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

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.

1165 Reporting Patient Selection in Robotic Cholecystectomy: Less than IDEAL? A Systematic Review

Introduction Laparoscopic cholecystectomy is the gold standard definitive treatment option for benign biliary disease. There has been increasing interest in novel robotic surgical techniques; robotic cholecystectomy (RC) represents the most recent innovation in the management of gallstones. The IDEAL Collaboration has provided guidance for the rigorous and comprehensive reporting of surgical innovations, despite this, transparency in patient selection has been limited. We aimed to assess the reporting of patient selection in studies reporting RC. Method A collaborative, systematic review was conducted in accordance with the PRISMA guidance to identify all published studies reporting RC. Study specific inclusion and exclusion criteria were detailed in a protocol. Results Searches identified 1425 abstracts; 90 papers were included for data extraction. Inclusion criteria were reported in 38 (42%) studies. The most frequently cited were age (20%), aetiology (20%), presence of symptoms (16%) and comorbidities (10%). Forty-nine (54%) studies reported exclusion criteria. Numerous and variably reported exclusion criteria were reported; acute cholecystitis (26%), previous abdominal surgery (25%), comorbidity (17%), pregnancy (13%), common bile duct stones (13%) and pancreatitis (10%) among others. Seven reported no exclusion criteria. Three reported numbers of patients who declined RC. Conclusions Patient selection criteria were inconsistently reported and when present lacked standardisation. Concern persists around patients being “cherry picked” for inclusion in studies reporting innovative robotic surgical procedures, making interpretation and applicability of results impossible. Standardised inclusion criteria are needed to enable greater transparency and reproducibility to ensure the safe adoption of new technologies into clinical practice.

1045 Summarising the Reporting of Regulatory Procedures in Robotic Cholecystectomy: A Systematic Review and Narrative Synthesis

Introduction Robotic cholecystectomy (RC) represents the most recent innovation in the management of gallstones. Whilst RC is becoming increasingly widespread, the evidence base surrounding its introduction has not been characterised. When evaluating innovative surgical techniques, adherence to regulatory and governance procedures is essential in maintaining patient safety. This study aims to appraise the reporting of studies of RC, focussing on regulatory procedures. Method Systematic searches identified all published studies reporting RC. Data collection was based on the IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) framework, and included general study characteristics, governance approvals, trial registration, study funding, conflicts of interests, and information communicated to patients. Results Systematic searches identified 1425 abstracts. Of the 90 full-text papers included, only three were randomised controlled trials. The majority (71%) were single-centre studies. Conflicts of interest were common, with 11 (12%) studies funded by the robot manufacturer, and 23 (26%) reporting conflicts related to authors. Ethical approval was confirmed in 51 (57%) studies; four reported prior registration with a register. Only forty-two studies (47%) documented obtaining patient consent for study participation. Only four documented discussions regarding the innovative nature of RC. In ten, modifications to the robot or technique were described, but it was not apparent if patients were informed of these. Conclusions This comprehensive review highlights multiple deficiencies in the reporting of regulatory procedures in the evaluation of RC. Improved reporting is required in studies of RC to ensure transparency, interpretability, and the safe, evidence-based adoption of new technologies into clinical practice.

P11 A systematic review of the reporting of robotic cholecystectomy

Introduction Robotic cholecystectomy (RC) is reported to be an innovative alternative to laparoscopic cholecystectomy for the surgical management of gallbladder disease. Perceived technical benefits of RC include enhanced ergonomic capabilities and visualisation. Whilst RC is becoming increasingly widespread, there is a paucity of high-quality data supporting its use, and conflicting evidence of outcomes in current literature. With accumulating reports citing complications associated with novel invasive procedures, experts have suggested that robust clinical evaluation is required. It is vital that techniques such as RC are evaluated consistently, in order for surgeons to fully educate patients about the treatment and obtain informed consent. This study aims to summarise and appraise the reporting of studies of RC. Methods Systematic searches identified all published studies reporting RC. Data collection was based on the IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) framework. This will be used to identify key areas of reporting including; general study characteristics, patient selection, regulatory and governance arrangements, operator and centre expertise, technique description, and outcome reporting. Because the study will not aim to draw conclusions about the effectiveness of robotic surgery, meta-analyses will not be not performed. Results Systematic searches identified 1425 abstracts; 90 full-text papers were included. Results will be summarised in a narrative synthesis and further data will be analysed prior to presentation. Conclusion This in-depth analysis of the published literature on RC will provide evidence to understand how this innovative procedure has been introduced and evaluated in relation to the IDEAL recommendations.