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Dismembered Pyeloplasty With and Without After Coming Stent

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ClinicalTrials.gov Identifier: NCT02138877
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
mohammed said elsheemy, Cairo University

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

Condition or disease Intervention/treatment Phase
Pelviureteric Junction Obstruction Pyeloplasty Neonatal Hydronephrosis Obstructive Uropathy Urinary Stent Procedure: After coming stent after dismembered pyeloplasty Procedure: Stentless dismembered pyeloplasty Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dismembered Pyeloplasty With and Without After Coming Stent in Neonatal Ureteropelvic Junction Obstruction
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative Hospital stay [ Time Frame: 1 week ]
    Postoperative Hospital stay

  2. Leakage [ Time Frame: 1 week ]
    occurrence of post operative leakage

  3. 2ry intervention [ Time Frame: 1 month ]
    Need for 2ry intervention in the form of insertion of ureteral stent

  4. Fever [ Time Frame: 1 month ]
    Postoperative fever


Secondary Outcome Measures :
  1. Assessment of kidney function after repair [ Time Frame: 6 months ]
    - Assessment of kidney function after repair using renogram and ultrasound

  2. success [ Time Frame: 6 months ]
    Need for 2ry treatment of persistent pelviureteric junction obstruction


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138877


Locations
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Egypt
Cairo University Hospitals
Cairo, Egypt, 12222
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Mohammed S ElSheemy, A professor Cairo University
More Information
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Responsible Party: mohammed said elsheemy, Associte professor of urology, Cairo University
ClinicalTrials.gov Identifier: NCT02138877    
Other Study ID Numbers: 61178
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by mohammed said elsheemy, Cairo University:
Pelviureteric junction obstruction
pyeloplasty
Neonate affected by hydronephrosis
obstructive uropathy
urinary stent
Additional relevant MeSH terms:
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Hydronephrosis
Urologic Diseases
Kidney Diseases