Comparative Study Between One-Shot Dilatation Versus Serial Dilatation Techniques for Access in Percutaneous Nephrolithotomy in Adult Patients

December 1, 2025 updated by: Ain Shams University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11865
        • Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Active Comparator: Patients receiving renal dilatation by metallic telescopic dilators (Alken).
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
Active Comparator: Patients receiving renal dilatation by sequential fascial dilators (Amplatz).
Procedure: renal dilatation by sequential fascial dilators (Amplatz)
sequential renal dilatation with Amplatz dilator set was used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Fluoroscopy time
Time Frame: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks
Mean access time
Time Frame: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks
Stone free rate
Time Frame: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks
Hospitalization Period
Time Frame: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Hisham Arafa, Consultant, Ain shams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2022

Primary Completion (Actual)

August 27, 2022

Study Completion (Actual)

August 5, 2023

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMASU MS133/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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