Comparison of High and Low Pulse Energy Dusting Protocols Using Holmium: YAG-laser in Flexible Ureteroscopy for Renal Stones Treatment

Rcompare high-energy versus low-energy laser settings in renal stone lithotripsy using low power machines) Holmium YAG 30 watts, examining their respective advantages, limitations, and overall efficacy.

Study Overview

• Status: Completed
• Conditions: Renal Stone
• Intervention / Treatment: Device: Holmium Yag laser

Detailed Description

The prevalence of urinary stone disease treatment has shown a continuous updating Within the armamentarium of urinary stone management, the laser has emerged as a cornerstone for lithotripsy in endourological procedures. The laser technology has witnessed a progressive evolution, transitioning from the established holmium: yttrium-aluminum-garnet (Ho:YAG) laser with pulse modulation to the advent of thulium fiber laser (TFL) and, more recently, the innovative pulsed thulium:YAG (p-Tm:YAG) laser Laser lithotripsy is prefered for its minimally invasive approach and high success rates in fragmenting stones, yet the ongoing debate continues regarding the optimal laser power settings for this procedure. contemporary approaches in laser lithotripsy focus on two primary strategies: fragmenting stones into smaller retrievable parts or breaking them into minute fragments, commonly referred to as 'dust,' facilitating the natural passage of smaller particles The choice between high power and low power settings in laser lithotripsy significantly influences treatment outcomes, including stone fragmentation efficiency, procedural time, and potential tissue damage. High-energy power laser settings offer rapid stone ablation capabilities, enabling quick fragmentation but potentially raising concerns about thermal injury to surrounding tissues. In contrast, low-energy power settings, while reducing the risk of tissue damage, might prolong the procedure and necessitate additional maneuvers for complete stone clearance This study aims to compare high-energy versus low-energy laser settings in renal stone lithotripsy using low power machines) Holmium YAG 30 watts, examining their respective advantages, limitations, and overall efficacy. By scrutinizing existing literature and recent studies, this study intends to provide a 56 comprehensive understanding of the clinical implications of choosing optimal laser settings in urolithiasis comprehensive understanding of the clinical implications of choosing optimal laser settings in urolithiasis.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • State Or Province
    • Shibīn Al Kawm, State Or Province, Egypt, 32511
      • Hossam Kandeel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult patients
• hard renal stones
• less than 2 cm
• Hounsfield unit of ≥ 1000

Exclusion Criteria:

• Patients less than 18 years
• ureteral stones
• stones with Hounsfield units less than 1000
• stones in calyceal diverticulum
• patients with coagulopathy were also excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: high-energy patients; Use high energy in stone management	Device: Holmium Yag laser; Use two laser energy low and high to reach the optimal setting for stone dusting
Other: Low energy patient; Use low energy in stone management	Device: Holmium Yag laser; Use two laser energy low and high to reach the optimal setting for stone dusting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rates	Assess stone free rate between two different setting	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative complications	To assess complications between low and high energy	One year

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: March 23, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 4-2024urol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No