RIRS for Treatment of Stones in Congenital Anomalous Kidneys

Al-Azhar University

Status: Enrolling

Conditions: Renal Anomaly; Renal Calculi

Treatments: Device: SWL; Device: RIRS

Study type: Interventional

Funder types: Other

Identifiers

NCT05240170

Uro_Azhar_1_022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

RIRS group

Experimental group

Description:

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.

Treatment:

Device: RIRS

SWL group

Experimental group

Description:

The medical records of all patients who underwent SWL at our institution in the past five years will be reviewed. Patients with renal rotation or position anomalies, as defined by NCCT and/or IVU, will be included for possible study participation.

Treatment:

Device: SWL