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Clinical Trials/NCT06199518
NCT06199518
Completed
Not Applicable

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.

Tanta University1 site in 1 country105 target enrollmentApril 1, 2021
ConditionsEndourology

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endourology
Sponsor
Tanta University
Enrollment
105
Locations
1
Primary Endpoint
stone free rate (SFR)
Status
Completed
Last Updated
2 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
April 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Zoeir

faculty of medicine, Tanta, ElGeish street, Egypt

Tanta University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

stone free rate (SFR)

Time Frame: immediate (initial SFR ) and 1 -month later (final SFR)

SFR is defined as no residual stones or fragments ≤ 4 mm.

Study Sites (1)

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