Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones

December 28, 2023 updated by: Ahmed Zoeir, Tanta University

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.

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Outside U.S./Canada
      • Tanta, Outside U.S./Canada, Egypt, 6620010
        • Urolgy Departement, Faculty of Medicine, Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediate (initial SFR ) and 1 -month later (final SFR)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34619/4/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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