Renal Calculi, Renal Anomaly
Conditions
Brief summary
The anatomic renal abnormalities like altered spatial relations with adjacent organs, abnormal calyceal orientation, and anomalous vascular patterns make the active treatment of stones in the congenitally malformed kidney a great challenge for urologists. In this prospective study, the investigators will evaluate the outcome of retrograde intrarenal surgery (RIRS) with extracorporeal shockwave lithotripsy (SWL) for the treatment of stones in the kidneys with rotation or position anomalies.
Detailed description
In current stone guidelines, the recommendations for stone therapy in the kidneys with normal anatomy are clearly stated; however, there is also no clear suggestion and treatment modality in regards to the stone treatment in anomalous kidneys. Nowadays, open surgery, percutaneous nephrolithotomy (PNL), SWL, and RIRS are used for the treatment of these kidney stones. However, there is no clear consensus on which treatment modalities should be used; each modality has its unique advantages and drawbacks. in this study, the investigators will prospectively evaluate the safety and efficacy of RIRS in treatment of stones in kidneys with rotation or position anomalies. The investigators will compare the results with a matched group of patients who were treated with SWL. The results of this study may help clarify treatment options in the management of patients with stones and renal anomalies.
Interventions
DEVICERIRS
The standard RIRS will be performed using a disposable flexible ureteroscope. Holmium: YAG laser will be used for stone dusting and fragmentation. If indicated, JJ ureteral stent will be placed at the end of the procedure.
DEVICESWL
Patients who underwent SWL at our institution in the past five years. According to (a) the type of renal anomaly (rotation, position, or rotation/position anomaly), (b) the size of the stone (±5 mm), (c) location of the stone (lower polar or non-lower polar), and (d) density of the stone (\>800 HU or ≤800 HU), matched cases will be selected for comparison.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The 1st group: RIRS The 2nd group: SWL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The study will include patients with renal stones up to 20 mm in size in a kidney with rotation or position anomalies.
Exclusion criteria
* Pregnant women. * Uncorrectable coagulation disorders. * Urinary tract obstruction distal to the stone. * Active infection. * Stone in a calyceal diverticulum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free rate | 3-months after the intervention. | Stone-free status is defined as no residual fragments of ≥3 mm on abdominal NCCT and/or X-ray KUB. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | intraoperative till 3 months postoperative complications | intraoperative and postoperative complications |
| operative time | the procedure time | from starting till the end of the procedure |
| Re-treatment rate | during the post-operative 3 months | need for reintervention |
Countries
Egypt
Contacts
Primary ContactAbul-fotouh Ahmed, MD
Outcome results
None listed