Retrograde Intrarenal Surgery (RIRS) With Suction

January 15, 2025 updated by: Elsayed Abdelhalim Elsayed, Kafrelsheikh University

Retrograde Intrarenal Surgery (RIRS) With Suction Using Direct in Scope Suction (DISS) Versus Flexible and Navigable Access Sheath (FANS): Randomized Controlled Study

Suction has been initially used in endoscopic stone management for more than 25 years during PCNL, but the emergence of new devices applying suction through patented ureteroscopes, ureteral access sheaths (UAS) and ureteral catheters led to application of suction in URS/RIRS. The application of ureteral access sheath (UAS) in RIRS can improve surgical vision , reduce intrarenal pressure (IRP) ,and decrease postoperative infectious complications .

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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
      • Zagazig, Egypt, 44749
        • Elsayed Abdelhalim

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:

  • Single stone
  • Medium sized stone ≤ 3 cm
  • Renal stone
  • age group > 18

Exclusion Criteria:

  • multiple renal stones
  • stone size > 3 cm
  • age group < 18
  • solitary kidney
  • Obstruction distal to the stone.
  • urinary tract 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Retrograde intrarenal surgery using DISS
Device: Retrograde intrarenal surgery using DISS
Retrograde intrarenal surgery using Direct in scope suction for renal stone up to 3 cm
Active Comparator: Retrograde intrarenal surgery using FANS
Device: Retrograde intrarenal surgery using FANS
Retrograde intrarenal surgery using Flexible and navigable suction for renal stone up to 3 cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: One month
No residual or non siginficant residual less than 4 mm
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operatove data
Time Frame: 2 hours
Operation and radiation time
2 hours
Post operative complication
Time Frame: 2 days
Fever , sepsis , vomitimg
2 days

Collaborators and Investigators

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

Sponsor

Kafrelsheikh 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, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFSIRB200-488

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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