ClinicalTrials.gg
CompletedNCT02138877Updated Jan 20, 2016

Dismembered Pyeloplasty With and Without After Coming Stent

An interventional study of After coming stent after dismembered pyeloplasty and Stentless dismembered pyeloplasty in Pelviureteric Junction Obstruction, Pyeloplasty and Neonatal Hydronephrosis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2016-01-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
Up to 6 Months
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

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

Keywords

  • Pelviureteric junction obstruction
  • pyeloplasty
  • Neonate affected by hydronephrosis
  • obstructive uropathy
  • urinary stent
03

In context

Multicystic renal dysplasia, bilateral

26 studies on the registry are indexed under Multicystic renal dysplasia, bilateral; 9 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 20 interventional studies indexed under Multicystic renal dysplasia, bilateral.

Browse Multicystic renal dysplasia, bilateral studies →

Lead sponsor

Cairo University is the lead sponsor of 4,951 studies on the registry; 1,463 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Secondary Pelvi-ureteric junction obstruction
  • Solitary kidney
  • Gross pyuria
  • Ectopic kidney
  • Dilated ureter
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    After coming stent

    Dismembered pyeloplasty with insertion of an after coming stent

    Procedure: After coming stent after dismembered pyeloplasty

  • Active comparator
    Stentless

    Stentless dismembered pyeloplasty

    Procedure: Stentless dismembered pyeloplasty

Interventions

  • ProcedureAfter 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.

  • ProcedureStentless dismembered pyeloplasty

    Dismembered pyeloplasty through lumbar incision. No stents are inserted

06

What researchers measure

Primary outcomes

  1. Postoperative Hospital stay

    Postoperative Hospital stay

    Time frame: 1 week

  2. Leakage

    occurrence of post operative leakage

    Time frame: 1 week

  3. 2ry intervention

    Need for 2ry intervention in the form of insertion of ureteral stent

    Time frame: 1 month

  4. Fever

    Postoperative fever

    Time frame: 1 month

Secondary outcomes

  1. Assessment of kidney function after repair

    - Assessment of kidney function after repair using renogram and ultrasound

    Time frame: 6 months

  2. success

    Need for 2ry treatment of persistent pelviureteric junction obstruction

    Time frame: 6 months

07

Study locations

1 site
  • Cairo University Hospitals
    Cairo, 12222, Egypt
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Mar 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2014
First posted
May 15, 2014
Start
Jan 2014
Primary completionActual
Mar 2015
CompletionActual
Jun 2015
Last update
Jan 20, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02138877
Lead sponsor
Cairo University
Responsible party
mohammed said elsheemy (Associte professor of urology, Cairo University) — Principal investigator
First posted
May 15, 2014
Start date
Jan 2014
Primary completion
Mar 2015
Completion
Jun 2015
Last update
Jan 20, 2016

Study contacts

Mohammed S ElSheemy, A professor
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion