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Flexible URS in Management of Renal Stones in Anomalous Kidney

Primary Purpose

Endourology, Stones, Kidney, Laser

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
flexible ureterorenoscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endourology

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assuit Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all patients having stones in the upper tract of anomalous kidney

Arm Description

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.

Outcomes

Primary Outcome Measures

stone free rate post-operative
CT will be done to evaluate the presence or absence of stone
Change from Baseline hematocrit after 1 day postoperative
bleeding due to any error either surgical or non surgical
time of operation
the operation will be recorded.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2022
Last Updated
March 18, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05299996
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2022 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endourology, Stones, Kidney, Laser, Congenital Disorders, Horseshoe Kidney, Malrotation of Kidney, Ectopic Kidney

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
all patients having stones in the upper tract of anomalous kidney
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
flexible ureterorenoscopy
Intervention Description
stone disintegration stricture dilation tumor resection access guidance
Primary Outcome Measure Information:
Title
stone free rate post-operative
Description
CT will be done to evaluate the presence or absence of stone
Time Frame
1 month after treatment
Title
Change from Baseline hematocrit after 1 day postoperative
Description
bleeding due to any error either surgical or non surgical
Time Frame
1 day after treatment
Title
time of operation
Description
the operation will be recorded.
Time Frame
during the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Not fit for surgery. Uncontrolled bleeding diathesis. Untreated preoperative urinary tract infection (UTI). non function kidney skeletal abnormality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
abdelrahman M abdelkader, M.D.
Phone
01068336396
Email
abdelrahmanmohamed.aa@aun.edu.eg
Facility Information:
Facility Name
Assuit Medical School
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71621
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28027075
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.
Results Reference
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PubMed Identifier
27306685
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.
Results Reference
background
PubMed Identifier
24962930
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.
Results Reference
background
PubMed Identifier
25093997
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.
Results Reference
background
PubMed Identifier
31101967
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.
Results Reference
background
PubMed Identifier
29515627
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.
Results Reference
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Flexible URS in Management of Renal Stones in Anomalous Kidney

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