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Completed

NCT Number: NCT02138877

Dismembered Pyeloplasty With and Without After Coming Stent

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

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Key information

Conditions

Pelviureteric Junction Obstruction Multicystic renal dysplasia, bilateral Neonatal Hydronephrosis Obstructive Uropathy Pyeloplasty Urinary Stent

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, 12222, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

After coming stent after dismembered pyeloplasty

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 dismembered pyeloplasty

Procedure

Dismembered pyeloplasty through lumbar incision. No stents are inserted

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 15, 2014
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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