Laser Lithotripsy for Ureteral Stones

NCT06465784 | Completed Phase 4 DMC

• 1 other identifier: Urosurg./Ms/2023/0001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteric Stone

Keywords

laser treatment; ureteric stones; ureteroscope; retrograde; antegrade

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  number of patients reported complete clearance of stones after intervention

  Direct after intervention

Study Arms (2)

Retrograde Ureteroscopic Laser Lithotripsy

ACTIVE COMPARATOR

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

Procedure: Retrograde and Antegrade Ureteroscopic Laser Lithotripsy

Antegrade Ureteroscopic Laser Lithotripsy

ACTIVE COMPARATOR

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.

Procedure: Retrograde and Antegrade Ureteroscopic Laser Lithotripsy

Interventions

Retrograde and Antegrade Ureteroscopic Laser Lithotripsy PROCEDURE

Comparison Between Retrograde and Antegrade Ureteroscopic Laser Lithotripsy for Management of Medium Sized Proximal Ureteral Stones: A Randomized Prospective Study

Antegrade Ureteroscopic Laser Lithotripsy; Retrograde Ureteroscopic Laser Lithotripsy

Eligibility Criteria

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

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahmoud Helmy El saeed Hussein: lead

Study Sites (1)

Damietta Faculty of Medicine, Al-Azhar University, Damietta, Egypt.

Damietta, 34517, Egypt

Location

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Used closed envelope method
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: laster lithotripsy for clearance of uretric stones

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 20, 2024
• Study Start: March 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)