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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1

Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group

Group Type OTHER

18F Peel-Way Sheath

Intervention Type DEVICE

Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath

Group 2

Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group

Group Type OTHER

18F access sheath with a suction-evacuation function

Intervention Type DEVICE

Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function

Interventions

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18F Peel-Way Sheath

Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath

Intervention Type DEVICE

18F access sheath with a suction-evacuation function

Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No