Comparison of Trifecta Analysis of Standard Versus Mini Percutaneous Nephrolithotomy in the Management of Urolithiasis

Not Applicable

Completed

• Conditions: Renal Stones; Urolithiasis, Calcium Oxalate

• Registration Number: NCT06836700
• Lead Sponsor: Hayat Abad Medical Complex, Peshawar.

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.

Study Timeline

• Study Start: 2022-01-10
• Primary Completion: 2024-03-10
• Study Completion: 2024-03-15
• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-15
• Last Update Submitted: 2025-02-15
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institute of Kidney Disease.; 🇵🇰 Peshawar, KPK, Pakistan