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    Mini percutaneous nephrolithotomy is a noninferior modality to standard percutaneous nephrolithotomy for the management of 20-40 mm renal calculi: A Multicenter randomized controlled trial
    (Elsevier, 2021) Zeng, Guohua; Cai, Chao; Duan, Xianzhong; Xun, Xu; Mao, Houping; Li, Xuedong; Nie, Yong; Xie, Jianjun; Li, Jiongming; Lu, Jun; Zou, Xiaofeng; Mok, Jianfeng; Li, Chengyang; Li, Jianzhong; Wang, Weiguo; Yu, Yonggang; Fei, Xiang; Gu, Xianen; Chen, Jianhui; Kong, Xiangbo; Pan, Jian; Zhu, Wei; Zhao, Zhijian; Wu, Wenqi; Sun, Hongling; Liu, Yongda; de la Rosette, Jean J. M. C. H.
    Background: High quality of evidence comparing mini percutaneous nephrolithotomy (mPNL) with standard percutaneous nephrolithotomy (sPNL) for the treatment of larger-sized renal stones is lacking. Objective: To compare the efficacy and safety of mPNL and sPNL for the treatment of 20–40 mm renal stones. Design, setting, and participants: A parallel, open-label, and noninferior randomized controlled trial was performed at 20 Chinese centers (2016–2019). The inclusion criteria were patients 18–70 yr old, with normal renal function, and 20–40 mm renal stones. Intervention: Percutaneous nephrolithotomy PNL was performed using either 18 F or 24 F percutaneous nephrostomy tracts. Outcome measurements and statistical analysis: The primary outcome was the one-session stone-free rate (SFR). The secondary outcomes included operating time, visual analog pain scale (VAS) score, blood loss, complications as per the Clavien-Dindo grading system, and length of hospitalization. Results and limitations: The 1980 intention-to-treat patients were randomized. The mPNL group achieved a noninferior one-session SFR to the sPNL group by the one-side noninferiority test (0.5% [difference], p < 0.001). The transfusion and embolization rates were comparable; however, the sPNL group had a higher hemoglobin drop (5.2 g/l, p < 0.001). The sPNL yielded shorter operating time (–2.2 min, p = 0.008) but a higher VAS score (0.8, p < 0.001). Patients in the sPNL group also had longer hospitalization (0.6 d, p < 0.001). There was no statistically significant difference in fever or urosepsis occurrences. The study's main limitation was that only 18F or 24F tract sizes were used. Conclusions: Mini mPNL achieves noninferior SFR outcomes to sPNL, but with reduced bleeding, less postoperative pain, and shorter hospitalization. Patient summary: We evaluated the surgical outcomes of percutaneous nephrolithotomy using two different sizes of nephrostomy tracts in a large population. We found that the smaller tract might be a sensible alternative for patients with 20–40 mm renal stones. This multicenter, parallel, open-label, and noninferior randomized controlled trial showed that mini percutaneous nephrolithotomy achieved noninferior stone-free rate with advantages of reduced blood loss, less postoperative pain, and shorter hospitalization. Mini percutaneous nephrolithotomy should be considered a sensible alternative treatment of 20–40 mm renal stones.
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    Recommended antibiotic prophylaxis regimen in retrograde intrarenal surgery: Evidence from a randomised controlled trial
    (Blackwell Publishing Ltd, 2019) Zhao, Zhijian; Fan, Junhong; Sun, Hongling; Zhong, Wen; Zhu, Wei; Liu, Yongda; Wu, Wenqi; de la Rosette, Jean J. M. C. H.; del Pilar Laguna Pes, Maria; Zeng, Guohua
    Objective: To study the incidence of postoperative systemic inflammatory response syndrome (SIRS) following different antibiotic prophylaxis (ABP) regimens in retrograde intrarenal surgery (RIRS). Patients and Methods: Single-centre, randomised, controlled trial (August 2014–September 2017) including 426 patients with renal stones with preoperative sterile urine managed by RIRS (ClinicalTrials.gov NCT02304822). Different ciprofloxacin-based ABP regimens were used and included a zero dose, single dose (30 min before surgery) or two doses (first dose at 30 min before RIRS and additional dose within 6 h after RIRS). The incidence of SIRS was compared using intention-to-treat (ITT) and per-protocol (PP) analyses. Results: Each group enrolled 142 patients. In the ITT analysis, a zero dose of ABP was statistically similar to the two ABP regimes for the incidence of SIRS (9.9% vs single dose 4.9%, P = 0.112; vs two doses 4.2%, P = 0.062). There were also no relevant differences across groups in the PP analysis; no urosepsis was recorded. In subgroup analysis with stratification by stone area, the three regimens all had a low and similar incidence of SIRS for stones of ?200 mm2 in the ITT analysis with a sufficient power value (5.4% vs 6.2% vs 3.6%, P = 0.945 vs single dose and P = 0.553 vs two doses). However, there was a greater chance of SIRS in patients who received no ABP with stones of >200 mm2 (18% vs single dose 4.3%, P = 0.036; vs two doses 5.5%, P = 0.044). Similar trends were seen in the PP analysis. Conclusions: For patients with preoperative sterile urine, ABP is not strongly recommended in patients with stones of ?200 mm2, but for stones >200 mm2 single-dose ABP is still required.

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