Clinical Significance of Supranormal Differential Renal Function in the Recovery of Hydronephrosis

April 21, 2013 updated by: Sung Yong Cho, Seoul National University Hospital

Clinical Significance of Supranormal Differential Renal Function in the Recovery of Unilateral Hydronephrosis After Surgery: Long-term Results

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Clinical parameters including age at the first visit, age at operation, gender, laterality, and follow-up period will be evaluated. To evaluate predictors of recovery from supranormal renal function according to the level of DRF, univariate and multivariate logistic regression analyses will be performed. Patients would be subcategorized into two groups; group A (DRF ≤60%) and group B (DRF >60%) in consideration of the mean value of preoperative DRF and each parameter of group A was compared to that of group B using independent sample's t test and chi square test. Kaplan-Meier analysis and log-rank test will be used to determine the difference of recovery time of obstructed hydronephrosis in each parameter.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with supranormal renal function
Patients with preoperative HN and supranormal renal function in DTPA renography
Procedure: dismembered pyeloplasty
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydronephrosis
Time Frame: postop 6 months
The grade of hydronephrosis would be check at 6 months postoperatively.
postop 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal parenchymal thickness
Time Frame: postop 6 months
Renal parenchymal thickness was measured.
postop 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Sung Yong Cho, M.D., Seoul national universitiy Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 25, 2011

First Submitted That Met QC Criteria

April 21, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 21, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • supranormal
  • supranormal DRF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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