Ureter Calculi
Conditions
Keywords
Ureteroscopy, Stone Cone Device, Pneumatic Lithotripsy, Stone Clearance, Randomized Controlled Trial
Brief summary
Retrograde migration of stone fragments into the kidney during ureteroscopic lithotripsy (URS) for proximal ureteral stones is a common technical challenge, occurring in 5-40% of cases. This can lead to residual fragments and lower stone-free rates. The Stone Cone is an anti-retropulsion device designed to trap fragments and prevent their migration. This study will test the hypothesis that the use of the Stone Cone during URS pneumatic lithotripsy will result in a significantly higher stone clearance rate at 48 hours post-procedure compared to the standard technique without the device.
Interventions
PROCEDUREUreteroscopic Pneumatic Lithotripsy with Cone Device
Patients will undergo ureteroscopic pneumatic lithotripsy under general anesthesia. The Stone Cone device (Boston Scientific, Natick, MA) will be advanced through the ureteroscope and positioned fluoroscopically proximal to the calculus before fragmentation. The device will create a mechanical barrier to prevent retrograde stone migration into the renal pelvis and will be used to trap and extract fragments upon withdrawal. A ureteral double-J stent will be placed at the end of the procedure.
PROCEDUREStandard Ureteroscopic Pneumatic Lithotripsy
Patients will undergo standard ureteroscopic pneumatic lithotripsy under general anesthesia without the use of any anti-retropulsion device. Stone fragmentation and fragment extraction will be performed using standard tools (pneumatic lithotripter, grasping forceps, or basket) as per the surgeon's discretion. A ureteral double-J stent will be placed at the end of the procedure.
Sponsors
Provincial Headquarter Teaching Hospital Gilgit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* A solitary proximal ureteral stone ≤ 2 cm in size as confirmed by imaging. * Normal renal function.
Exclusion criteria
* Active urinary tract infection (clinical features or pyuria). * Bleeding disorder (abnormal prothrombin time or activated partial thromboplastin time). * Chronic kidney disease (raised urea and creatinine). * Stone \> 2 cm in size.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Clearance Rate | 48 hours | The proportion of participants achieving a stone-free status, defined as the absence of stones on plain X-ray of the kidneys, ureters, and bladder (KUB) and abdominal ultrasonography performed 48 hours after the ureteroscopic lithotripsy procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intraoperative Complications | 2 hours | The number of participants experiencing complications such as ureteral perforation or significant bleeding during the procedure. |
| Operative Time | 120 minutes | The total duration of the ureteroscopic procedure, measured in minutes. |
| Hospital Stay Duration | 5 days | The length of the patient's hospital stay following the procedure. |
Countries
Pakistan
Contacts
STUDY_DIRECTORKhawar Suliman, MBBS, FCPS
Provincial Headquarter Teaching Hospital Gilgit
Outcome results
None listed