Dismembered Pyeloplasty With and Without After Coming Stent

Study Overview
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Brief Summary
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to compare outcome of pyeloplasty in pediatric population less than 6 months in age using an after coming stent versus stentless pyeloplasty.

Detailed Description
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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

Official Title
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Dismembered Pyeloplasty With and Without After Coming Stent in Neonatal Ureteropelvic Junction Obstruction

Conditions
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Pyeloplasty, Urinary Stent, Pelviureteric Junction Obstruction, Neonatal Hydronephrosis, Obstructive Uropathy

Intervention / Treatment
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* Procedure: After coming stent after dismembered pyeloplasty
* Procedure: Stentless dismembered pyeloplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: After coming stent<br>Dismembered pyeloplasty with insertion of an after coming stent | Procedure: After coming stent after dismembered pyeloplasty<br>* 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.<br>|
| Active Comparator: Stentless<br>Stentless dismembered pyeloplasty | Procedure: Stentless dismembered pyeloplasty<br>* Dismembered pyeloplasty through lumbar incision. No stents are inserted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Hospital stay | Postoperative Hospital stay | 1 week | 
| Leakage | occurrence of post operative leakage | 1 week | 
| 2ry intervention | Need for 2ry intervention in the form of insertion of ureteral stent | 1 month | 
| Fever | Postoperative fever | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of kidney function after repair | - Assessment of kidney function after repair using renogram and ultrasound | 6 months | 
| success | Need for 2ry treatment of persistent pelviureteric junction obstruction | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelviureteric junction obstruction, pyeloplasty, Neonate affected by hydronephrosis, obstructive uropathy, urinary stent