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Completed

NCT Number: NCT05240170

RIRS for Treatment of Stones in Congenital Anomalous Kidneys

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.

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Key information

Conditions

Renal Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Anomaly Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology Department, Al-Azhar University Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIRS

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.

Other names: Retrograde flexible ureteroscopy

SWL

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.

Primary outcomes

  1. Stone-free rate

    Time frame: 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 outcomes

  1. Complication rate

    Time frame: intraoperative till 3 months postoperative complications

    intraoperative and postoperative complications

  2. operative time

    Time frame: the procedure time

    from starting till the end of the procedure

  3. Re-treatment rate

    Time frame: during the post-operative 3 months

    need for reintervention

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 15, 2022
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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