Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607507031872 Date of Registration: 02/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment Modalities For Residual Renal Stones Post Percutaneous Nephrolithotomy
Official scientific title Treatment Modalities For Residual Renal Stones Post Percutaneous Nephrolithotomy
Brief summary describing the background and objectives of the trial Urinary tract stone disease is one of the most common pathologies in urology practice. Treatment of stone kidney using percutaneous nephrolithotomy (PNL) is often reserved for patients who fail or have contraindications to Ureteroscopy or ESWL. This work aimed to evaluate the different treatment modalities for residual renal stones post-percutaneous nephrolithotomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/09/2024
Actual trial start date 01/09/2024
Anticipated date of last follow up 01/09/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ESWL 1h Patients allocated to the ESWL group underwent extracorporeal shock wave lithotripsy using a standard lithotripter. Stone localization was performed under fluoroscopic and/or ultrasonographic guidance. Shock waves were delivered at gradually increasing energy levels according to patient tolerance and stone characteristics. Patients were followed clinically and radiologically to assess stone fragmentation, stone-free rate, and procedure-related complications 25 Active-Treatment of Control Group
Experimental Group second look PCNL 1 h Second-look PCNL is a repeat percutaneous procedure performed through the existing nephrostomy tract to remove residual renal stones after an initial PCNL, thereby improving the overall stone-free rate. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients with residual renal stones post PNL post PNL stone free skeletal deformity uncorrectable bleeding disorders active urinary tract infection pregnancy patients Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 Year(s) Both
adult patients with residual renal stones post PNL post PNL stone free skeletal deformity uncorrectable bleeding disorders active urinary tract infection pregnancy patients Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 13/08/2024 research ethics committee
Ethics Committee Address
Street address City Postal code Country
King Faisal ST Assuit 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stone-Free Rate (SFR) at 3 months after treatment at 3 months after treatment
Secondary Outcome postoperative complications, emergency department visits, and postoperative renal function 3 months after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Urololgy Department King Faisal ST Assuit 71524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Urology King Faisal ST Assuit 71524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar university king faisal st Assuit Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Taha Abdullah tahaalmallwany@gmail.com 00201116967374 Neza El-Mohzamin
City Postal code Country Position/Affiliation
Gehena Center Sohag Governorate Egypt Egypt resident physician of Urology department
Role Name Email Phone Street address
Public Enquiries Mohamed Ali drmtahtawy2017@yahoo.com 00201125136237 tahta
City Postal code Country Position/Affiliation
Sohag Egypt Lecturer of Urology department Faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Hazem Dief Hazemdeif@yahoo.com 00201017343238 king faisal st
City Postal code Country Position/Affiliation
Assuit Egypt Assistant Professor and head of Urology department Faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data that underlie the results reported in this study will be available after de-identification to researchers who provide a methodologically sound proposal Study Protocol 9 months of publication and extend 36 months after publication open
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 02/07/2026 PACTR Admin 01 Sep 2024