Dismembered Pyeloplasty With and Without After Coming Stent

NCT ID: NCT02138877

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

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

Conditions

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Pelviureteric Junction Obstruction Pyeloplasty Neonatal Hydronephrosis Obstructive Uropathy Urinary Stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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After coming stent

Dismembered pyeloplasty with insertion of an after coming stent

Group Type ACTIVE_COMPARATOR

After coming stent after dismembered pyeloplasty

Intervention Type PROCEDURE

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

Stentless dismembered pyeloplasty

Group Type ACTIVE_COMPARATOR

Stentless dismembered pyeloplasty

Intervention Type PROCEDURE

Dismembered pyeloplasty through lumbar incision. No stents are inserted

Interventions

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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.

Intervention Type PROCEDURE

Stentless dismembered pyeloplasty

Dismembered pyeloplasty through lumbar incision. No stents are inserted

Intervention Type PROCEDURE

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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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mohammed said elsheemy

Associte professor of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed S ElSheemy, A professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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61178

Identifier Type: -

Identifier Source: org_study_id

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