Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones

Not Applicable

Completed

• Conditions: Endourology
• Interventions: Procedure: transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)

• Registration Number: NCT06199518
• Lead Sponsor: Tanta University

Brief 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)

Detailed 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)

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-04-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2023-12-28
• Last Update Submitted: 2023-12-28
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Adults patients
• large proximal ureteral stones(1.5-2 cm)

Exclusion Criteria

• larger stones
• multiple stones
• bleeding tendency
• active UTI
• distal stricture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP (B):retrograde flexible ureteroscopy (R-URS)	transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)	laser lithotripsy of proximal ureteral stones via flexible ureteroscopy retrograde
GROUP(A):transperitoneal laparoscopic ureterolithotomy (T-LUL)	transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)	extraction of proximal ureteral stones by laparoscopic surgery via transperitoneal approach
GROUP (C):Antegrade mini-percutaneous flexible ureteroscopy (A-URS)	transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)	laser lithotripsy of proximal ureteral stones via percutanous antegrade flexible ureteroscopy

Primary Outcome Measures

Name	Time	Method
stone free rate (SFR)	immediate (initial SFR ) and 1 -month later (final SFR)	SFR is defined as no residual stones or fragments ≤ 4 mm.

Trial Locations

Locations (1)

Urolgy Departement, Faculty of Medicine, Tanta University; 🇪🇬 Tanta, Outside U.S./Canada, Egypt