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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group | Experimental | 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). |
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| Antegrade Suction with Flexible Ureteroscopy (FURS) Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexible & Navigable Suction Ureteral Access Sheath (FANS) | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-Free Rate (SFR) | 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. | 1 Month Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | 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. | During Surgery |
| Intraoperative Bleeding Requiring Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamer Diab, MD | Contact | 01003583264 | +2 | tamer.diab@fmed.bu.edu.eg |
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De-identified individual participant data (IPD) will be shared, including baseline characteristics, intraoperative details, postoperative outcomes, and complication data for research purposes. No personally identifiable information will be disclosed.
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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:
The study will assess stone-free rates (SFR), operative time, and complications.
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This is an open-label trial with no masking, as both the surgeon and patient will be aware of the assigned intervention.
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| Antegrade Suction via Percutaneous Nephrostomy | Procedure | 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. |
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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. |
| During Surgery |
| Ureteral Injury | 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. | During Surgery |
| Postoperative Hematuria | 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). | Within 7 Days Postoperative |
| Postoperative Urosepsis | 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. | Within 7 Days Postoperative |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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