Thomas Pinkney

Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial).

Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery. Design Multicentre observer blinded randomised controlled trial. Participants Patients undergoing laparotomy at 21 UK hospitals. Interventions Standard care or the use of a wound edge protection device during surgery. Main outcome measures Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient’s self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device. Results 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device. Conclusions Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended. Trial registration Current Controlled Trials ISRCTN 40402832

Biliary epithelium and liver B cells exposed to bacteria activate intrahepatic MAIT cells through MR1

Background & Aims Mucosal-Associated Invariant T (MAIT) cells are innate-like T cells characterised by the invariant TCR-chain, Vα7.2-Jα33, and are restricted by MR1, which presents bacterial vitamin B metabolites. They are important for antibacterial immunity at mucosal sites; however, detailed characteristics of liver-infiltrating MAIT (LI-MAIT) and their role in biliary immune surveillance remain unexplored. Methods The phenotype and intrahepatic localisation of human LI-MAIT cells was examined in diseased and normal livers. MAIT cell activation in response to E. coli-exposed macrophages, biliary epithelial cells (BEC) and liver B cells was assessed with/without anti-MR1. Results Intrahepatic MAIT cells predominantly localised to bile ducts in the portal tracts. Consistent with this distribution, they expressed biliary tropic chemokine receptors CCR6, CXCR6, and integrin αEβ7. LI-MAIT cells were also present in the hepatic sinusoids and possessed tissue-homing chemokine receptor CXCR3 and integrins LFA-1 and VLA-4, suggesting their recruitment via hepatic sinusoids. LI-MAIT cells were enriched in the parenchyma of acute liver failure livers compared to chronic diseased livers. LI-MAIT cells had an activated, effector memory phenotype, expressed α4β7 and receptors for IL-12, IL-18, and IL-23. Importantly, in response to E. coli-exposed macrophages, liver B cells and BEC, MAIT cells upregulated IFN-γ and CD40 Ligand and degranulated in an MR1-dependent, cytokine-independent manner. In addition, diseased liver MAIT cells expressed T-bet and RORγt and the cytokines IFN-γ, TNF-α, and IL-17. Conclusions Our findings provide the first evidence of an immune surveillance effector response for MAIT cells towards BEC in human liver; thus they could be manipulated for treatment of biliary disease in the future.

Systematic review of the clinical effectiveness of wound-edge protection devices in reducing surgical site infection in patients undergoing open abdominal surgery

Objective:Assess the existing evidence on the clinical effectiveness of wound-edge protection devices (WEPDs) in reducing the surgical site infection (SSI) rate in patients undergoing open abdominal surgery. Background:Surgical site infections are a common postoperative complication associated with considerable morbidity, extended hospital stay, increased health care costs, and reduced quality of life. Wound-edge protection devices have been used in surgery to reduce SSI rates for more than 40 years; however, they are yet to be cited in major clinical guidelines addressing SSI management. Methods:A review protocol was prespecified. A variety of sources were searched in November 2010 for studies containing primary data on the use of WEPDs in reducing SSI compared with standard care in patients undergoing open abdominal surgery. The outcome of interest was a well-specified, clinically based definition of an SSI. No language or time restrictions were applied. The quality assessment of the studies and the quantitative analyses were performed in line with the principles of the Cochrane Collaboration. Results:Twelve studies reporting primary data from 1933 patients were included in the review. The quality assessment found all of them to be at considerable risk of bias. An exploratory meta-analysis was performed to provide a quantitative indication on the effect of WEPDs. The pooled risk ratio under a random effects model was 0.60 (95% confidence interval, 0.41–0.86), indicating a potentially significant benefit from the use of WEPDs. No indications of significant between-study heterogeneity or publication bias, respectively, were identified. Conclusions:Evidence to date suggests that WEPDs may be efficient in reducing SSI rates in patients undergoing open abdominal surgery. However, the poor quality of the existing studies and their small sample sizes raise the need for a large, good quality randomized controlled trial to validate this indication.

Identifying research priorities in anaesthesia and perioperative care: final report of the joint National Institute of Academic Anaesthesia/James Lind Alliance Research Priority Setting Partnership

Objective To identify research priorities for Anaesthesia and Perioperative Medicine. Design Prospective surveys and consensus meetings guided by an independent adviser. Setting UK. Participants 45 stakeholder organisations (25 professional, 20 patient/carer) affiliated as James Lind Alliance partners. Outcomes First ‘ideas-gathering’ survey: Free text research ideas and suggestions. Second ‘prioritisation’ survey: Shortlist of ‘summary’ research questions (derived from the first survey) ranked by respondents in order of priority. Final ‘top ten’: Agreed by consensus at a final prioritisation workshop. Results First survey: 1420 suggestions received from 623 respondents (49% patients/public) were refined into a shortlist of 92 ‘summary’ questions. Second survey: 1718 respondents each nominated up to 10 questions as research priorities. Top ten: The 25 highest-ranked questions advanced to the final workshop, where 23 stakeholders (13 professional, 10 patient/carer) agreed the 10 most important questions: ▸ What can we do to stop patients developing chronic pain after surgery? ▸ How can patient care around the time of emergency surgery be improved? ▸ What long-term harm may result from anaesthesia, particularly following repeated anaesthetics? ▸ What outcomes should we use to measure the ‘success’ of anaesthesia and perioperative care? ▸ How can we improve recovery from surgery for elderly patients? ▸ For which patients does regional anaesthesia give better outcomes than general anaesthesia? ▸ What are the effects of anaesthesia on the developing brain? ▸ Do enhanced recovery programmes improve short and long-term outcomes? ▸ How can preoperative exercise or fitness training, including physiotherapy, improve outcomes after surgery? ▸ How can we improve communication between the teams looking after patients throughout their surgical journey? Conclusions Almost 2000 stakeholders contributed their views regarding anaesthetic and perioperative research priorities. This is the largest example of patient and public involvement in shaping anaesthetic and perioperative research to date.

ECCO-ESCP Consensus on Surgery for Crohn's Disease

Willem A. Bemelman, Janindra Warusavitarne, Gianluca M. Sampietro, Zuzana Serclova, Oded Zmora, Gaetano Luglio, Anthony de Buck van Overstraeten, John P. Burke, Christianne J. Buskens, Francesco Colombo, Jorge Amil Dias, Rami Eliakim, Tomás Elosua, I. Ethem Gecim, Sanja Kolacek, Jaroslaw Kierkus, Kaija-Leena Kolho, Jérémie H. Lefevre, Monica Millan, Yves Panis, Thomas Pinkney, Richard K. Russell , Chaya Shwaartz, Carolynne Vaizey, Nuha Yassin, André D’Hoore, On behalf of the European Crohns and Colitis Organisation (ECCO) and the European Society of Coloproctology (ESCP)

How to set up and manage a trainee-led research collaborative

BackgroundEnsuring that doctors in training acquire sufficient knowledge, experience and understanding of medical research is a universal and longstanding issue which has been brought into sharper focus by the growth of evidence based medicine. All healthcare systems preparing doctors in training for practice have to balance the acquisition of specific clinical attitudes, knowledge and skills with the wider need to ensure doctors are equipped to remain professionally competent as medical science advances. Most professional medical bodies acknowledge that this requires trainee doctors to experience some form of research education, not only in order to carry out original research, but to acquire sufficient academic skills to become accomplished research consumers in order to remain informed throughout their professional practice. There are many barriers to accomplishing this ambitious aim.DiscussionThis article briefly explains why research collaboratives are necessary, describes how to establish a collaborative, and recommends how to run one. It is based on the experiences of the pioneering West Midlands Research Collaborative and draws on the wider literature about the organisation and delivery of high quality research projects. Practical examples of collaborative projects are given to illustrate the potential of this form of research organisation.SummaryThe new trainee-led research collaboratives provide a supportive framework for planning, ownership and delivery of high quality multicentre research. This ensures clinical relevance, increases the chances of research findings being translated into changes in practice and should lead to improved patient outcomes. Research collaboratives also enhance the research skills and extend the scientific horizons of doctors in training.

The Cost-Effectiveness of Wound-Edge Protection Devices Compared to Standard Care in Reducing Surgical Site Infection after Laparotomy: An Economic Evaluation alongside the ROSSINI Trial

Background Wound-edge protection devices (WEPDs) have been used in surgery for more than 40 years to reduce surgical site infection (SSI). No economic evaluation of WEPDs against any comparator has ever been conducted. The aim of the paper was to assess whether WEPDs are cost-effective in reducing SSI compared to standard care alone in the United Kingdom. Methods and Findings An economic evaluation was conducted alongside the ROSSINI trial. The study perspective was that of the UK National Health Service and the time horizon was 30 days post-operatively. The study was conducted in 21 UK hospitals. 760 patients undergoing laparotomy were randomised to either WEPD or standard care and 735 were included in the primary analysis. The main economic outcome was cost-effectiveness based on incremental cost (£) per quality adjusted life year (QALY) gained. Patients in the WEPD arm accessed health care worth £5,420 on average and gained 0.02131 QALYs, compared to £5,130 and 0.02133 QALYs gained in the standard care arm. The WEPD strategy was more costly and equally effective compared to standard care, but there was significant uncertainty around incremental costs and QALYs. The findings were robust to a range of sensitivity analyses. Conclusions There is no evidence to suggest that WEPDs can be considered a cost effective device to reduce SSI. Their continued use is a waste of limited health care resources.

The effect of trainee research collaboratives in the UK

Trainee-led networks have pioneered a novel collaborative approach to research in the UK. Established at a similar time to the UK National Institute for Health Research in 2006, collaborative groups have developed new pathways for doctors in full-time specialty training to design, disseminate, and deliver high-quality, multicentre research. In parallel, the National Institute for Health Research set up Clinical Research Networks (CRNs) to coordinate delivery of research across 30 clinical specialties and 15 English regional networks. Analogous networks have also been established by the devolved administrations in Scotland, Northen Ireland, and Wales. CRNs provide infrastructure to promote and coordinate research, including funding research support staff and providing research skills training. Using gastrointestinal surgery as an example, we sought to quantify trainee-led collaborative research network engagement and compare hospital participation with CRN studies. We only considered CRN and trainee-led collaborative studies involving ten or more hospitals with information available about participating sites. We searched the CRN portfolio for closed gastrointestinal and general surgery studies. We contacted trainee networks via a national mailing list to identify trainee studies. We derived denominators from the total number of hospitals offering emergency or major elective gastrointestinal surgery. Overall, 238 (99%) of 241 UK hospitals providing general surgery services participated in one or more trainee-led collaborative studies over the past decade compared with 191 (79%) of 241 for CRN studies. With the three trainee-led studies that had been adopted into the CRN portfolio excluded, participation in trainee-led research remained similar, at 236 (98%) of 241. Trainee groups delivered 15 studies overall: 12 observational studies and three randomised controlled trials (RCTs), coordinated by five regional and two national trainee networks (appendix). These numbers compared with three observational studies and eight RCTs coordinated by the CRN. We noted strong participation in trainee collaborative studies, even in regions with low CRN coverage, with the mean number of studies per hospital greater for collaboratives than for CRNs (appendix). Regions with a Royal College of Surgeons Surgical Trials Centre had greater participation in both trainee and CRN studies: the mean number of studies per hospital was 8·2 versus 6·0 in regions without. Trainee-led collaboratives have driven substantial additional research participation across the UK, on top of that achievable through CRNs alone, and have engaged additional gastrointestinal surgery units with little infrastructure or associated costs. This success is now being replicated in other specialties, with the British Neurosurgical Trainee Research Collaborative engaging 26 of 30 UK adult trauma-receiving neurosurgical units in the RESCUE-ASDH RCT. As the collaborative model is extended globally, it offers a powerful opportunity to promote a collaborative research culture and grow capacity with minimal investment. Synergy between trainee-led networks and CRNs could maximise delivery of high-quality research across the UK.

The ‘colostomy impact score’: development and validation of a patient reported outcome measure for rectal cancer patients with a permanent colostomy. a population-based study

The aim was to develop and validate a simple scoring system evaluating the impact of colostomy dysfunction on quality of life (QOL) in patients with a permanent stoma after rectal cancer treatment.

Reduction of surgical site infection using a novel intervention (ROSSINI): study protocol for a randomised controlled trial

BackgroundSurgical site infection (SSI) is a common complication following abdominal surgery. It is associated with considerable morbidity and mortality, and its management results in significant cost to health services within both primary and secondary care. Some surgeons believe that the use of a wound-edge protection device may reduce the incidence of SSI. Whilst there is some encouraging evidence showing that such devices may lead to a reduction in SSI, there are no controlled trials of sufficient size or quality to support their routine use.Methods/Design750 patients will be recruited from around 20 surgical units within the United Kingdom. Patients undergoing laparotomy through any major abdominal incision for any indication, elective or emergency, are eligible. Patients under the age of 18, those undergoing a laparoscopic assisted procedure or who have undergone laparotomy within the previous 3 months, and those who are unable to give informed consent will be excluded. Patients will be randomised (1:1 ratio) to the use of a wound-edge protection device or no wound-edge protection device during surgery.Follow up will consist of blinded clinical wound reviews at 5-7 days and 30-33 days postoperatively with a self-completed questionnaire covering the intervening period. Quality of life questionnaires will be completed prior to surgery and at the subsequent wound review points and information on resource usage will also be captured.The primary outcome measure is SSI within 30 days of surgery. Secondary outcomes include the impact of the degree of wound contamination, patient comorbidity, and operative characteristics on the efficacy of a wound-edge protection device in reducing SSI and whether the use of a wound-edge protection device has an effect on health-related quality of life or length of hospital stay and is cost-effective.DiscussionRossini is the first multicentre observer-blinded randomised controlled trial of sufficient size and quality to establish whether the use of a wound-edge protection device in adult patients undergoing abdominal surgery leads to a lower rate of SSI. The results of this study will be used to inform current surgical practice and may potentially benefit patients undergoing surgery in the future.Trial registration numberCurrent Controlled Trials ISRCTN: ISRCTN40402832