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.

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 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.

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.

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 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.

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.

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.

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.

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.

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.

Randomised controlled trial to establish the clinical and cost-effectiveness of expectant management versus preoperative imaging with magnetic resonance cholangiopancreatography in patients with symptomatic gallbladder disease undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones (The Sunflower Study): a study protocol.

INTRODUCTION: Surgery 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 ANALYSIS: We 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 DISSEMINATION: This 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 NUMBER: ISRCTN10378861.

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.

Surgical Management of Non-Metastatic Pancreatic Cancer in the United Kingdom: Results of a Nationwide Survey on Current Practice.

BACKGROUND: It is presently unclear what clinical pathways are followed for patients with non-metastatic PDAC in specialised centres for pancreatic surgery across the United Kingdom (UK). METHODS: Between August 2019 and August 2020 an electronic survey was conducted aiming at a national cohort of pancreatic surgeons in the UK. Participants replied to a list of standardised questions and clinical vignettes, and data were collected and analysed focusing on management preferences, resectability criteria, and contraindications to surgery. RESULTS: Within the study period, 65 pancreatic surgeons from 27 specialist centres in the UK (96%) completed the survey. Multidisciplinary team meetings are utilised universally for the management of patients with PDAC, however, different staging systems for resectability classification are being applied. In borderline resectable PDAC, most surgeons were keen to proceed with surgical exploration post NAT, but differences were noted in preferred chemotherapy regimens. Surgeons from standard volume institutions performed fewer vein resections annually and were more likely to deem patients with locally advanced PDAC as unresectable. Intra-institutional variability in patient management was also present and ranging between 20-80%. CONCLUSIONS: Significant variability in the surgical management of non-metastatic PDAC was identified both on inter- and intra-institutional level.

Using Telemedicine to Diagnose Surgical Site Infections in Low- and Middle-Income Countries: Systematic Review.

BACKGROUND: A high burden of preventable morbidity and mortality due to surgical site infections (SSIs) occurs in low- and middle-income countries (LMICs), and most of these SSIs occur following discharge. There is a high loss to follow-up due to a wide geographical spread of patients, and cost of travel can result in delayed and missed diagnoses. OBJECTIVE: This review analyzes the literature surrounding the use of telemedicine and assesses the feasibility of using mobile phone technology to both diagnose SSIs remotely in LMICs and to overcome social barriers. METHODS: A literature search was performed using Medline, Embase, CINAHL, PubMed, Web of Science, the Cochrane Central Register of Controlled Trials and Google Scholar. Included were English language papers reporting the use of telemedicine for detecting SSIs in comparison to the current practice of direct clinical diagnosis. Papers were excluded if infections were not due to surgical wounds, or if SSIs were not validated with in-person diagnosis. The primary outcome of this review was to review the feasibility of telemedicine for remote SSI detection. RESULTS: A total of 404 articles were screened and three studies were identified that reported on 2082 patients across three countries. All studies assessed the accuracy of remote diagnosis of SSIs using predetermined telephone questionnaires. In total, 44 SSIs were accurately detected using telemedicine and an additional 14 were picked up on clinical follow-up. CONCLUSIONS: The use of telemedicine has shown to be a feasible method in remote diagnosis of SSIs. Telemedicine is a useful adjunct for clinical practice in LMICs to decrease loss to postsurgical follow-up.