NCT02138877

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

May 10, 2014

Last Update Submit

January 19, 2016

Conditions

Pelviureteric Junction ObstructionPyeloplastyNeonatal HydronephrosisObstructive UropathyUrinary Stent

Keywords

Pelviureteric junction obstructionpyeloplastyNeonate affected by hydronephrosisobstructive uropathyurinary stent

Outcome Measures

Primary Outcomes (4)

  • Postoperative Hospital stay

    Postoperative Hospital stay

    1 week

  • Leakage

    occurrence of post operative leakage

    1 week

  • 2ry intervention

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

    1 month

  • Fever

    Postoperative fever

    1 month

Secondary Outcomes (2)

  • Assessment of kidney function after repair

    6 months

  • success

    6 months

Study Arms (2)

After coming stent

ACTIVE COMPARATOR

Dismembered pyeloplasty with insertion of an after coming stent

Procedure: After coming stent after dismembered pyeloplasty

Stentless

ACTIVE COMPARATOR

Stentless dismembered pyeloplasty

Procedure: Stentless dismembered pyeloplasty

Interventions

After coming stent after dismembered pyeloplastyPROCEDURE

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.

After coming stent
Stentless dismembered pyeloplastyPROCEDURE

Dismembered pyeloplasty through lumbar incision. No stents are inserted

Stentless

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, 12222, Egypt

Location

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral

Study Officials

  • Mohammed S ElSheemy, A professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associte professor of urology

Study Record Dates

First Submitted

May 10, 2014

First Posted

May 15, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

EG(1)