Prospective evaluation with standardised criteria for postoperative complications after laparoendoscopic single-site surgery for upper urinary tract diseases. Francesco Grecoa*, Luca Cindolob*, Riccardo Autorinoc, Salvatore Micalid, Giampaolo Bianchid, Caterina Fanizzae, Jihad Kaoukc, Luigi Schipsb, Paolo Fornaraa a Department of Urology and renal transplantation, Martin-Luther-University, Halle/Saale, Germany b Department of Urology, “S. Pio da Pietrelcina’’ Hospital, Vasto (CH), Italy c Department of Urology, Cleveland Clinic Foundation, Cleveland, USA d Department of Urology, University of Modena, Italy e Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy Keywords: laparoendoscopic single-site surgery, renal diseases, outcomes, complications Objectives: LESS has been developed in an attempt to further reduce the morbidity and scarring associated with surgical intervention. Early clinical series have demonstrated the feasibility as well as the safe and successful completion of LESS urologic procedures. Herein, we evaluate the incidence and the risk factors of complications in a series of patients who have undergone LESS for upper urinary tract diseases. Materials and Methods: Between September 2007 and February 2011, all consecutive patients underwent LESS for upper urinary tract diseases at four institutions. Data were collected in a prospective multi-institutional database (demographic, preoperative and postoperative variables,intraoperative data, pathological reports. Also postoperative pain by VAPS at the discharge, incision length and subjective scar satisfaction were collected. All complications classified as early (onset: <30d), intermediate (onset: 31–90d), or late (onset: >90 d) occurring at any time after surgery were captured. For late complications, those deemed to be related or possibly related to LESS were captured, regardless of how long after surgery the onset occurred. All complications were recorded according to the modified Clavien classification. Results: 192 patients were enrolled (84% extripative, 16% reconstructive), mean age 55±18y, mean BMI 26.5±4.8kg/m2. The mean operative time was 164±63min (mean EBL 147±221ml). In 40% the surgeons required additional ports, with a 6% (12/192) of standard laparoscopy conversion (4 difficulties during dissection and exposure and 8 cases demanding suture). Mean hospital stay 3.3±2.3d, mean VAPS 1.7±1.43. The mean length of skin incision was 3.97± 1.33 cm. 33 complications were recorded (30 early,2 intermediate,1 late) with a 17% of overall complication rate. Statistically significant associations were found between the occurrence of a complication and age, ASA score, EBL, LOS, and malignant disease. Interestingly no associations between complications and BMI, comorbidities, kind of surgery, use of additional ports, complexity score were recorded. The univariate and the multivariate analyses confirmed that higher ASA score (IRR 1.4,CI1.0-2.1 p=0,034) and an oncological indication (IRR 2.5,CI1.3-4.7 p=0,039) represent risk factor for complications. Conclusion The LESS surgery for upper urinary tract is technically feasible for a variety of ablative and reconstructive applications, offering high patient satisfaction and shortened convalescence. With proper patient selection, conversion and complications rates are low. Further clinical research is warranted to determine selection criteria, to fully prove the benefits over conventional laparoscopy and define the role of LESS in the field of minimally invasive surgery. Nevertheless malignant disease at pathology represents a predictive factor for complication so that LESS in urologic malignancies requires a more careful selection of the patients. In these cases an additional trocar can be required and reduce the complications rate.