Management of Lower Pole Renal Hard Stones ≤2 cm

Renal Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06120257
• Other study ID #: KFSIRB200-69
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Stones

Intervention

Procedure:
• lithotripsy using Flexible ureteroscope
using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate
• extracorporeal shock wave lithotripsy (ESWL)
using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate
• holmium laser lithotripsy using Karl® Storz MIP set
using holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University hospital	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Elsayed Abdelhalim Elsayed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone free rate	no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.	after two weeks from primary procedure
Secondary	assess operative time.	assess operative time.in minutes	during the procedure
Secondary	visual analog scale	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.	immediately after the surgery
Secondary	Radiation time	Time of patient exposure for radiation in minutes	during the procedure
Secondary	Post operative complication	Complication may occur post operative complication like fever, sever pain	Up to 48 hours