Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones

Endourology Clinical Trial

Official title:

Comparison of Laparoscopic Ureterolithotomy, Retrograde Flexible Ureteroscopy, and Mini- Percutaneous Antegrade Ureteroscopic Lithotripsy for the Management of Large Proximal Ureteral Stones (1.5-2 cm): A Prospective Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06199518
• Other study ID #: 34619/4/21
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: December 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

a prospective comparative study designed to compare the outcomes of transperitoneal Laparoscopic ureterolithotomy (T-LUL), mini-percutaneous antegrade ureteroscopy (A-URS) and retrograde ureteroscopy (R-URS) in treating patients with LPUS (15-20 mm). the following parameters were assessed and compared (demographic data and stones characteristics, Stone free rate and complications)

Description:

we aimed in the current study to comprehensively evaluate and to compare the outcome of transperitoneal laparoscopic ureterolithtomy, retrograde ureteroscopy and mini-percutaneous antegrade ureteroscopy for management of large proximal ureteric stone (15 -20 mm) with regards to; operative time, stone free rate, success rate, hospital stay and complications.

A total of 105 participants were enrolled in the trial between April 2021 and June 2023 to accomplish this. Inclusion criteria for this study included patients who had a single proximal Ureteral stone (between the pelvi ureteric junction and the upper border of the sacroiliac joint) measuring 15-20 mm in diameter.

Patients were randomly allocated to receive either TPLU, RURS, or Minin-perc Antegrade URS, with a 1:1:1 allocation ratio. After providing informed permission, the patients were randomly assigned to one of three groups: Group I (35 patients treated with TPLU), Group II (35 patients treated with RURS), and Group III (35 patients not treated with either TPLU or RURS) (Included 35 patients who were treated by Mini-perc Antegrade URS)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults patients

• large proximal ureteral stones(1.5-2 cm)

Exclusion Criteria:

• larger stones

• multiple stones

• bleeding tendency

• active UTI

• distal stricture

Related Conditions & MeSH terms

• Endourology
• Ureteral Calculi
• Ureterolithiasis

Intervention

Procedure:
• transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)
extraction or fragmentation of large proximal ureteral stones via different minimally invasive procedures

Locations

Country	Name	City	State
Egypt	Urolgy Departement, Faculty of Medicine, Tanta University	Tanta	Outside U.S./Canada

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone free rate (SFR)	SFR is defined as no residual stones or fragments = 4 mm.	immediate (initial SFR ) and 1 -month later (final SFR)