Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy As Primary Treatment in Renal Stones 2-3 Cm

March 21, 2025 updated by: Hesham Kamal Torad, Cairo University
Flexible Ureteroscopy versus Percutaneous Nephrolithotomy as Primary Treatment in Renal Stones 2-3 Cm

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

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, Egypt, 38516
        • Hesham Torad

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:

stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.

Exclusion Criteria:

stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIRS
RIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed.
Procedure: RIRS
RIRS performed in lithotomy position for which guide wire pass to the kidney, then passing ureteral dilators up to 14F and ureteral access sheath. Dusting stones by RIRS and holmium laser Fiber 200 mm, at the end of operation DJ was fixed.
Experimental: PNL
PNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation.
Procedure: PNL
PNL performed in prone position, after passing guide wire and ureteric catheter in lithotomy position. Puncture to the kidney, passing 2 wires, then using renal dilators and access sheath to enter kidney by nephroscopy, fragment stones by pneumatic and remove stones, then place nelaton 28F at end of operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stone free rate percentage defined as number of patients who have no stone residual
Time Frame: 18 months
assessed by Plain urinary tract and ultrasound for confirmation of the presence of residual stone fragments.
18 months

Collaborators and Investigators

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

Sponsor

Cairo University

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)

January 1, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FURS-PCNL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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