NCT06199518

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

December 28, 2023

Last Update Submit

December 28, 2023

Conditions

Endourology

Outcome Measures

Primary Outcomes (1)

  • stone free rate (SFR)

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

    immediate (initial SFR ) and 1 -month later (final SFR)

Study Arms (3)

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

ACTIVE COMPARATOR

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)

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

ACTIVE COMPARATOR

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)

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

ACTIVE COMPARATOR

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)

Interventions

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

GROUP (B):retrograde flexible ureteroscopy (R-URS)GROUP (C):Antegrade mini-percutaneous flexible ureteroscopy (A-URS)GROUP(A):transperitoneal laparoscopic ureterolithotomy (T-LUL)

Eligibility Criteria

Age26 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urolgy Departement, Faculty of Medicine, Tanta University

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

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
faculty of medicine, Tanta, ElGeish street, Egypt

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 10, 2024

Study Start

April 1, 2021

Primary Completion

December 1, 2022

Study Completion

April 1, 2023

Last Updated

January 10, 2024

Record last verified: 2023-12

Locations

EG(1)