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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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    Super-mini percutaneous nephrolithotomy (SMP) vs retrograde intrarenal surgery for the treatment of 1-2 cm lower-pole renal calculi: An international multicentre randomised controlled trial
    (Wiley, 2018) Zeng, Guohua; Zhang, Tao; Agrawal, Madhu; He, Xiang; Zhang, Wei; Xiao, Kefeng; Li, Hulin; Li, Xuedong; Xu, Changbao; Yang, Sixing; de la Rosette, Jean J. M. C. H.; Fan, Junhong; Zhu, Wei; Sarıca, Kemal
    Objectives To compare the safety and effectiveness of super-minipercutaneous nephrolithotomy (SMP) and retrograde intrarenal surgery (RIRS) for the treatment of 1-2 cm lowerpole renal calculi (LPC). Patients and Methods An international multicentre, prospective, randomised, unblinded controlled study was conducted at 10 academic medical centres in China, India, and Turkey, between August 2015 and June 2017. In all, 160 consecutive patients with 1-2 cm LPC were randomised to receive SMP or RIRS. The primary endpoint was stone-free rate (SFR). Stone-free status was defined as no residual fragments of >= 0.3 cm on plain abdominal radiograph of the kidneys, ureters and bladder, and ultrasonography at 1-day and on computed tomography at 3-months after operation. Secondary endpoints included blood loss, operating time, postoperative pain scores, auxiliary procedures, complications, and hospital stay. Postoperative follow-up was scheduled at 3 months. Analysis was by intention-totreat. The trial was registered at http://clinicaltrials. gov/ (NCT02519634). Results The two groups had similar baseline characteristics. The mean (SD) stone diameters were comparable between the groups, at 1.50 (0.29) cm for the SMP group vs 1.43 (0.34) cm for the RIRS group (P = 0.214). SMP achieved a significantly better 1-day and 3-month SFR than RIRS (1-day SFR 91.2% vs 71.2%, P = 0.001; 3-months SFR 93.8% vs 82.5%, P = 0.028). The auxiliary procedure rate was lower in the SMP group. RIRS was found to be superior with lower haemoglobin drop and less postoperative pain. Blood transfusion was not required in either group. There was no significant difference in operating time, hospital stay, and complication rates, between the groups. Conclusions SMP was more effective than RIRS for treating 1-2 cm LPC in terms of a better SFR and lesser auxiliary procedure rate. The complications and hospital stay were comparable. RIRS has the advantage of less postoperative pain.