Safety and Efficacy of Fluoroscopy-free Technique During Retrograde Intrarenal Surgery for Renal Stones

NCT ID: NCT05269108

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-25
• Study Completion Date: 2024-04-30

Brief Summary

Aiming to reduce radiation exposure to patients and physicians, the investigators conduct this study protocol to evaluate the possibility of performing retrograde intrarenal surgery (RIRS) under direct visualization without fluoroscopy. the investigators will prospectively evaluate the outcome of fluoroscopy-free RIRS for renal stones in comparison with the standard technique. The investigators expected that the fluoroscopy-free technique has high safety and efficacy even in complicated cases.

Detailed Description

With improved flexible URS instrumentation and lithotripsy technology, retrograde intrarenal surgery (RIRS) became an alternative and excellent option for renal stones. Fluoroscopy imaging may be necessary during various steps of RIRS, such as insertion of a guidewire and stent, access sheath insertion, detection of stone location and size, and assessment of collecting system anatomy.

In an effort to decrease radiation exposure, several studies were conducted to evaluate the possibility of performing RIRS under direct visualization without fluoroscopy. Most studies concluded that fluoroscopy-free RIRS is a feasible, effective, and safe technique. The reported stone-free rate ranged from 83.8% to 95.7%. No major complications were observed.

Despite the reported high safety and efficacy of the fluoroscopy-free RIRS technique, most of the studies were retrospective and included only uncomplicated cases, and none of the studies address its results against control.

In the present study, the investigators will prospectively evaluate the efficacy and safety of fluoroscopy-free RIRS for renal stones in comparison with fluoroscopy-guided technique as standard control. The study will include all patients with renal stones amenable to RIRS. The investigators expected that the fluoroscopy-free technique can deal with large stones and complex situations with high safety and success rate. The study hypothesis is that "the fluoroscopy-free technique has efficacy and safety similar to the fluoroscopy-guided technique".

The investigators also aim to determine the patients and surgical characteristics impacting the need for fluoroscopy. The intra-operative fluoroscopy imaging is expected to be necessary during RIRS, especially in complicated cases. In the fluoroscopic-free group, the fluoroscopic equipment will be available in the operating room and will be used if needed.

Conditions

Kidney Calculi; Radiation Exposure; Retrograde Intrarenal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fluoroscopy-free RIRS

Patients will be treated by RIRS without fluoroscopy

Group Type: EXPERIMENTAL

Fluoroscopy-free RIRS

Intervention Type: PROCEDURE

RIRS for renal stone under direct visualization, without fluoroscopy

Standard RIRS

Standard RIRS under fluoroscopy-guidance will be performed

Group Type: ACTIVE_COMPARATOR

Standard RIRS

Intervention Type: PROCEDURE

RIRS for renal stone under fluoroscopy-guidance

Interventions

Fluoroscopy-free RIRS

RIRS for renal stone under direct visualization, without fluoroscopy

Intervention Type: PROCEDURE

Standard RIRS

RIRS for renal stone under fluoroscopy-guidance

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Renal stone.
• Stone size: ≥10 mm.

Exclusion Criteria

• Partial and complete staghorn stones.
• Pregnant women.
• Morbid obesity.
• Uncorrectable coagulation disorders.
• Active urinary tract infection (UTI).
• Stone in a calyceal diverticulum.
• Urinary tract obstruction distal to the stone.
• Concomitant pathology that needs intervention in the same setting.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Abul-fotouh Ahmed

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abul-fotouh Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University Hospitals, Cairo, Egypt

Locations

Urology Department, Al-Azhar University Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abul-fotouh Ahmed, MD

Role: CONTACT

abulfotouhahmed@yahoo.com

00201001066756

Facility Contacts

Ahmed Fahim, MD

Role: primary

urologyhospital@gmail.com

002025107333

Other Identifiers

Uro_Azhar_2_022

Identifier Type: -

Identifier Source: org_study_id