RIRS for Treatment of Stones in Congenital Anomalous Kidneys

Renal Calculi Clinical Trial

Official title:

Retrograde Intrarenal Surgery for Treatment of Stones in Congenital Anomalous Kidneys: Case Matched Comparative Study With Extracorporeal Shockwave Lithotripsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240170
• Other study ID #: Uro_Azhar_1_022
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: July 15, 2024

Study information

• Verified date: April 2022
• Source: Al-Azhar University
• Contact: Abul-fotouh Ahmed, MD
• Phone: 00201001066756
• Email: abulfotouhahmed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Calculi

Intervention

Device:
• RIRS
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.
• SWL
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.

Locations

Country	Name	City	State
Egypt	Urology Department, Al-Azhar University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone-free rate	Stone-free status is defined as no residual fragments of =3 mm on abdominal NCCT and/or X-ray KUB.	3-months after the intervention.
Secondary	Complication rate	intraoperative and postoperative complications	intraoperative till 3 months postoperative complications
Secondary	operative time	from starting till the end of the procedure	the procedure time
Secondary	Re-treatment rate	need for reintervention	during the post-operative 3 months