Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05240170
Other study ID # Uro_Azhar_1_022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT01450566 - Intraureteral Lidocaine for Post-Ureteroscopy Pain N/A
Recruiting NCT05701098 - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) N/A
Not yet recruiting NCT01008267 - Shockwave Lithotripsy (SWL) Under Selective, General Anesthesia. N/A
Completed NCT00250406 - Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation Phase 2
Recruiting NCT00169806 - Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis N/A
Not yet recruiting NCT02734914 - Suctioning Flexible Ureteroscopy With Intelligent Control of Renal Pelvic Pressure N/A
Completed NCT00169741 - Renogram Study With Percutaneous Nephrolithotomy (PERC): Alterations in Renal Blood Flow as a Consequence of PERC N/A
Completed NCT05972408 - Evaluation of Prevalence, Molecular and Genetic Backgrounds of Calcium-Based Stones Among Patients With Renal Calcular Disease in Mansoura Urology and Nephrology Center
Enrolling by invitation NCT02408211 - Preoperative Antibiotic PNL Study Phase 4
Completed NCT01437904 - A Pilot Study Assessing The Feasibility Of Outpatient Tubeless Percutaneous Nephrolithotomy (PCNL) N/A
Completed NCT00857090 - Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones Phase 1/Phase 2
Completed NCT03112499 - The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury N/A
Recruiting NCT03206515 - The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones N/A
Completed NCT03344107 - Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents N/A
Recruiting NCT05077007 - Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers N/A
Completed NCT03614247 - Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones N/A
Recruiting NCT05739812 - The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery N/A
Recruiting NCT05869890 - Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi N/A
Completed NCT00893282 - Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy N/A
Completed NCT00169715 - Database and Registry for Renal Diverticulum N/A