Flexible URS in Management of Renal Stones in Anomalous Kidney

March 18, 2022 updated by: Abdelrahman Mohamed Abdelkader, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 71621
        • Assuit Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: flexible ureterorenoscopy
stone disintegration stricture dilation tumor resection access guidance

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-URS in abnormal kidney

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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