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NCT Number: NCT01839006

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

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.

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Key information

Conditions

Hydronephrosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dismembered Pyeloplasty

Procedure

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.

Primary outcomes

  1. Hydronephrosis

    Time frame: postop 6 months

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

Secondary outcomes

  1. renal parenchymal thickness

    Time frame: postop 6 months

    Renal parenchymal thickness was measured.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 24, 2013
Registry last updated
Apr 24, 2013

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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