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OBJECTIVE: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts.SUMMARY OF BACKGROUND DATA: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence.METHODS: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory.RESULTS: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700.CONCLUSIONS: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials.ETHICAL APPROVAL: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.TRIAL REGISTRATION NUMBER: ISRCTN59036820, ISRCTN10386621.

Introduction: Innovation in surgery drives improvements to patient care. New surgical procedures and devices typically undergo a series of modifications as they are developed and refined during their introduction into clinical practice. These changes should ideally be reported and shared between surgeon-innovators to promote efficient, safe and transparent innovation. Currently, agreement on how modifications should be defined, conceptualised and classified, so they can be reported and shared efficiently and transparently, is lacking. The aim of this review is to examine and summarise existing literature on definitions, perceptions and classifications of modifications to surgical procedures/devices, including views on how to measure and report them. The findings will inform future work to standardise reporting and sharing of modifications in surgical innovation.Materials and Methods: A systematic scoping review will be conducted adhering to PRISMA-ScR guidelines. Included articles will focus on review articles and opinion pieces relevant to modifications to new surgical procedures or devices introduced to clinical practice. Methods to identify relevant literature will include systematic searches in MEDLINE (Ovid version), targeted internet searches (Google Scholar) and snowball searches. A two-stage screening process (titles/abstracts/keywords and full-texts) will use specified exclusion/inclusion criteria to identify eligible articles. Data on how modifications are i) defined, ii) perceived, and iii) classified, and iv) views on how modifications should be measured and reported, will be extracted verbatim. Inductive thematic analysis will be applied to extracted data where appropriate. Results will be presented as a narrative summary including descriptive characteristics of included articles. Findings will inform a preliminary conceptual framework to facilitate the systematic reporting and sharing of modifications to novel procedures and devices.HighlightsThis work will generate an in-depth understanding of how modifications are currently defined, perceived and classified, and views on how they may be reported, in the context of surgical innovation.Rigorous and comprehensive search methods will be applied to identify a wide range of diverse data sources for inclusion in the review.A summary of existing relevant literature on modifications is a necessary step to inform development of a framework for transparent, real-time reporting and sharing of modifications in future studies of innovative invasive procedures/devices.

The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges.To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials.To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout.A workshop to discuss and summarise the existing knowledge and to develop the new guidelines.To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect.The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial.Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS.Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space.Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.One of the best ways to prove that a new medicine really works is to use a scientific test called a ‘placebo-controlled trial’. In this type of test, half of the participants are given a new pill and the other half are given a ‘placebo’, which is a dummy pill (usually a sugar pill) that is made to taste and look the same as the active pill, but has no active ingredients. The results are then compared. Just like medicines, new surgical procedures need to be tested to show that they are safe and benefit patients. Ideally, they would also be tested using the ‘placebo-controlled trial’ approach, but asking patients to have ‘dummy’ surgery is not the same as asking people to take a dummy pill. Placebo surgery raises lots of ethics questions and is controversial. As it is controversial, guidelines are needed to recommend when placebo surgery studies can be used (if at all) and what special considerations need to be taken into account. Our research team was commissioned to develop these guidelines.We summarised, to the best of our knowledge, all previous research that had used placebo surgery and reviewed all the ethics literature on this topic. We also looked at the latest scientific understanding of how placebos work. We then held a workshop to discuss and summarise the existing knowledge and to develop the new guidelines. This involved an international team of patients, surgeons, researchers, ethicists, psychologists, physiologists and funders. We published the guidelines [i.e. the ASPIRE (Applying Surgical Placebo in Randomised Evaluations) guidelines] in an influential medical journal and also wrote several other publications. This report provides a slightly more detailed version of our findings and recommendations.The guidelines will help researchers and doctors know when, and how, to best design placebo surgery studies in the future.

OBJECTIVE: To assess the impact of type of bariatric surgery on pregnancy outcomes. STUDY DESIGN: This is a national prospective observational study using the UK Obstetric Surveillance System (UKOSS). Data collection was undertaken in 200 consultant-led NHS maternity units between November 2011 and October 2012 (gastric banding), and April 2014 and March 2016 (gastric bypass and sleeve gastrectomy). Participants were pregnant women following gastric banding (n = 127), gastric bypass (n = 134) and sleeve gastrectomy (n = 29). Maternal and perinatal outcomes were compared using generalised linear and linear mixed models. Maternal outcomes included gestational weight gain, pre-eclampsia, gestational diabetes, anaemia, surgical complications. Perinatal outcomes included birthweight, small/large for gestational age (SGA/LGA), preterm birth, stillbirth. RESULTS: Maternal: Women pregnant after gastric banding and sleeve gastrectomy had a lower risk of anaemia compared with gastric bypass (banding (16 %) vs bypass (39 %): p = 0.002, sleeve (21 %) vs bypass: p = 0.04). Gestational diabetes risk was lower after gastric banding compared with gastric bypass (7 % vs 16 %, p = 0.03) despite women with banding having significantly greater weight at booking as well as gestational weight gain. Women pregnant after gastric banding and sleeve gastrectomy had a lower risk of surgical complications than after gastric bypass (banding (0.9 %) vs bypass (11.4 %): p = 0.03, sleeve (0.0 %) vs bypass: p = 0.06). Perinatal: Infants born to mothers after gastric banding had a higher birthweight than those born to mothers after gastric bypass (mean difference = 260 g (125-395), p < 0.001). Infants were more likely to be LGA if their mothers had gastric banding compared with gastric bypass or sleeve gastrectomy (banding (21 %) vs bypass (5 %): p = 0.006; banding vs sleeve (3 %): p = 0.03). Risk of preterm birth was higher in women with gastric banding compared with gastric bypass (13 % vs 8 %, p = 0.04). CONCLUSIONS: Women planning bariatric surgery should be counselled regarding the differing impacts of different types of procedure on any future pregnancy. Pre-existing gastric bypass is associated with higher rates of potentially serious surgical complications during pregnancy.

Endoscopic sleeve gastroplasty (ESG) is a novel endoscopic procedure used to treat obesity-related comorbidities. Whilst its use is increasing in clinical practice, there is comparatively little understanding about how it has been evaluated. This study aimed to systematically summarize and appraise the reporting of ESG in the context of guidelines for evaluating innovative surgical devices and procedures. Systematic searches were used to identify all published studies reporting ESG insertion. Data collected included patient selection, governance arrangements, proceduralist expertise, technique description and outcome reporting. Searches identified 2289 abstracts; 37 full-text papers were included (one prospective comparative cohort study, 16 retrospective cohort studies, 17 prospective cohort studies and three case reports). No randomized trials were identified. Eighteen studies were conducted prospectively. The number of patients in the included studies ranged from 1 to 1000. The lower BMI limit ranged from 27 to 35 kg/m2. Research approvals were reported in 26 studies. Two studies reported on the learning curve. All studies reported some aspect of technical implementation, but many variations were noted. Suturing device used and suture pattern were the most commonly reported aspects (32 studies). Follow-up ranged from 1 to 24 months, but was 12 months or less in 28 studies. Forty-eight different outcomes were reported across all studies. The literature on ESG has demonstrated some progression in reporting and analysis and the next stage of assessment should be a randomized controlled trial to demonstrate efficacy.

Summary Interventions from randomised controlled trials can only be replicated if they are reported in sufficient detail. The results of trials can only be confidently interpreted if the delivery of the intervention was systematic and the protocol adhered to. We systematically reviewed trials of anaesthetic interventions published in 12 journals from January 2016 to September 2019. We assessed the detail with which interventions were reported, using the Consolidated Standards of Reporting Trials statement for non‐pharmacological treatments. We analysed 162 interventions reported by 78 trials in 18,675 participants. Detail sufficiently precise to replicate the intervention was reported for 111 (69%) interventions. Intervention standardisation was reported for 135 (83%) out of the 162 interventions, and protocol adherence was reported for 20 (12%) interventions. Sixty (77%) out of the 78 trials reported the administrative context in which interventions were delivered and 36 (46%) trials detailed the expertise of the practitioners. We conclude that bespoke reporting tools should be developed for anaesthetic interventions and interventions in other areas such as critical care.

IntroductionThe development of innovative invasive procedures and devices are essential to improving outcomes in healthcare. However, how these are introduced into practice has not been studied in detail. The Lotus study will follow a wide range of ‘case studies’ of new procedures and/or devices being introduced into NHS trusts to explore what information is communicated to patients, how procedures are modified over time and how outcomes are selected and reported.Methods and analysisThis qualitative study will use ethnographic approaches to investigate how new invasive procedures and/or devices are introduced. Consultations in which the innovation is discussed will be audio-recorded to understand information provision practice. To understand if and how procedures evolve, they will be video recorded and non-participant observations will be conducted. Post-operative interviews will be conducted with the innovating team and patients who are eligible for the intervention. Audio-recordings will be audio-recorded, transcribed verbatim and analysed thematically using constant comparison techniques. Video-recordings will be reviewed to deconstruct procedures into key components and document how the procedure evolves. Comparisons will be made between the different data sources.Ethics and disseminationThe study protocol has Health Research Authority (HRA) and Health and Care Research Wales approval (Ref 18/SW/0277). Results will be disseminated at appropriate conferences and will be published in peer-reviewed journals. The findings of this study will provide a better understanding of how innovative invasive procedures and/or devices are introduced into practice.

Background In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty. Methods Systematic review of MEDLINE, EMBASE, SCOPUS, Web of Science, BIOSIS, CINAHL and CENTRAL from inception to November 2020. All study designs reporting pyrocarbon proximal interphalangeal joint arthroplasty in humans were included. Data extracted included information about study characteristics, patient selection, regulatory (gaining research ethics approval) and governance issues (reporting of conflicting interests), operator and centre experience, technique description and outcome reporting. Descriptive and narrative summaries were reported. Results From 4316 abstracts, 210 full-text articles were screened. A total of 38 studies and 1434 (1–184) patients were included. These consisted of three case reports, 24 case series, 10 retrospective cohort studies and one randomised trial. Inclusion and exclusion criteria were stated in 25 (66%) studies. Most studies (n = 27, 71%) gained research ethics approval to be conducted. Six studies reported conflicting interests. Experience of operating surgeons was reported in nine (24%) and caseload volume in five studies. There was no consensus about the optimal surgical approach. Technical aspects of implant placement were reported frequently (n = 32) but the detail provided varied widely. Studies reported multiple, heterogenous outcomes. The most commonly reported outcome was range of motion (n = 37). Conclusions This systematic review identified inconsistencies in how studies describing the early use and update of an innovative procedure were reported. Incremental evidence was lacking, risking the implant being adopted without robust evaluation. This review adds to evidence highlighting the need for more rigorous evaluation of how implantable medical devices are used in practice following licencing.

Background Robot-assisted cholecystectomy (RC) has seen increasing adoption into clinical practice despite a lack of evidence to demonstrate superiority over conventional methods. Consistency in outcome selection, definition and reporting between studies is required for effective evidence synthesis and to minimise research waste. The aim of this study was to conduct an in-depth analysis of the outcomes reported in studies of RC. This work will inform the need for a core outcome set (COS). Method Systematic searches identified all published studies reporting RC, from inception to February 2020. Outcomes reported in each manuscript were recorded verbatim and categorised into domains. All outcomes were coded in duplicate. Where reported, the follow up period of each study was documented. Results Of 1425 abstracts screened, ninety studies met the criteria for inclusion. A total of 878 outcomes were reported. Each study included a median of 8 outcomes (range 3-26). Outcome selection was heterogeneous, with those relating to technical/operative factors (n = 383, 88 studies), complications (n = 245, 81 studies) and health economics (n = 139, 72 studies) used most frequently. No single outcome, or outcome domain, was reported in all studies. Only 30 studies reported a follow-up period, which ranged from 14 days to 46 months. In thirteen, the follow-up was for less than or equal to one month. Conclusions We identified significant heterogeneity in the selection and reporting of outcomes in studies of RC and support calls for standardisation and development of a COS.

Aim The General Medical Council (GMC) requires all newly qualified doctors to be competent in certain surgical skills, including the provision of basic wound closure. Yet there is a profound lack of undergraduate competence in, and exposure to, basic surgical skills such as wound closure. The Surgical Skills Day (SSD) aimed to provide medical students with additional skills training. Method Student self-assessment and instructors’ assessment forms were completed prior to and following a workshop on basic wound closure skills. Paired t-tests were used to statistically compare the two pre- and post-instruction data sets. Results A total of 46 students attended the SSD; 29 consented to the skills assessment. 100% (n = 29) self-reported improved competency in at least one of the skills following tuition (p Conclusions Current clinical teaching in basic suturing is unsuitable for long term retention. SSDs can improve skills acquisition and elevate student confidence. This data builds on our previous work by documenting the high efficacy in skills acquisition as a result of SSD tuition. We recommend that SSDs be integrated into medical school curricula in order to address shortcomings in current undergraduate programmes.

Older adults undergoing emergency abdominal surgery have significantly poorer outcomes than younger adults. For those who survive, the level of care required on discharge from hospital is unknown and such information could guide decision-making. The ELF (Emergency Laparotomy and Frailty) study aimed to determine whether preoperative frailty in older adults was associated with increased dependence at the time of discharge.The ELF study was a UK-wide multicentre prospective cohort study of older patients (65 years or more) undergoing emergency laparotomy during March and June 2017. The objective was to establish whether preoperative frailty was associated with increased care level at discharge compared with preoperative care level. The analysis used a multilevel logistic regression adjusted for preadmission frailty, patient age, sex and care level.A total of 934 patients were included from 49 hospitals. Mean(s.d.) age was 76·2(6·8) years, with 57·6 per cent women; 20·2 per cent were frail. Some 37·4 per cent of older adults had an increased care level at discharge. Increasing frailty was associated with increased discharge care level, with greater predictive power than age. The adjusted odds ratio for an increase in care level was 4·48 (95 per cent c.i. 2·03 to 9·91) for apparently vulnerable patients (Clinical Frailty Score (CFS) 4), 5·94 (2·54 to 13·90) for those mildly frail (CFS 5) and 7·88 (2·97 to 20·79) for those moderately or severely frail (CFS 6 or 7), compared with patients who were fit.Over 37 per cent of older adults undergoing emergency laparotomy required increased care at discharge. Frailty scoring was a significant predictor, and should be integrated into all acute surgical units to aid shared decision-making and discharge planning.Los adultos mayores sometidos a cirugía abdominal de urgencia tienen resultados significativamente peores que los adultos jóvenes. Para aquellos pacientes que sobreviven, el nivel de atención que requieren tras el alta hospitalaria se desconoce y esta información podría servir de guía en la toma de decisiones. El estudio ELF (Emergency Laparotomy and Frailty) tenía como objetivo determinar si la fragilidad preoperatoria en adultos mayores se asociaba con un aumento de la dependencia en el momento del alta. MÉTODOS: El estudio ELF era un estudio multicéntrico extenso efectuado en el Reino Unido (n = 49) que incluyó una cohorte prospectiva de 934 pacientes mayores ( 65 años) sometidos a laparotomía de urgencia durante marzo-junio de 2017. El objetivo fue establecer si la fragilidad preoperatoria aumentaba el nivel de asistencia en el momento del alta en comparación con el nivel de asistencia preoperatorio. Para el análisis se utilizó una regresión logística multinivel ajustada a características previas al ingreso: fragilidad, edad del paciente, género, y nivel de asistencia.La edad media de los pacientes fue 76,2 años (DE = 6,83), con un 57% de mujeres, un 20,2% de pacientes frágiles y un 37,4% de adultos mayores que presentaron un aumento en el nivel de asistencia en el momento del alta. Un aumento de la fragilidad se asoció con un incremento en el nivel de asistencia en el momento del alta (y mayor poder predictivo que la edad). La razón de oportunidades (odds ratio, OR) ajustada por el aumento del nivel de asistencia fue 4,48 (i.c. del 95% 2,03-9,91) para pacientes aparentemente vulnerables (Clinical Frailty Scale, CFS 4); 5,94 (i.c. del 95% 2,54-13,90) para aquellos ligeramente frágiles (CFS 5); y 7,88 (i.c. del 95% 2,97-20,79) para aquellos con fragilidad moderada o grave (CFS 6 and 7) en comparación con pacientes en buenas condiciones. CONCLUSIÓN: Este es el primer estudio que documenta que más del 37% de adultos mayores sometidos a laparotomía de urgencia precisaron un aumento en el nivel de asistencia en el momento del alta. La evaluación de la fragilidad debería integrarse en todas las unidades quirúrgicas de agudos para ayudar a compartir la toma de decisiones y los planes de tratamiento.

AIM Abdominal surgery sometimes necessitates the creation of a stoma, which can cause future complications including parastomal hernia (PSH), an incisional hernia adjacent to and related to the stoma. PSH affects approximately 40% of patients within 2 years of stoma formation. Complications of PSH reduce a patient's quality of life and can be severe (e.g. bowel obstruction). PSHs are difficult to manage and can recur after surgical repair. Therefore, it is very important to prevent a PSH. Surgeons create stomas in different ways and both patient and surgical factors are believed to influence the development of PSH. The aim of the CIPHER study is to investigate the influence of different surgical techniques on the development of PSH. METHOD The UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study) aims to recruit 4000 patients undergoing elective or expedited surgery with the intention of forming an ileostomy or colostomy, irrespective of the primary indication for the planned surgery. For each patient, surgeons will describe their methods of trephine formation, mesh reinforcement of the stoma trephine, use of the stoma as a specimen extraction site and wound closure. The primary outcome will be incident PSH during follow-up, defined as symptoms of PSH (custom-designed questionnaire) and anatomical PSH, ascertained by independent reading of usual care CT scans. Secondary outcomes will include surgical site infection, the Comprehensive Complication Index, quality of life (EQ-5D-5L and SF-12), PSH repair and use of NHS resources. RESULTS Results of the study will be submitted for publication in peer-reviewed journals. All publications relating to the results of CIPHER will use a corporate authorship, 'The CIPHER Study Investigators' with named writing committee members. CONCLUSION The CIPHER study will be the first to investigate detailed surgical methods of stoma formation in a large, representative cohort of patients with a range of primary indications, both cancer and noncancer.

ObjectivesCOVID-19 presents a risk of infection and transmission for operating theatre teams. Guidelines to protect patients and staff emerged and changed rapidly based on expert opinion and limited evidence. This paper presents the experiences and innovations developed by international surgical teams during the early stages of the pandemic to attempt to mitigate risk.DesignIn-depth, semistructured interviews were audio recorded, transcribed and analysed thematically using methods of constant comparison.Participants43 participants, including surgeons from a range of specialties (primarily general surgery, otolaryngology, neurosurgery, cardiothoracic and ophthalmology), anaesthetists and those in nursing roles.SettingThe UK, Italy, Spain, the USA, China and New Zealand between March and May 2020.ResultsSurgical teams sought to mitigate COVID-19 risks by modifying their current practice with an abundance of strategies and innovations. Communication and teamwork played an integral role in how teams adapted, although participants reflected on the challenges of having to improvise in real time. Uncertainties remained about optimal surgical practice and there were significant tensions where teams were forced to balance what was best for patients while contemplating their own safety.ConclusionsThe perceptions of risks during a pandemic such as COVID-19 can be complex and context dependent. Management of these risks in surgery must be driven by evidence‐based practice resulting from a pragmatic and novel approach to collation of global evidence. The context of surgery has changed dramatically, and surgical teams have developed a plethora of innovations. There is an urgent need for high-quality evidence to inform surgical practice that optimises the safety of both patients and healthcare professionals as the COVID-19 pandemic unfolds.

IntroductionSurgery to remove the gallbladder (laparoscopic cholecystectomy (LC)) is the standard treatment for symptomatic gallbladder disease. One potential complication of gallbladder disease is that gallstones can pass into the common bile duct (CBD) where they may remain dormant, pass spontaneously into the bowel or cause problems such as obstructive jaundice or pancreatitis. Patients requiring LC are assessed preoperatively for their risk of CBD stones using liver function tests and imaging. If the risk is high, guidelines recommend further investigation and treatment. Further investigation of patients at low or moderate risk of CBD stones is not standardised, and the practice of imaging the CBD using magnetic resonance cholangiopancreatography (MRCP) in these patients varies across the UK. The consequences of these decisions may lead to overtreatment or undertreatment of patients.Methods and analysisWe are conducting a UK multicentre, pragmatic, open, randomised controlled trial with internal pilot phase to compare the effectiveness and cost-effectiveness of preoperative imaging with MRCP versus expectant management (ie, no preoperative imaging) in adult patients with symptomatic gallbladder disease undergoing urgent or elective LC who are at low or moderate risk of CBD stones. We aim to recruit 13 680 patients over 48 months. The primary outcome is any hospital admission within 18 months of randomisation for a complication of gallstones. This includes complications of endoscopic retrograde cholangiopancreatography for the treatment of gallstones and complications of LC. This will be determined using routine data sources, for example, National Health Service Digital Hospital Episode Statistics for participants in England. Secondary outcomes include cost-effectiveness and patient-reported quality of life, with participants followed up for a median of 18 months.Ethics and disseminationThis study received approval from Yorkshire & The Humber – South Yorkshire Research Ethics Committee. Results will be submitted for publication in a peer-reviewed journal.Trial registration numberISRCTN10378861.

Objective To explore optimum use of the Odon Device by establishing the optimal device design, describing the ‘usual’ steps for use and setting clinical parameters for device use. Design Qualitative case study methodology was embedded in the ASSIST Study – a feasibility study of the Odon Device. Setting Central Delivery Suite, North Bristol NHS Trust, UK. Population Women who required a clinically indicated assisted vaginal birth. Methods Each case was determined by the single use of the Odon Device and could contain data from one or more of the following: formal observation of the Odon assisted birth, an interview with obstetricians, midwives or women involved in an Odon assisted birth. Data collection and analysis ran iteratively and in parallel enabling rapid dissemination of findings. Main outcome measures Determining the optimal steps for device use, recommendations for optimal device design and defining clinical parameters for device use. Results Optimal steps included applying the device during rather than between contractions, having a flexible approach to the application angle and deflating the air cuff sooner than originally proposed. Three design modifications were proposed. The device can be used under local or regional anaesthetic and is successful with all vertex presentations. It is not successful at assisting birth when the vertex is at station spines. Conclusions Case study methodology facilitated rapid insight into optimum device design, device use and key clinical parameter for successful use. This methodology should be considered whenever innovative devices are introduced to clinical trials and settings.

Introduction Diagnosing appendicitis remains challenging, despite being the most common surgical emergency. We conducted a single-centre mixed method quality improvement project to assess the validity of a diagnostic algorithm for appendicitis and the diagnostic impact of increasing cross-sectional imaging during the Covid-19 pandemic. Method Adult histology reports and preoperative imaging data were retrospectively retrieved for patients operated on between 1/7/19-31/12/19 (‘baseline data’) and an appendicitis diagnostic algorithm was developed. Imaging and risk stratification data were prospectively collected, as part of a national audit, between 20/03/30-23/6/20 for all adult appendicitis patients. This data was used to evaluate the efficacy of the proposed diagnostic algorithm. Use of imaging and histological diagnoses was compared between datasets. Results 194 patients were included across both time periods. The rate of cross-sectional imaging increased from 36.6% to 76% and the normal appendicectomy rate (NAR) decreased from 5.22% to 2.4%. Thirty-six percent of patients in the latter time period were not managed in accordance with the proposed algorithm. The proposed diagnostic algorithm may have prevented up to 87.5% of normal appendicectomies across both time periods. Conclusions Increasing cross-sectional imaging was associated with a decrease in the NAR. The use of the proposed diagnostic algorithm may have reduced the NAR further.

Background Innovation in surgery is growing. The rigour of reporting of innovation must therefore be examined to ensure evaluations are thorough and transparent. The Idea, Development, Exploration, Assessmemt, Long-term follow-up (IDEAL) framework was developed in 2009 to help researchers evaluate innovative procedures. However, it is not known whether the IDEAL principles have been adopted into the reporting of robotic surgery. The aim of this study is to identify and summarise published literature for robotically assisted anti-reflux surgery, to understand whether evaluations are being performed in a robust way. Methods Systematic literature searches were undertaken to identify studies relating to robotic anti-reflux surgery. All primary research studies pertaining to robotically-assisted surgery for adults with symptomatic gastro-oesophageal reflux disease were included. Studies examining multiple interventions, where the outcomes could not be separated, were excluded. Data will be doubly extracted using tailored online forms. Data extraction themes include: study characteristics, technique description and evolution, governance/ethical factors and outcome reporting. Data will be synthesised into tables and summarised in a narrative synthesis. A meta-analysis will not be performed as we aim to examine reporting, rather than the efficacy of robotically-assisted anti-reflux surgery. Results 824 abstracts were identified, of which 80 were included for full text review. Summarised data will be used to propose a standard of reporting which will inform future work in the field. Conclusion The findings will feed in to the other six arms of RoboSurg to examine reporting in robotic upper gastrointestinal surgery more generally.

Introduction The process of innovation in the field of surgery has largely resulted in improved patient outcomes. However, the uncertainty around the potential benefits and harms of innovative procedures mean that both research governance and ethics are important considerations for those who innovate. Though the need for ethical approval is standardised, other patient safeguards are surgeon and procedure dependent, such as the information provided during the consent procedure. It is currently unknown how ethical considerations in innovative surgery have been reported. This systematic review aims to evaluate the reporting of governance arrangements and ethical safeguards applied to innovative surgical procedures, using a case study of robotic upper gastrointestinal surgery. Methods The RoboSurg collaboration is conducting a set of systematic reviews to evaluate reports of innovative robotic surgical procedures including: pancreatectomies, gastrectomies, Roux-en-Y gastric bypasses, oesophagectomies, liver resections, cholecystectomies and anti-reflux operations. Databases were searched in April 2020 using relevant search terms including ‘oesophagectomy’ and ‘robotics’. Data extracted include details of approvals from Institutional Review Boards, ethics committees and clinical effectiveness groups, a priori study registration, and patient consent. Results Interim results for the reporting of governance arrangements and ethical safeguards from studies detailing robotic oesophagectomies will be presented. The search yielded 1908 abstracts for screening, of which 101 were included. The proportion of studies reporting on each ethical safeguard for patients undergoing this innovative procedure will be described and summarised. Conclusion This review will evaluate how governance and ethical safeguards in studies of innovative surgical procedures have been reported.

BACKGROUND: Acute appendicitis is the most common surgical emergency in children. Differentiation of acute appendicitis from conditions that do not require operative management can be challenging in children. This study aimed to identify the optimum risk prediction model to stratify acute appendicitis risk in children. METHODS: We did a rapid review to identify acute appendicitis risk prediction models. A prospective, multicentre cohort study was then done to evaluate performance of these models. Children (aged 5-15 years) presenting with acute right iliac fossa pain in the UK and Ireland were included. For each model, score cutoff thresholds were systematically varied to identify the best achievable specificity while maintaining a failure rate (ie, proportion of patients identified as low risk who had acute appendicitis) less than 5%. The normal appendicectomy rate was the proportion of resected appendixes found to be normal on histopathological examination. FINDINGS:15 risk prediction models were identified that could be assessed. The cohort study enrolled 1827 children from 139 centres, of whom 630 (34·5%) underwent appendicectomy. The normal appendicectomy rate was 15·9% (100 of 630 patients). The Shera score was the best performing model, with an area under the curve of 0·84 (95% CI 0·82-0·86). Applying score cutoffs of 3 points or lower for children aged 5-10 years and girls aged 11-15 years, and 2 points or lower for boys aged 11-15 years, the failure rate was 3·3% (95% CI 2·0-5·2; 18 of 539 patients), specificity was 44·3% (95% CI 41·4-47·2; 521 of 1176), and positive predictive value was 41·4% (38·5-44·4; 463 of 1118). Positive predictive value for the Shera score with a cutoff of 6 points or lower (72·6%, 67·4-77·4) was similar to that of ultrasound scan (75·0%, 65·3-83·1). INTERPRETATION: The Shera score has the potential to identify a large group of children at low risk of acute appendicitis who could be considered for early discharge. Risk scoring does not identify children who should proceed directly to surgery. Medium-risk and high-risk children should undergo routine preoperative ultrasound imaging by operators trained to assess for acute appendicitis, and MRI or low-dose CT if uncertainty remains. FUNDING: None.

Background There are a variety of surgical and endoscopic interventions available to treat gastroesophageal reflux disease. There is, however, no consensus on which approach is best. The aim of this national audit is to describe the current variation in the UK clinical practice in relation to anti-reflux surgery (ARS) and to report adherence to available clinical guidelines. Methods This national audit will be conducted at centers across the UK using the secure online web platform ALEA. The study will comprise two parts: a registration questionnaire and a prospective multicenter audit of ARS. All participating centers will be required to complete the registration questionnaire comprising details regarding pre-, peri-, and post-operative care pathways and whether or not these are standardized within each center. Following this, a 12-month multicenter prospective audit will be undertaken to capture data including patient demographics, predominant symptoms, preoperative investigations, surgery indication, intraoperative details, and postoperative outcomes within the first 90 days. Local teams will retain access to their own data to facilitate local quality improvement. The full dataset will be reported at national and international scientific congresses and will contribute to peer-reviewed publications and national quality improvement initiatives. Conclusions This study will identify and explore variation in the processes and outcomes following ARS within the UK using a collaborative cohort methodology. The results generated by this audit will facilitate local and national quality improvement initiatives and generate new possibilities for future research in anti-reflux interventions.

ObjectivesLittle is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures.DesignQualitative study involving semi-structured interviews. Interviews were audio recorded, transcribed and analysed thematically.Participants42 interviews were conducted (26 surgeons and 16 governance representatives).SettingSurgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK.ResultsParticipants stated that if a procedure was innovative, patients should be provided with additional information extending beyond that given during routine surgical consultations. However, difficulty defining innovation had implications for whether patients were informed about novel components of surgery and how the procedure was introduced (ie, as part of a research study, trust approval or in routine clinical practice). Furthermore, data suggest surgeons found it difficult to establish what information is essential and how much detail is sufficient, and governance surrounding written and verbal information provision differed between NHS Trusts. Generally, surgeons believed patients held a view that ‘new’ was best and reported that managing these expectations could be difficult, particularly if patient views aligned with their own.ConclusionsThis study highlights the challenges of information provision and obtaining informed consent in the context of innovative surgery, including establishing if and how a procedure is truly innovative, determining the key information to discuss with patients, ensuring information provision is objective and balanced, and managing patient expectations and preferences. This suggests that surgeons may require support and training to discuss novel procedures with patients. Further work should capture consultations where new procedures are discussed with patients and patients’ views of these information exchanges.

Highlights • Reporting standards of device RCTs are vital, ensuring correct implementation. • Assisted vaginal birth interventions are complex and use devices to achieve birth. • Reporting standards of assisted vaginal birth trials lack detail or clarity. • Clearer reporting standards guidelines must be produced, ensuring transparent findings., Objective Assisted vaginal birth (AVB) is a complex intervention involving medical devices, comprising multiple components. This complexity creates difficulties when designing and conducting randomised controlled trials (RCTs), in terms of describing, standardising and monitoring the intervention, and accounting for differing clinician expertise. This review examines the reporting standards of complex interventions involving a medical device, in the context of AVB RCTs. Study design Searches were undertaken from the start of indexing to March 2021, and limited to RCTs, feasibility and pilot studies including at least one device for AVB. RCTs were selected if they included participants having an AVB with any device, with or without a comparator group. Reporting details were assessed according to the Consolidating Standards of Reporting Trials extension for non-pharmacological treatments (CONSORT-NPT), focusing on intervention descriptions, standardization, adherence and clinician expertise. Screening of abstracts, full-text articles and data extraction was performed by two independent reviewers. Results Of 4098 abstracts and 83 full-text articles, 39 papers were included, investigating 80 interventions. Twenty-seven different named devices were identified. Intervention descriptions were provided in 20 (55%) papers with varying levels of detail and with only one covering the entire procedure. Standardization of interventions was mentioned in 25 papers (64%). Only eight (21%) papers reported any form of adherence to the intended procedure. Some data regarding expertise were reported in 25 (64%) papers. Conclusions Despite some compliance with reporting standards, there is a lack of detail regarding intervention description, standardization, adherence and expertise in RCTs of AVB. This creates difficulties in understanding how intervention delivery was intended and what actually occurred. Clearer guidelines for the reporting of invasive procedures and devices are required.

IntroductionThe number of laparoscopic liver resections undertaken has increased. However, lesions located postero-superiorly are difficult to access. This may be overcome by the novel use of transthoracic port(s). Methods for the safe and transparent introduction of new and modified surgical procedures are limited and a summary of these issues, for minimally invasive trans thoracic liver resections (MITTLR), is lacking. This study aims to understand and summarize technique description, governance procedures and reporting of outcomes for MITTLR.MethodsA systematic literature search to identify primary studies of all designs describing MITTLR was undertaken. How patients were selected for the new technique was examined. The technical components of MITTLR were identified and summarized to understand technique development over time. Governance arrangements (e.g. IRB approval) and steps taken to mitigate harm were recorded. Finally, specific outcomes reported across studies were documented.ResultsOf 2067 83 screened articles, 16 were included reporting data from 145 patients and six countries. Selection criteria for patients was explicitly stated in two papers. No studies fully described the technique. Five papers reported ethical approval and three gave details of patient consent. No study reported on steps taken to mitigate harm. Technical outcomes were commonly reported e.g. blood loss (15/16 studies), operative time (15/16) and margin status (11/16). Information on patient reported outcomes and costs werelacking.ConclusionsTechnical details and governance procedures were poorly described. Outcomes focussed on short term details alone. Transparency is needed for reporting the introduction of new surgical techniques to allow their safe dissemination

BackgroundThe General Medical Council (GMC) requires all newly qualified doctors to be competent in certain surgical skills, including the provision of basic wound closure. Yet there is a profound lack of undergraduate competence in, and exposure to, basic surgical skills such as wound closure. The Surgical Skills Day (SSD) aimed to provide medical students with additional skills training.MethodsStudent self-assessment and instructors’ assessment forms were completed prior to and following a workshop on basic wound closure skills. Paired t-tests was used to statistically compare the two pre and post-instruction data sets.ResultsA total of 46 students attended the SSD; 29 consented to the skills assessment. 100% (n = 29) self-reported improved competency in at least one of the skills following tuition (p < 0.001). Instructors’ assessment agreed that 100% (n = 29) of students improved in at least one of the skills assessed (p < 0.001). 100% of the attendees agreed that additional practical surgical skills should be incorporated into the undergraduate curriculum. 64% (n = 21) of students also confirmed that they were more likely to pursue a career in surgery following the SSD.ConclusionCurrent clinical teaching in basic suturing is unsuitable for long term retention. SSDs can improve skills acquisition and elevate student confidence. This data builds on our previous work by documenting the high efficacy in skills acquisition as a result of SSD tuition. We recommend that SSDs be integrated into medical school curricula in order to address shortcomings in current undergraduate programmes.

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.

Objectives To examine key methodological considerations for using a placebo intervention in randomized controlled trials (RCTs) evaluating invasive procedures, including surgery. Study Design and Setting RCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to December 31, 2017, were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, by handsearching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centers) and key methodological (rationale for using placebos, minimization of risk, information provision, offering the treatment intervention to patients randomized to placebo, delivery of cointerventions, and intervention standardization and fidelity) were extracted and summarized descriptively. Results One hundred thirteen articles reporting 96 RCTs were identified. Most were conducted in gastrointestinal surgery (n = 40, 42%) and evaluated minimally invasive procedures (n = 44, 46%). Over two-thirds randomized fewer than 100 patients (n = 65, 68%) and a third were single center (n = 31, 32%). A third (n = 33, 34%) did not report a rationale for using a placebo. Most common strategies to minimize patient risk were operator skill (n = 22, 23%) and independent data monitoring (n = 28, 29%). Provision of patient information regarding placebo use was infrequently reported (n = 11, 11%). Treatment interventions were offered to patients randomized to placebo in 43 trials (45%). Cointerventions were inconsistently reported, but 64 trials (67%) stated that anesthesia was matched between groups. Attempts to standardize interventions and monitor their delivery were reported in n = 7, (7%) and n = 4, (4%) trials, respectively. Conclusion Most placebo-controlled trials in surgery evaluate minor surgical procedures and currently there is inconsistent reporting of key trial methods. There is a need for guidance to optimize the transparency of trial reporting in this area.

Background Placebo‐controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In‐depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs. Methods A preliminary framework was developed using published literature to: expand the scope of an existing typology, which facilitates the deconstruction of invasive interventions; and identify placebo optimization strategies. The framework was refined after consultation with key stakeholders in surgical trials, consensus methodology and medical ethics. Results The resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co‐interventions; identify critical surgical element(s); take out the critical element(s); think risk, feasibility and role of placebo in the trial when considering remaining components; and optimize placebo to ensure effective blinding of patients and trial personnel. Conclusion DITTO considers invasive placebo composition systematically, accounting for risk, feasibility and placebo optimization. Use of the framework can support the design of high‐quality RCTs, which are needed to underpin delivery of healthcare interventions., There are challenges in RCTs of invasive interventions with a placebo control. The DITTO framework outlines five stages to optimize invasive placebo design and delivery: deconstruction of the treatment intervention, identification (and removal) of the critical surgical element from the proposed placebo, consideration of risk, feasibility and the role of the placebo in the RCT, and optimization of placebo delivery to ensure effective blinding of patients and trial personnel. DITTO will be useful

IntroductionThe application of artificial intelligence (AI) technologies as a diagnostic aid in healthcare is increasing. Benefits include applications to improve health systems, such as rapid and accurate interpretation of medical images. This may improve the performance of diagnostic, prognostic and management decisions. While a large amount of work has been undertaken discussing the role of AI little is understood regarding the performance of such applications in the clinical setting. This systematic review aims to critically appraise the diagnostic performance of AI algorithms to identify disease from cross-sectional radiological images of the abdominopelvic cavity, to identify current limitations and inform future research.Methods and analysisA systematic search will be conducted on Medline, EMBASE and the Cochrane Central Register of Controlled Trials to identify relevant studies. Primary studies where AI-based technologies have been used as a diagnostic aid in cross-sectional radiological images of the abdominopelvic cavity will be included. Diagnostic accuracy of AI models, including reported sensitivity, specificity, predictive values, likelihood ratios and the area under the receiver operating characteristic curve will be examined and compared with standard practice. Risk of bias of included studies will be assessed using the QUADAS-2 tool. Findings will be reported according to the Synthesis Without Meta-analysis guidelines.Ethics and disseminationNo ethical approval is required as primary data will not be collected. The results will inform further research studies in this field. Findings will be disseminated at relevant conferences, on social media and published in a peer-reviewed journal.PROSPERO registration numberCRD42021237249.

Objectives This study aimed to explore variations in the provision of integrated academic surgical training across the UK. Design This is an online cross-sectional survey (consisting of 44 items with a range of free-text, binomial and 5-point Likert scale responses) developed by the Association of Surgeons in Training. Setting A self-reported survey instrument was distributed to academic surgical trainees across the UK (n=276). Participants 143 (51.9%) responses were received (81% male, median age: 34 years), spanning all UK regions and surgical specialties. Of the 143 trainees, 29 were core trainees (20.3%), 99 were specialty trainees (69.2%) and 15 (10.5%) described themselves as research fellows. Results The structure of academic training varied considerably, with under a third of trainees receiving guaranteed protected time for research. Despite this, however, 53.1% of the respondents reported to be satisfied with how their academic training was organised. Covering clinical duties during academic time occurred commonly (72.7%). Although most trainees (n=88, 61.5%) met with their academic supervisor at least once a month, six (4.2%) never had an academic supervisory meeting. Most trainees (n=90, 62.9%) occupied a full-time rota slot and only 9.1% (n=13) described their role as ‘supernumerary’. Although 58.7% (n=84) of the trainees were satisfied with their clinical competence, 37.8% (n=54) felt that clinical time focused more on service provision than the acquisition of technical skills. 58 (40.6%) had experienced some form of negative sentiment relating to their status as an academic trainee. Conclusions Integrated academic training presents unique challenges and opportunities within surgery. This survey has identified variation in the quality of current programmes, meaning that the future provision of integrated surgical academic training should be carefully considered.

Background The evidence for treatment decision‐making in emergency general surgery has not been summarized previously. The aim of this overview was to review the quantity and quality of systematic review evidence for the most common emergency surgical conditions. Methods Systematic reviews of the most common conditions requiring unplanned admission and treatment managed by general surgeons were eligible for inclusion. The Centre for Reviews and Dissemination databases were searched to April 2014. The number and type (randomized or non‐randomized) of included studies and patients were extracted and summarized. The total number of unique studies was recorded for each condition. The nature of the interventions (surgical, non‐surgical invasive or non‐invasive) was documented. The quality of reviews was assessed using the AMSTAR checklist. Results The 106 included reviews focused mainly on bowel conditions (42), appendicitis (40) and gallstone disease (17). Fifty‐one (48·1 per cent) included RCTs alone, 79 (74·5 per cent) included at least one RCT and 25 (23·6 per cent) summarized non‐randomized evidence alone. Reviews included 727 unique studies, of which 30·3 per cent were RCTs. Sixty‐five reviews compared different types of surgical intervention and 27 summarized trials of surgical versus non‐surgical interventions. Fifty‐seven reviews (53·8 per cent) were rated as low risk of bias. Conclusion This overview of reviews highlights the need for more and better research in this field., Evidence still limited

Background: Surgical site infections (SSIs) are the third most common hospital-associated infection and can lead to significant patient morbidity and healthcare costs. Identification of SSIs is key to surveillance and research but reliable assessment is challenging, particularly after hospital discharge when most SSIs present. Existing SSI measurement tools have limitations and their suitability for post-discharge surveillance is uncertain. Aims: This study aimed to develop a single measure to identify SSI after hospital discharge, suitable for patient or observer completion. Methods: A three-phase mixed methods study was undertaken: Phase 1, an analysis of existing tools and semi-structured interviews with patients and professionals to establish the content of the measure; Phase 2, development of questionnaire items suitable for patients and professionals; Phase 3, pre-testing the single measure to assess acceptability and understanding to both stakeholder groups. Interviews and pre-testing took place over 12 months in 2014–2015 with patients and professionals from five specialties recruited from two UK hospital Trusts. Findings: Analyses of existing tools and interviews identified 19 important domains for assessing SSIs. Domains were developed into provisional questionnaire items. Pre-testing and iterative revision resulted in a final version with 16 items that were understood and easily completed by patients and observers (healthcare professionals). Conclusion: A single patient and observer measure for post-discharge SSI assessment has been developed. Further testing of the validity, reliability and accuracy of the measure is underway.

IntroductionThere is significant variation in how anaesthesia is defined and reported in clinical research. This lack of standardisation complicates the interpretation of published evidence and planning of future clinical trials. This systematic review will assess the reporting of anaesthesia as an intervention in randomised controlled trials (RCT) against the Consolidated Standards of Reporting Trials for Non-Pharmacological Treatments (CONSORT-NPT) framework.Methods and analysisOnline archives of the top six journals ranked by impact factor for anaesthesia and the top three general medicine and general surgery journals will be systematically hand searched over a 42-month time period to identify RCTs describing the use of anaesthetic interventions for any invasive procedure. All modes of anaesthesia and anaesthesia techniques will be included. All study data, including the type of anaesthetic intervention described, will be extracted in keeping with the CONSORT-NPT checklist. Descriptive statistics will be used to summarise general study details including types/modes of anaesthetic interventions, and reporting standards of the trials.Ethics and disseminationNo ethical approval is required. The results will be used to inform a funding application to formally standardise general, local, regional anaesthesia and sedation for use in clinical research. The systematic review will be disseminated via peer-reviewed manuscript and conferences.PROSPERO registration numberCRD42019141670.

IntroductionSurgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life.Methods and analysisWe will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery.Ethics and disseminationThis study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal.Trial registration numberNCT10386621.

Background The Odon Device™ is a new device for assisted vaginal birth that employs an air cuff around the fetal head for traction. Assisted vaginal birth (AVB) is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for AVB (forceps and ventouse) are often not used in settings where there is most clinical need often due to lack of training and resources, resulting in maternal and neonatal morbidity and mortality which could have been prevented. This is often due to a lack of trained operators as well as difficulties in the sterilisation and maintenance of AVB devices. This novel, single use device has the potential to mitigate these difficulties as it is single use and is potentially simpler to use than forceps and ventouse. All the studies of the Odon Device to date (pre-clinical, preliminary developmental and clinical) suggest that the Odon Device does not present a higher risk to mothers or babies compared to current standard care, and recruitment to intrapartum research exploring the device is feasible and acceptable to women. The first study in which the Odon Device was used in clinically indicated conditions (the ASSIST Study) reported a lower efficacy than those reported with established devices. The reasons need to be explored, specifically focussing on learning curve, the technique of the doctors using this new device and potential modifications to device design. A follow-on clinical study to further investigate the efficacy and safety of the Odon Device in its indicated use, the ASSIST II Study, is therefore being undertaken. Methods The primary feasibility outcome is study feasibility (recruitment and retention rates) whilst the primary clinical outcome successful vaginal birth completed with the Odon Device. Key secondary feasibility outcomes include participant withdrawal, compliance in data collection and acceptability of the device to women and operators. Secondary clinical outcomes include maternal, neonatal and device outcomes. Safety data will be reviewed following every birth exploring maternal, neonatal and device risks. Using A’Hern approach for sample size calculation, we aim to recruit 104 women requiring an assisted vaginal birth for a recognised clinical indication. Assuming an AVB success rate of 65% or more, a one-sided alpha risk of 5% and power of 90%. Discussion The data from the ASSIST II Study will provide the information required regarding acceptability, recruitment, outcome data collection, device design, technique of device use and operator learning curve in order to design a future randomised controlled trial of the Odon Device versus current modes of assisted vaginal birth. Trial registration ISRCTN registration: 38829082 (prospectively registered July 26, 2019)

Background: Wound healing after surgery may be complicated by surgical site infection (SSI). SSI development may be influenced by surgical techniques surrounding primary wound closure; for example, the standard to which surgical wounds are closed at the end of an operation. Aim: This study aimed to identify indicators of the quality of wound closure, and factors affecting this, to enable the future development of a tool to measure the quality of wound closure in the context of abdominal surgery. Methods: This study was undertaken within the context of an ongoing feasibility study comparing dressing strategies for patients undergoing abdominal surgery. Content analysis of published literature, non-participant observations of wound closure in the operating theatre, and semi-structured interviews with clinicians were used to identify indicators of the quality of wound closure. Results: A long list ( n = 38 domains) was categorized into visible markers indicating the quality of wound closure (e.g. suture visibility, apposition of wound edges, evidence of gaps in the wound or tethering of the skin edges), factors that might influence this (e.g. surgeon’s expertise, time taken to closure the wounds) and patient factors (e.g. obesity, skin conditions). Conclusions: This is the first study to investigate what is meant by ‘good wound closure’ and factors that might influence it. Findings will result in the development of a tool to assess quality of primary wound closure.

Worldwide, there are at least 230 million invasive procedures performed annually and most of us will undergo several in our lifetime. There is therefore a need for high-quality evidence to underpin this clinical area. Currently, however, there is no widely accepted definition of an invasive procedure and the terms ‘surgery’ and ‘interventional procedure’ are characterised inconsistently. We propose a definition for invasive procedures which addresses the limitations of those currently available. Our definition was developed from an analysis of the 3946 papers from the last decade. A preliminary definition was created based on existing definitions and applied to a variety of papers reporting all types of procedures. This definition was continuously updated and applied iteratively to all articles. The definition has three key components: (1) method of access to the body, (2) instrumentation and (3) requirement for operator skill. It therefore encapsulates all types of invasive procedure regardless of the method of access to the body (incision, natural orifice or percutaneous access), and is relevant whatever the clinical discipline (eg, obstetric, cardiac, dental, interventional cardiology or radiology). Crucially, the definition excludes medicinal products, except where their administration occurs within an invasive procedure (and thereby involves operator skill). The application of a universal definition of an invasive procedure will (1) inform the selection of relevant methods for study design, (2) streamline evidence synthesis and (3) improve research tracking, helping to identify evidence gaps and direct research funds.

Background Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. Objective To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. Design Phase A – semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B – pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. Setting Usual NHS care. Participants Patients undergoing elective/non-elective abdominal surgery, including caesarean section. Interventions Phase A – none. Phase B – simple dressing, glue-as-a-dressing (tissue adhesive) or ‘no dressing’. Main outcome measures Phase A – pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B – participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. Data sources Phase A – interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B – participants and HCPs in five hospitals. Results Phase A – we interviewed 102 participants. HCPs interpreted ‘dressing’ variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a ‘no dressing’ group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B – from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients’ understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test–retest and Cronbach’s alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. Limitations Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. Conclusions A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4–8 weeks. Trial registration Phase A – Current Controlled Trials ISRCTN06792113; Phase B – Current Controlled Trials ISRCTN49328913. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

Background Magnetic sphincter augmentation (MSA) is reported to be an innovative alternative to antireflux surgery for patients with gastro‐oesophageal reflux disease. Although used in practice, little is known about how it has been evaluated. This study aimed to systematically summarize and appraise the reporting of MSA and its introduction into clinical practice, in the context of guidelines (such as IDEAL) for evaluating innovative surgical devices. Methods Systematic searches were used to identify all published studies reporting MSA insertion. Data collected included patient selection, governance arrangements, surgeon expertise, technique description and outcome reporting. Results Searches identified 587 abstracts; 39 full‐text papers were included (1 RCT 5 cohort, 3 case–control, 25 case series, 5 case reports). Twenty‐one followed US Food and Drug Administration eligibility criteria for MSA insertion. Twenty‐six documented that ethical approval was obtained. Two reported that participating surgeons received training in MSA; 18 provided information about how MSA insertion was performed, although techniques varied between studies. Follow‐up ranged from 4 weeks to 5 years; in 14 studies, it was less than 1 year. Conclusion Most studies on MSA lacked information about patient selection, governance, expertise, techniques and outcomes, or varied between studies. Currently, MSA is being used despite a lack of robust evidence for its effectiveness., This systematic review summarizes published evidence for a novel procedure, magnetic sphincter augmentation of the oesophagus, a treatment for gastro‐oesophageal reflux. It found limited governance arrangements, a lack of long‐term follow‐up and varied methods of device insertion. There is a need for improvement in the rigour with which innovative surgical procedures are evaluated. Ideally, this would comprise high‐quality RCTs and long‐term registries, to allow safe adoption of the device into clinical practice. Innovation in need for IDEAL investigation

Contains fulltext : 203365.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To update, clarify, and extend IDEAL concepts and recommendations. BACKGROUND: New surgical procedures, devices, and other complex interventions need robust evaluation for safety, efficacy, and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analyzing data throughout the life cycle of surgical innovations. The IDEAL Framework and Recommendations were designed to provide this pathway and they have been used increasingly since their introduction in 2009. Based on a Delphi survey, expert workshop and major discussions during IDEAL conferences held in Oxford (2016) and New York (2017), this article updates and extends the IDEAL Recommendations, identifies areas for future research, and discusses the ethical problems faced by investigators at each IDEAL stage. METHODS: The IDEAL Framework describes 5 stages of evolution for new surgical therapeutic interventions-Idea, Development, Exploration, Assessment, and Long-term Study. This comprehensive update proposes several modifications. First, a "Pre-IDEAL" stage describing preclinical studies has been added. Second we discuss potential adaptations to expand the scope of IDEAL (originally designed for surgical procedures) to accommodate therapeutic devices, through an IDEAL-D variant. Third, we explicitly recognise the value of comprehensive data collection through registries at all stages in the Framework and fourth, we examine the ethical issues that arise at each stage of IDEAL and underpin the recommendations. The Recommendations for each stage are reviewed, clarified and additional detail added. CONCLUSIONS: The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.

Background Accurate assessment of surgical‐site infection (SSI) is crucial for surveillance and research. Self‐reporting patient measures are needed because current SSI tools are limited for assessing patients after leaving hospital. The Bluebelle Wound Healing Questionnaire (WHQ) was developed for patient or observer completion; this study tested its acceptability, scale structure, reliability and validity in patients with closed primary wounds after abdominal surgery. Methods Patients completed the WHQ (self‐assessment) within 30 days after leaving hospital and returned it by post. Healthcare professionals completed the WHQ (observer assessment) by telephone or face‐to‐face. Questionnaire response rates and patient acceptability were assessed. Factor analysis and Cronbach's α examined scale structure and internal consistency. Test–retest and self‐ versus observer reliability assessments were performed. Sensitivity and specificity for SSI discrimination against a face‐to‐face reference diagnosis (using Centers for Disease Control and Prevention criteria) were examined. Results Some 561 of 792 self‐assessments (70·8 per cent) and 597 of 791 observer assessments (75·5 per cent) were completed, with few missing data or problems reported. Data supported a single‐scale structure with strong internal consistency (α greater than 0·8). Reliability between test–retest and self‐ versus observer assessments was good (κ 0·6 or above for the majority of items). Sensitivity and specificity for SSI discrimination was high (area under the receiver operating characteristic (ROC) curve 0·91). Conclusion The Bluebelle WHQ is acceptable, reliable and valid with a single‐scale structure for postdischarge patient or observer assessment of SSI in closed primary wounds., Simple and valid

Background No new method of assisting vaginal birth has been introduced into clinical practice since the development of the vacuum extractor in the 1950s. The Odon Device is a new device that employs a circumferential air cuff over the fetal head to assist birth. In this study, the Odon Device has been used to assist vaginal birth for standard clinical indications. Objective This study aimed to investigate the clinical impact, safety, and acceptability of the Odon Device to women, their babies, and clinicians and to assess the feasibility of recruiting women to an interventional intrapartum research study. Study Design This is a nonrandomized, single-arm interventional feasibility study of the Odon Device for operative vaginal birth undertaken in a single maternity unit: Southmead Hospital, Bristol, United Kingdom. The Odon Device was used to assist birth in 40 women who required the birth to be assisted for suspected fetal compromise and/or prolonged second stage of labor. The primary clinical outcome was the proportion of births successfully assisted with the Odon Device, and the primary feasibility outcome was the proportion of eligible women who were approached and who agreed to participate. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90. Results Between October 2018 and January 2019, 298 of 384 approached, eligible women (77.6%) consented to participate. Of these women, 40 received the intervention—the use of the Odon Device. Birth was assisted in all cephalic (occiput anterior, occiput transverse, and occiput posterior) fetal positions, at all stations at or below the ischial spine and with or without regional analgesia. The Odon Device was effective in 19 of 40 cases (48%). Of the 40 births, 21 (52.5%) required additional assistance: 18 of 40 births (45%) were completed using nonrotational forceps, 1 of 40 births (3%) required rotational forceps, and 2 of 40 births (5%) required an emergency cesarean delivery. There was no serious maternal or neonatal adverse event related to the use of the device, and there was no serious adverse device effect. There were 4 devices (10%) that were ineffective because of a manufacturing fault. Furthermore, 39 of 40 women (98%) reported a high birth perception score. All practitioners were able to use the device as intended, although some steps in using the device were reported to be easier to perform (setup and deflation of air chamber) than others (application of the device and withdrawal of the applicator). Conclusion Recruitment to an interventional study of a new device for operative vaginal birth was feasible; 78% of eligible women were willing to participate, often expressing an aspiration for an alternative to forceps and vacuum. The success rate of the Odon Device was lower than reported success rates of vacuum and forceps; however, in this study, the device had been used to assist birth for standard clinical indications. There was no significant maternal or neonatal safety concern associated with the use of the device, although the number of births studied was small. Further feasibility study to establish iterative changes to the device, technique, and clinical indications is necessary.

e13598 Background: The impact on cancer outcomes from the Covid-19 pandemic has yet to be determined. Concerns persist on screening, delays in diagnosis, treatment interruptions and outcomes of infection in the immunosuppressed. The need for agile working has been exemplified by establishment of Nightingale Hospitals, staff redeployment and sudden integration of virtual consultations into clinical working. With most cancer clinical trials halted, recruitment into COVID-19 research became essential and embedded into the everyday. Here we present how rapid implementation of COVID-19 randomised clinical trials within an NHS organisation during the pandemic was achieved. Methods: A COVID-19 senior facilitation committee was set up to provide oversight, maximise staff capacity and resource and prioritise studies. Specific strategies to maximise access and clinical trials recruitment for patients including children and those with solid tumours were designed. These included presence of a research nurse at clinical ward rounds and team meetings, the promotion of protocol and informed consent training to all including doctors in the acute settings and weekly research meetings to share-best practice. Reflecting on learnings from this time provide an opportunity to consider how we adjust working for our patients in the future. Results: The integration of research into the everyday working of clinical teams looking after patients with COVID-19 has become the norm. The provision of protocol and informed consent training for all levels of staff and the consideration of all patients for trials during clinical ward rounds and multi-disciplinary meetings, have ensured access to trials has become embedded. The integration of research nurses working, upskilling and prompting clinical colleagues has ensured equity of access and provided a research presence and focus during the busy clinical day. The adoption of cross-disciplinary working, sharing best practice and a culture of commitment and support to the trials ensures no patient is denied the opportunity to participate. Three RTCs opened over 7 weeks. At one site 1904 patients were screened for one of the randomised-controlled trials and over 18% of these patients (351) were recruited and 175 patients declined. Conclusions: The pandemic has had a devastating impact across the UK. However, a coordinated and collaborative multi-disciplinary approach has supported high recruitment and equity of access for patients into COVID-19 trials. Learnings from this work may lead to embedding clinical trials and access to translational research for cancer patients in the future as we recover from the full impact of the pandemic. COVID-19 research has demonstrated how increased recruitment accelerates access and implementation of new innovations and novel drug combinations.The full impact of improved access to cancer research in the future during COVID recovery is worthy of more research.

Background Designing RCTs in surgery requires consideration of existing evidence, stakeholders' views and emerging interventions, to ensure that research questions are relevant to patients, surgeons and the health service. When there is uncertainty about RCT design, feasibility work is recommended. This study aimed to assess how feasibility work could inform the design of a future pilot study and RCT (Bluebelle, HTA ‐ 12/200/04). Methods This was a prospective survey of dressings used to cover abdominal wounds. Surgical trainees from 25 hospitals were invited to participate. Information on patient risk factors, operation type and type of wound dressings used was recorded for elective and unplanned abdominal procedures over a 2‐week interval. The types of dressing used were summarized, and associations with operation type and patient risk factors explored. Results Twenty hospitals participated, providing data from 727 patients (1794 wounds). Wounds were predominantly covered with basic dressings (1203 of 1769, 68·0 per cent) and tissue adhesive was used in 27·4 per cent (485 of 1769); dressing type was missing for 25 wounds. Just 3·6 per cent of wounds (63 of 1769) did not have a dressing applied at the end of the procedure. There was no evidence of an association between type of dressing used and patient risk factors, type of operation, or elective and unscheduled surgery. Conclusion Based on the findings from this large study of current practice, the pilot study design has evolved. The inclusion criteria have expanded to encompass patients undergoing unscheduled surgery, and tissue adhesive as a dressing will be evaluated as an additional intervention group. Collaborative methods are recommended to inform the design of RCTs in surgery, helping to ensure they are relevant to current practice., Relevant background work

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What you need to know Laparoscopy has revolutionised abdominal surgery over the past 30 years. Fifteen million laparoscopic surgical operations are performed worldwide every year, of which 10% are performed in the UK.1 Laparoscopy involves the use of cameras and specially designed instruments that enable surgeons to perform operations without making large abdominal incisions. It has gained worldwide popularity and acceptance by surgeons and patients alike. Better intraoperative visibility, minimal scarring, less pain, shorter hospital stay, and faster recovery are the main advantages of laparosocopic surgery.2 This practice pointer discusses the considerations around management of patients following laparoscopic surgical procedures. It is predominantly UK focused, although information about wound care, thromboprophylaxis, and complications should equally apply elsewhere. As well as cholecystectomy, appendicectomy, and tubo-ovarian procedures, laparoscopy is now increasingly used for hysterectomy, bariatric procedures, and many gastrointestinal and urological cancer resections, and it is also possible to perform aortic aneurysm repair laparoscopically.345 Technological advances have resulted in the development of several variations on the “standard” laparoscopic approach. These are described in box 1. Box 1 ### Variations on standard laparoscopic techniques #### Single incision laparoscopic surgery The surgeon operates almost exclusively through a single entry point, typically the patient’s umbilicus, leaving a single scar #### Natural orifice endoscopic surgery Performed with an endoscope passed through a natural orifice (eg, mouth or anus) then through an internal incision (eg, stomach or colon), thus … RETURN TO TEXT

Unplanned general surgery represents a major workload and requires comprehensive evaluation with appropriate outcomes. This study aimed to summarize current reporting of patient-reported outcomes (PROs) in randomized clinical trials (RCTs) in unplanned general surgery. A systematic review identified RCTs reporting PROs in the commonest six areas of unplanned general surgery. Details of the PRO measures were examined using the CONSORT extension for PRO reporting in RCTs. Extracted information about each PRO domain included the reporting of baseline PROs, rationale for PRO selection and whether PRO findings were used in conjunction with clinical outcomes to inform treatment recommendations. The internal validity of included studies was assessed using the Cochrane risk of bias tool. 12,519 abstracts were screened and 20 RCTs containing data from 2037 patients included. Included studies used 14 separate PRO measures covering 35 different health domains. A visual analogue assessment of pain was most frequently reported (n = 13). Reporting of baseline PRO data was uncommon (11/35 PRO domains). The rationale for PRO data collection and a PRO-specific hypothesis were provided for 9 (25.7 %) and 5 (14.3 %) domains, respectively. Seventeen RCTs (85.0 %) used the PRO data alongside clinical outcomes to inform treatment recommendations. Of the 116 risk of bias assessments, 77 (66.0 %) were judged as high or unclear. There is a lack of well designed, and conducted RCTs in unplanned general surgery that include PROs. Future work to define relevant PROs and methods for optimal assessment are needed to inform health care decision-making.

IntroductionTransoral robotic surgery (TORS) has been adopted in some parts of the world as an innovative approach to the resection of oropharyngeal tumours. The development, details and outcomes of early-to-later phase evaluation of this technique and the quality of evidence to support its adoption into practice have hitherto not been summarised. The aim of this review is to identify and summarise the early and later phase studies of, and evidence for, TORS and to understand how early phase studies report intervention development, governance procedures and selection and reporting of outcomes to optimise methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for surgical innovation that informs evidence-based practice. The protocol has been written in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist.Methods and analysisElectronic searches in OVID SP versions of Medline and EMBASE, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews from the start of indexing to 30 April 2017 will identify studies reporting TORS. At least two independent researchers will identify studies for inclusion. Two researchers will extract data from each paper. Studies will be categorised into IDEAL stages of study design from ‘pre-IDEAL’ to randomised controlled trials (stage 3). Data will be collected about the (1) novel intervention and criteria for modification, (2) governance arrangements and patient information provision, (3) outcome domains selected and reported and (4) quality of study design, conduct and reporting. Descriptive statistics and a narrative synthesis will be presented.Ethics and disseminationThe results of this systematic review will be presented at relevant conferences. The methods will be used to inform future reviews exploring other novel surgical innovations. The findings will be published in a peer-reviewed journal. This study does not require ethical approval.

Background The IDEAL framework (Idea, Development, Exploration, Assessment, Long-term study) proposes a staged assessment of surgical innovation, but whether it can be used in practice is uncertain. This study aimed to review the reporting of a surgical innovation according to the IDEAL framework. Methods Systematic literature searches identified articles reporting laparoendoscopic excision for benign colonic polyps. Using the IDEAL stage recommendations, data were collected on: patient selection, surgeon and unit expertise, description of the intervention and modifications, outcome reporting, and research governance. Studies were categorized by IDEAL stages: 0/1, simple technical preclinical/clinical reports; 2a, technique modifications with rationale and safety data; 2b, expanded patient selection and reporting of both innovation and standard care outcomes; 3, formal randomized controlled trials; and 4, long-term audit and registry studies. Each stage has specific requirements for reporting of surgeon expertise, governance details and outcome reporting. Results Of 615 abstracts screened, 16 papers reporting outcomes of 550 patients were included. Only two studies could be put into IDEAL categories. One animal study was classified as stage 0 and one clinical study as stage 2a through prospective ethical approval, protocol registration and data collection. Studies could not be classified according to IDEAL for insufficient reporting details of patient selection, relevant surgeon expertise, and how and why the technique was modified or adapted. Conclusion The reporting of innovation in the context of laparoendoscopic colonic polyp excision would benefit from standardized methods.