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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03932370

Recruitment Status Not yet recruiting

First Posted April 30, 2019

Last update posted April 30, 2019

Study Description

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:Stone;Renal
  • Intervention/Treatment: Procedure: endoscopic surgery
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: May 2020
Groups and Cohorts
Groups/Cohorts 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
  • Primary Outcome Measures: 1. stone clerance [ Time Frame: postoperative within the first 24 hours ]
  • 2. Haemoglobin drop [ Time Frame: within 24 hours ]
Eligibility Criteria
  • Ages Eligible for Study: 16 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

-

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Assiut University

More Information
  • Responsible Party: Assiut University
  • ClinicalTrials.gov Identifier: NCT03932370 History of Changes
  • Other Study ID Numbers: flexible ureteroscopy
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 30, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Kidney Calculi
    Nephrolithiasis
    Calculi