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.: PACTR202312566150876 Date of Registration: 22/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Which Is Easier for Beginners: Supine or Prone Position Percutaneous Nephrolithotomy? Assessment of the Learning Curve in Novice Urologists in A Prospective Randomized Trial.
Official scientific title Which Is Easier for Beginners: Supine or Prone Position Percutaneous Nephrolithotomy? Assessment of the Learning Curve in Novice Urologists in A Prospective Randomized Trial.
Brief summary describing the background and objectives of the trial Percutaneous nephrolithotomy (PCNL) could be performed in both prone and supine positions. Each position has its own advantages and disadvantages. ‘‘Learning curve” is a graph that represents progress of a skill against the time needed to master the technique. The objectives: to assess the learning curve of prone and supine PCNL in novice urologists to detect which technique is easier in beginners.
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 Education /Training
Anticipated trial start date 20/12/2021
Actual trial start date 25/12/2021
Anticipated date of last follow up 01/10/2022
Actual Last follow-up date 25/12/2022
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 150
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Percutaneous nephrolithotomy about 110 minutes Prone PCNL 75 Active-Treatment of Control Group
Experimental Group percutaneous nephrolithotomy about 90 minutes supine PCNL 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients single or multiple renal stones patients who are unfit for surgery, pediatric patients, complete staghorn stones, uncorrected coagulopathy, obese patients (body mass index >35), active urinary tract infections (UTIs). Middle Aged: 45 Year(s)-64 Year(s) 38 Year(s) 66 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 19/12/2021 Research ethics committee at Tanta University
Ethics Committee Address
Street address City Postal code Country
ElGeish Tanta 6620010 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome learning curve of operative time plateau and stone free rate after surgery and 1 month later
Secondary Outcome intraoperative and postoperative complications after surgery and 1 month later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Urology Department at Tanta University Hospital ElGeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no ElGeish Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Urology Department at Tanta University ElGeish Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Zoeir drahmedzoeir27@gmail.com 00201008634198 ElGeish
City Postal code Country Position/Affiliation
Tanta Egypt Urology Departement Tanta University Egypt
Role Name Email Phone Street address
Public Enquiries Abdullah ALdebeiky abdullah.aldebeiky@med.tanta.edu.eg 00201221430915 ElGeish
City Postal code Country Position/Affiliation
Tanta Egypt Urolgy departemnt Tanta University Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Eissa ahmed.taha.eissa@gmail.com 00201110304666 ElGeish
City Postal code Country Position/Affiliation
Tanta Egypt Urology Departement Tanta University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all the collected IPD that underlie results will be shared Study Protocol the data will be available within 1 month controlled access to other reserachers
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 01/12/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 10/12/2023 Result - 10/12/2023 Result - 15/12/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information