Evaluation of post-operative surveillance strategies and surgeon perceptions and beliefs of surveillance for pancreatic ductal adenocarcinoma in the UK.

BACKGROUND: Despite high rates of recurrence after surgery for pancreatic ductal adenocarcinoma (PDAC) there is lack of standardised surveillance practices. We aimed to identify UK surveillance practice and interrogate surgeon beliefs around surveillance. METHODS: A web-based survey was sent to all UK pancreatic units to assess surveillance practice for resected PDAC, factors influencing surveillance protocols, and perceptions and beliefs surrounding on current postoperative surveillance. RESULTS: There was wide variation in reported practice between 40 consultant surgeons from 28 pancreatic units (100% unit response rate). 26% had standardised surveillance compared to 18% with no standardised practice. 16% individualised surveillance to the patient, and 40% reported differing practices between surgeons within units despite local surveillance protocols. 66% felt surveillance should be tailored to patient factors, and 58% to patient preference. There was a broad belief regarding a lack of robust evidence supporting surveillance making a trial necessary. Thematic analysis identified surveillance barriers, considerations for trial design, necessity for patient engagement and potential benefits of surveillance. DISCUSSION: Wide variation in surveillance practice exists within and between units. A surveillance trial was deemed beneficial, however identified barriers potentially preclude a trial. Future work should assess acceptability for patients including impact on anxiety and quality-of-life.

A systematic review of post-pancreatectomy haemorrhage management stratified according to ISGPS grading.

BACKGROUND: Morbidity and mortality from post-pancreatectomy haemorrhage (PPH) remains high. The International Study Group of Pancreatic Surgery (ISGPS) published guidelines to standardise definitions of PPH severity, management and reporting. This study aimed to i) identify the number of studies reporting PPH using ISGPS guidelines (Grade A, B or C) and ii) describe treatment modality success by grade. METHODS: A systematic literature review was performed, identifying studies reporting PPH by ISGPS Grade and their subsequent management. RESULTS: Of 62 studies reporting on PPH management, 17 (27.4%) stratified by ISGPS guidelines and included 608 incidences of PPH: 48 Grade A, 274 Grade B (62 early, 166 late, 46 unspecified) and 286 Grade C. 96% of Grade A PPH were treated conservatively. Of 62 early Grade B, 54.8% were managed conservatively and 37.1% surgically. Late Grade B were managed non-operatively in 25.3% (42/166), with successful endoscopy in 90.9% (10/11) and angiography in 90.3% (28/31). In Grade C, endoscopic treatment was successful in 64.4% (29/45) and angiography in 90.8% (108/119). Surgical intervention was required in 43.5% early Grade B, 7.8% late Grade B and 33.2% Grade C. CONCLUSION: PPH grading is underreported and despite guidelines, inconsistencies remain when using definitions and reporting of outcomes.

Early oral feeding after pancreatoduodenectomy: a systematic review and meta-analysis.

BACKGROUND: The effect of early oral feeding (EOF) after pancreatoduodenectomy (PD) upon perioperative complications and outcomes is unknown, therefore the aim of this systematic review and meta-analysis was to investigate the effect of EOF on clinical outcomes after PD, such as postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE) and length of stay (LOS). METHODS: A systematic review and meta-analysis was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance and assimilated evidence from studies reporting outcomes for patients who received EOF after PD compared to enteral tube feeding (EN) or parenteral nutrition (PN). RESULTS: Four studies reported outcomes after EOF compared to EN/PN after PD and included 553 patients. Meta-analyses showed no difference in rates of CR-POPF (OR 0.74; 95%CI 0.44-1.24; p = 0.25) or DGE (Grade B/C) (OR 0.83; 95%CI 0.31-2.21; p = 0.70). LOS was significantly shorter in the EOF group compared to the EN/PN group (Mean Difference -3.40 days; 95% -6.11-0.70 days; p = 0.01). CONCLUSION: Current available evidence suggests that EOF after PD is not associated with increased risk of DGE, does not exacerbate POPF and appears to reduce length of stay.

A Systematic Review of Minimally Invasive Trans-thoracic Liver Resection to Examine Intervention Description, Governance, and Outcome Reporting of an Innovative Technique.

INTRODUCTION: The 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 trans-thoracic 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. METHODS: A 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 (eg, Institutional Review Board approval) and steps taken to mitigate harm were recorded. Finally, specific outcomes reported across studies were documented. RESULTS: Of 2067 screened articles, 16 were included reporting data from 145 patients and 6 countries. Selection criteria for patients was explicitly stated in 2 papers. No studies fully described the technique. Five papers reported ethical approval and 3 gave details of patient consent. No study reported on steps taken to mitigate harm.Technical outcomes were commonly reported, for example, blood loss (15/16 studies), operative time (15/16), and margin status (11/16). Information on patient-reported outcomes and costs were lacking. CONCLUSIONS: Technical 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.

Impact of SARS-CoV-2 pandemic on pancreatic cancer services and treatment pathways: United Kingdom experience.

INTRODUCTION: The SARS-CoV-2 pandemic presented healthcare providers with an extreme challenge to provide cancer services. The impact upon the diagnostic and treatment capacity to treat pancreatic cancer is unclear. This study aimed to identify national variation in treatment pathways during the pandemic. METHODS: A survey was distributed to all United Kingdom pancreatic specialist centres, to assess diagnostic, therapeutic and interventional services availability, and alterations in treatment pathways. A repeating methodology enabled assessment over time as the pandemic evolved. RESULTS: Responses were received from all 29 centres. Over the first six weeks of the pandemic, less than a quarter of centres had normal availability of diagnostic pathways and a fifth of centres had no capacity whatsoever to undertake surgery. As the pandemic progressed services have gradually improved though most centres remain constrained to some degree. One third of centres changed their standard resectable pathway from surgery-first to neoadjuvant chemotherapy. Elderly patients, and those with COPD were less likely to be offered treatment during the pandemic. CONCLUSION: The COVID-19 pandemic has affected the capacity of the NHS to provide diagnostic and staging investigations for pancreatic cancer. The impact of revised treatment pathways has yet to be realised.

Immediate Impact of Centralization on Abdominal Aortic Aneurysm Repair Outcomes for a Vascular Network in the South West of England: A Retrospective Cohort Study.

OBJECTIVE: Our aim was to assess the short-term impact of centralization on the outcomes of patients undergoing abdominal aortic aneurysm repair in a vascular network in the South West of England. BACKGROUND: The centralization of vascular services has been implemented nationally across the National Health Service to improve patient outcomes. The full impact of these major changes has not yet been fully analyzed. METHODS: A retrospective cohort study examining outcomes of patients undergoing abdominal aortic aneurysm repair, based on prospectively entered National Vascular Registry data, pre and post centralization in the South West of England. The primary outcome was mortality at 30 days. Secondary measures included 30-day morbidity, length of hospital stay, and length of intensive care unit stay. RESULTS: The 30-day mortality was unchanged pre and post-centralization (11% vs 12%, P = 0.84). The 30-day morbidity rate was also unchanged (24% vs 25%, P = 0.83), as was length of intensive care unit stay (3 vs 3 days, P = 0.74). Overall length of stay was not significantly different (8 vs 6 days, P = 0.76). Subgroup analysis of patients with elective, ruptured, and symptomatic aneurysm repair demonstrated no differences in 30-day mortality. There was a significantly shorter stay post-centralization for patients with symptomatic aneurysms (6 vs 12 days pre-centralization, P = 0.012). CONCLUSIONS: The process of centralization of abdominal aortic aneurysm repair in a vascular network was safe for patients and had no immediate impact on outcomes. Longer-term outcome measures and financial data will be required to further assess the benefit of centralization.

Use of a modified Delphi approach to develop research priorities in HPB surgery across the United Kingdom.

BACKGROUND: Research prioritisation can help identify clinically relevant questions and encourage high-quality, patient-centred research. Delphi methodology aims to develop consensus opinion within a group of experts, with recent Delphi projects helping to define the research agenda and funding within several medical and surgical specialties. METHODS: All members of the Association of Upper Gastrointestinal Surgeons (AUGIS) were asked to submit clinical research questions using an online survey (Phase 1). Two consecutive rounds of Delphi prioritisation by multidisciplinary HPB healthcare professionals (Phase 2) were undertaken to establish a final list of the most highly prioritised research questions. A multidisciplinary steering committee analysed the results of each phase. RESULTS: Ninety-three HPB-focussed questions were identified in Phase 1, with thirty-seven questions of sufficient priority to enter a further prioritisation round. A final group of 11 questions considered highest priority were identified. The most highly ranked research questions related to treatment pathways, operative strategies and the impact of HPB procedures on quality of life, particularly for malignant disease. CONCLUSION: Expert consensus has identified research priorities within the UK HPB surgical community over the coming years. Funding applications, to establish well-designed, high quality collaborative research are now required to address these questions.

A systematic review of new treatments for cryptoglandular fistula in ano.

AIM: In 2007 the ACPGBI published a position statement on the management of cryptoglandular fistula in ano. Over the last seven years a number of new treatments have been developed and the aim of this systematic review was to assess their effectiveness. METHOD: A systematic review of all English language literature relevant to novel treatment strategies for cryptoglandular fistula in ano, published between 1 January 2007 and 31 Dec 2014 was carried out using MEDLINE (PubMed and Ovid), EMBASE (Ovid) and the Cochrane Library of Systematic Reviews/Controlled Trials for relevant literature. Technical notes, commentaries, letters and meeting abstracts were excluded. The different treatments were assessed with regards to fistula closure rate in relation to length of follow up and reported complications. RESULTS: Seventy potential articles published between 1 January 2007 and 31 December 2014 were identified from the initial literature search. Twenty-one articles were included for final analysis although only two were randomized controlled trials, the remainder being retrospective or prospective series. CONCLUSION: This systematic review has demonstrated that whilst there have been technological advances to treat complex cryptoglandular fistula in ano, these are in an early stage of evolution and although early results were promising they are difficult to reproduce. Longer follow up data is not currently available and these treatments should not be introduced without further evidence.

Impact of margin status and neoadjuvant chemotherapy on survival, recurrence after liver resection for colorectal liver metastasis.

BACKGROUND: This study was designed to determine the impact of positive margin and neoadjuvant chemotherapy (NAC) on recurrence and survival after resection of colorectal liver metastasis (CRLM). METHODS: Prospective analysis of 1,255 patients undergoing resection of CLRM was undertaken. The impact of NAC, site of recurrence, and survival between R0 and R1 groups was analysed. RESULTS: The R0 and R1 resection rates were 68.9 % (n = 865) and 31.1 % (390). The median OS for R0 group was 2.7 years (95 % CI 2.56-2.85) and R1 group 2.28 years (CI 2.06-2.52; P < 0.001). The median DFS for R0 group was 1.52 years (CI 1.38-1.66) and R1 group 1.04 years (CI 0.94-1.19; P < 0.001). The intrahepatic recurrence was higher in R1 group 132 (33.8 %) versus 142 (16.4 %) [P = 0.0001]. A total of 103 (11.9 %) patients in R0 group underwent redo liver resection for recurrence compared with 66 (16.9 %) patients in R1 group (P = 0.016). NAC did not impact recurrence rate (57.8 % vs. 61.5 %, P = 0.187) and redo liver surgery between R0 and R1 groups (13 % vs. 17 %, P = 0.092). Within the R1 group, the intrahepatic recurrence rates were similar with and without NAC (33.9 % vs. 33.7 %, P = 0.669). However, DFS was longer in the no chemotherapy group than the chemotherapy group. CONCLUSIONS: R1 resections increase the likelihood of recurrence in the liver and redo liver surgery. NAC does not seem to improve survival in margin positive patients or have an impact on recurrence or reduce need for redo liver surgery for recurrence. In patients with R1 resection, neoadjuvant chemotherapy may have adverse outcome on disease free survival.

Impact of the new fast track kidney allocation scheme for declined kidneys in the United Kingdom.

INTRODUCTION: A "new" fast track kidney allocation scheme (FTKAS) was implemented in the UK in 2012 for offering of previously declined kidneys. We evaluated the impact of the FTKAS in utilization of declined kidneys and outcome. METHODS: Adult renal transplant centers were surveyed. Overall utilization was evaluated using National Health Service Blood and Transplant (NHSBT) data. Outcome of FTKAS kidneys in our center was analyzed. RESULTS: Centers cited graft, patient outcome concerns, and inadequate logistical support for their non-FTKAS participation. In the first year of the scheme, 266 kidneys were offered through the FTKAS, 158 were transplanted in 10 centers (59%). In comparison, 166 kidneys were offered through previous system over five yr (2006-2011), and 65 were utilized in 59 transplants (39%). In our center, 42 kidneys were transplanted in 39 recipients. One-yr graft and patient survival were both 95%. Results were comparable to a matched group of kidney transplants during the same periods allocated via the standard scheme. CONCLUSIONS: The FTKAS has led to effective utilization of the declined kidneys with outcome comparable to kidneys allocated through the standard scheme. Non-participation based on outcome concerns is mostly subjective while logistical issues need to be addressed.

Prognostic significance of pre-operative C-reactive protein and the neutrophil-lymphocyte ratio in resectable pancreatic cancer: a systematic review.

BACKGROUND: Better pre-operative risk stratification may improve patient selection for pancreatic resection in pancreatic cancer. C-reactive protein (CRP) and the neutrophil-lymphocyte ratio (NLR) have demonstrated prognostic value in some cancers. The role of CRP and NLR in predicting outcome in pancreatic cancer after curative resection is not well established. METHODS: An electronic search of MEDLINE, EMBASE and CINAHL was performed to identify studies assessing survival in patients after pancreatic cancer resection with high or low pre-operative CRP or NLR. Systematic review was undertaken using the PRISMA protocol. RESULTS: In total, 327 studies were identified with 10 reporting on survival outcomes after a pancreatic resection in patients with high or low CRP, NLR or both. All but one paper showed a trend of lower inflammatory markers in patients with longer survival. Three studies from six showed low CRP to be independently associated with increased survival and two studies of eight showed the same for NLR. All studies were retrospective cohort studies of low to moderate quality. DISCUSSION: Inflammatory markers might prove useful guides to the management of resectable pancreatic cancer but, given the poor quality of evidence, further longitudinal studies are required before incorporating pre-operative inflammatory markers into clinical decision making.

A Systematic Review to Summarise and Appraise the Reporting of Surgical Innovation: a Case Study in Robotic Roux-en-Y Gastric Bypass.

Robotic Roux-en-Y gastric bypass (RRYGB) is an innovative alternative to traditional laparoscopic approaches. Literature has been published investigating its safety/efficacy; however, the quality of reporting is uncertain. This systematic review used the Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) framework to assess the reporting quality of available literature. A narrative summary was formulated, assessing how comprehensively governance/ethics, patient selection, demographics, surgeon expertise/training, technique description and outcomes were reported. Forty-seven studies published between 2005 and 2024 were included. There was incomplete/inconsistent reporting of governance/ethics, patient selection, surgeon expertise/training and technique description, with heterogenous outcome reporting. RRYGB reporting was poor and did not align with IDEAL guidance. Robust prospective studies reporting findings using IDEAL/other guidance are required to facilitate safe widespread adoption of RRYGB and other surgical innovations.

Follow up after surgery for colorectal liver metastases: A systematic review.

INTRODUCTION: Recurrence post hepatectomy for colorectal liver metastases (CRLM) occurs in 70 % of patients within two years. No established guidance on the method or intensity of follow-up currently exists. The aim of this systematic review was to summarise literature and determine whether it is possible to identify an optimal follow up regime. To this date there are no randomised prospective studies investigating this. METHODS: A systematic review was performed according to PRISMA guidelines. Outcomes included general demographics, method, frequency and duration of follow up, survival and recurrence data. Quality assessment of the papers was performed. RESULTS: Twenty-five articles published between 1994 and 2022 were included, including 9945 patients. CT was the most common imaging modality (n = 14) and CEA most common blood test (n = 11). Intensity of follow up was higher in the first two years post resection and only two papers continued follow up post 5 years resection. There was wide variation in outcome measures - Overall survival (OS) was most commonly reported. Nine papers reported OS ranging between 39 and 78.1 %. CONCLUSIONS: There is wide variation in follow up methods and outcome reporting. There is no strong evidence to support intensive follow up, and the benefits of long term follow up are also unknown due to the lack of patient centred data. High quality, prospective studies should be the focus of future research as further retrospective data is unlikely to resolve uncertainties around optimal follow up.

A systematic review of robot-assisted anti-reflux surgery to examine reporting standards.

Robot-assisted anti-reflux surgery (RA-ARS) is increasingly being used to treat refractory gastro-oesophageal reflux disease. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow up) Collaboration's framework aims to improve the evaluation of surgical innovation, but the extent to which the evolution of RA-ARS has followed this model is unclear. This study aims to evaluate the standard to which RA-ARS has been reported during its evolution, in relation to the IDEAL framework. A systematic review from inception to June 2020 was undertaken to identify all primary English language studies pertaining to RA-ARS. Studies of paraoesophageal or giant hernias were excluded. Data extraction was informed by IDEAL guidelines and summarised by narrative synthesis. Twenty-three studies were included: two case reports, five case series, ten cohort studies and six randomised controlled trials. The majority were single-centre studies comparing RA-ARS and laparoscopic Nissen fundoplication. Eleven (48%) studies reported patient selection criteria, with high variability between studies. Few studies reported conflicts of interest (30%), funding arrangements (26%), or surgeons' prior robotic experience (13%). Outcome reporting was heterogeneous; 157 distinct outcomes were identified. No single outcome was reported in all studies.The under-reporting of important aspects of study design and high degree of outcome heterogeneity impedes the ability to draw meaningful conclusions from the body of evidence. There is a need for further well-designed prospective studies and randomised trials, alongside agreement about outcome selection, measurement and reporting for future RA-ARS studies.

A rare case of tension pneumoperitoneum secondary to gastric perforation associated with severe aortic compression.

A 36-year-old male was critically unwell with acute central abdominal pain and distension. CT demonstrated severe pneumoperitoneum leading to compression and total occlusion of the inferior vena cava and occlusion of the aorta. At laparotomy, a perforated posterior gastric ulcer was found with four quadrant contamination. A damage control procedure was performed and a re-look laparotomy was carried out 2 days later where bowel ischaemia was found. Despite being supported on the intensive care unit, unfortunately the patient died. Tension pneumoperitoneum leading to occlusion of the aorta is very rare and the severity of this condition should be recognised; it has never been survived in the reported literature. Rapid assessment and investigation is essential to ensure the timely treatment of this disease.

Systematic review of the incidence and risk factors for chyle leak after pancreatic surgery.

BACKGROUND: The incidence of and risk factors for chyle leak, as defined by the 2017 International Study Group on Pancreatic Surgery, remain unknown. METHODS: MEDLINE, EMBASE, and Scopus were systematically searched for studies of patients undergoing pancreatectomy that reported chyle leak according to the 2017 International Study Group on Pancreatic Surgery definition. The primary outcomes were the incidence of overall and clinically relevant chyle leak. A random-effects pairwise meta-analysis was used to calculate the incidence of chyle leak. RESULTS: Thirty-five studies including 7,083 patients were included in the meta-analysis. The weighted incidence of overall chyle leak was 6.8% (95% confidence interval 5.6-8.2), and clinically relevant chyle leak was 5.5% (95% confidence interval 3.8-7.7). Pancreaticoduodenectomy, total pancreatectomy, and distal pancreatectomy were associated with a CL incidence of 7.3%, 4.3%, and 5.8%, respectively. Fourteen individual risk factors for chyle leak were identified from included studies. Younger age, low prognostic nutritional index, para-aortic node manipulation, lymphatic involvement, and post-pancreatectomy pancreatitis were significantly associated with chyle leak, all from individual studies. CONCLUSION: The incidence of overall chyle leak and clinically relevant chyle leak after pancreatic surgery, as defined by the 2017 International Study Group on Pancreatic Surgery, is 6.8% and 5.5%, respectively. Several risk factors for chyle leak were identified in the present review; however, larger high-quality studies are needed to more accurately define these risks.

Does ALT Correlate with Survival After Liver Resection for Colorectal Liver Metastases?

Background: The pringle manoeuvre is commonly used during hepatectomy, which may cause ischaemia-reperfusion injury and transient liver dysfunction. Post-operative liver transaminases are often used to assess ischaemia-reperfusion injury, although there is conflicting evidence on survival outcomes. The primary aim was to assess post-operative alanine aminotransferase (ALT) with survival outcomes. Secondary aims were to assess ALT level with the length of stay and overall complications. Methods: Post-operative day 2 ALT levels of five times the upper limit of normal (i.e. 280 U/L) were considered as clinically significant transaminitis. Kaplan-Meier survival curves were studied using log-rank analysis to identify the predictors of overall survival (OS) and recurrence-free survival (RFS). Results: Out of 752 patients who underwent hepatectomy, 527 (70.1%) patients had low ALT (<280 U/L) and 225 (29.9%) patients had high ALT on day 2 post-op. Post-operative ALT did not affect OS (P = 0.883) or RFS (P = 0.063). Factors associated with a worse OS and RFS on multivariate analysis were pre-operative chemotherapy, number of tumours and largest tumour size (>4 cm). A high post-operative ALT was not associated with the increased length of stay or more complications. Conclusions: Post-operative ALT does not affect survival outcomes post-hepatectomy for colorectal liver metastases.

Impact of routine nasogastric decompression versus no nasogastric decompression after pancreaticoduodenectomy on perioperative outcomes: meta-analysis.

BACKGROUND: Consensus on the use of nasogastric decompression (NGD) after pancreaticoduodenectomy (PD) is lacking. This meta-analysis reviewed current evidence on the impact of routine NGD versus no NGD after PD on perioperative outcomes. METHODS: PubMed, Medline, Scopus, Embase and Cochrane databases were searched for studies reporting on the role of NGD after PD on perioperative outcomes. Data up to January 2021were retrieved and analysed. RESULTS: Eight studies were included, with a total of 1301 patients enrolled, of whom 668 had routine NGD. Routine NGD was associated with a higher incidence of overall delayed gastric emptying (DGE) (odds ratio (OR) 2.51, 95 per cent c.i. 1.12 to 5.63, I2 = 83 per cent; P = 0.03) and clinically relevant DGE (OR 3.64, 95 per cent c.i. 1.83 to 7.25, I2 = 54 per cent; P < 0.01), a higher rate of Clavien-Dindo grade II or higher complications (OR 3.12, 95 per cent c.i. 1.05 to 9.28, I2 = 88 per cent; P = 0.04) and increased length of hospital stay (mean difference 2.67, 95 per cent c.i. 0.60 to 4.75, I2 = 97 per cent; P = 0.02). There were no significant differences in overall complications (OR 1.07, 95 per cent c.i. 0.79 to 1.46, I2 = 0 per cent; P = 0.66) or postoperative pancreatic fistula (OR 1.21, 95 per cent c.i. 0.86 to 1.72, I2 = 0 per cent; P = 0.28) between patients with or those without routine NGD. CONCLUSION: Routine NGD was associated with increased rates of DGE, major complications and longer length of stay after PD.

Making large-scale surgical trials possible: collaboration and the role of surgical trainees.

BACKGROUND: Recruitment to surgical randomised controlled trials (RCTs) can be challenging. The Sunflower study is a large-scale multi-centre RCT that seeks to establish the clinical and cost effectiveness of pre-operative imaging versus expectant management in patients with symptomatic gallstones undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones. Trials such as Sunflower, with a large recruitment target, rely on teamworking. Recruitment can be optimised by embedding a QuinteT Recruitment Intervention (QRI). Additionally, engaging surgical trainees can contribute to successful recruitment, and the NIHR Associate Principal Investigator (API) scheme provides a framework to acknowledge their contributions. METHODS: This was a mixed-methods study that formed a component part of an embedded QRI for the Sunflower RCT. The aim of this study was to understand factors that supported and hindered the participation of surgical trainees in a large-scale RCT and their participation in the API scheme. It comprised semi-structured telephone interviews with consultant surgeons and surgical trainees involved in screening and recruitment of patients, and descriptive analysis of screening and recruitment data. Interviews were analysed thematically to explore the perspectives of-and roles undertaken by-surgical trainees. RESULTS: Interviews were undertaken with 34 clinicians (17 consultant surgeons, 17 surgical trainees) from 22 UK hospital trusts. Surgical trainees contributed to patient screening, approaches and randomisation, with a major contribution to the randomisation of patients from acute admissions. They were often encouraged to participate in the study by their centre principal investigator, and career development was a typical motivating factor for their participation in the study. The study was registered with the API scheme, and a majority of the trainees interviewed (n = 14) were participating in the scheme. CONCLUSION: Surgical trainees can contribute substantial activity to a large-scale multi-centre RCT. Benefits of trainee engagement were identified for trainees themselves, for local sites and for the study as a whole. The API scheme provided a formal framework to acknowledge engagement. Ensuring that training and support for trainees are provided by the trial team is key to optimise success for all stakeholders.