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Management of Lower Pole Renal Hard Stones ≤2 cm

Sponsor
Elsayed Abdelhalim Elsayed (Other)
Overall Status
Completed
CT.gov ID
NCT06120257
Collaborator
(none)
138
Enrollment
1
Location
3
Arms
12
Actual Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: lithotripsy using Flexible ureteroscope
  • Procedure: extracorporeal shock wave lithotripsy (ESWL)
  • Procedure: holmium laser lithotripsy using Karl® Storz MIP set
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Mar 1, 2023
Actual Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A :Flexible ureteroscope group

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

Procedure: lithotripsy using Flexible ureteroscope
using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate
Active Comparator: Group B : extracorporeal shock wave lithotripsy (ESWL) group

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

Procedure: extracorporeal shock wave lithotripsy (ESWL)
using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate
Active Comparator: Group C : Mini perc group

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

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

Outcome Measures

Primary Outcome Measures

  1. stone free rate [after one month from primary procedure]

    no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up four weeks

Secondary Outcome Measures

  1. assess operative time. [during the procedure]

    assess operative time.in minutes

  2. 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.

  3. Radiation time [during the procedure]

    Time of patient exposure for radiation in minutes

  4. Post operative complication [Up to 48 hours]

    Complication may occur post operative complication like fever, sever pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kafrelsheikh University hospital Kafr Ash Shaykh Egypt

Sponsors and Collaborators

  • Elsayed Abdelhalim Elsayed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elsayed Abdelhalim Elsayed, Principal Investigator, Kafrelsheikh University
ClinicalTrials.gov Identifier:
NCT06120257
Other Study ID Numbers:
  • KFSIRB200-69
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elsayed Abdelhalim Elsayed, Principal Investigator, Kafrelsheikh University
Hard stones
Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Calculi

Study Results

No Results Posted as of Nov 8, 2023