Flexible URS in Management of Renal Stones in Anomalous Kidney

NCT ID: NCT05299996

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2023-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Endourology Stones, Kidney Laser Congenital Disorders Horseshoe Kidney Malrotation of Kidney Ectopic Kidney

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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all patients having stones in the upper tract of anomalous kidney

patients 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.

Group Type EXPERIMENTAL

flexible ureterorenoscopy

Intervention Type PROCEDURE

stone disintegration stricture dilation tumor resection access guidance

Interventions

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flexible ureterorenoscopy

stone disintegration stricture dilation tumor resection access guidance

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman Mohamed Abdelkader

principal investigator , urologist , teaching assisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assuit Medical School

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

Central Contacts

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abdelrahman M abdelkader, M.D.

Role: CONTACT

01068336396

References

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

Reference Type BACKGROUND
PMID: 28027075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27306685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24962930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25093997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31101967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29515627 (View on PubMed)

Other Identifiers

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F-URS in abnormal kidney

Identifier Type: -

Identifier Source: org_study_id

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