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A Randomized Study of Minimally Invasive Percutaneous Nephrolithotomy (MPCNL) with the aid of a patented suctioning sheath in the treatment of renal calculus complicated by pyonephrosis by one surgery. BACKGROUND: Calculus pyonephrosis is difficult to manage. The aim of this study is to explore the value of a patented suctioning sheath assisted minimally invasive percutaneous nephrolithotomy (MPCNL) in the treatment of calculus pyonephrosis. METHODS: One hundred and eighty two patients with calculus pyonephrosis were randomizely divided into observation group (n = 91) and control group (n = 91). The control group was treated with MPCNL traditionally using peel-away sheath while the observation group was treated with MPCNL using the patented suctioning sheath. RESULTS: All the patients in the observation group underwent one stage surgical treatment, 14 patients in the control group underwent first-stage surgery with the rest of the group underwent one stage surgery. The complication rate was 12.1% in the observation group, significantly lower than the rate in the control group which was 51.6%; One surgery stone clearance in the observation group was 96.7% while it was 73.6% in the control group; operative time in the observation group was (54.5 ± 14.5) min, compared to (70.2 ± 11.7) min in the control group; the bleeding amount in the observation group was (126.4 ± 47.2) ml, compared to (321.6 ± 82.5) ml in the control group; the hospitalization duration for the observation group was (6.4 ± 2.3) days, compared to (10.6 ± 3.7) days in the control group. Comparison of the above indicators, the observation group was better than the control group with significant difference (p < 0.001 each). CONCLUSIONS: Minimally invasive percutaneous nephrolithotomy with the aid of the patented suctioning sheath in the treatment of calculus pyonephrosis in one surgery is economic, practical, and warrants clinical promotion. TRIAL REGISTRATION: This study was registered with Chinese Clinical Trial Registry on May 18, 2016 (retrospective registration) with a trial registration number of ChiCTR-IOR-16008490 .

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