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.: PACTR202308603946944 Date of Approval: 01/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Perioperative Outcomes of Papillary Versus Non-Papillary Access in Percutaneous Nephrolithotomy: Results from a prospective randomized trial
Official scientific title The Perioperative Outcomes of Papillary Versus Non-Papillary Access in Percutaneous Nephrolithotomy: Results from a prospective randomized trial
Brief summary describing the background and objectives of the trial Percutaneous nephrolithotomy (PCNL) is considered as the gold standard treatment option for renal stones larger than 2 cm and it can also be used to manage smaller renal stones. The percutaneous access is achieved by puncturing the pelvicalyceal system (PCS) under fluoroscopic guidance followed by dilation of the access route. The standard punctures must be done through the papilla of the posterior renal calyx to avoid the injury of the vascular structures of the kidney. In 2017, Kallidonis et al. published a prospective randomized trial that compared papillary versus non-papillary access in PCNL, and they found that access to infundibulum is a feasible and safe procedure. Additionally, it was not associated with neither higher blood loss nor transfusion rate. The aim of this study is to prospectively compare the perioperative outcomes of the standard papillary and the non-papillary accesses in cases of percutaneous nephrolithotomy in terms of safety, feasibility, and efficacy.
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 01/07/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 01/08/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Papillary puncture Non applicable In papillary access group: the papilla of the calyx will be punctured. 35 Active-Treatment of Control Group
Experimental Group Non papillary puncture Non applicable In non-papillary access group: the puncture will be made through infundibulum of the calyx. After insertion of hydrophilic guide wire all cases will be dilated up to 16 F with dilators and then balloon dilatation will be made up to 30 F. Rigid nephroscope and pneumatic lithotripter will be used to remove calculi. Fragments will be removed using forceps. At the end of the procedure, 14 F nephrostomy catheter will be inserted in all cases. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients with renal stones who are fit for surgical intervention and planned to have PCNL. • Patients who are unfit for surgery due to chronic debilitating diseases (e.g., severe hepatic cirrhosis), uncorrectable bleeding diathesis or immunodeficiency syndromes. • Patients with solitary kidney or single functioning kidney. • Patients with congenital anatomical variants (horseshoe kidney or ectopic kidney). • Patients with chronic renal impairment of serum creatinine > 2 mg/dL • Patients who refuse surgery. • Pregnant females. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 70 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 13/04/2023 Research Ethics Committee at Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
2 El Geesh Street, Medical Campus Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The aim of this study is to prospectively compare the perioperative outcomes of the standard papillary and the non-papillary accesses in cases of percutaneous nephrolithotomy in terms of safety, feasibility, and efficacy. The primary outcome is safety of the technique, whichwhich will be evaluated by assessing the perioperative complications’ rate and type including fever, elevation of serum creatinine, hemoglobin drop, blood transfusion, injury to the lungs or bowel or other abdominal organs, persistent nephrocutaneous fistula, infundibular stenosis and death. Intraoperative, postoperative , one week , one month
Secondary Outcome Feasibility will be assessed by calculating the success rate of obtaining an access and the fluoroscopy time passed till puncture is made. intraoperative
Secondary Outcome Efficacy will be measured by recording the one-month stone free rate in each arm and the need for any auxiliary procedures. one month postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital 2 ElGeesh Street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Faculty of Medicine 2 El Geesh street, Medical Campus Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospital 2 El Geesh Street, Medical Campus Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elhalaby ahmedessamelhalaby@gmail.com 00201289727004 2 El Geesh Street, Medical Campus, Urology Department , El Talaba Hospital , 3rd Floor
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Resident of Urology
Role Name Email Phone Street address
Principal Investigator Mohammed Lotfi Amer drmlamer@med.tanta.edu.eg 00201001862621 2 El Geesh Street, Medical Campus, Urology Department
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer and Consultant of Urology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Radwan drradwam@yahoo.com 00201006714078 2 El Geesh Street, Medical Campus, Urology Department
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor and Consultant of Urology
Role Name Email Phone Street address
Public Enquiries Mohamed Elbendary mohamed.elnady@med.tanta.edu.eg 00201006824248 2 El Geesh Street, Medical campus, Urology Department
City Postal code Country Position/Affiliation
Tanta Egypt Professor and Consultant of Urology
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 sign a data access consent form.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
will be available immediately after publication 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