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

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-27

Study Completion Date

2023-08-05

Brief Summary

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This comparative study aims to compare and assess the safety, efficacy, outcome, feasibility, intraoperative and postoperative complications of one-shot dilatation versus serial dilatation techniques for access during percutaneous nephrolithotomy for management of renal stone disease in adult patients.

Detailed Description

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Conditions

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Percutaneous Nephrolithotomy (PCNL) Renal Stone Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Patients receiving renal dilatation by metallic telescopic dilators (Alken).

Group Type ACTIVE_COMPARATOR

renal dilatation by metallic telescopic dilators (Alken).

Intervention Type PROCEDURE

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).

Group Type ACTIVE_COMPARATOR

renal dilatation by sequential fascial dilators (Amplatz)

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

renal dilatation by one-shot dilatation technique

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

renal dilatation by sequential fascial dilators (Amplatz)

sequential renal dilatation with Amplatz dilator set was used

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients aged between 18 and 70 years.
* 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 aged below 18 or above 70 years.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Egypt

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.

Reference Type BACKGROUND
PMID: 7218439 (View on PubMed)

Other Identifiers

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FMASU MS133/2022

Identifier Type: -

Identifier Source: org_study_id

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