Endourology, Nephrolithiasis, Urolithiasis
Conditions
Keywords
Flexible Ureteroscopy (FURS), Ureteral Access Sheath (UAS), Suction Ureteral Access Sheath (FANS), Antegrade Suction, Percutaneous Nephrostomy (PCN), Laser Lithotripsy
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.
Interventions
PROCEDUREFlexible & Navigable Suction Ureteral Access Sheath (FANS)
The Flexible & Navigable Suction Ureteral Access Sheath (FANS) is used during retrograde flexible ureteroscopy (FURS) for renal stones (1.5-2 cm). It allows continuous active suctioning, improving stone fragment evacuation, reducing operative time, lowering intrarenal pressure, and optimizing stone-free rates (SFR). The procedure involves inserting the Navigator 10F, 55 cm YIGAOMED FANS over a guidewire, followed by flexible ureteroscopy with PUSEN® 9.2 Fr ureteroscope and laser lithotripsy using Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W).
PROCEDUREAntegrade Suction via Percutaneous Nephrostomy
This technique involves antegrade suction from the kidney during flexible ureteroscopy (FURS) without the use of a ureteral access sheath. A percutaneous nephrostomy (PCN) tract is created using an 18G needle, and a 6F renal dilator is placed and fixed to the skin, allowing for direct suctioning from the collecting system. Following this, retrograde flexible ureteroscopy (FURS) is performed using the PUSEN® 9.2 Fr ureteroscope and Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W) for stone fragmentation. This technique aims to improve stone clearance while minimizing ureteral trauma associated with access sheaths.
Sponsors
Benha University
Study design
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.
Intervention model description
This is a randomized controlled trial comparing two different suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones. Participants will be assigned to one of two groups: * Group A (Intervention Group) - flexible ureteroscopy (FURS) with Flexible & Navigable Suction Ureteral Access Sheath (FANS) * Group B (Control Group) - flexible ureteroscopy (FURS) with Antegrade Suction via percutaneous nephrostomy. The study will assess stone-free rates (SFR), operative time, and complications.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactTamer Diab, MD
Outcome results
None listed