Skip to main content
OpenTrials
Completed

NCT Number: NCT03932370

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut Urology and Nephrology Hospital

Asyut, Asyut Governorate, 71515, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flexible ureteroscopy

Procedure

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.

Other names: RIRS, f.URS, Retrograde Intrarenal Surgery

mini-Percutaneus nephrolithotomy

Procedure

The procedure is done in the prone position under fluoroscopy guidance with a semi-rigid 12Fr. Nephroscope

Other names: Mini-perc, Mini-PCNL, m.PCNL

Primary outcomes

  1. 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

  2. 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

  1. Operative time

    Time frame: Within 24 hours

    time passed during the operation

  2. Hospital stay

    Time frame: Within a week from the operation

    Number of days the patient has been hospitalised

  3. Haemoglobin drop

    Time frame: within 24 hours

    The percentage of haemoglobin drop before and after the operation

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2019
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.