Effectiveness of LASER in Treatment of Ureteric Stones.

NCT06975488 | Completed DMC

• 1 other identifier: 195
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Ureteroscopic laser lithotripsy is becoming the most commonly utilized treatment for patients with ureteral stone. The Holmium: YAG laser is integral to the operation and is the preferred flexible intracorporeal lithotripsy. It is considered cost-effective and efficient choice in ureteroscopic lithotripsy on all types of stones. As in recent years, there has been increasing interest in examining the effect of varying the laser settings on the effectiveness of stone treatment. The objective of the study is to compare the fragmentation and dusting modalities utilizing Holmium YAG laser in ureteroscopy for ureteral stone treatment. It will be a randomized control trial (RCT) in which 160 patients visiting Sahiwal Teaching Hospital, Sahiwal will be included. The patients will be divided into two groups. Group-A patients will be treated with fragmentation modality utilizing Holmium YAG laser while Group-B patients will be treated with dusting modality utilizing Holmium YAG laser. Simple random sampling technique will be carried out. The patients' age, gender, stone number, stone laterality, stone location, ureteral condition, reteropulsion, stricture formation, stone clearance, operative time, hospital stay, presence of retropulsion and complications will be recorded. Data will be collected through proforma, which will be entered and analyzed using SPSS version 26.0. For quantitative variables such as: age, operation time, hospital stay, stone number ,mean and standard deviation will be calculated and for qualitative variables such as: gender, and laterality, stone location, ureter condition, prevalence of pyuria, stone clearance, presence of retropulsion, ureter injury, frequency and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. Chi-square test will be used to estimate the association between study variables. P-value \<0.05 will be considered significant. It is anticipated that the results of this study will be helpful for health care planners and surgeons to provide better treatment option to the patients with ureteral stone.

Conditions

Ureteric Stone

Keywords

Laser; URS; DJ Stent; Lithotripsy; ESWL; URSL

Outcome Measures

Primary Outcomes (2)

• Stone Free Rate

  Stone-free will be defined as no residual stones \> 3 mm in the ureter of the affected side at one month postoperatively on computerized tomography (CT KUB Plain).

  There would be 4 follow up visits. First visit will be after 1 week of URSL and X Ray KUB will be done. Second visit will be after 2 weeks of URSL and we will plan the removal of DJ stent. Those cases in which ureteral inury is suspected or stone burden

• Reteropulstion

  Retropulsion, defined as unintended migration of stone into the kidney, leads to failure and results in a lower SFR.

  During procedure.

Secondary Outcomes (1)

• Uretral Stricture Formation

  Post-URS ureteral stricture is defined as complete or partial ureteral obstruction as shown by the excretory phase of CTU, which was confirmed with delayed or absent radioactive tracer washout at 8 weeks after stent removal.

Study Arms (2)

Group A

EXPERIMENTAL

Group A patients will be treated with fragmentation modality utilizing Holmium YAG laser.

Procedure: LASER Lithotripsy ( Fragmentation modality)

Group B

EXPERIMENTAL

Group B patients will be treated with dusting modality utilizing Holmium YAG laser.

Procedure: LASER lithotripsy (Dusting Modality)

Interventions

LASER Lithotripsy ( Fragmentation modality) PROCEDURE

Group-A patients will be treated with fragmentation modality utilizing Holmium YAG laser.

Group A

LASER lithotripsy (Dusting Modality) PROCEDURE

Group-B patients will be treated with dusting modality utilizing Holmium YAG laser.

Group B

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stone size 1cm to 1.5cm at proximal Ureter.
• Patients aged between 15 to 70 years.
• Both genders.

You may not qualify if:

• Patients with active urinary tract infection
• Pregnancy
• Immunocompromised patients

Sponsors & Collaborators

• District Headquarters Teaching Hospital Sahiwal: lead

Study Sites (1)

District Headquarters Teaching Hospital Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

Location

Related Publications (1)

• Chen BH, Lin TF, Tsai CC, Chen M, Chiu AW. Comparison of Fragmentation and Dusting Modality Using Holmium YAG Laser during Ureteroscopy for the Treatment of Ureteral Stone: A Single-Center's Experience. J Clin Med. 2022 Jul 17;11(14):4155. doi: 10.3390/jcm11144155.

  PMID: 35887919 RESULT

Related Links

• Laser lithotripsy in treatment of ureteric stones

MeSH Terms

Conditions

Ureterolithiasis

Interventions

Lithotripsy, Laser

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Lithotripsy; Ablation Techniques; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• U A IFTIHKAR, MS

  District Headquarters Teaching Hospital Sahiwal

  PRINCIPAL INVESTIGATOR

• A RIAZ, MD

  Sahiwal medical college sahiwal

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 16, 2025
• Study Start: April 14, 2024
• Primary Completion: April 13, 2025
• Study Completion: April 20, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)