Dismembered Pyeloplasty With and Without After Coming Stent

Obstructive Uropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138877
• Other study ID #: 61178
• Status: Completed
• Phase: N/A
• First received: May 10, 2014
• Last updated: January 19, 2016
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hydronephrosis
• Neonatal Hydronephrosis
• Obstructive Uropathy
• Pelviureteric Junction Obstruction
• Pyeloplasty
• Urinary Stent

Intervention

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.
• Stentless dismembered pyeloplasty
Dismembered pyeloplasty through lumbar incision. No stents are inserted

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Hospital stay	Postoperative Hospital stay	1 week	Yes
Primary	Leakage	occurrence of post operative leakage	1 week	Yes
Primary	2ry intervention	Need for 2ry intervention in the form of insertion of ureteral stent	1 month	Yes
Primary	Fever	Postoperative fever	1 month	Yes
Secondary	Assessment of kidney function after repair	- Assessment of kidney function after repair using renogram and ultrasound	6 months	No
Secondary	success	Need for 2ry treatment of persistent pelviureteric junction obstruction	6 months	No