Clinical trial NCT05299996: Flexible URS in Management of Renal Stones in Anomalous Kidney
Official title: Flexible URS in Management of Renal Stones in Anomalous Kidney, A Prospective Case Series Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endourology
Stones, Kidney
Laser
Congenital Disorders
Horseshoe Kidney
Malrotation of Kidney
Ectopic Kidney
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: stone free rate post-operative
timeFrame: 1 month after treatment
measure: Change from Baseline hematocrit after 1 day postoperative
timeFrame: 1 day after treatment
measure: time of operation
timeFrame: during the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit Medical School
state: Assuit
Study officials:
References:
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.
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.
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.
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.
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.
citation: 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.