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.: PACTR202310463530731 Date of Approval: 23/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A novel technique in Mini-PCNL
Official scientific title A novel technique in Mini-PCNL: Results from a prospective clinical trial
Brief summary describing the background and objectives of the trial To assess our novel modified technique of mini-percutaneous nephrolithotomy (Mini-PCNL) using counter irrigation through a separate upper pole access in terms of stone free rate and safety. Minimizing the stone migration could lead to better surgical outcomes, higher stone free rates as well as reduction of the operative time [10]. Size of the working channel, the instruments used during lithotripsy, type of irrigation system deployed; all may have a direct impact on stone migration. Although additional disposable devices have been used to prevent ureteral stone migration, this increased the complexity and cost of the procedure. Moreover, the proximal migration and scattering in other renal calyces is yet a challenging problem to handle. The idea behind the study: Considering the fluid mechanics; the Reynolds number is the ratio of inertial forces to viscous forces within a fluid which is subjected to relative internal movement in case of a bounding surface such as the interior of a pipe. Laminar flow occurs at low Reynolds numbers, where viscous forces are dominant, and is characterized by smooth and constant fluid motion. In contrary, turbulent flow occurs at high Reynolds numbers, and is dominated by inertial forces, which tend to produce chaotic eddies, vortices and other flow instabilities. Assuming that with counter irrigation through a separate tract the flow will be laminar rather than turbulent which tend to occur with the standard technique, especially, that the Amplatz is the inflow and the outflow at the same.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) mini PCNL
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 01/08/2020
Actual trial start date 01/08/2020
Anticipated date of last follow up 01/10/2021
Actual Last follow-up date 01/10/2021
Anticipated target sample size (number of participants) 49
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL will be available immediately after publication
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 Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group counter irrigation in mini PCNL for management of renal stone not applicable not applicable To assess our novel modified technique of mini-percutaneous nephrolithotomy (Mini-PCNL) using counter irrigation through a separate upper pole access in terms of stone free rate and safety. Then, the desired posterior inferior calyx was punctured. Proper calyceal puncture was confirmed. Starting the irrigation from the nephrostomy at the upper calyx while the outflow from the Amplatz. either pneumatic or laser (Holmium) lithotripters were used to break stones into manageable fragments. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
We included adult patients diagnosed with unilateral renal stone ≤ 20-30 mm in its maximum diameter associated with moderate to marked hydronephrosis in non-contrast computed tomography (NCCT) of the urinary tract. We excluded patients with renal stone with non-dilated normal upper calyx, active urinary tract infection (UTI), chronic kidney disease or abnormal renal function, pregnant females, bleeding disorders, morbidly obese patients (BMI  40 kg/m2) patients with spine deformities Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 17 Year(s) 54 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 18/07/2020 Tanta University Faculty of medicine research ethics committee
Ethics Committee Address
Street address City Postal code Country
2 Elgish street , Tanta ,Gharbyya , Egypt Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary end point is to evaluate one-session stone free rate (SFR) by obtaining a NCCT of the urinary tract within 72 hours after removal of nephrostomy tube to avoid any hidden significant fragments. one month
Secondary Outcome The secondary end points are to assess perioperative parameters including baseline hemoglobin drop, operative time, length of hospital stay, early post-operative complications (stratified by Clavien-Dindo grading system), and assessment of postoperative pain using Visual Analogue Scale. one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital 2 Elgish street, Tanta, Elgharbyya, Egypt Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Faculty of medicine 2 Elgish street, Tanta ,Gharbyya, Egypt Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University 2 Elgish street , Tanta, Gharbyya, Egypt Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Amer drmlamer@med.tanta.edu.eg 00201001862621 2 El-Geish Street, Medical Campus, Faculty of Medicine, Urology Department, Tanta, Gharbeya Governorate, Egypt.
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Mostafa Elgendy mselgendy93@gmail.com 00201095571690 2 El-Geish Street, Medical Campus, Faculty of Medicine, Urology Department, Tanta, Gharbeya Governorate, Egypt
City Postal code Country Position/Affiliation
Tanta Egypt assistant lecturer
Role Name Email Phone Street address
Principal Investigator Ahmed Elsaka zalabatta@gmail.com 00201200274374 2 El-Geish Street, Medical Campus, Faculty of Medicine, Urology Department, Tanta, Gharbeya Governorate, Egypt.
City Postal code Country Position/Affiliation
tanta Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries abdelhamed elbahnasy mrabdo65@yahoo.com 00201006722959 2 Elgish streat, University campus
City Postal code Country Position/Affiliation
Tanta Egypt professor
Role Name Email Phone Street address
Scientific Enquiries abdelnaser elgamasy abdelnaserelgamasy@med.tanta.edu.eg 02001001345414 2 elgish sreet, university campus
City Postal code Country Position/Affiliation
Tanta Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available (including data dictionaries). Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available. Study Protocol also will be available. Data will be available immediately following publication. No end date. Data will be available to researchers who provide a methodologically sound proposal for any type of analysis. Proposals should be directed to drmlamer@med.tanta.edu.eg. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included later). Study Protocol immediately after publication any researcher who provide a methodologically sound proposal and signed adata access consent form
URL Results Available Results Summary Result Posting Date First Journal Publication Date
immediately after publication Yes 14/10/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 14/10/2023 Result - 14/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information