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

NCT05269108 | Unknown

• 1 other identifier: Uro_Azhar_2_022
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi; Radiation Exposure; Retrograde Intrarenal Surgery

Outcome Measures

Primary Outcomes (2)

• stone-free rate

  defined as no residual stone or residual fragment(s) less than 4 mm (as confirmed by CT-UT).

  3-months after the intervention.

• complication rate

  intraoperative and postoperative complications

  intraoperative till 3-months postoperative complications

Secondary Outcomes (3)

• fluoroscopy time

  intraoperative

• Operative time

  The procedure time

• the need for fluoroscopy

  Intraoperative

Study Arms (2)

Fluoroscopy-free RIRS

EXPERIMENTAL

Patients will be treated by RIRS without fluoroscopy

Procedure: Fluoroscopy-free RIRS

Standard RIRS

ACTIVE COMPARATOR

Standard RIRS under fluoroscopy-guidance will be performed

Procedure: Standard RIRS

Interventions

Fluoroscopy-free RIRS PROCEDURE

RIRS for renal stone under direct visualization, without fluoroscopy

Fluoroscopy-free RIRS

Standard RIRS PROCEDURE

RIRS for renal stone under fluoroscopy-guidance

Standard RIRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal stone.
• Stone size: ≥10 mm.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Urology Department, Al-Azhar University Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Abul-fotouh Ahmed, MD

  Al-Azhar University Hospitals, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abul-fotouh Ahmed, MD

CONTACT

00201001066756; abulfotouhahmed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The 1st group: Fluoroscopy-free RIRS. The 2nd group: Fluoroscopy-guided RIRS.

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 7, 2022
• Study Start: February 25, 2022
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

EG (1)