Aim
FOxTROT1 established a new standard of care for managing locally advanced colon cancer (CC) with neoadjuvant chemotherapy (NAC). Six weeks of neoadjuvant oxaliplatin and fluoropyrimidine (OxFp) ...chemotherapy was associated with greater 2‐year disease‐free survival (DFS) when compared with proceeding straight to surgery (STS). There is now a need to refine the use of NAC and identify those most likely to benefit. FOxTROT2 will aim to investigate NAC in older adults and those with frailty. FOxTROT3 will aim to assess whether intensified triplet NAC provides additional benefits over OxFp.
Method
FOxTROT2 and FOxTROT3 are international, open‐label, phase III randomized controlled trials. Eligible patients will be identified by the multidisciplinary team. Patient age, frailty and comorbidities will be considered to guide trial entry. Participants will be randomized 2:1 to the intervention or control arm: 6 weeks of dose‐adapted neoadjuvant OxFp versus STS in FOxTROT2 and 6 weeks of neoadjuvant modified oxaliplatin, 5‐fluorouracil and irinotecan versus OxFp in FOxTROT3. The primary endpoint in FOxTROT2 is 3‐year DFS. In FOxTROT3, tumour regression grade and 3‐year DFS are co‐primary endpoints.
Discussion
FOxTROT2 and FOxTROT3 will establish the FOxTROT platform, a key part of our long‐term strategy to develop neoadjuvant treatments for CC. FOxTROT2 will investigate NAC in a population under‐represented in FOxTROT1 and wider research. FOxTROT3 will assess whether it is possible to induce greater early tumour responses and whether this translates to superior long‐term outcomes. Looking ahead, the FOxTROT platform will facilitate further trial comparisons and extensive translational research to optimize the use of NAC in CC.
Abstract
Background
Surgeons urgently need guidance on how to deliver surgical services safely and effectively during the COVID-19 pandemic. The aim was to identify the key domains that should be ...considered when developing pandemic preparedness plans for surgical services.
Methods
A scoping search was conducted to identify published articles relating to management of surgical patients during pandemics. Key informant interviews were conducted with surgeons and anaesthetists with direct experience of working during infectious disease outbreaks, in order to identify key challenges and solutions to delivering effective surgical services during the COVID-19 pandemic.
Results
Thirteen articles were identified from the scoping search, and surgeons and anaesthetists representing 11 territories were interviewed. To mount an effective response to COVID-19, a pandemic response plan for surgical services should be developed in advance. Key domains that should be included are: provision of staff training (such as patient transfers, donning and doffing personal protection equipment, recognizing and managing COVID-19 infection); support for the overall hospital response to COVID-19 (reduction in non-urgent activities such as clinics, endoscopy, non-urgent elective surgery); establishment of a team-based approach for running emergency services; and recognition and management of COVID-19 infection in patients treated as an emergency and those who have had surgery. A backlog of procedures after the end of the COVID-19 pandemic is inevitable, and hospitals should plan how to address this effectively to ensure that patients having elective treatment have the best possible outcomes.
Conclusion
Hospitals should prepare detailed context-specific pandemic preparedness plans addressing the identified domains. Specific guidance should be updated continuously to reflect emerging evidence during the COVID-19 pandemic.
Graphical Abstract
During pandemics, surgical services need to balance supporting the whole hospital response and minimizing the risk of nosocomial spread of COVID-19 against continuing care for acute surgical conditions and managing urgent elective surgery. This article identifies the key considerations that should be included in pandemic plans for surgical services.
Graphical Abstract
Best available advice
Campbell, Weijer, and colleagues debate the duty to take part in pragmatic randomised trials. 1 Randomised controlled trials in surgery are frequently pragmatic because of unique challenges related ...to complex interventions. In surgery, one in five randomised controlled trials is discontinued early, and one in three completed trials remains unpublished. 6 Similar problems arise in other medical and allied specialties. 7 Failure to disseminate research findings leads to hidden trial data, unrealised knowledge, and the...
Medical students often struggle to engage in extra-curricular research and audit. The Student Audit and Research in Surgery (STARSurg) network is a novel student-led, national research collaborative. ...Student collaborators contribute data to national, clinical studies while gaining an understanding of audit and research methodology and ethical principles. This study aimed to evaluate the educational impact of participation.
Participation in the national, clinical project was supported with training interventions, including an academic training day, an online e-learning module, weekly discussion forums and YouTube® educational videos. A non-mandatory, online questionnaire assessed collaborators' self-reported confidence in performing key academic skills and their perceptions of audit and research prior to and following participation.
The group completed its first national clinical study ("STARSurgUK") with 273 student collaborators across 109 hospital centres. Ninety-seven paired pre- and post-study participation responses (35.5%) were received (male = 51.5%; median age = 23). Participation led to increased confidence in key academic domains including: communication with local research governance bodies (p < 0.001), approaching clinical staff to initiate local collaboration (p < 0.001), data collection in a clinical setting (p < 0.001) and presentation of scientific results (p < 0.013). Collaborators also reported an increased appreciation of research, audit and study design (p < 0.001).
Engagement with the STARSurg network empowered students to participate in a national clinical study, which increased their confidence and appreciation of academic principles and skills. Encouraging active participation in collaborative, student-led, national studies offers a novel approach for delivering essential academic training.
ObjectivesThis study aimed to understand the role of surgical Trainee Research Collaboratives (TRCs) in conducting randomised controlled trials and identify strategies to enhance trainee engagement ...in trials.DesignThis is a mixed methods study. We used observation of TRC meetings, semi-structured interviews and an online survey to explore trainees’ motivations for engagement in trials and TRCs, including barriers and facilitators. Interviews were analysed thematically, alongside observation field notes. Survey responses were analysed using descriptive statistics. Strategies to enhance TRCs were developed at a workshop by 13 trial methodologists, surgical trainees, consultants and research nurses.SettingThis study was conducted within a secondary care setting in the UK.ParticipantsThe survey was sent to registered UK surgical trainees. TRC members and linked stakeholders across surgical specialties and UK regions were purposefully sampled for interviews.ResultsWe observed 5 TRC meetings, conducted 32 semi-structured interviews and analysed 73 survey responses. TRCs can mobilise trainees thus gaining wider access to patients. Trainees engaged with TRCs to improve patient care, surgical evidence and to help progress their careers. Trainees valued the TRC infrastructure, research expertise and mentoring. Challenges for trainees included clinical and other priorities, limited time and confidence, and recognition, especially by authorship. Key TRC strategies were consultant support, initial simple rapid studies, transparency of involvement and recognition for trainees (including authorship policies) and working with Clinical Trials Units and research nurses. A 6 min digital story on YouTube disseminated these strategies.ConclusionTrainee surgeons are mostly motivated to engage with trials and TRCs. Trainee engagement in TRCs can be enhanced through building relationships with key stakeholders, maximising multi-disciplinary working and offering training and career development opportunities.
This study aimed to explore variations in the provision of integrated academic surgical training across the UK.
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.
A self-reported survey instrument was distributed to academic surgical trainees across the UK (n=276).
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.
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.
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.
Introduction Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as postoperative analgesia by the Enhanced Recovery After Surgery Society. Recent studies have raised concerns that NSAID ...administration following colorectal anastomosis may be associated with increased risk of anastomotic leak. This multicentre study aims to determine NSAIDs’ safety profile following gastrointestinal resection. Methods and analysis This prospective, multicentre cohort study will be performed over a 2-week period utilising a collaborative methodology. Consecutive adults undergoing open or laparoscopic, elective or emergency gastrointestinal resection will be included. The primary end point will be the 30-day morbidity, assessed using the Clavien-Dindo classification. This study will be disseminated through medical student networks, with an anticipated recruitment of at least 900 patients. The study will be powered to detect a 10% increase in complication rates with NSAID use. Ethics and dissemination Following the Research Ethics Committee Chairperson's review, a formal waiver was received. This study will be registered as a clinical audit or service evaluation at each participating hospital. Dissemination will take place through previously described novel research collaborative networks.
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