Flexible URS in Management of Renal Stones in Anomalous Kidney

Congenital Disorders Clinical Trial

Official title:

Flexible URS in Management of Renal Stones in Anomalous Kidney, A Prospective Case Series Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05299996
• Other study ID #: F-URS in abnormal kidney
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2022
• Source: Assiut University
• Contact: abdelrahman M abdelkader, M.D.
• Phone: 01068336396
• Email: abdelrahmanmohamed.aa[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The urotheliasis is a common problem encountered daily by all urologists worldwide with rates up to 13% in North America, 9% in Europe and 5% in Asia . The urotheliasis is treated by conservation, medical treatment and surgery according to many factors . Anomalies in the kidney happens due to failure in ascending , fusion, rotation or all together, horse-shoe kidney is the most common example , found in one of 400 patients . PCNL and URS are the golden standard method for stone extraction worldwide, since their introduction 1975 by Fernstrom and Johansson & Arthur Smith respectively in normal kidney .Since the development of the endourological procedures and instrument , continuous updates and upgrades have been applied ,such as enhancing the optical systems ,reducing the diameter, navigation (deflection angles) and stone fragmentation .Stone treatment in anomalous kidney is more demanding, requires more skills and training . The flexible ureterorenoscopy has some problems first the cost but this problem is being now solved by the use of disposable scopes , second the skills it requires , third the possibility of sepsis is higher . To our knowledge most of the studies in the literature are retrospective, carrying some weakness in them. There is no agreed-upon therapeutic method for treatment of stones in anomalous kidney so the investigators will evaluate the role of F-URS in a prospective study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Males and females age above 15 years.

2. Renal and ureteric stones either single or multiple wherever the site and site.

3. Pelvi-uretreic junction obstruction

4. Previous stented ureter.

5. Poorly functioning kidney.

6. Single functioning kidney.

7. Chronic kidney disease patient not on dialysis.

8. Previous operation in this kidney.

9. failed ESWL.

Exclusion Criteria:

1. Not fit for surgery.

2. Uncontrolled bleeding diathesis.

3. Untreated preoperative urinary tract infection (UTI).

4. non function kidney

5. skeletal abnormality

Related Conditions & MeSH terms

• Congenital Disorders
• Endourology
• Kidney Calculi
• Laser
• Nephrolithiasis
• Stones, Kidney

Intervention

Procedure:
• flexible ureterorenoscopy
stone disintegration stricture dilation tumor resection access guidance

Locations

Country	Name	City	State
Egypt	Assuit Medical School	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Alelign T, Petros B. Kidney Stone Disease: An Update on Current Concepts. Adv Urol. 2018 Feb 4;2018:3068365. doi: 10.1155/2018/3068365. eCollection 2018. Review. — View Citation

Emiliani E, Traxer O. Single use and disposable flexible ureteroscopes. Curr Opin Urol. 2017 Mar;27(2):176-181. doi: 10.1097/MOU.0000000000000371. Review. — View Citation

Giusti G, Proietti S, Peschechera R, Taverna G, Sortino G, Cindolo L, Graziotti P. Sky is no limit for ureteroscopy: extending the indications and special circumstances. World J Urol. 2015 Feb;33(2):257-73. doi: 10.1007/s00345-014-1345-y. Epub 2014 Jun 25. Review. — View Citation

Lavan L, Herrmann T, Netsch C, Becker B, Somani BK. Outcomes of ureteroscopy for stone disease in anomalous kidneys: a systematic review. World J Urol. 2020 May;38(5):1135-1146. doi: 10.1007/s00345-019-02810-x. Epub 2019 May 17. — View Citation

Patel SR, Nakada SY. The modern history and evolution of percutaneous nephrolithotomy. J Endourol. 2015 Feb;29(2):153-7. doi: 10.1089/end.2014.0287. Epub 2014 Sep 17. — View Citation

Singh AG, Chhabra JS, Sabnis R, Ganpule A, Jairath A, Shah D, Desai M. Role of flexible uretero-renoscopy in management of renal calculi in anomalous kidneys: single-center experience. World J Urol. 2017 Feb;35(2):319-324. doi: 10.1007/s00345-016-1881-8. Epub 2016 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone free rate post-operative	CT will be done to evaluate the presence or absence of stone	1 month after treatment
Primary	Change from Baseline hematocrit after 1 day postoperative	bleeding due to any error either surgical or non surgical	1 day after treatment
Primary	time of operation	the operation will be recorded.	during the operation