to Study the Role of Retrograde Intrarenal Surgery in Management of Renal Stones

January 14, 2023 updated by: Mohammed Ali abdelghaffar, Menoufia University

Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience

Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

With the advancements in endourologic technology, in the last 30 years, renal stone treatment has dramatically changed, and minimally invasive treatments options, such as extracorporeal shock wave lithotripsy (SWL), percutaneous nephrolithotomy (PCNL), mini-PCNL, retrograde intrarenal surgery (RIRS) or laparoscopy, have replaced open surgery.

Although, minimally invasive treatment modalities have an excellent stone fragmentation rate, the clearance of stone fragments may not be immediate and can occur for any time after the intervention.

The European Association of Urology (EAU) guidelines, recommends PCNL for renal stones greater than 2 cm, and SWL is suggested primarily for stones less than 1 cm in size. Although SWL, RIRS and PCNL are all presented as treatment options for renal stones between, which application is a matter of preference.

The treatment modality selection of renal stones usually depends on stone-related factors (location, size, and composition), clinical factors (patient's comorbidities, patient's compliance, solitary kidney, and abnormal anatomy), and technical factors (equipment available for treatment, success rates, possible complications, invasiveness, the need for anesthetics, hospitalization times, and costs).

PCNL can achieve better results but is more invasive, is associated with greater morbidity and complications, and may be reserved for selected circumstances.

Stone clearance following kidney stone treatment is not well defined. For lower pole stones, Sener and colleagues compared RIRS with SWL and reported a stone-free rate of 52.3% with patients treated using RIRS one week after treatment. However after three months, the stone-free rate improved to 100%.

Ureteroscopic lithotripsy has been the most widely applied treatment for urinary tract stones, with high success and low complication rates. The holmium laser has facilitated the disintegration of stones and increased the effectiveness of ureteroscopic lithotripsy.

Improvements in the new generation of flexible ureteroscopes have made retrograde endoscopic ureteroscopy and laser lithotripsy for renal calculi more popular. The overall success rates of retrograde intrarenal surgery have been reported as 75% to 95% for intrarenal stones > 2 cm after the first or second treatment, whereas the major and minor complication rates vary from 1.5% to 12%, which are less frequent than rates in PCNL procedures.

Study Type

Interventional

Enrollment (Anticipated)

77

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
    • Al-Minufiyah
      • Shibin-al-Kawm, Al-Minufiyah, Egypt, 32616
        • Recruiting
        • Menoufia Faculty of Medicine
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with renal stones were eligible for the procedure. Patients with difficult PCNL

Exclusion Criteria:

  • Uncorrected coagulopathy Distal obstruction Active urinary tract infection Ureteropelvic junction obstruction Congenital renal anomalies Staghorn 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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 43 semirigid ureteropyeloscopy
43 Patients underwent semirigid ureteropyeloscopy
Device: Ureteroscope
Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience
Active Comparator: 34 flexible ureteropyeloscopy
34 patients with flexible ureteropyeloscopy
Device: Ureteroscope
Role Of Retrograde Intrarenal Surgery In Management Of Renal Stones: Single Center Experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stone free rates and complications
Time Frame: Up to 6 months
Stone free rates of both semirigid and flexible URS
Up to 6 months

Collaborators and Investigators

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

Sponsor

Menoufia 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 1, 2020

Primary Completion (Anticipated)

February 25, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 14, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/2020 urol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After completing the thesis, I'll share IPD to other researchers

IPD Sharing Time Frame

October 2022

IPD Sharing Access Criteria

Clinical trial.gov

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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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