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

NCT06836700 | Completed DMC

• 2 other identifiers: 341/Chairman/R&E/ComitteeInstitute of Kidney Diseases
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Stones; Urolithiasis, Calcium Oxalate

Keywords

Renal stone; PCNL

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Mini PCNL Group

ACTIVE COMPARATOR

Participant in this group were subjected to MINI PCNL procedure.

Procedure: Mini PCNL

Standard PCNL Group

ACTIVE COMPARATOR

Participants in this group were subjected to Standard PCNL procedure

Procedure: Mini PCNL

Interventions

Mini PCNL PROCEDURE

90 Participants underwent MINI PCNL in MIN PCNL arm and 90 Participants underwent Standard PCNL in Standard PCNL arm.

Mini PCNL Group; Standard PCNL Group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Study Sites (1)

Institute of Kidney Disease.

Peshawar, KPK, 25124, Pakistan

Location

MeSH Terms

Conditions

Nephrolithiasis; Nephrolithiasis, Calcium Oxalate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident

Model Details: 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:

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 20, 2025
• Study Start: January 10, 2022
• Primary Completion: March 10, 2024
• Study Completion: March 15, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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.
• 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.

Locations

PA (1)