Comparison of Surgical Outcomes in the Treatment of Renal Stones Larger Than 1 Centimeters Between MPCNL and RIRS: a Single-center, Randomized, Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- stone-free rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
RIRS (retrograde intrarenal surgery)
Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract
Intervention: RIRS (Device)
MPCNL (mini-perc)
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
Intervention: MPCNL (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- pain(postoperative 1 day)
- hemoglobin drop(postoperative 1 day)
- occurrence of complications(postoperative 1 day, and the postop 1month at OPD)
- hospital stay(postoperative 1 month)
Investigators
Hyeon Jeong
associate professor
Seoul National University Hospital