Renal SWE as a Predictor After Pediatric Pyeloplasty for UPJO (UPJO-SWE)
Renal Cortical Shear Wave Elastography as a Predictor of Functional Recovery After Open Pyeloplasty for Unilateral Pediatric Ureteropelvic Junction Obstruction: A Prospective Cohort Study
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Hany F Badawy, MD
- 전화번호: +201149525028
- 이메일: HANYFATHY86@GMAIL.COM
연구 연락처 백업
- 이름: Ghada S Etman, MD
- 전화번호: +201211874080
- 이메일: Drhanyfathy86@GMAIL.COM
연구 장소
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, 이집트
- 모병
- Department of Urology- Beni-Suef University Hospitals
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연락하다:
- Hany F Badawy, MD
- 전화번호: +201149525028
- 이메일: HANYFATHY86@GMAIL.COM
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Children aged 6 months to 18 years.
- Diagnosis of unilateral primary ureteropelvic junction obstruction.
- Planned for open dismembered pyeloplasty.
- Availability of preoperative renal ultrasonography, renal cortical shear wave elastography, and diuretic renography.
- Written informed consent obtained from parent or legal guardian.
Exclusion Criteria:
- Bilateral ureteropelvic junction obstruction.
- Secondary ureteropelvic junction obstruction.
- Previous ipsilateral upper urinary tract surgery.
- Associated major urinary tract anomalies likely to independently affect renal function, including vesicoureteral reflux, megaureter, duplex system, posterior urethral valves, or ectopic kidney.
- Active urinary tract infection at the time of assessment.
- Known intrinsic renal parenchymal disease unrelated to obstruction.
- Inability to obtain reliable shear wave elastography measurements.
- Incomplete planned follow-up.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Predictive Accuracy of 3-Month Change in Renal Cortical SWE for 6-Month Functional Recovery
기간: Baseline to 6 months after open pyeloplasty
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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.
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Baseline to 6 months after open pyeloplasty
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Association Between 3-Month Renal Cortical SWE and 6-Month Functional Recovery
기간: 3 months to 6 months after open pyeloplasty
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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.
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3 months to 6 months after open pyeloplasty
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Association Between 6-Month Change in Renal Cortical SWE and 6-Month Isotope Findings
기간: Baseline to 6 months after open pyeloplasty
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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.
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Baseline to 6 months after open pyeloplasty
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Longitudinal Change in Renal Cortical SWE After Pyeloplasty
기간: Baseline, 3 months, and 6 months after open pyeloplasty.
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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
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Baseline, 3 months, and 6 months after open pyeloplasty.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Ultrasonographic Anteroposterior Pelvic Diameter
기간: Baseline, 3 months, and 6 months after open pyeloplasty
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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.
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Baseline, 3 months, and 6 months after open pyeloplasty
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hany F Badawy, Faculty of medicine, BeniSuef University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FMBSUREC05052026BadawySWE
- FMBSUREC/05052026/Badawy (기타 식별자: FM-BSU REC)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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