Management of Lower Pole Renal Hard Stones ≤2 cm

Elsayed Abdelhalim Elsayed

Status: Completed

Conditions: Renal Stones

Treatments: Procedure: holmium laser lithotripsy using Karl® Storz MIP set; Procedure: lithotripsy using Flexible ureteroscope; Procedure: extracorporeal shock wave lithotripsy (ESWL)

Study type: Interventional

Funder types: Other

Identifiers

NCT06120257

KFSIRB200-69

Details and patient eligibility

About

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.

Enrollment: 414 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

414 participants in 3 patient groups

Group A :Flexible ureteroscope group

Active Comparator group

Description:

Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue)

Treatment:

Procedure: lithotripsy using Flexible ureteroscope

Group B : extracorporeal shock wave lithotripsy (ESWL) group

Active Comparator group

Description:

extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany)

Treatment:

Procedure: extracorporeal shock wave lithotripsy (ESWL)

Group C : Mini perc group

Active Comparator group

Description:

Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

Treatment:

Procedure: holmium laser lithotripsy using Karl® Storz MIP set