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OpenTrials
Completed

NCT Number: NCT06120257

Management of Lower Pole Renal Hard Stones ≤2 cm

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.

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Key information

Conditions

Renal Stones Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University hospital

Kafr ash Shaykh, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lithotripsy using Flexible ureteroscope

Procedure

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

Extracorporeal shock wave lithotripsy (ESWL)

Procedure

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

holmium laser lithotripsy using Karl® Storz MIP set

Procedure

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

Primary outcomes

  1. stone free rate

    Time frame: 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 outcomes

  1. assess operative time.

    Time frame: during the procedure

    assess operative time.in minutes

  2. visual analog scale

    Time frame: 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

    Time frame: during the procedure

    Time of patient exposure for radiation in minutes

  4. Post operative complication

    Time frame: Up to 48 hours

    Complication may occur post operative complication like fever, sever pain

Sponsors and collaborators

Lead sponsor

Elsayed Abdelhalim Elsayed

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 7, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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