(During Surgery)
- Intraoperative Bleeding Requiring Intervention(During Surgery)
- Ureteral Injury(During Surgery)
- Postoperative Hematuria(Within 7 Days Postoperative)
- Postoperative Urosepsis(Within 7 Days Postoperative)
Investigators
Tamer Abd El-Wahab Diab
Lecturer of Urology, Faculty of Medicine.
Benha University