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

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.

Study Overview

• Status: Completed
• Conditions: Renal Stones; Urolithiasis, Calcium Oxalate
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25124
      • Institute of Kidney Disease.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mini PCNL Group; Participant in this group were subjected to MINI PCNL procedure.	Procedure: Mini PCNL; 90 Participants underwent MINI PCNL in MIN PCNL arm and 90 Participants underwent Standard PCNL in Standard PCNL arm.
Active Comparator: Standard PCNL Group; Participants in this group were subjected to Standard PCNL procedure	Procedure: Mini PCNL; 90 Participants underwent MINI PCNL in MIN PCNL arm and 90 Participants underwent Standard PCNL in Standard PCNL arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rates	This outcome measures that which modality provide better stone free rates. Mini or standard PCNL.	up to 4 weeks on post follow up imaging i.e CT KUB without contrast
Post operative complications rate	To find which modality has got lesser number of complications. Mini or standard PCNL	Up to 4 weeks days post operative period
Need of auxiliary Procedures	to find which modality require the need of auxiliary Procedures like ESWL, URS, or Re DJS stenting.	Up to 4 weeks post operatively

Collaborators and Investigators

• Sponsor: Hayat Abad Medical Complex, Peshawar.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): March 10, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PCNL; Renal stone
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Calculi; Nephrolithiasis; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: 341/Chairman/R&E/Comittee; Institute of Kidney Diseases (Other Identifier: Institute of Kidney Diseases)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

As part of our commitment to research transparency and data-sharing practices, we plan to share individual participant data (IPD) obtained from this clinical trial. The purpose of sharing IPD is to enable further research, facilitate meta-analyses, and contribute to scientific advancements that can improve patient care and clinical outcomes.

Scope of Data to be Shared

The de-identified individual participant data that will be shared includes:

Demographic details such as age, sex, and relevant baseline characteristics Clinical and laboratory data collected during the study Outcome measures related to the study objectives Adverse event reports and safety data All shared data will be de-identified to ensure participant confidentiality and privacy in accordance with applicable ethical guidelines and regulatory requirements.

• IPD Sharing Time Frame: The data will be made publicly available six months after the primary study results are published in a peer-reviewed journal. The dataset will remain accessible for a period of five years from the initial release, after which continued access will be evaluated based on scientific interest and data usage.

IPD Sharing Access Criteria

The IPD will be stored in a secure, electronic form with the principal investigator. Researchers interested in accessing the data will be required to submit a request to the principal author via this email: ahaseeb.dr@gmail.com

Conditions for Data Access Access to the shared data will be granted to qualified researchers affiliated with recognized academic or clinical institutions. Interested researchers must submit a methodologically sound research proposal outlining the objectives and intended use of the data. Approval will be based on scientific merit and alignment with ethical standards.

Before access is granted, researchers will be required to:

Sign a Data Use Agreement (DUA) to ensure appropriate use of the dataset Agree to maintain confidentiality and not attempt to re-identify participants Provide a commitment to acknowledge the original study and funding sources in any resulting publications.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Study Data/Documents

1. Clinical Study Report
   Information identifier: 10.7759/cureus
   Information comments: Further information including data sheets will be provided upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No