Skip to main content
Clinical Trials/NCT03932370
NCT03932370
Completed
Not Applicable

Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones 2 Cm or Less; A Randomised, Comparative Study.

Assiut University1 site in 1 country118 target enrollmentMay 27, 2019
ConditionsStone;Renal

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stone;Renal
Sponsor
Assiut University
Enrollment
118
Locations
1
Primary Endpoint
initial stone clearance
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 27, 2019
End Date
December 27, 2021
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Esam Saad Mohamed Darwish

assistant lecturer of urology

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Uncorrectable bleeding diathesis
  • Current pregnancy

Outcomes

Primary Outcomes

initial stone clearance

Time Frame: 24 hours after the operation

Number of participants who has been totally cleared of stones as measured by KUB and ultrasound

final stone clearance

Time Frame: 90 days after the operation

Number of participants who has been totally cleared of stones as measured by non-contrast CT

Secondary Outcomes

  • Haemoglobin drop(within 24 hours)
  • Operative time(Within 24 hours)
  • Hospital stay(Within a week from the operation)

Study Sites (1)

Loading locations...

Similar Trials