Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202207502298164 Date of Approval: 18/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of pyeloplasty repair outcome for ureteoplevic junction obstruction by renal Doppler ultrasound versus Radioisotop scanning in children
Official scientific title Evaluation of pyeloplasty repair outcome for ureteoplevic junction obstruction by renal Doppler ultrasound versus Radioisotop scanning in children
Brief summary describing the background and objectives of the trial Evaluation of pyeloplasty repair outcome for ureteoplevic junction obstruction by renal Doppler ultrasound versus Radioisotop scanning in children
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 07/07/2022
Actual trial start date 07/07/2022
Anticipated date of last follow up 07/06/2023
Actual Last follow-up date 07/07/2024
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Doppler ultrasonographey once Duplex Doppler study of small intrarenal vessels, although not technically difficult, does require knowledge of the proper technique to obtain useful measurements. The majority of reported renal Doppler research has used 3, 3.5-, or 5-MHz transducers, and has not required color Doppler imaging [6-1 ]. Typically, the Doppler sample volume is set at 2-5 mm. Most prior studies have concentrated on the study of distal intrarenal vessels, which are not actually seen during the examination but are detected by sampling the Doppler spectrum at the corticomedullary junction or along borders of medullary pyramids To characterize the intrarenal Doppler waveform, most investigators have used the resistive index (RI). This easily calculated parameter is defined as ([peak systolic shift - minimum diastolic shift]/peak systolic shift). Increases in downstream resistance result in a relative reduction in diastolic flow compared with systolic. Hence, RI can be used as an estimate of the state of renal arterial resistance. Since normality and abnormality are based on RI measurements, it is important to actually measure the RI and not rely on qualitative waveform assessment. The presence of detectable end-diastolic flow is not sufficient to ensure a low-resistance (normal) state. Relying on a purely visual assessment of the Doppler spectrum can lead to misinterpretation of the obtained Doppler waveform. 50 Active-Treatment of Control Group
Control Group doppler sonar once resistive index measure 50 Active-Treatment of Control Group
Experimental Group doppler sonar once resistive index measurement 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age include from 1month to 18 years presented by hydronephrosis Unilateral or bilateral hydronephrosis included Patients with UPJO who have had a history of previous failed pyeloplasty, patients with renal anomalies including vascular anomalies, horseshoe and pelvic kidneys, obstructions secondary to the nephrolithiasis, tumor or abdominal mass, patients with surgery contraindication, including active urinary tract infections and uncorrected coagulopathy or severe comorbidity preventing anesthesia and patients who have no follow-up condition in terms Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Day(s) 19 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/06/2022 medical research ethics committee faculty of medicine sohag univeristey
Ethics Committee Address
Street address City Postal code Country
sohag sohag 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The main purpose of this study is to validate the usefulness of Doppler ultrasound measurement of RI in differentiating obstructive from non-obstructive hydronephrosis in children. It is hoped that the results of this study would support the use of Doppler ultrasound as an alternative non-ionizing investigation in the assessment of hydronephrosis in children at our center, other than VCUG and DTPA which use ionizing radiation, and in areas where DTPA is not available year
Secondary Outcome It is hoped that the results of this study would support the use of Doppler ultrasound as an alternative non-ionizing investigation in the assessment of hydronephrosis in children at our center, other than VCUG and DTPA which use ionizing radiation, and in areas where DTPA is not available year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
sohag university hospital sohag sohag 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SOHAG UNIVERISTEY FACULTEY OF MEDICINE SOHAG NASSSER STREET SOHAG 82524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sohag universitey sohag sohag 0000 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
UROLOGY DEPARTMENT FACULTY OF MEDICINE SOHAG UINVERSITEY SOHAG NASSER CITEY SOHAG 82524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator abdelbasset badawey mosmamoud@yahoo.com 02001020099373 sohag
City Postal code Country Position/Affiliation
sohag 0000 Egypt prof
Role Name Email Phone Street address
Principal Investigator elnisr rashed momamoud@yahoo.com 02001017761922 sohag
City Postal code Country Position/Affiliation
sohag 0000 Egypt prpf
Role Name Email Phone Street address
Principal Investigator ahmed riad mosmamoud@YAHOO.COM 02001060054972 sohag
City Postal code Country Position/Affiliation
sohag 0000 Egypt prof
Role Name Email Phone Street address
Public Enquiries abdelbasset badawey mosmamoud@yahoo.com 02001010538659 sohG
City Postal code Country Position/Affiliation
SOHAG 0000 Egypt PROF
Role Name Email Phone Street address
Scientific Enquiries ABDELBASET BADWAY MOSMAMOUD@YAHOO.COM 02001010528659 SOHAG
City Postal code Country Position/Affiliation
SOHAG 0000 Egypt PROF
Role Name Email Phone Street address
Principal Investigator Ebtesam Ahmed Mostafa.abc14@yahoo.com 01010538659 Sohag
City Postal code Country Position/Affiliation
Sohag Egypt Lecturer of radiologey
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the result reported in this research after denitrification (text,tables,figures,) Clinical Study Report,Statistical Analysis Plan,Study Protocol start from 1-7-2022 to 1-7-2023 it will be opened
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information