Back to resultsFunctional Outcome After Minimally Invasive Pyeloplasty for Adult Patients With UPJO
Primary Purpose
Ureteropelvic Junction Obstruction
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
pyeloplasty
Sponsored by
About this trial
This is an interventional treatment trial for Ureteropelvic Junction Obstruction
Eligibility Criteria
Inclusion Criteria: all patients with UPJO above 18 years UPJO caused by crossing vessels confirmed by CT angiography Symptomatic UPJO Exclusion Criteria: recurrent UPJO after a previous trial of open repair , secondary UPJO after open renal surgery. UPJO in non functioning kidney
Sites / Locations
- Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
vascular hitch
Dismembered pyeloplasty
Arm Description
displacement of the lower polar crossing vessels causing the UPJO
classic Anderson-Hynes procedure
Outcomes
Primary Outcome Measures
comparing the two techniques regarding the success rate
both techniques are supposed to have similar results
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05895422
Brief Title
Functional Outcome After Minimally Invasive Pyeloplasty for Adult Patients With UPJO
Official Title
Functional Outcome After Laparoscopic and Robot Assisted Management of Uretero-pelvic Junction Obstruction Disease Caused by Crossing Vessels for Adult Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
an intervention study on adult patients with uretero-pelvic junction obstruction (UPJO) due to crossing vessels would be managed either through classic dismembered pyeloplasty or vascular hitch.
Detailed Description
in recent studies, some patients with crossing vessels UPJO could be managed by vascular displacement of these vessels, what is named as vascular hitch or vasculopexy in a way to avoid classic dismembered technique. this newer technique is supposed to provide comparable results to the classic technique but with lesser operative time and shorter hospital stay. in the era of minimally invasive procedures, robotic assisted or laparoscopic vascular hitch could provide many advantages over the classic open technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteropelvic Junction Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized intervention study
Masking
Participant
Masking Description
one blind
Allocation
Randomized
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vascular hitch
Arm Type
Experimental
Arm Description
displacement of the lower polar crossing vessels causing the UPJO
Arm Title
Dismembered pyeloplasty
Arm Type
Active Comparator
Arm Description
classic Anderson-Hynes procedure
Intervention Type
Procedure
Intervention Name(s)
pyeloplasty
Intervention Description
repair of the uPJO
Primary Outcome Measure Information:
Title
comparing the two techniques regarding the success rate
Description
both techniques are supposed to have similar results
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients with UPJO above 18 years
UPJO caused by crossing vessels confirmed by CT angiography
Symptomatic UPJO
Exclusion Criteria:
recurrent UPJO after a previous trial of open repair ,
secondary UPJO after open renal surgery.
UPJO in non functioning kidney
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Rammah, MD
Phone
2001005622939
Email
ahmedrammah2013@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Islam N Abdel Aziz, M.sc
Phone
2001013132994
Email
islamnasser54asdasd@gmail.com
Facility Information:
Facility Name
Faculty of Medicine
City
Cairo
ZIP/Postal Code
115
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Rammah, MD
Phone
2001005622939
Email
ahmedrammah2013@gmail.com
First Name & Middle Initial & Last Name & Degree
Islam N Abdel AZIA, M.sc
Phone
2001013132994
Email
islamnasser54asdasd@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
the researchers would determine whether they would share or not during the study
Learn more about this trial
Functional Outcome After Minimally Invasive Pyeloplasty for Adult Patients With UPJO
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