Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones

NCT ID: NCT06199518

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-04-01

Brief Summary

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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

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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)

Conditions

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Endourology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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GROUP(A):transperitoneal laparoscopic ureterolithotomy (T-LUL)

extraction of proximal ureteral stones by laparoscopic surgery via transperitoneal approach

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

GROUP (B):retrograde flexible ureteroscopy (R-URS)

laser lithotripsy of proximal ureteral stones via flexible ureteroscopy retrograde

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

GROUP (C):Antegrade mini-percutaneous flexible ureteroscopy (A-URS)

laser lithotripsy of proximal ureteral stones via percutanous antegrade flexible ureteroscopy

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* larger stones
* multiple stones
* bleeding tendency
* active UTI
* distal stricture
Minimum Eligible Age

26 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Zoeir

faculty of medicine, Tanta, ElGeish street, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Urolgy Departement, Faculty of Medicine, Tanta University

Tanta, Outside U.S./Canada, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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34619/4/21

Identifier Type: -

Identifier Source: org_study_id

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