Clinical trial NCT06836700: Comparison of Trifecta Analysis of Standard Versus Mini Percutaneous Nephrolithotomy in the Management of Urolithiasis
Official title: Comparison of Trifecta Analysis of Standard Versus Mini Percutaneous Nephrolithotomy in the Management of Urolithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stones
Urolithiasis, Calcium Oxalate
Keywords: Renal stone
PCNL
Lead sponsor: Hayat Abad Medical Complex, Peshawar.
Sponsor class: OTHER_GOV
First posted: 2025-02-20
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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:
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stone free rates
timeFrame: up to 4 weeks on post follow up imaging i.e CT KUB without contrast
measure: Post operative complications rate
timeFrame: Up to 4 weeks days post operative period
measure: Need of auxiliary Procedures
timeFrame: Up to 4 weeks post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Institute of Kidney Disease.
state: KPK
Study officials:
References: