RIRS for Treatment of Stones in Congenital Anomalous Kidneys

NCT ID: NCT05240170

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2024-07-15

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.

Conditions

Renal Calculi; Renal Anomaly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RIRS group

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.

Group Type: EXPERIMENTAL

RIRS

Intervention Type: DEVICE

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 group

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.

Group Type: EXPERIMENTAL

SWL

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Retrograde flexible ureteroscopy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Abul-fotouh Ahmed

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abul-fotouh Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University Hospitals, Cairo, Egypt

Locations

Urology Department, Al-Azhar University Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abul-fotouh Ahmed, MD

Role: CONTACT

abulfotouhahmed@yahoo.com

00201001066756

Facility Contacts

Ahmed Fahim, MD

Role: primary

urologyhospital@gmail.com

002025107333

Other Identifiers

Uro_Azhar_1_022

Identifier Type: -

Identifier Source: org_study_id