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Background Surgical innovations, such as robotic surgery, are critical to advancing surgical care. Innovation in the absence of supporting frameworks and effective evaluation risks patient safety and may hinder efficient innovation. The adoption of robotic surgery across the United Kingdom has increased dramatically over the past decade. Its use in upper gastrointestinal surgery remains innovative and continues to evolve. In the early stages of innovation, procedures tend to be modified or refined. Modifications to procedures could be beneficial, ineffective or harmful. There is currently limited understanding of modifications, and no standardized way to report or share modifications. Ineffective reporting of modifications could prevent shared learning in evolving innovative surgical procedures. Furthermore, the National Institute for Health and Care Excellence (NICE) requires ‘major modifications’ to procedures or technologies to potentially undergo re-evaluation to establish safety and efficacy, yet classifications for types of modifications are lacking. This study aimed to examine current reporting of modifications in robotic surgery through a systematic review and qualitative case study in robotic cholecystectomy. The findings were used to develop a conceptual framework for reporting modifications in robotic surgery. Methods A systematic review was performed to identify studies on robotic cholecystectomy. Comprehensive search strategies were developed with a specialist librarian. The OVID SP version of MEDLINE and Cochrane Controlled Trials Register were searched using keywords for i) robotics and ii) cholecystectomy. Searches were limited to human studies published in the English language, up to and including April 2021. Abstracts and conference reports were excluded. Titles and abstracts of records were screened for eligibility by two reviewers with a clinical background. References of retrieved articles were manually searched to identify potentially relevant further studies. All published primary research studies reporting on robotic cholecystectomy for any indication, except biliary malignancy, were eligible for inclusion. Full-text articles were retrieved and examined for details of reporting modifications. Any data on modifications were extracted verbatim using a standardized proforma. A broad working definition of ‘modification’ was developed by the study team for the purposes of this study. Characteristics of published studies were summarized with descriptive statistics. A qualitative grounded-theory approach was taken for data analysis. Thematic analysis of the extracted data was undertaken to inductively generate themes and make comparisons across studies. Themes were organized into a conceptual framework for reporting modifications in robotic cholecystectomy. Results A total of 2,048 records were identified in total. After de-duplication of results, titles and abstracts of 1,499 records were screened, of which 1,185 were excluded. The remaining 314 records were assessed for eligibility by reviewing full-text articles, of which 219 were excluded. A total of 95 articles reporting robotic cholecystectomy were included in the analysis. The majority of studies were single-centre (n = 86, 90.5%); most were from North America (n = 43, 45.3%). Comparative studies (n = 47, 49.5%) and case series (n = 40, 42.1%) accounted for over 90% of all study types. Of the 95 studies, half (n = 48, 51%) contained data pertaining to modifications, many of which were case series (n = 27, 56.3%). Thematic analysis generated four overarching themes: ‘Descriptions of Modifications’, ‘Rationale for Modifications’, ‘Planned or Unplanned Modifications’ and ‘Outcomes of Modifications.’ These themes informed a conceptual framework for reporting modifications. Conclusions The current reporting and sharing of modifications in robotic cholecystectomy are unstandardised and inconsistent. Findings from this study have informed a proposed framework to support a more systematic approach to reporting and sharing modifications in robotic cholecystectomy. Further work is now needed to evaluate the acceptability of such a framework to surgeon innovators and its generalisability to other robotic procedures.

P-O16 A framework for reporting modifications in robotic surgery: a systematic review and case study in robotic cholecystectomy