Management of Lower Pole Renal Hard Stones ≤2 cm

Not Applicable

Completed

• Conditions: Renal Stones
• Interventions: Procedure: lithotripsy using Flexible ureteroscope; Procedure: extracorporeal shock wave lithotripsy (ESWL); Procedure: holmium laser lithotripsy using Karl® Storz MIP set

• Registration Number: NCT06120257
• Lead Sponsor: Elsayed Abdelhalim Elsayed

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Study First Submitted: 2023-10-22
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A :Flexible ureteroscope group	lithotripsy using Flexible ureteroscope	Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue)
Group B : extracorporeal shock wave lithotripsy (ESWL) group	extracorporeal shock wave lithotripsy (ESWL)	extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany)
Group C : Mini perc group	holmium laser lithotripsy using Karl® Storz MIP set	Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

Primary Outcome Measures

Name	Time	Method
stone free rate	after two weeks from primary procedure	no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.

Secondary Outcome Measures

Name	Time	Method
Post operative complication	Up to 48 hours	Complication may occur post operative complication like fever, sever pain
Radiation time	during the procedure	Time of patient exposure for radiation in minutes
assess operative time.	during the procedure	assess operative time.in minutes
visual analog scale	immediately after the surgery	Patient 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.

Trial Locations

Locations (1)

Kafrelsheikh University hospital; 🇪🇬 Kafr Ash Shaykh, Egypt