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EndourologyNCT05299996

Flexible URS in Management of Renal Stones in Anomalous Kidney

A study testing flexible ureterorenoscopy in people with Endourology and Stones, Kidney, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 15 to 90 years
Conditions the study is for
Endourology, Stones, Kidney, Laser
What is being tested?
flexible ureterorenoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
15 Apr 2022to 1 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • Chronic kidney disease patient not on dialysis.
  • Previous operation in this kidney.
  • failed ESWL.

Who cannot join

  • Not fit for surgery.
  • Uncontrolled bleeding diathesis.
  • Untreated preoperative urinary tract infection (UTI).
  • non function kidney
  • skeletal abnormality

Trial locations and contacts

1 site in 1 country.

abdelrahman M abdelkader, M.D. contact

01068336396

abdelrahmanmohamed.aa@aun.edu.eg

Egypt1 site

  • Assuit Medical School

    Asyut, Assuit, 71621

Other trials in Egypt

About this study

Official title: 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.

Being tested
flexible ureterorenoscopy
Medical subject headings
Kidney Calculi, Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Fused Kidney

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • flexible ureterorenoscopyProcedure or surgery

    stone disintegration stricture dilation tumor resection access guidance

Study groups in NCT05299996
Study groupRoleWhat they receive
all patients having stones in the upper tract of anomalous kidneyExperimentalpatients 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.
Receives: Procedure: flexible ureterorenoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. stone free rate post-operative

    CT will be done to evaluate the presence or absence of stone

    Measured: 1 month after treatment

  2. Change from Baseline hematocrit after 1 day postoperative

    bleeding due to any error either surgical or non surgical

    Measured: 1 day after treatment

  3. time of operation

    the operation will be recorded.

    Measured: during the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2022
  2. Study start15 Apr 2022 (estimated)
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05299996
Sponsor's protocol ID
F-URS in abnormal kidney
Status last verified
Feb 2022
First submitted
22 Feb 2022
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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

    PubMed 28027075

  • 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.

    PubMed 27306685

  • 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.

    PubMed 24962930

  • 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.

    PubMed 25093997

  • 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.

    PubMed 31101967

  • 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.

    PubMed 29515627

Questions about this trial

What is this clinical trial studying?

A study testing flexible ureterorenoscopy in people with Endourology and Stones, Kidney, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact abdelrahman M abdelkader, M.D. (01068336396, abdelrahmanmohamed.aa@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

stone free rate post-operative (time frame: 1 month after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05299996, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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