Skip to content

Management of Lower Pole Renal Hard Stones ≤2 cm

Flexible Ureteroscopy , Extracorporeal Shock Wave Lithotripsy and Mini Percutaneous Nephrolithotomy for Management of Lower Pole Renal Hard Stones ≤2 cm: Prospective Comparative Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06120257
Enrollment
414
Registered
2023-11-07
Start date
2022-03-01
Completion date
2022-09-01
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stones

Keywords

Hard stones

Brief summary

The study has been conducted in Urology department at Kafrelsheikh University Hospital between March 2022 to March 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

Interventions

using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate

using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate

PROCEDUREholmium laser lithotripsy using Karl® Storz MIP set

using holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate

Sponsors

Elsayed Abdelhalim Elsayed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adult patient older than 18 years. * single renal stone. * medium sized Stone up to 2.0 cm . * Do novo * Stone in lower calyceal stone * Hard stone

Exclusion criteria

* • multiple renal stones * stone size \> 2 cm * age group \< 18 * solitary kidney * Patients with BMI \> 40 kg/m2 * bleeding disorders * anatomical renal abnormalities * Obstruction distal to the stone. * Musculoskeletal deformities

Design outcomes

Primary

MeasureTime frameDescription
stone free rateafter two weeks from primary procedureno stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.

Secondary

MeasureTime frameDescription
assess operative time.during the procedureassess operative time.in minutes
visual analog scaleimmediately after the surgeryPatient self dependent to assess degree of own pain, consists of a 10cm line, with two end points representing 0 minimum score('no pain') and 10 maximum score('pain as bad as it could possibly be').higher scores mean a worse outcome.
Radiation timeduring the procedureTime of patient exposure for radiation in minutes
Post operative complicationUp to 48 hoursComplication may occur post operative complication like fever, sever pain

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026