Laser Lithotripsy for Ureteral Stones

Phase 4

Completed

• Conditions: Ureteric Stone
• Interventions: Procedure: Retrograde and Antegrade Ureteroscopic Laser Lithotripsy

• Registration Number: NCT06465784
• Lead Sponsor: Mahmoud Helmy El saeed Hussein

Brief Summary

Objectives: To present the outcomes of retrograde and antegrade ureteroscopic laser lithotripsy in the treatment of proximal ureteral stones ranging in size from 10 to 20 millimeters in diameter.

Patients and methods: From March 2023 to December 2023, 70 patients were included in this prospective randomized double-arm interventional study. Patients were divided into two groups: Group 1: (35 patients) had semi-rigid retrograde ureteroscopic laser lithotripsy and group 2: (35 patients) had semi-rigid antegrade ureteroscopic laser lithotripsy.

Detailed Description

The present study was conducted in Al-Azhar University Hospital (Damietta branch), urology department,at the period from March 2023 to December 2023. Seventy patients with symptomatic proximal medium sized ureteric stones were classified in two groups Retrograde Uretroscopic Laser Lithotripsy (group 1) and Antegrade Ureteroscopic Laser Lithotripsy (group 2) .

The preoperative-(patient- and stone-related), intraoperative- and postoperative- related parameters that might influence the perioperative course and short-term clinical outcomes were evaluated.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-05-29
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients with medium-sized proximal ureteral stones (10-20 mm) situated between the ureteropelvic junction and the top edge of the L5 vertebral body; age 18-65 years

Exclusion Criteria

• Pregnancy, bleeding disorders, morbid obesity (BMI > 35), patients with stenosis of the ureter, history of previous surgery on the ipsilateral ureter, patients with a simultaneous kidney stone requiring surgery, and patients with an active urinary tract infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retrograde Ureteroscopic Laser Lithotripsy	Retrograde and Antegrade Ureteroscopic Laser Lithotripsy	In this arm we used the retrograde ureteroscopic Laser lithotripsy to clear the uretric stones. After the end of the procedure, all patients were followed for stone free rate as the primary outcome
Antegrade Ureteroscopic Laser Lithotripsy	Retrograde and Antegrade Ureteroscopic Laser Lithotripsy	In this arm we used the antegrade ureteroscopic Laser lithotripsy to clear the uretric stones. After the end of the procedure, all patients were followed for stone free rate as the primary outcome.

Primary Outcome Measures

Name	Time	Method
Stone free rate	Direct after intervention	number of patients reported complete clearance of stones after intervention

Trial Locations

Locations (1)

Damietta Faculty of Medicine, Al-Azhar University, Damietta, Egypt.; 🇪🇬 Damietta, Egypt