UrolithiasisNCT04153461
Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.
A study testing MINI-PERCUTANEOUS NEPHROLITHOTOMY and STANDARD PERCUTANEOUS NEPHROLITHOTOMY in people with Urolithiasis and Stone;Renal, run by Mansoura University at 1 site in Egypt.
Trial summary
The EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only one of which was RCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Stone;Renal, Nephrolithiasis
- What is being tested?
- MINI-PERCUTANEOUS NEPHROLITHOTOMY and STANDARD PERCUTANEOUS NEPHROLITHOTOMY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 1 May 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18 years or older.
- ASA I or II
- Renal stones ≥ 2 cm
- Lower calyceal stone ≥ 1 cm
- Failure of other modalities of treatment as ESWL and RIRS.
Who cannot join
- S.creatinine > 2mg/dl.
- Patients with active UTI.
- Patients on anticoagulant.
- Age <18 years.
- Ureteral obstruction preventing the insertion of a ureteral stent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial
The EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only one of which was RCT. The risks of bias and confounding were high, highlighting the need for more reliable data from RCTs. So, the Panel recommended for more clinical research .
The aim of this study is to compare between PNL and mPNL through a randomized controlled trial.
- Conditions
- Urolithiasis, Stone;Renal, Nephrolithiasis, PNL, PCNL, NEPHROLITHOTOMY
- Being tested
- MINI-PERCUTANEOUS NEPHROLITHOTOMY, STANDARD PERCUTANEOUS NEPHROLITHOTOMY
- Keywords
- urolithiasis, stone, renal, nephrolithiasis, PNL, PCNL, NEPHROLITHOTOMY, MINIPERC, MINI-PERC, BLOOD LOSS, NEPHROSTOMY SIZE
- Medical subject headings
- Urolithiasis, Nephrolithiasis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINI-PERCUTANEOUS NEPHROLITHOTOMYProcedure or surgery
Also called MINIPERC, MINI-PERC
MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION
STANDARD PERCUTANEOUS NEPHROLITHOTOMYProcedure or surgery
Also called PNL, PCNL, STANDARD PNL
PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION
| Study group | Role | What they receive |
|---|---|---|
| MINI-PERCUTANEOUS NEPHROLITHOTOMY | Active comparator | MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION Receives: Procedure: MINI-PERCUTANEOUS NEPHROLITHOTOMY |
| STANDARD PERCUTANEOUS NEPHROLITHOTOMY | Active comparator | PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION Receives: Procedure: STANDARD PERCUTANEOUS NEPHROLITHOTOMY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of stone free rate (SFR)
defined as less than 4mm by non contrast computed tomography
Measured: 2 years
Secondary outcomes (4)
assessment of haemoglobin loss
measured by haemoglobin change pre and postoperative (measured by grams/ deciliter)
Measured: 2 years
assessment of pain
measured by visual analogue scale
Measured: 2 years
assessment of renal function
measured by serum creatinine measured by Milligram/ deciliter
Measured: 2 years
assessment of patient satisfaction
measured by freiburg index of patient satisfaction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 May 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Elgamal, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153461
- Sponsor's protocol ID
- MiniPNL
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04153461
- Acronym / sponsor ID
- MiniPNL
- Conditions
- Urolithiasis, Stone;Renal, Nephrolithiasis, PNL, PCNL, NEPHROLITHOTOMY
- Keywords
- urolithiasis, stone, renal, nephrolithiasis, PNL, PCNL, NEPHROLITHOTOMY, MINIPERC, MINI-PERC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 6 Nov 2019 (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.
The EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only one of which was RCT. The risks of bias and confounding were high, highlighting the need for more reliable data from RCTs. So, the Panel recommended for more clinical research .
The aim of this study is to compare between PNL and mPNL through a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINI-PERCUTANEOUS NEPHROLITHOTOMY | Active comparator | Procedure: MINI-PERCUTANEOUS NEPHROLITHOTOMYMINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION |
| STANDARD PERCUTANEOUS NEPHROLITHOTOMY | Active comparator | Procedure: STANDARD PERCUTANEOUS NEPHROLITHOTOMYPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient 18 years or older.
- ASA I or II
- Renal stones ≥ 2 cm
- Lower calyceal stone ≥ 1 cm
- Failure of other modalities of treatment as ESWL and RIRS.
Key exclusion criteria (5 listed)
- S.creatinine > 2mg/dl.
- Patients with active UTI.
- Patients on anticoagulant.
- Age <18 years.
- Ureteral obstruction preventing the insertion of a ureteral stent.
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-PERCUTANEOUS NEPHROLITHOTOMYAlso: MINIPERC, MINI-PERCMINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION | Procedure or surgery | MINI-PERCUTANEOUS NEPHROLITHOTOMY |
| STANDARD PERCUTANEOUS NEPHROLITHOTOMYAlso: PNL, PCNL, STANDARD PNLPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION | Procedure or surgery | STANDARD PERCUTANEOUS NEPHROLITHOTOMY |
Primary outcome
Assessment of stone free rate (SFR)
Time frame: 2 years
defined as less than 4mm by non contrast computed tomography
4 secondary outcomes
assessment of haemoglobin loss
Time frame: 2 years
assessment of pain
Time frame: 2 years
assessment of renal function
Time frame: 2 years
assessment of patient satisfaction
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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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-PERCUTANEOUS NEPHROLITHOTOMY and STANDARD PERCUTANEOUS NEPHROLITHOTOMY in people with Urolithiasis and Stone;Renal, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. 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 Egypt. 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?
Results are not available in the source record.
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?
Assessment of stone free rate (SFR) (time frame: 2 years). 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 13 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.