NCT06120257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

October 22, 2023

Last Update Submit

December 15, 2023

Conditions

Renal Stones

Keywords

Hard stones

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • assess operative time.

    during the procedure

  • visual analog scale

    immediately after the surgery

  • Radiation time

    during the procedure

  • Post operative complication

    Up to 48 hours

Study Arms (3)

Group A :Flexible ureteroscope group

ACTIVE COMPARATOR

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

Procedure: lithotripsy using Flexible ureteroscope

Group B : extracorporeal shock wave lithotripsy (ESWL) group

ACTIVE COMPARATOR

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)

Group C : Mini perc group

ACTIVE COMPARATOR

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

Procedure: holmium laser lithotripsy using Karl® Storz MIP set

Interventions

lithotripsy using Flexible ureteroscopePROCEDURE

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

Group A :Flexible ureteroscope group
extracorporeal shock wave lithotripsy (ESWL)PROCEDURE

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

Group B : extracorporeal shock wave lithotripsy (ESWL) group
holmium laser lithotripsy using Karl® Storz MIP setPROCEDURE

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

Group C : Mini perc group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University hospital

Kafr ash Shaykh, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 39736616DERIVED

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2023

First Posted

November 7, 2023

Study Start

March 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations

EG(1)