The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Group 1 Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group |
Device: 18F Peel-Way Sheath
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath
|
Other: Group 2 Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group |
Device: 18F access sheath with a suction-evacuation function
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function
|
Outcome Measures
Primary Outcome Measures
- The renal pelvic pressure [During the procedure]
To measure the renal pelvic pressure during mini-PCNL procedure
Secondary Outcome Measures
- Perioperative complications [Intraoperatively or ≤ 1 month postoperatively]
Invaluate perioperative complications by modified Clavien system
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients consent for percutaneous renal stone removal
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Age 18 to 70 years
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Normal renal function
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ASA score Ⅰ and Ⅱ
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Renal stones 20-50mm
Exclusion Criteria:
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Patients with solitary kidney
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Uncorrected coagulopathy and active urinary tract infection (UTI)
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Morbid obese patients
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Patients who underwent transplant or urinary diversion
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Congenital abnormalities
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Patients will be excluded from the study if the undergoing standard PNL/mini-perc have purulent fluid in the initial puncture
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | 510230 |
Sponsors and Collaborators
- The First Affiliated Hospital of Guangzhou Medical University
Investigators
- Study Chair: Guohua Zeng, PH.D and M.D, The First Affiliated Hospital of Guangzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MRER(17)2016