Endoscopic Guided PCNL Versus Standard PCNL

July 17, 2022 updated by: Waleed El-Shaer, MD, Benha University

Endoscopic Combined Intrarenal Surgery for Management of Large Renal Stones: A Randomized Controlled Trial

currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm.

the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.

patients & methods: Patients will randomly be divided into two equal groups:

Group A: Patient will undergo ECIRS.

Group B: Patient will undergo standard PCNL

Study Type

Interventional

Enrollment (Anticipated)

150

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 Contact

Study Locations

  • Egypt
    • Qalubia
      • Banhā, Qalubia, Egypt, 13511
        • Recruiting
        • Banha University Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with renal stones diameter of at least 2 cm.
  • American Society of Anesthesiology score ≤ 2.

Exclusion Criteria:

  • patients with renal anomalies.
  • transplanted kidney.
  • uncorrected coagulopathy.
  • active infection.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECIRS-Group
Procedure: Endoscopic compbined guided PCNL
patient undergo stone removal by ECIRS
Active Comparator: SPCNL-GRoup
Procedure: Standard PCNL
patient undergo SPCNL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone Free Rate
Time Frame: 1day after operation.
If their is any residual stones
1day after operation.
Stone Free Rate
Time Frame: 1 months post operative
If their is any residual stones
1 months post operative
Stone Free Rate
Time Frame: 3 months post-operative
If their is any residual stones
3 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: intra oprative
the length of operation
intra oprative
blood loss
Time Frame: pre-operative and 1 day post-oprative
hemoglobin drop
pre-operative and 1 day post-oprative

Collaborators and Investigators

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

Sponsor

Benha 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)

October 20, 2019

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDIRB2017122601-268

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.

Clinical Trials on Stones, Kidney

Clinical Trials on Endoscopic compbined guided PCNL

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe