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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202312813983865 Date of Registration: 22/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Analysis of stones retrieved in a tertiary care center over one year ‎
Official scientific title Analysis of stones retrieved in a tertiary care center over one year ‎
Brief summary describing the background and objectives of the trial A retrospective analysis of patients admitted and underwent ‎intervention for stone disease (PCNL or URETEROSCOPY) in urology ‎and nephrology Center Mansoura university from January 2021 to December ‎‎2022 Urology and Nephrology Center is a tertiary care center for Egypt with over 100 million population as well as referred patients from African and Arab countries. The aim of the study was to establish the prevalence of urinary stones in our facility as an indicator for the prevalence of different stone types in the whole region ‎ Nephrolithiasis is a highly prevalent disease worldwide with rates ‎ranging from 7 to 13% in North America, 5–9% in Europe, and 1–5% in ‎Asia (Ramello et al., 2001)There is growing evidence for an increasing ‎incidence of stones in the United States (US) with recent data finding an ‎overall prevalence of stone disease in 8.8% of the population (men ‎‎10.6%, women 7.1%) which is an increase from the 5.2% prevalence of ‎kidney stone disease from 1988 to 1994 (Stamatelou et al., 2003)‎ Patients’ demographics, peri-operative variables, and stone ‎analysis were retrieved from the archived computer files. This involved ‎access granted to review patients’ admission notes, laboratory, ‎radiological and histopathological data ‎ The number of patients who underwent stone analysis was 748. ‎ The data includes the age of the patients, gender, medical and ‎surgical history, and stone analysis results obtained from the patients ‎information system (PIS) of the hospital.‎ Stone analysis was done using Perkin-Elmer spectrum two FT-IR ‎spectrometer.‎The outcome of this study is to identify the composition of stones ‎in patients with stone disease in a single tertiary center in Egypt .‎ Statistical analysis was done where Continuous variables were ‎interpreted as mean with standard deviation (SD) or median with range ‎as appropriate, while categorical values were recorded as frequencies. All ‎data were computed using a commercial program,(
Type of trial Observational
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 Diagnosis / Prognosis
Anticipated trial start date 01/01/2021
Actual trial start date 01/01/2021
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 748
Actual target sample size (number of participants)
Recruitment status Completed
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Stone analysis of stones retrieved from patients Single time 30 minutes Stone analysis was done using Perkin-Elmer spectrum two FT-IR ‎spectrometer.‎ 748
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults Undergoing stone extraction by ureteroscopy or PCNL Children Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 10/08/2021 IRB of UNC Mansoura University
Ethics Committee Address
Street address City Postal code Country
Gomhorria Mansoura 35516c Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome stone composition once
Secondary Outcome Stone analysis Once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Urology and Nephrology Center Mansoura University Gomhorria Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Institutional Gomhorria Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Urology and Nephrology Center Gomhorria st Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Bassem S Wadie Gomhorria st Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Bassem Wadie bassem_wadie@mans.edu.eg 20502160817 Gomhorria
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of Urology Mansoura University
Role Name Email Phone Street address
Public Enquiries Rawdy Ashour rawdyashour@gmail.com 20502202222 Gomhoria
City Postal code Country Position/Affiliation
Mansoura Egypt Doctor in urology dept.
Role Name Email Phone Street address
Principal Investigator Bassem Wadie bassem_wadie@mans.edu.eg 20502160817 Gomhoria
City Postal code Country Position/Affiliation
Mansoura Egypt Professor of Urology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD are available in the attached Excel file. All collected participant data is included in the file underlying the results of this article after de-identification Study protocol is also available on request Data are available immediately after publication and for 5 years afterwards Data should be available for investigators whos proposal is reviewed by an independent review committee To achieve aims of the approved proposal Proposals should be directed to bassem_wadie@mans.edu.eg for 5 years starting from publication of the study Statistical Analysis Plan,Study Protocol 12 months of the study completed data The principal investigator is the one who controls access to data as well as data analysis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 29/11/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information