Renal StoneNCT02067221
Comparison of Surgical Outcomes Between MPCNL and RIRS
A study testing RIRS and MPCNL in people with Renal Stone, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The objective of this research is to investigate the surgical outcomes of minimally invasive percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with renal stone larger than 1cm. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Renal Stone
- What is being tested?
- RIRS and MPCNL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Feb 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The person who has been diagnosed with renal stone larger than 1cm renal and who has been supposed to undergo MPCNL or RIRS.
- The person who signed up for participation and agree with intention of clinical test.
Who cannot join
- The patient whose medical record has been omitted from database.
- The patient who has an anatomical abnormality of urinary tract and/or metabolic illness
- The patient who do not agree with the intention of the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Surgical Outcomes in the Treatment of Renal Stones Larger Than 1 Centimeters Between MPCNL and RIRS: a Single-center, Randomized, Prospective Study
The objective of this research is to investigate the surgical outcomes of minimally invasive percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with renal stone larger than 1cm.
Read the detailed description
It is pointed out that there is the disadvantage of conventional PCNL technique which showed dramatic decrease in Hb and renal damage even though it has some advantages of a short operation time and a high stone-free rate. MPCNL and RIRS has recently been considered as very efficacious methods.
- Conditions
- Renal Stone
- Being tested
- RIRS, MPCNL
- Keywords
- percutaneous nephrolithotomy, renal calculi, ureteroscopy
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIRSDevice
Also called retrograde intrerenal surgery
- RIRS arm
- Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract
MPCNLDevice
Also called minimally invasive percuntaneous nephrolithotomy, mini-perc
- MPCNL arm
- A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.
| Study group | Role | What they receive |
|---|---|---|
| RIRS (retrograde intrarenal surgery) | Active comparator | Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract Receives: Device: RIRS |
| MPCNL (mini-perc) | Experimental | A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.
Patients will be randomized and assigned to each group at the ratio 1:1 Receives: Device: MPCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone-free rate
We will check the non-contrast CT scan at postoperative 1month when the patient visit the outpatient department. If the patient does not have any residual stone fragment, it will be reported to 'success.' Otherwise, we will measure the size of each stone of residual fragments.
Measured: postoperative 1 month
Secondary outcomes (4)
pain
Visual analogue scale will be measured: 0 (no pain) -> 10 (the most worst pain ever experienced)
Measured: postoperative 1 day
hemoglobin drop
preoperative Hb level - Hb level of immediate postoperative 1 day
Measured: postoperative 1 day
occurrence of complications
occurrence of stricture in non-contrast CT scan history taking of hematuria or fever
Measured: postoperative 1 day, and the postop 1month at OPD
hospital stay
calculation of days of hospital stay
Measured: postoperative 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startMay 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SK Telecom Consortium
- Responsible party
- Principal investigator, Hyeon Jeong, Seoul National University Hospital
- Investigators
- Sung Yong Cho, Ph.D, Study director, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067221
- Sponsor's protocol ID
- MPCNL Study
- Status last verified
- Jun 2015
- First submitted
- 12 Feb 2014
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Outcomes in the Treatment of Renal Stones Larger Than 1 Centimeters Between MPCNL and RIRS: a Single-center, Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT02067221
- Acronym / sponsor ID
- MPCNL Study
- Conditions
- Renal Stone
- Keywords
- percutaneous nephrolithotomy, renal calculi, ureteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SK Telecom Consortium
- Study start
- May 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Feb 2014 (estimated)
- 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 objective of this research is to investigate the surgical outcomes of minimally invasive percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with renal stone larger than 1cm.
Detailed description
It is pointed out that there is the disadvantage of conventional PCNL technique which showed dramatic decrease in Hb and renal damage even though it has some advantages of a short operation time and a high stone-free rate. MPCNL and RIRS has recently been considered as very efficacious methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIRS (retrograde intrarenal surgery) | Active comparator | Device: RIRSUse of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract |
| MPCNL (mini-perc) | Experimental | Device: MPCNLA new technique that reduced the size of percutaneous tract to make renal stone into small pieces. Patients will be randomized and assigned to each group at the ratio 1:1 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The person who has been diagnosed with renal stone larger than 1cm renal and who has been supposed to undergo MPCNL or RIRS.
- The person who signed up for participation and agree with intention of clinical test.
Key exclusion criteria (3 listed)
- The patient whose medical record has been omitted from database.
- The patient who has an anatomical abnormality of urinary tract and/or metabolic illness
- The patient who do not agree with the intention of the clinical study.
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 |
|---|---|---|
| RIRSAlso: retrograde intrerenal surgery* RIRS arm * Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract | Device | RIRS (retrograde intrarenal surgery) |
| MPCNLAlso: minimally invasive percuntaneous nephrolithotomy, mini-perc* MPCNL arm * A new technique that reduced the size of percutaneous tract to make renal stone into small pieces. | Device | MPCNL (mini-perc) |
Primary outcome
stone-free rate
Time frame: postoperative 1 month
We will check the non-contrast CT scan at postoperative 1month when the patient visit the outpatient department. If the patient does not have any residual stone fragment, it will be reported to 'success.' Otherwise, we will measure the size of each stone of residual fragments.
4 secondary outcomes
pain
Time frame: postoperative 1 day
hemoglobin drop
Time frame: postoperative 1 day
occurrence of complications
Time frame: postoperative 1 day, and the postop 1month at OPD
hospital stay
Time frame: postoperative 1 month
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 23 Jun 2015.
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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.
Sung Yong Cho, Ph.D study director
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIRS and MPCNL in people with Renal Stone, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 3 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 23 Jun 2015. 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 South Korea. 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 rate (time frame: postoperative 1 month). 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 23 Jun 2015.