NCT01839006

Brief Summary

The purpose of this study is to assess the clinical significance of supranormal differential renal function (DRF) in the recovery of unilateral hydronephrosis (HN) after surgery, pediatric patients who underwent pyeloplasty for ureteropelvic junction obstruction (UPJO) who showed supranormal DRF (\> 55%) in the DTPA renography will be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2011

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

Same day

First QC Date

June 25, 2011

Last Update Submit

April 21, 2013

Conditions

Keywords

hydronephrosisultrasonographyKidney Function TestPatients with unilateral UPJO and patients with preop HN in USG and supranormal renal function in DTPA renography

Outcome Measures

Primary Outcomes (1)

  • Hydronephrosis

    The grade of hydronephrosis would be check at 6 months postoperatively.

    postop 6 months

Secondary Outcomes (1)

  • renal parenchymal thickness

    postop 6 months

Study Arms (1)

patients with supranormal renal function

Patients with preoperative HN and supranormal renal function in DTPA renography

Procedure: dismembered pyeloplasty

Interventions

Using a flank approach, as the patient was placed in the lateral decubitus position, and an anterior subcostal incision was made. The narrow segment of UPJ was identified and resected, and then the proximal edge of the ureter was spatulated to allow a wide anastomosis between the ureter and the most dependent part of the renal pelvis. The extent of renal pelvis reduction was decided by the surgeon.

patients with supranormal renal function

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with unilateral UPJO pediatric patients who underwent dismembered pyeloplasty and preoperative HN in USG and supranormal renal function in DTPA renography

You may qualify if:

  • ureteropelvic junction obstruction
  • hydronephrosis
  • differential renal function more than 55% in DTPA
  • follow-up period more than 1 year

You may not qualify if:

  • urological anomalies, such as vesicoureteral reflux, ureterocele, cystic kidney disease, posterior urethral valves, duplex anomalies, neurogenic bladder, and solitary kidney or patients who underwent any previous urological surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Sung Yong Cho, M.D.

    Seoul National Universitiy Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seoul National University Hospital

Study Record Dates

First Submitted

June 25, 2011

First Posted

April 24, 2013

Study Start

June 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations