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Management of Lower Pole Renal Hard Stones ≤2 cm

NCT ID: NCT06120257

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-09-01

Brief Summary

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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

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Conditions

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Renal Stones

Keywords

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Hard stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A :Flexible ureteroscope group

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

Group Type ACTIVE_COMPARATOR

lithotripsy using Flexible ureteroscope

Intervention Type PROCEDURE

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

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)

Group Type ACTIVE_COMPARATOR

extracorporeal shock wave lithotripsy (ESWL)

Intervention Type PROCEDURE

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

Group C : Mini perc group

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

Group Type ACTIVE_COMPARATOR

holmium laser lithotripsy using Karl® Storz MIP set

Intervention Type PROCEDURE

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

Interventions

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lithotripsy using Flexible ureteroscope

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

Intervention Type PROCEDURE

extracorporeal shock wave lithotripsy (ESWL)

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

Intervention Type PROCEDURE

holmium laser lithotripsy using Karl® Storz MIP set

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elsayed Abdelhalim Elsayed

OTHER

Sponsor Role lead

Responsible Party

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Elsayed Abdelhalim Elsayed

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kafrelsheikh University hospital

Kafr ash Shaykh, , Egypt

Site Status

Countries

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Egypt

References

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Zeinelabden KM, Abdelhalim E, Galal M, Abdelbaky T, Nabeeh H. Flexible ureteroscopy, extracorporeal shock wave lithotripsy and mini percutaneous nephrolithotomy for management of lower pole renal hard stones </= 2 cm: a prospective randomized study. BMC Urol. 2024 Dec 30;24(1):288. doi: 10.1186/s12894-024-01644-z.

Reference Type DERIVED
PMID: 39736616 (View on PubMed)

Other Identifiers

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KFSIRB200-69

Identifier Type: -

Identifier Source: org_study_id