Kidney Stone, Nephrolithiasis, Pediatric Urolithiasis
Conditions
Keywords
Flexible Ureterorenoscopy, Retrograde Intrarenal Surgery, Ureteral Access Sheath, Suction-Assisted Ureteroscopy, Pediatric Urology
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStandard Ureteral Access Sheath (Boston Scientific).
Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr)
DEVICEFlexible and Navigable Suction UAS (ClearPetra).
Suction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric patients (age ≤ 18 years) 2. Patients with renal stones less than 2 cm 3. Indicated for flexible ureterorenoscopy 4. Fit for general anesthesia 5. Informed consent obtained from parents or guardians
Exclusion criteria
1. Stones larger than 2 cm 2. Active urinary tract infection 3. Congenital urinary tract anomalies affecting access 4. Previous ureteral surgery affecting the ureter 5. Coagulopathy or unfit for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free rate (SFR) | 1 month postoperatively | Absence of residual fragments or presence of clinically insignificant residual fragments measuring \< 3 mm, assessed by postoperative CT scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperatively . from insertion of sheath | — |
| Intraoperative visibility and ease of access | intraoperatively | Intraoperative visibility and ease of access using scale (good-moderate-poor) |
| Intraoperative complications | intraoperatively | — |
| Postoperative complications | up to 30 days postoperatively | Postoperative complications (according to Clavien-Dindo classification). |
| Need for auxiliary procedures. | up to 30 days postoperatively | 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 |
| Length of hospital stay. | From the day of surgery up to hospital discharge (estimated average of 3 days) | 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 |
Countries
Egypt
Contacts
CONTACTkhaled Mostafa elmaradney, MD
CONTACTmohamed ebrahim elmaadawy, MD.PHD
STUDY_CHAIRsalah abdelmnsef nagla, MD-PHD
Tanta unversity
STUDY_DIRECTORosama mostafa elgamal, MD-PHD
Tanta unversity
STUDY_DIRECTORMohamed ebrahim elmaadawy, MD-PHD
Tanta unversity
Outcome results
None listed