Renal Stones, Urolithiasis, Calcium Oxalate
Conditions
Keywords
Renal stone, PCNL
Brief summary
Introduction: Urolithiasis is a common urological condition, and percutaneous nephrolithotomy (PCNL) is a widely used treatment option. Trifecta analysis, which includes stone-free rate, reduced complications (Clavien- Dindo classification), and minimal need for auxiliary procedures, provides a standardized way to compare outcomes. This study evaluates the trifecta outcomes of standard PCNL and mini PCNL.
Detailed description
Methodology: This prospective cohort study was conducted at the department of urology, Institute of Kidney Diseases, Peshawar from Jan 2022 to March 2024. 180 consecutive individuals who were subjected to percutaneous nephrolithotomy (PCNL) were registered for the study. Patients were randomly assigned into two equal groups using a lottery method. Both the standard PCNL group and mini PCNL group consisted of 90 patients each. Patients who required a change in the planned surgical procedure were replaced with new participants from the sample frame. A structured proforma was filled out for all preoperative, perioperative, and postoperative variables in administration of trifecta, and the data was analyzed using SPSS. An assessment was done for predictive factors for the trifecta using logistic regression to calculate the odds ratio, confidence interval (CI), and p value.
Interventions
PROCEDUREMini PCNL
90 Participants underwent MINI PCNL in MIN PCNL arm and 90 Participants underwent Standard PCNL in Standard PCNL arm.
Sponsors
Hayat Abad Medical Complex, Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study was executed as a single institution prospective cohort study at the department of urology, Institute of Kidney Diseases, Peshawar, Pakistan. The study was conducted between January 2022 and March 2024, focusing on patients who were eligible for percutaneous nephrolithotomy (PCNL) for stone treatment. After getting IREB approval from the Institute of Kidney Diseases, Peshawar, (certificate no 341), all participants received a detailed explanation of the study objectives, methodology, potential benefits, and risks before providing informed consent. Sample Size Calculation & Patient Selection: The sample size was determined using OpenEpi calculator and a total of 180 consecutive patients scheduled for PCNL were selected from an initial sample frame of 200. To maintain randomness in group allocation, a simple random sampling technique using the lottery method was applied. Patients were equally distributed into two Groups:
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 16 and 65 years having renal stones exceeding 20 mm in diameter or having a density more than 1000 Hounsfield Units (HU) were included.
Exclusion criteria
* Patients with residual stones following prior PCNL or other endourological procedures or active, untreated urinary tract infections or sepsis or patients with deranged coagulation profiles, were excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone free rates | up to 4 weeks on post follow up imaging i.e CT KUB without contrast | This outcome measures that which modality provide better stone free rates. Mini or standard PCNL. |
| Post operative complications rate | Up to 4 weeks days post operative period | To find which modality has got lesser number of complications. Mini or standard PCNL |
| Need of auxiliary Procedures | Up to 4 weeks post operatively | to find which modality require the need of auxiliary Procedures like ESWL, URS, or Re DJS stenting. |
Countries
Pakistan
Outcome results
None listed