Renal Calculi
Conditions
Keywords
Renal Pelvic Pressure
Brief summary
Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of \>20mm kidney stones. Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications. At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on. But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness. Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.
Detailed description
Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of \>20mm kidney stones. Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications. At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on. But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness. Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.
Interventions
DEVICE18F Peel-Way Sheath
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath
DEVICE18F access sheath with a suction-evacuation function
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients consent for percutaneous renal stone removal * Age 18 to 70 years * Normal renal function * ASA score Ⅰ and Ⅱ * Renal stones 20-50mm
Exclusion criteria
* Patients with solitary kidney * Uncorrected coagulopathy and active urinary tract infection (UTI) * Morbid obese patients * Patients who underwent transplant or urinary diversion * Congenital abnormalities * Patients will be excluded from the study if the undergoing standard PNL/mini-perc have purulent fluid in the initial puncture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The renal pelvic pressure | During the procedure | To measure the renal pelvic pressure during mini-PCNL procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative complications | Intraoperatively or ≤ 1 month postoperatively | Invaluate perioperative complications by modified Clavien system |
Countries
China
Contacts
Primary ContactGuohua Zeng, PH.D and M.D
Backup ContactGuangming Chen
Outcome results
None listed