Clinical trial NCT06975488: Effectiveness of LASER in Treatment of Ureteric Stones.
Official title: Comparison Between Fragmentation and Dusting Modalities Utilizing Holmium YAG Laser in Ureteroscopy for Ureteral Stone Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteric Stone
Keywords: Laser
URS
DJ Stent
Lithotripsy
ESWL
URSL
Lead sponsor: District Headquarters Teaching Hospital Sahiwal
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 160
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Stone Free Rate
timeFrame: 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
measure: Reteropulstion
timeFrame: During procedure.
Secondary outcomes:
measure: Uretral Stricture Formation
timeFrame: 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.
Other outcomes:
Locations:
city: Sahiwal
country: Pakistan
facility: District Headquarters Teaching Hospital Sahiwal
state: Punjab
Study officials:
affiliation: District Headquarters Teaching Hospital Sahiwal
name: U A IFTIHKAR, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahiwal medical college sahiwal
name: A RIAZ, MD
role: STUDY_DIRECTOR
References:
citation: 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.