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Completed

NCT Number: NCT06199518

Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones

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)

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Key information

Conditions

Endourology

Age range

26 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urolgy Departement, Faculty of Medicine, Tanta University

Tanta, Outside U.S./Canada, 6620010, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)

Procedure

extraction or fragmentation of large proximal ureteral stones via different minimally invasive procedures

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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