Flexible URS in Management of Renal Stones in Anomalous Kidney
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 29, 2022
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedMarch 29, 2022
February 1, 2022
11 months
February 22, 2022
March 18, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
stone free rate post-operative
CT will be done to evaluate the presence or absence of stone
1 month after treatment
Change from Baseline hematocrit after 1 day postoperative
bleeding due to any error either surgical or non surgical
1 day after treatment
time of operation
the operation will be recorded.
during the operation
Study Arms (1)
all patients having stones in the upper tract of anomalous kidney
EXPERIMENTALpatients having stones in abnormal anatomy , example horse-shoe kidney ,malrotation, crossed fusion , duplex collecting system. The stone size is 1 cm to 2.5 cm or 3.5 cm with variable density , located in calyx or the pelvis , single or multiple. the patient complain may be abdominal pain , loin pain, uremic symptoms .ct-kub non contrast , full lab \& fitness before the operation.
Interventions
stone disintegration stricture dilation tumor resection access guidance
Eligibility Criteria
You may qualify if:
- Males and females age above 15 years.
- Renal and ureteric stones either single or multiple wherever the site and site.
- Pelvi-uretreic junction obstruction
- Previous stented ureter.
- Poorly functioning kidney.
- Single functioning kidney.
- Chronic kidney disease patient not on dialysis.
- Previous operation in this kidney.
- failed ESWL.
You may not qualify if:
- Not fit for surgery.
- Uncontrolled bleeding diathesis.
- Untreated preoperative urinary tract infection (UTI).
- non function kidney
- skeletal abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assuit Medical School
Asyut, Assuit, 71621, Egypt
Related Publications (6)
Emiliani E, Traxer O. Single use and disposable flexible ureteroscopes. Curr Opin Urol. 2017 Mar;27(2):176-181. doi: 10.1097/MOU.0000000000000371.
PMID: 28027075BACKGROUNDSingh 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.
PMID: 27306685BACKGROUNDGiusti 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.
PMID: 24962930BACKGROUNDPatel 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.
PMID: 25093997BACKGROUNDLavan 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.
PMID: 31101967BACKGROUNDAlelign 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.
PMID: 29515627BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator , urologist , teaching assisstant
Study Record Dates
First Submitted
February 22, 2022
First Posted
March 29, 2022
Study Start
April 15, 2022
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
March 29, 2022
Record last verified: 2022-02