HydronephrosisNCT01839006
Clinical Significance of Supranormal Differential Renal Function in the Recovery of Hydronephrosis
An observational study of Hydronephrosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hydronephrosis
- What is being tested?
- dismembered pyeloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with unilateral UPJO pediatric patients who underwent dismembered pyeloplasty and preoperative HN in USG and supranormal renal function in DTPA renography
Who may be able to join
- ureteropelvic junction obstruction
- hydronephrosis
- differential renal function more than 55% in DTPA
- follow-up period more than 1 year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hydronephrosis
- Being tested
- dismembered pyeloplasty
- Keywords
- hydronephrosis, ultrasonography, Kidney Function Test, Patients with unilateral UPJO and patients with preop HN in USG and supranormal renal function in DTPA renography
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dismembered pyeloplastyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| patients with supranormal renal function | Patients with preoperative HN and supranormal renal function in DTPA renography Receives: Procedure: dismembered pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydronephrosis
The grade of hydronephrosis would be check at 6 months postoperatively.
Measured: postop 6 months
Secondary outcomes (1)
renal parenchymal thickness
Renal parenchymal thickness was measured.
Measured: postop 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJun 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydronephrosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yong Cho, Seoul National University Hospital
- Investigators
- Sung Yong Cho, M.D., Principal investigator, Seoul National Universitiy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839006
- Sponsor's protocol ID
- supranormal
- Other IDs
- supranormal DRF
- Status last verified
- Apr 2013
- First submitted
- 25 Jun 2011
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Supranormal Differential Renal Function in the Recovery of Unilateral Hydronephrosis After Surgery: Long-term Results
- ClinicalTrials.gov ID
- NCT01839006
- Acronym / sponsor ID
- supranormal
- Conditions
- Hydronephrosis
- Keywords
- hydronephrosis, ultrasonography, Kidney Function Test, Patients with unilateral UPJO and patients with preop HN in USG and supranormal renal function in DTPA renography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with supranormal renal function | – | Procedure: dismembered pyeloplastyPatients with preoperative HN and supranormal renal function in DTPA renography |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with unilateral UPJO pediatric patients who underwent dismembered pyeloplasty and preoperative HN in USG and supranormal renal function in DTPA renography
Key inclusion criteria (4 listed)
- ureteropelvic junction obstruction
- hydronephrosis
- differential renal function more than 55% in DTPA
- follow-up period more than 1 year
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dismembered pyeloplastyUsing 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. | Procedure or surgery | patients with supranormal renal function |
Primary outcome
Hydronephrosis
Time frame: postop 6 months
The grade of hydronephrosis would be check at 6 months postoperatively.
1 secondary outcome
renal parenchymal thickness
Time frame: postop 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Yong Cho, M.D. principal investigator
Seoul National Universitiy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydronephrosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydronephrosis (time frame: postop 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.