Laser Lithotripsy for Ureteral Stones

NCT ID: NCT06465784

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Ureteric Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

laster lithotripsy for clearance of uretric stones
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Used closed envelope method

Study Groups

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Retrograde 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

Group Type ACTIVE_COMPARATOR

Retrograde and Antegrade Ureteroscopic Laser Lithotripsy

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Retrograde and Antegrade Ureteroscopic Laser Lithotripsy

Intervention Type PROCEDURE

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

Interventions

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Retrograde and Antegrade Ureteroscopic Laser Lithotripsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahmoud Helmy El saeed Hussein

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Helmy El saeed Hussein

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Damietta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Urosurg./Ms/2023/0001

Identifier Type: -

Identifier Source: org_study_id

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