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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Standard UAS | Active Comparator | Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr) used during flexible ureteroscopic stone fragmentation using Holmium:YAG laser. |
|
| Group B: Suction UAS (FAAN) | Experimental | Suction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end enabling continuous drainage and suction during laser stone fragmentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Ureteral Access Sheath (Boston Scientific). | Device | Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate (SFR) | Absence of residual fragments or presence of clinically insignificant residual fragments measuring < 3 mm, assessed by postoperative CT scan. | 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Intraoperatively . from insertion of sheath | |
| Intraoperative visibility and ease of access | Intraoperative visibility and ease of access using scale (good-moderate-poor) | intraoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| khaled Mostafa elmaradney, MD | Contact | +201014508582 | khaledelmaradney@gmail.com | |
| mohamed ebrahim elmaadawy, MD.PHD | Contact | +201060245430 | mohamed.elmaadawy@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| salah abdelmnsef nagla, MD-PHD | Tanta unversity | Study Chair |
| osama mostafa elgamal, MD-PHD | Tanta unversity | Study Director |
| Mohamed ebrahim elmaadawy, MD-PHD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | Gharbia Governorate | 31527 | Egypt |
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Eligible pediatric patients will be randomly allocated into two equal parallel groups (1:1 ratio). Group A will undergo flexible ureterorenoscopy (FURS) using a standard ureteral access sheath (UAS), while Group B will undergo FURS using a flexible and navigable suction ureteral access sheath (FANS). Both groups will be followed up postoperatively to compare efficacy and safety outcomes.
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| Flexible and Navigable Suction UAS (ClearPetra). | Device | Suction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end |
|
| Intraoperative complications | intraoperatively |
| Postoperative complications | Postoperative complications (according to Clavien-Dindo classification). | 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 | 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 | From the day of surgery up to hospital discharge (estimated average of 3 days) |
| Tanta unversity |
| Study Director |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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