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Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones

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ClinicalTrials.gov Identifier: NCT03932370
Recruitment Status : Not yet recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Amr Esam Saad Mohamed Darwish, Assiut University

Study Description
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Brief Summary:

Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL).

Despite being the only truly-non-invasive, outpatient procedure, stone-free rates (SFRs) of ESWL are lower than both mini-PCNL and f-URS. Furthermore, ESWL has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (>2cm); stones with high densities (>970/1000 Hounsfield units); ESWL-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; Morbidities of the conventional PCNL are significantly minimised by using less access diameters in PCNL while providing comparable SFRs. Additionally, Mini and Micro PCNL result in shorter hospital stay and higher tubeless rates compared to conventional PCNL.

Flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than PCNL and mini-PCNL in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. Additionally, f-URS is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. Nevertheless, its poor durability and high costs remain major limitations for f-URS, especially in developing countries.


Condition or disease Intervention/treatment
Stone;Renal Procedure: endoscopic surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones 2 Cm or Less; A Randomised, Comparative Study.
Estimated Study Start Date : May 27, 2019
Estimated Primary Completion Date : May 27, 2020
Estimated Study Completion Date : May 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Groups and Cohorts
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Group/Cohort Intervention/treatment
f-URS Procedure: endoscopic surgery
The procedure will be performed in an endourology room where a radiolucent operative table together with a C-arm, a video-camera unit and a Laser device are available. Irrigation fluids include normal saline and/or sterile water
mini-PCNL Procedure: endoscopic surgery
The procedure will be performed in an endourology room where a radiolucent operative table together with a C-arm, a video-camera unit and a Laser device are available. Irrigation fluids include normal saline and/or sterile water


Outcome Measures
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Primary Outcome Measures :
  1. stone clerance [ Time Frame: postoperative within the first 24 hours ]
  2. Haemoglobin drop [ Time Frame: within 24 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
no specific criteria
Criteria

Inclusion Criteria:

  1. Age above than 15 years
  2. Renal stone(s) with total burden of 2 cm or less
  3. Signature on written, informed consents with the details of this study requirements.
  4. Inappropriateness or failure of ESWL (examples of ESWL inappropriateness: patient preference; distal obstruction; contraindications of ESWL)

Exclusion Criteria:

1- asymptomatic bacteruria 2- active urinary tract infection (UTI) 3- uncorrected coagulopathy 4- current use of antiplatelet therapy 5- pregnancy

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Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Amr Esam Saad Mohamed Darwish, Dr Amr Darwish, Assiut University
ClinicalTrials.gov Identifier: NCT03932370    
Other Study ID Numbers: flexible ureteroscopy
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
 Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi