Dismembered Pyeloplasty With and Without After Coming Stent

Not Applicable

Completed

• Conditions: Pyeloplasty; Pelviureteric Junction Obstruction; Obstructive Uropathy; Urinary Stent; Neonatal Hydronephrosis
• Interventions: Procedure: Stentless dismembered pyeloplasty; Procedure: After coming stent after dismembered pyeloplasty

• Registration Number: NCT02138877
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-05-10
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Primary Completion: 2015-03
• Study Completion: 2015-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stentless	Stentless dismembered pyeloplasty	Stentless dismembered pyeloplasty
After coming stent	After coming stent after dismembered pyeloplasty	Dismembered pyeloplasty with insertion of an after coming stent

Primary Outcome Measures

Name	Time	Method
Postoperative Hospital stay	1 week	Postoperative Hospital stay
Fever	1 month	Postoperative fever
Leakage	1 week	occurrence of post operative leakage
2ry intervention	1 month	Need for 2ry intervention in the form of insertion of ureteral stent

Secondary Outcome Measures

Name	Time	Method
success	6 months	Need for 2ry treatment of persistent pelviureteric junction obstruction
Assessment of kidney function after repair	6 months	- Assessment of kidney function after repair using renogram and ultrasound

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt