Effectiveness of LASER in Treatment of Ureteric Stones.

NCT ID: NCT06975488

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-14
• Study Completion Date: 2025-04-20

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

Study Design

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

Study Groups

Group A

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

Group Type: EXPERIMENTAL

LASER Lithotripsy ( Fragmentation modality)

Intervention Type: PROCEDURE

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

Group B

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

Group Type: EXPERIMENTAL

LASER lithotripsy (Dusting Modality)

Intervention Type: PROCEDURE

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

Interventions

LASER Lithotripsy ( Fragmentation modality)

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

Intervention Type: PROCEDURE

LASER lithotripsy (Dusting Modality)

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Stone size 1cm to 1.5cm at proximal Ureter.

2. Patients aged between 15 to 70 years.

3. Both genders.

Exclusion Criteria

1. Patients with active urinary tract infection

2. Pregnancy

3. Immunocompromised patients

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

District Headquarters Teaching Hospital Sahiwal

OTHER

Sponsor Role: lead

Responsible Party

Ussama Iftikhar

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

U A IFTIHKAR, MS

Role: PRINCIPAL_INVESTIGATOR

District Headquarters Teaching Hospital Sahiwal

A RIAZ, MD

Role: STUDY_DIRECTOR

Sahiwal medical college sahiwal

Locations

District Headquarters Teaching Hospital Sahiwal

Sahiwal, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: RESULT

PMID: 35887919 (View on PubMed)

Related Links

https://pmc.ncbi.nlm.nih.gov/articles/PMC9324266/

Laser lithotripsy in treatment of ureteric stones

Other Identifiers

195

Identifier Type: -

Identifier Source: org_study_id