Back to resultsDismembered Pyeloplasty With and Without After Coming Stent
Primary Purpose
Pelviureteric Junction Obstruction, Pyeloplasty, Neonatal Hydronephrosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
After coming stent after dismembered pyeloplasty
Stentless dismembered pyeloplasty
Sponsored by
About this trial
This is an interventional treatment trial for Pelviureteric Junction Obstruction focused on measuring Pelviureteric junction obstruction, pyeloplasty, Neonate affected by hydronephrosis, obstructive uropathy, urinary stent
Eligibility Criteria
Inclusion Criteria:
- Pelvi-ureteric junction obstruction (PUJO)
- Asymptomatic obstruction with reduced function (less than 35-40%)
- Asymptomatic obstruction with antero-posterior diameter exceed 40 mm
- Asymptomatic obstruction with deterioration on conservative follow up.
- Symptomatic PUJ obstruction, e.g. pain, renal mass, fever and stones.
Exclusion Criteria:
- Secondary Pelvi-ureteric junction obstruction
- Solitary kidney
- Gross pyuria
- Ectopic kidney
- Dilated ureter
Sites / Locations
- Cairo University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
After coming stent
Stentless
Arm Description
Dismembered pyeloplasty with insertion of an after coming stent
Stentless dismembered pyeloplasty
Outcomes
Primary Outcome Measures
Postoperative Hospital stay
Postoperative Hospital stay
Leakage
occurrence of post operative leakage
2ry intervention
Need for 2ry intervention in the form of insertion of ureteral stent
Fever
Postoperative fever
Secondary Outcome Measures
Assessment of kidney function after repair
- Assessment of kidney function after repair using renogram and ultrasound
success
Need for 2ry treatment of persistent pelviureteric junction obstruction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02138877
Brief Title
Dismembered Pyeloplasty With and Without After Coming Stent
Official Title
Dismembered Pyeloplasty With and Without After Coming Stent in Neonatal Ureteropelvic Junction Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
to compare outcome of pyeloplasty in pediatric population less than 6 months in age using an after coming stent versus stentless pyeloplasty.
Detailed Description
A prospective randomized control study including patients divided into two groups,all patient undergoes dismembered pyeloplasty First group will be with an after coming stent ,Second group will be stentless to compare outcome of pyeloplasty in pediatric population less than 6 months in age
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelviureteric Junction Obstruction, Pyeloplasty, Neonatal Hydronephrosis, Obstructive Uropathy, Urinary Stent
Keywords
Pelviureteric junction obstruction, pyeloplasty, Neonate affected by hydronephrosis, obstructive uropathy, urinary stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
After coming stent
Arm Type
Active Comparator
Arm Description
Dismembered pyeloplasty with insertion of an after coming stent
Arm Title
Stentless
Arm Type
Active Comparator
Arm Description
Stentless dismembered pyeloplasty
Intervention Type
Procedure
Intervention Name(s)
After coming stent after dismembered pyeloplasty
Intervention Description
Dismembered pyeloplasty through lumbar incision. The patients who are randomized to the after coming stent arm, an after coming stent is inserted. Distal part of it is positioned in the mid ureter. The proximal end is passed through the renal parenchyma (usually the lower kidney calyx) to be exteriorized through stab wound and fixed to the skin. The size of external stent is 4-5 F.
Intervention Type
Procedure
Intervention Name(s)
Stentless dismembered pyeloplasty
Intervention Description
Dismembered pyeloplasty through lumbar incision. No stents are inserted
Primary Outcome Measure Information:
Title
Postoperative Hospital stay
Description
Postoperative Hospital stay
Time Frame
1 week
Title
Leakage
Description
occurrence of post operative leakage
Time Frame
1 week
Title
2ry intervention
Description
Need for 2ry intervention in the form of insertion of ureteral stent
Time Frame
1 month
Title
Fever
Description
Postoperative fever
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Assessment of kidney function after repair
Description
- Assessment of kidney function after repair using renogram and ultrasound
Time Frame
6 months
Title
success
Description
Need for 2ry treatment of persistent pelviureteric junction obstruction
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pelvi-ureteric junction obstruction (PUJO)
Asymptomatic obstruction with reduced function (less than 35-40%)
Asymptomatic obstruction with antero-posterior diameter exceed 40 mm
Asymptomatic obstruction with deterioration on conservative follow up.
Symptomatic PUJ obstruction, e.g. pain, renal mass, fever and stones.
Exclusion Criteria:
Secondary Pelvi-ureteric junction obstruction
Solitary kidney
Gross pyuria
Ectopic kidney
Dilated ureter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed S ElSheemy, A professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
ZIP/Postal Code
12222
Country
Egypt
12. IPD Sharing Statement
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Dismembered Pyeloplasty With and Without After Coming Stent
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