Renal StonesTrifectaNCT06836700
Comparison of Trifecta Analysis of Standard Versus Mini Percutaneous Nephrolithotomy in the Management of Urolithiasis
A study testing Mini PCNL in people with Renal Stones and Urolithiasis, Calcium Oxalate, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Renal Stones, Urolithiasis, Calcium Oxalate
- What is being tested?
- Mini PCNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2022to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Renal Stones, Urolithiasis, Calcium Oxalate
- Being tested
- Mini PCNL
- Keywords
- Renal stone, PCNL
- Medical subject headings
- Nephrolithiasis, Nephrolithiasis, Calcium Oxalate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini PCNLProcedure or surgery
90 Participants underwent MINI PCNL in MIN PCNL arm and 90 Participants underwent Standard PCNL in Standard PCNL arm.
| Study group | Role | What they receive |
|---|---|---|
| Mini PCNL Group | Active comparator | Participant in this group were subjected to MINI PCNL procedure. Receives: Procedure: Mini PCNL |
| Standard PCNL Group | Active comparator | Participants in this group were subjected to Standard PCNL procedure Receives: Procedure: Mini PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rates
This outcome measures that which modality provide better stone free rates. Mini or standard PCNL.
Measured: 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
Measured: 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.
Measured: Up to 4 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start10 Jan 2022
- Primary completion10 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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:
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdul Haseeb, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836700
- Sponsor's protocol ID
- 341/Chairman/R&E/Comittee
- Other IDs
- Institute of Kidney Diseases
- Acronym
- Trifecta
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Trifecta Analysis of Standard Versus Mini Percutaneous Nephrolithotomy in the Management of Urolithiasis
- ClinicalTrials.gov ID
- NCT06836700
- Acronym / sponsor ID
- Trifecta / 341/Chairman/R&E/Comittee
- Conditions
- Renal Stones, Urolithiasis, Calcium Oxalate
- Keywords
- Renal stone, PCNL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hayat Abad Medical Complex, PeshawarOther government
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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:
| Arm | Type | Receives |
|---|---|---|
| Mini PCNL Group | Active comparator | Procedure: Mini PCNLParticipant in this group were subjected to MINI PCNL procedure. |
| Standard PCNL Group | Active comparator | Procedure: Mini PCNLParticipants in this group were subjected to Standard PCNL procedure |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini PCNL90 Participants underwent MINI PCNL in MIN PCNL arm and 90 Participants underwent Standard PCNL in Standard PCNL arm. | Procedure or surgery | Mini PCNL Group, Standard PCNL Group |
Primary outcome
Stone free rates
Time frame: 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
Time frame: 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
Time frame: Up to 4 weeks post operatively
to find which modality require the need of auxiliary Procedures like ESWL, URS, or Re DJS stenting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini PCNL in people with Renal Stones and Urolithiasis, Calcium Oxalate, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rates (time frame: up to 4 weeks on post follow up imaging i.e CT KUB without contrast). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.