Dismembered Pyeloplasty With and Without After Coming Stent

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

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

Study Overview

• Status: Completed
• Conditions: Pyeloplasty; Obstructive Uropathy; Pelviureteric Junction Obstruction; Neonatal Hydronephrosis; Urinary Stent
• Intervention / Treatment: Procedure: After coming stent after dismembered pyeloplasty; Procedure: Stentless dismembered 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12222
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 10, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: pyeloplasty; urinary stent; obstructive uropathy; Pelviureteric junction obstruction; Neonate affected by hydronephrosis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Hydronephrosis
• Other Study ID Numbers: 61178