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| ID | Type | Description | Link |
|---|---|---|---|
| FMBSUREC/05052026/Badawy | Other Identifier | Research Ethics Committee, Faculty of Medicine, Beni-Suef University |
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Ureteropelvic junction obstruction is an important cause of hydronephrosis and potentially reversible renal functional impairment in children. Although open pyeloplasty is an effective standard treatment, the degree of postoperative renal functional recovery varies between patients.
This prospective observational cohort study will evaluate whether renal cortical shear wave elastography can predict renal functional recovery after open pyeloplasty in children with unilateral primary ureteropelvic junction obstruction. Renal cortical shear wave elastography will be assessed before surgery and during follow-up, and the change in elastography values will be compared with renal isotope findings after surgery.
The primary objective is to evaluate the predictive value of the change in renal cortical shear wave elastography from baseline to 3 months after surgery for isotope-defined renal functional recovery at 6 months after open pyeloplasty.
This is a prospective longitudinal observational cohort study conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University.
The study will include children aged 6 months to 18 years with unilateral primary ureteropelvic junction obstruction who are scheduled for open dismembered pyeloplasty. Eligible children will undergo standard preoperative clinical assessment, laboratory investigations, renal ultrasonography, renal cortical shear wave elastography, and renal isotope assessment.
Preoperative imaging will include renal ultrasonography to assess hydronephrosis, anteroposterior pelvic diameter, and renal cortical thickness. Renal cortical shear wave elastography will be performed to measure cortical stiffness in the affected kidney. Renal isotope assessment will include diuretic renography for differential renal function and drainage assessment, with renal cortical scintigraphy when clinically indicated according to the approved protocol.
All included patients will undergo open dismembered pyeloplasty according to standard surgical principles. Postoperative follow-up will include clinical assessment, renal ultrasonography, and renal cortical shear wave elastography at 3 and 6 months. A repeat renal isotope study will be performed at 6 months after surgery to reassess differential renal function and drainage.
The primary outcome is the predictive performance of the change in renal cortical shear wave elastography from baseline to 3 months postoperatively for 6-month isotope-defined renal functional recovery after pyeloplasty. Secondary outcomes include the association between 3-month postoperative shear wave elastography and functional recovery, longitudinal changes in shear wave elastography, postoperative changes in differential renal function and drainage parameters, and improvement in ultrasonographic parameters after pyeloplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children With Unilateral UPJO Undergoing Open Pyeloplasty | Children aged 6 months to 18 years with unilateral primary ureteropelvic junction obstruction scheduled for open dismembered pyeloplasty. Participants will undergo preoperative renal ultrasonography, renal cortical shear wave elastography, and renal isotope assessment, followed by postoperative clinical, ultrasound, shear wave elastography, and isotope follow-up according to the study protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Predictive Accuracy of 3-Month Change in Renal Cortical SWE for 6-Month Functional Recovery | The change in renal cortical shear wave elastography from baseline to 3 months after open pyeloplasty will be evaluated for its ability to predict renal functional recovery at 6 months. | Baseline to 6 months after open pyeloplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between 3-Month Renal Cortical SWE and 6-Month Functional Recovery | The association between the renal cortical shear wave elastography value measured at 3 months after open pyeloplasty and renal functional recovery at 6 months will be assessed. | 3 months to 6 months after open pyeloplasty |
| Association Between 6-Month Change in Renal Cortical SWE and 6-Month Isotope Findings |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ultrasonographic Anteroposterior Pelvic Diameter | Anteroposterior pelvic diameter of the affected kidney will be measured by renal ultrasonography before surgery and during postoperative follow-up to assess improvement in hydronephrosis. | Baseline, 3 months, and 6 months after open pyeloplasty |
Inclusion Criteria:
Exclusion Criteria:
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Children aged 6 months to 18 years with unilateral primary ureteropelvic junction obstruction who are scheduled for open dismembered pyeloplasty at the Department of Urology, Faculty of Medicine, Beni-Suef University.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hany F Badawy, MD | Contact | +201149525028 | HANYFATHY86@GMAIL.COM | |
| Ghada S Etman, MD | Contact | +201211874080 | Drhanyfathy86@GMAIL.COM |
| Name | Affiliation | Role |
|---|---|---|
| Hany F Badawy | Faculty of medicine, BeniSuef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology- Beni-Suef University Hospitals | Recruiting | Banī Suwayf | Beni Suweif Governorate | Egypt |
Individual participant data will not be shared. Only aggregated, de-identified study results will be reported. Individual-level pediatric clinical and imaging data will remain confidential and will be accessible only to the study investigators and authorized regulatory or ethics committee representatives if required.
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| ID | Term |
|---|---|
| C537373 | Multicystic renal dysplasia, bilateral |
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The change in renal cortical shear wave elastography from baseline to 6 months after open pyeloplasty will be assessed in relation to 6-month renal isotope findings. |
| Baseline to 6 months after open pyeloplasty |
| Longitudinal Change in Renal Cortical SWE After Pyeloplasty | Renal cortical shear wave elastography values will be compared over time at baseline, 3 months, and 6 months after open pyeloplasty to assess postoperative changes in renal | Baseline, 3 months, and 6 months after open pyeloplasty. |