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

NCT03932370 | Completed

• 1 other identifier: NCT03932370
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Stone;Renal

Outcome Measures

Primary Outcomes (2)

• initial stone clearance

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

  24 hours after the operation

• final stone clearance

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

  90 days after the operation

Secondary Outcomes (3)

• Operative time

  Within 24 hours

• Hospital stay

  Within a week from the operation

• Haemoglobin drop

  within 24 hours

Study Arms (2)

f-URS

Procedure: Flexible ureteroscopy

mini-PCNL

Procedure: mini-Percutaneus nephrolithotomy

Interventions

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.

Also known as: RIRS, f.URS, Retrograde Intrarenal Surgery

f-URS

mini-Percutaneus nephrolithotomy PROCEDURE

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

Also known as: Mini-perc, Mini-PCNL, m.PCNL

mini-PCNL

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

no specific criteria

You may qualify if:

• 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)

You may not qualify if:

• Uncorrectable bleeding diathesis
• Current pregnancy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Urology and Nephrology Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of urology

Study Record Dates

• First Submitted: April 27, 2019
• First Posted: April 30, 2019
• Study Start: May 27, 2019
• Primary Completion: July 30, 2021
• Study Completion: December 27, 2021
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)