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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2024-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Stones Urolithiasis, Calcium Oxalate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mini PCNL Group

Participant in this group were subjected to MINI PCNL procedure.

Group Type ACTIVE_COMPARATOR

Mini PCNL

Intervention Type PROCEDURE

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

Standard PCNL Group

Participants in this group were subjected to Standard PCNL procedure

Group Type ACTIVE_COMPARATOR

Mini PCNL

Intervention Type PROCEDURE

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

Interventions

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Mini PCNL

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No