Comparative Study Between One-Shot Dilatation Versus Serial Dilatation Techniques for Access in Percutaneous Nephrolithotomy in Adult Patients
NCT ID: NCT07279389
Last Updated: 2025-12-12
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-02-27
2023-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Patients receiving renal dilatation by metallic telescopic dilators (Alken).
renal dilatation by metallic telescopic dilators (Alken).
insertion of the Alken guide followed by a telescopic dilator between 9Fr to 30Fr, then an Amplatz sheath 30Fr was advanced over the dilator which was then removed, leaving the Amplatz sheath in the collecting system
Patients receiving renal dilatation by sequential fascial dilators (Amplatz).
renal dilatation by sequential fascial dilators (Amplatz)
sequential renal dilatation with Amplatz dilator set was used
Patients receiving renal dilatation by one-shot dilatation technique
renal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod.
renal dilatation by one-shot dilatation technique
renal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod.
Interventions
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renal dilatation by one-shot dilatation technique
renal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod.
renal dilatation by metallic telescopic dilators (Alken).
insertion of the Alken guide followed by a telescopic dilator between 9Fr to 30Fr, then an Amplatz sheath 30Fr was advanced over the dilator which was then removed, leaving the Amplatz sheath in the collecting system
renal dilatation by sequential fascial dilators (Amplatz)
sequential renal dilatation with Amplatz dilator set was used
Eligibility Criteria
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Inclusion Criteria
* Patients with renal stones which their size in maximum diameter is more than 2cm and indicated for percutaneous nephrolithotomy.
* Patients clinically fit for surgery.
* Patients with normal anatomy of urinary tract.
* Patients able to understand the procedure and accept to sign the informed consent.
Exclusion Criteria
* Patients with renal stones which their size in maximum diameter is less than 2cm or contraindicated for endoscopic management.
* Patients with urinary tract infection, abnormal coagulopathy state or clinically unfit for surgery.
* Patients with nephrostomy tube in situ.
* Patients with more than single access tract.
* Patients undergoing simultaneous bilateral stone procedures.
* Patients with urinary tract abnormalities or history of renal transplantation.
* Renal insufficiency with serum creatinine above 3.0mg/dL
* Patients unable to understand the procedure or refuse to sign the informed consent.
18 Years
70 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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Hisham Arafa, Consultant
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Locations
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Ain Shams University
Cairo, Cairo Governorate, Egypt
Countries
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References
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Alken P, Hutschenreiter G, Gunther R, Marberger M. Percutaneous stone manipulation. J Urol. 1981 Apr;125(4):463-6. doi: 10.1016/s0022-5347(17)55073-9.
Other Identifiers
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FMASU MS133/2022
Identifier Type: -
Identifier Source: org_study_id
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