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

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ClinicalTrials.gov Identifier: NCT01839006
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):
Sung Yong Cho, Seoul National University Hospital

Tracking Information
First Submitted Date June 25, 2011
First Posted Date April 24, 2013
Last Update Posted Date April 24, 2013
Study Start Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2013)
Hydronephrosis [ Time Frame: postop 6 months ]
The grade of hydronephrosis would be check at 6 months postoperatively.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 21, 2013)
renal parenchymal thickness [ Time Frame: postop 6 months ]
Renal parenchymal thickness was measured.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Significance of Supranormal Differential Renal Function in the Recovery of Hydronephrosis
Official Title Clinical Significance of Supranormal Differential Renal Function in the Recovery of Unilateral Hydronephrosis After Surgery: Long-term Results
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Hydronephrosis
Intervention 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.
Study Groups/Cohorts patients with supranormal renal function
Patients with preoperative HN and supranormal renal function in DTPA renography
Intervention: Procedure: dismembered pyeloplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 21, 2013)
34
Original Actual Enrollment Same as current
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01839006
Other Study ID Numbers supranormal
supranormal DRF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sung Yong Cho, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Sung Yong Cho, M.D. Seoul National Universitiy Hospital
PRS Account Seoul National University Hospital
Verification Date April 2013