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Comparison of Surgical Outcomes Between MPCNL and RIRS

Comparison of Surgical Outcomes in the Treatment of Renal Stones Larger Than 1 Centimeters Between MPCNL and RIRS: a Single-center, Randomized, Prospective Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02067221
Enrollment
70
Registered
2014-02-20
Start date
2013-05-31
Completion date
2015-02-28
Last updated
2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stone

Keywords

percutaneous nephrolithotomy, renal calculi, ureteroscopy

Brief 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.

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.

Interventions

DEVICERIRS

* RIRS arm * Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract

DEVICEMPCNL

* MPCNL arm * A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.

Sponsors

SK Telecom Consortium
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
stone-free ratepostoperative 1 monthWe 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.

Secondary

MeasureTime frameDescription
painpostoperative 1 dayVisual analogue scale will be measured: 0 (no pain) -\> 10 (the most worst pain ever experienced)
hemoglobin droppostoperative 1 daypreoperative Hb level - Hb level of immediate postoperative 1 day
occurrence of complicationspostoperative 1 day, and the postop 1month at OPDoccurrence of stricture in non-contrast CT scan history taking of hematuria or fever
hospital staypostoperative 1 monthcalculation of days of hospital stay

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026