RIRS for Treatment of Stones in Congenital Anomalous Kidneys

NCT05240170 | Unknown

• 1 other identifier: Uro_Azhar_1_022
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Calculi; Renal Anomaly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Complication rate

  intraoperative till 3 months postoperative complications

• operative time

  the procedure time

• Re-treatment rate

  during the post-operative 3 months

Study Arms (2)

RIRS group

EXPERIMENTAL

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.

Device: RIRS

SWL group

EXPERIMENTAL

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.

Device: SWL

Interventions

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.

Also known as: Retrograde flexible ureteroscopy

RIRS group

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.

SWL group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will include patients with renal stones up to 20 mm in size in a kidney with rotation or position anomalies.

You may not qualify if:

• Pregnant women.
• Uncorrectable coagulation disorders.
• Urinary tract obstruction distal to the stone.
• Active infection.
• Stone in a calyceal diverticulum

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Urology Department, Al-Azhar University Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

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

Study Officials

• Abul-fotouh Ahmed, MD

  Al-Azhar University Hospitals, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abul-fotouh Ahmed, MD

CONTACT

00201001066756; abulfotouhahmed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The 1st group: RIRS The 2nd group: SWL

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: March 15, 2022
• Primary Completion: February 15, 2024
• Study Completion: July 15, 2024
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

EG (1)