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.: PACTR202301585882096 Date of Approval: 16/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title repaire of uretropelvic junction obstruction
Official scientific title Prospective randomised comparative study between ureter first approach and traditional open Anderson-Hyenes pyeloplasty.
Brief summary describing the background and objectives of the trial The authors Anderson and Hynes, described a specific procedure that involved the utilization of an L-shaped cut with a pelvic flap fashioned from the redundant dilated renal pelvis. This was performed so as to prevent a stenosis developing along the anastomotic site. The inferior rotation of the lower limb of the ‘L’ allowed for a dependent, funnelled anastomosis with the spatulated ipsilateral ureter Until now the aetiology and pathogenesis of this anomaly are still unclear. They involved either genetic and/or environmental factors and the mechanism may involve abnormal innervation, impaired differentiation of smooth muscle and failure in development or recanalization of the uretero-pelvic junction. In ureteropelvic junction (UPJ) obstruction, there is an impaired flow of urine from pelvis to proximal ureter leading to dilatation of the pelvi calyceal system with the risk of renal damage In this study we aim to compare between anterior wall first technique and conventional open Anderson-Hynes pyeloplasty as regard feasibility, duration of operation, efficacy, and complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/03/2022
Actual trial start date 23/03/2022
Anticipated date of last follow up 01/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
1279 The local Ethics Committee of the Quality Education Assurance Unit, Al-Azhar Faculty of medicine, Nasr City, Cairo, Egypt
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group anterior wall first approach follow up for at least 3 months An L-shaped incision with developing of a flap from the redundant part of the renal pelvis. Then another stay suture was taken in the anterior wall of the ureter, spatulation of the ureter laterally to the healthy part and then anastomosis was done between the ureter and pelvis. Before completion of the anastomosis, a stent was introduced through the ureter in that patients. After completion of the anastomosis, a drain was placed through another stab incision. 15
Control Group traditional follow up at least 3 months an L-shaped cut with a pelvic flap fashioned from the redundant dilated renal pelvis. This was performed so as to prevent a stenosis developing along the anastomotic site. The inferior rotation of the lower limb of the ‘L’ allowed for a dependent, funnelled anastomosis with the spatulated ipsilateral ureter 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with primary Uretero-pelvic junction obstruction Patients underwent previous repair. Uncorrectable coagulopathy & untreated UTI. Patients with other congenital urological anomalies. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 3 Month(s) 14 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 23/03/2022 FMG IRB
Ethics Committee Address
Street address City Postal code Country
Nasr city Cairo 11765 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Comparison between anterior wall first technique and conventional open Anderson-Hynes pyeloplasty as regard feasibility, duration of operation, efficacy, and complications. after follow up 3 months post operative for all cases
Secondary Outcome anterior wall first technique and conventional open Anderson-Hynes pyeloplasty as regard feasibility, efficacy, and complications. 3 months post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Zahraa university hospital the Greek Hospital street, Sarayat , Abbasia cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
principle investigator Greek Hospital street, abassiyia Cairo 11535 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed el gammal 6 El Gabl El Aghdar buildings, nasr City Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Basem fathy basemhara@gmail.com 01117991955 Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Lecturer of urology faculty of medicine Al Azhar University
Role Name Email Phone Street address
Public Enquiries Hesham elsayed Aboziedhesham@gmail.com 01062087567 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of urology Faculty of medicine AlAzhar University
Role Name Email Phone Street address
Scientific Enquiries Ahmed ElRefaey a7medrefa3y.ash@gmail.com 01149394121 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of urology faculty of medicine Al Azhar University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the datasetof the current study ( individual deidentfial particioient data ) will be available from the corresponding auther upon reasonable request and will be shared with other researchers if needed by direct contact with corresponding author. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol data requested can be submitted starting 9 months after article publicationand the date will be made accessibleble for up to 24 months available from corresponding author upon reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
sending e mail 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