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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03932370
Collaborator
(none)
80
12

Study Details

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 Intervention/Treatment Phase
  • Procedure: endoscopic surgery

Study Design

Study Type:
Observational
Anticipated 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.
Anticipated Study Start Date :
May 27, 2019
Anticipated Primary Completion Date :
May 27, 2020
Anticipated Study Completion Date :
May 27, 2020

Arms and Interventions

Arm 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 [postoperative within the first 24 hours]

  2. Haemoglobin drop [within 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Esam Saad Mohamed Darwish, Dr Amr Darwish, Assiut University
ClinicalTrials.gov Identifier:
NCT03932370
Other Study ID Numbers:
  • flexible ureteroscopy
First Posted:
Apr 30, 2019
Last Update Posted:
Apr 30, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 30, 2019