Corresponding Author: Daniel Pucheril (

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1 PRISMA-P 2015 CHECKLIST ADMINISTRATIVE INFORMATION Title: An updated systematic review of complications following Robotic-Assisted Laparoscopic Radical Prostatectomy: A guide to avoiding and managing complications Registration: This systematic review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on ##DATE## and was last updated on ##DATE## (Registration Number:###) Authors: Daniel Pucheril MD, MBA 1 ; Logan Campbell MD 1 ; Ricarda Bauer MD 3 ; Francesco Montorsi MD 2 ; Jesse D. Sammon DO 1 ; Thorsten Schlomm MD 4 Contact: Corresponding Author: Daniel Pucheril ( [email protected]) Author Affiliations: 1. VUI Center for Outcomes Research, Analytics and Evaluation, Detroit, MI, USA 2. Department of Urology, University Vita-Salute San Raffaele, Milan, Italy 3. Department of Urology, Ludwig-Maximilians-University, Munich, Germany 4. Martini-Klinik, Prostate Cancer Center, University Medical Center Hamburg- Eppendorf, Hamburg, Germany Contributions: DP, LC, and JS drafted the manuscript. All authors read, provided feedback, and approved the final manuscript. Amendments:

2 In the event of protocol amendments, the date of each amendment will be accompanied by a description of the change and the rationale in this section. Changes will not be incorporated into the protocol. Support: Sources: Sponsor: Role of sponsor/funder: INTRODUCTION: Rationale: In 2010, an estimated 85% of radical prostatectomies performed in the United States were conducted using the robotic platform 1, and over the last several years robotic-assisted radical prostatectomy (RARP) has continued to gain in popularity and surgical preference globally. 2-5 As with any surgical procedure, it is crucial for surgeons and patients alike to be aware of rates of peri-operative complication. The last major systematic review specifically addressing perioperative complication following RARP analyzed published series up until August 2011, with rates of overall complication ranging from 3-26%. 6 Given the rapid diffusion and adoption of this technique it is valuable to periodically contemporize and collect published outcomes. Objectives: The aim of this work is to systematically review contemporary rates of complication following RARP and to provide surgeons with an evidence-based approach to avoiding and treating common complications should they occur. METHODS: Eligibility Criteria: Studies will be eligible for consideration if published after August 2011 and reporting perioperative rates of complication (excluding functional outcomes of continence and potency) following at least 100 consecutive Robotic Assisted Radical Prostatectomies. Both comparative (ex. RARP vs LRP) and noncomparative studies will be collected and considered for final inclusion. Studies

3 reporting outcomes following simple prostatectomy will not be included. Further, studies published as abstracts, reports from meetings, comments, or editorials will not be considered. Studies must be published in the English language and restricted to human male subjects. Additionally, for studies reporting outcomes from the same institution, only the most recent publication will be included. Information Sources: A systematic review of the PubMed database will be conducted with the following predefined free text search terms: robot* AND radical prostatectomy. To ensure literature saturation, reference lists of included studies will be scanned for other relevant publications which will be included if the above described eligibility criteria are met. Search Strategy: Database: PubMed Search Terms: robot* AND radical prostatectomy Date Range: 08/01/2011 to 08/31/2015 Study Records: Data management: Initial literature search results will be transferred to an EndNote library. The EndNote library will then uploaded to the Distiller Systematic Review (DSR) software. DSR is an Internet based resource that is specifically designed to facilitate team-based screening and processing of references ( DSR allows the authors to create question forms that are used at various levels of screening and data extraction. There will be three different levels: Title screening, Abstract Screening, and Data Extraction. Selection process: Two of the review authors (DP and LC) will independently screen each title at Level 1. Titles that appear consistent with the study aim will be advanced to the next level if either reviewer feels that it should be included. At Level 2, the abstracts of included titles will be reviewed to determine if the study meets the inclusion criteria. To be advanced to Level 3, both reviewers must agree that the study in questions meets inclusion criteria. Any conflicts will be resolved by JS. At Level 3, full text articles will be obtained and further scrutinized to ensure that all inclusion criteria are present. At Level 4 data will be extracted in accordance with the below noted

4 Data items: primary and secondary outcomes. At this Level, reference lists of included studies will be reviewed for other pertinent references. We will record reason for exclusion for all studies. No reviewer will be blinded to journal title or study author affiliations. Data collection process: Data will be extracted from the full text articles into DSR and from there exported to Excel for table creation. Extracted data will be verified for accuracy by author JS. Any disagreement or discrepancy will be resolved by group consenus. For each included series we will extract First Author, Institution, Number of Cases, Study Design, Overall Complication rate, Complication rate by Clavien-Dindo classification (if provided), rates of specific complications (if provided), and any stratification strategies utilized by the authors (if provided). Outcomes and prioritization: The primary outcome of interest will be overall rate of perioperative complication; secondary outcomes of interest will be rates of specific perioperative complications. Risk of bias in individual studies: All papers will be categorized according to the 2011 level of evidence for therapeutic studies. 7 Data Synthesis Data will not be synthesized for meta-analysis.

5 REFERENCES 1. Kolkata G. Results Unproven, Robotic Surgery Wins Converts. New York Times2010;Health. 2. Chang SL, Kibel AS, Brooks JD, Chung BI. The impact of robotic surgery on the surgical management of prostate cancer in the USA. BJU international. Jun 2015;115(6): Imkamp F, Herrmann TR, Tolkach Y, et al. Acceptance, Prevalence and Indications for Robot- Assisted Laparoscopy - Results of a Survey Among Urologists in Germany, Austria and Switzerland. Urologia internationalis. Jul Nishimura K. Current status of robotic surgery in Japan. Korean journal of urology. Mar 2015;56(3): Seo IY. Urologic robotic surgery in Korea: Past and present. Korean journal of urology. Aug 2015;56(8): Novara G, Ficarra V, Rosen RC, et al. Systematic review and meta- analysis of perioperative outcomes and complications after robot- assisted radical prostatectomy. European urology. Sep 2012;62(3): Howick J, Chalmers I, Glasziou P, et al. The Oxford 2011 Levels of Evidence. Oxford Centre for Evidence Based Medicine; 2011.