Lasting Symptoms After Esophageal Resection (LASER): European Multicenter Cross-sectional Study.

OBJECTIVE: To identify the most prevalent symptoms and those with greatest impact upon health-related quality of life (HRQOL) among esophageal cancer survivors. BACKGROUND: Long-term symptom burden after esophagectomy, and associations with HRQOL, are poorly understood. PATIENTS AND METHODS: Between 2010 and 2016, patients from 20 European Centers who underwent esophageal cancer surgery, and were disease-free at least 1 year postoperatively were asked to complete LASER, EORTC-QLQ-C30, and QLQ-OG25 questionnaires. Specific symptom questionnaire items that were associated with poor HRQOL as identified by EORTC QLQ-C30 and QLQ-OG25 were identified by multivariable regression analysis and combined to form a tool. RESULTS: A total of 876 of 1081 invited patients responded to the questionnaire, giving a response rate of 81%. Of these, 66.9% stated in the last 6 months they had symptoms associated with their esophagectomy. Ongoing weight loss was reported by 10.4% of patients, and only 13.8% returned to work with the same activities.Three LASER symptoms were correlated with poor HRQOL on multivariable analysis; pain on scars on chest (odds ratio (OR) 1.27; 95% CI 0.97-1.65), low mood (OR 1.42; 95% CI 1.15-1.77) and reduced energy or activity tolerance (OR 1.37; 95% CI 1.18-1.59). The areas under the curves for the development and validation datasets were 0.81 ±â€Š0.02 and 0.82 ±â€Š0.09 respectively. CONCLUSION: Two-thirds of patients experience significant symptoms more than 1 year after surgery. The 3 key symptoms associated with poor HRQOL identified in this study should be further validated, and could be used in clinical practice to identify patients who require increased support.

Minimal access rectal cancer surgery: an observational study of patient outcomes from a district general hospital with over a decade of experience with robotic rectal cancer surgery.

AIM: Robotic surgery for colorectal cancer has become established more slowly than in other specialities. The aim of this study was to assess the risks and benefits of the use of robotic rectal cancer surgery in comparison with laparoscopic surgery within the confines of a subspecialist rectal cancer service in a district general hospital. METHOD: Outcomes from consecutive patients undergoing minimal access rectal cancer surgery between July 2008 and January 2020 were analysed. Comparisons were made between short-term outcomes including conversion rates, anastomotic leakage and pathological outcomes as well as long-term survival and cancer recurrence. RESULTS: A total of 337 patients were included in the analysis, 204 (60.5%) of whom underwent robotic surgery. Demographic characteristics and use of neoadjuvant chemoradiotherapy were similar between groups. However, patients having robotic surgery had significantly lower tumours than in the laparoscopic group (7.6 cm vs. 9.8 cm, p = 0.003). Conversion to open surgery in the robotic group was significantly less likely (9.8% vs. 22.6%, p = 0.001). Operative mortality, clinical leakage and major complications were similar between groups. While asymptomatic 'radiological' leaks were significantly more common following robotic surgery (13.7% vs. 5.3%, p = 0.017) this did not affect the long-term stoma closure rate. Pathological outcomes were similar with the exception of shorter mean distal resection margins (25.9 mm vs. 32.8 mm, p = 0.001) for the robotic group of patients. There was no statistical difference in 5-year survival between groups (78.7% robotic vs. 85.4% laparoscopic, p = 0.263) nor local recurrence (2.0% robotic vs. 3.8% laparoscopic, p = 0.253). CONCLUSIONS: These results illustrate how the selective use of robotic surgery by a dedicated rectal cancer team can achieve low rates of cancer recurrence and low permanent stoma rates.

Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests.

Background This study aimed to develop the Point-of-Care Key Evidence Tool (POCKET); a multi-dimensional checklist to guide the evaluation of point-of-care tests (POCTs) incorporating validity, utility, usability, cost-effectiveness and patient experience. The motivation for this was to improve the efficiency of evidence generation in POCTs and reduce the lead-time for the adoption of novel POCTs. Methods A mixed qualitative and quantitative approach was applied. Following a literature search, a three round Delphi process was undertaken incorporating a semi-structured interview study and two questionnaire rounds. Participants included clinicians, laboratory personnel, commissioners, regulators (including members of National Institute for Health and Care Excellence [NICE] committees), patients, industry representatives and methodologists. Qualitative data were analysed based on grounded theory. The final tool was revised at an expert stakeholder workshop. Results Forty-three participants were interviewed within the semi-structured interview study, 32 participated in the questionnaire rounds and nine stakeholders attended the expert workshop. The final version of the POCKET checklist contains 65 different evidence requirements grouped into seven themes. Face validity, content validity and usability has been demonstrated. There exists a shortfall in the evidence that industry and research methodologists believe should be generated regarding POCTs and what is actually required by policy and decision makers to promote implementation into current healthcare pathways. Conclusions This study has led to the development of POCKET, a checklist for evidence generation and synthesis in POCTs. This aims to guide industry and researchers to the evidence that is required by decision makers to facilitate POCT adoption so that the benefits they can bring to patients can be effectively realised.

The influence of procedural volume and proficiency gain on mortality from upper GI endoscopic mucosal resection.

OBJECTIVE: Endoscopic mucosal resection (EMR) is established for the management of benign and early malignant upper GI disease. The aim of this observational study was to establish the effect of endoscopist procedural volume on mortality. DESIGN: Patients undergoing upper GI EMR between 1997 and 2012 were identified from the Hospital Episode Statistics database. The primary outcome was 30-day mortality and secondary outcomes were 90-day mortality, requirement for emergency intervention and elective cancer re-intervention. Risk-adjusted cumulative sum (RA-CUSUM) analysis was used to assess patient mortality risk during initial stage of endoscopist proficiency gain and the effect of endoscopist and hospital volume. Mortality was compared before and after the change point or threshold in the RA-CUSUM curve. RESULTS: 11 051 patients underwent upper GI EMR. Endoscopist procedure volume was an independent predictor of 30-day mortality. Fifty-eight per cent of EMR procedures were performed by endoscopists with annual volume of 2 cases or less, and had a higher 30-day and 90-day mortality rate for patients with cancer, 6.1% vs 0.4% (p<0.001) and 12% vs 2.1% (p<0.001), respectively. The requirement for emergency intervention after EMR for cancer was also greater with low volume endoscopists (1.8% vs 0.1%, p=0.002). In patients with cancer, the RA-CUSUM curve change points for 30-day mortality and elective re-intervention were 4 cases and 43 cases, respectively. CONCLUSIONS: EMR performed by high volume endoscopists is associated with reduced adverse outcomes. In order to reach proficiency, appropriate training and procedural volume accreditation training programmes are needed nationally.

Practice Patterns and Outcomes After Hospital Admission With Acute Para-esophageal Hernia in England.

OBJECTIVE: (i) To establish at a national level clinical outcomes from patients presenting with acute para-esophageal hernia (PEH); and (ii) to determine if a hospital volume-outcome relationship exists for the management of acute PEH. BACKGROUND: Currently, no clear guidelines exist regarding the management of acute PEH, and practice patterns are based upon relatively small case series. METHODS: Patients admitted as an emergency for the treatment of acute PEH between 1997 and 2012 were included from the Hospital Episode Statistics database. The influence of hospital volume upon clinical outcomes was analyzed in unmatched and matched comparisons to control for patient age, medical comorbidities, and incidence of PEH hernia gangrene. RESULTS: Over the 16-year study period, 12,441 patients were admitted as an emergency with a PEH causing obstruction or gangrene. Of these, 90.8% patients were admitted with PEH with obstruction in the absence of gangrene and 9.2% with PEH with gangrene. The incidences of 30 and 90-day mortality were 7% and 11.5%, respectively, which did not decrease during the study period. Unmatched and matched comparisons showed, in high-volume centers, there were significant reductions in utilization of emergency surgery (8.8% vs 14.9%; P < 0.0001), 30-day (5.3% vs 7.8%; P < 0.0001), and 90-day mortality (9.3% vs 12.7%; P < 0.0001). Multivariate analysis also confirmed high hospital volume was independently associated with reduced 30 and 90-day mortality from acute PEH. CONCLUSIONS: Acute PEH represents a highly morbid condition, and treatment in high-volume centers provides the appropriate multidisciplinary infrastructure to manage these complex patients reducing associated mortality.

Improving Escalation of Care: Development and Validation of the Quality of Information Transfer Tool.

OBJECTIVE: To develop and provide validity and feasibility evidence for the QUality of Information Transfer (QUIT) tool. BACKGROUND: Prompt escalation of care in the setting of patient deterioration can prevent further harm. Escalation and information transfer skills are not currently measured in surgery. METHODS: This study comprised 3 phases: the development (phase 1), validation (phase 2), and feasibility analysis (phase 3) of the QUIT tool. Phase 1 involved identification of core skills needed for successful escalation of care through literature review and 33 semistructured interviews with stakeholders. Phase 2 involved the generation of validity evidence for the tool using a simulated setting. Thirty surgeons assessed a deteriorating postoperative patient in a simulated ward and escalated their care to a senior colleague. The face and content validity were assessed using a survey. Construct and concurrent validity of the tool were determined by comparing performance scores using the QUIT tool with those measured using the Situation-Background-Assessment-Recommendation (SBAR) tool. Phase 3 was conducted using direct observation of escalation scenarios on surgical wards in 2 hospitals. RESULTS: A 7-category assessment tool was developed from phase 1 consisting of 24 items. Twenty-one of 24 items had excellent content validity (content validity index >0.8). All 7 categories and 18 of 24 (P < 0.05) items demonstrated construct validity. The correlation between the QUIT and SBAR tools used was strong indicating concurrent validity (r = 0.694, P < 0.001). Real-time scoring of escalation referrals was feasible and indicated that doctors currently have better information transfer skills than nurses when faced with a deteriorating patient. CONCLUSIONS: A validated tool to assess information transfer for deteriorating surgical patients was developed and tested using simulation and real-time clinical scenarios. It may improve the quality and safety of patient care on the surgical ward.

Laparoscopic repair of hiatus hernia: Does mesh type influence outcome? A meta-analysis and European survey study.

BACKGROUND: Synthetic mesh (SM) has been used in the laparoscopic repair of hiatus hernia but remains controversial due to reports of complications, most notably esophageal erosion. Biological mesh (BM) has been proposed as an alternative to mitigate this risk. The aim of this study is to establish the incidence of complications, recurrence and revision surgery in patients following suture (SR), SM or BM repair and undertake a survey of surgeons to establish a perspective of current practice. METHODS: An electronic search of EMBASE, MEDLINE and Cochrane database was performed. Pooled odds ratios (PORs) were calculated for discrete variables. To survey current practice an online questionnaire was sent to emails registered to the European Association for Endoscopic Surgery. RESULTS: Nine studies were included, comprising 676 patients (310 with SR, 214 with SM and 152 with BM). There was no significant difference in the incidence of complications with mesh compared to SR (P = 0.993). Mesh significantly reduced overall recurrence rates compared to SR [14.5 vs. 24.5 %; POR = 0.36 (95 % CI 0.17-0.77); P = 0.009]. Overall recurrence rates were reduced in the SM compared to BM groups (12.6 vs. 17.1 %), and similarly compared to the SR group, the POR for recurrence was lower in the SM group than the BM group [0.30 (95 % CI 0.12-0.73); P = 0.008 vs. 0.69 (95 % CI 0.26-1.83); P = 0.457]. Regarding surgical technique 503 survey responses were included. Mesh reinforcement of the crura was undertaken by 67 % of surgeons in all or selected cases with 67 % of these preferring synthetic mesh to absorbable mesh. One-fifth of the respondents had encountered mesh erosion in their career. CONCLUSIONS: Both SM and BM reduce rates of recurrence compared to SR, with SM proving most effective. Surgical practice is varied, and there remains insufficient evidence regarding the optimum technique for the repair of hiatal hernia.

Single port Billroth I gastrectomy.

INTRODUCTION: Experience has allowed increasingly complex procedures to be undertaken by single port surgery. We describe a technique for single port Billroth I gastrectomy with a hand-sewn intracorporeal anastomosis in the resection of a benign tumour diagnosed incidentally on a background of cholelithiasis. MATERIALS AND METHODS: Single port Billroth I gastrectomy and cholecystectomy was performed using a transumbilical quadport. Flexible tipped camera and straight conventional instruments were used throughout the procedure. The stomach was mobilised including a limited lymph node dissection and resection margins in the proximal antrum and duodenum were divided with a flexible tipped laparoscopic stapler. The lesser curve was reconstructed and an intracorporal hand sewn two layer end-to-end anastomosis was performed using unidirectional barbed sutures. Intraoperative endoscopy confirmed the anastomosis to be patent without leak. RESULTS: Enteral feed was started on the day of surgery, increasing to a full diet by day 6. Analgesic requirements were a patient-controlled analgesia morphine pump for 4 postoperative days and paracetamol for 6 days. There were no postoperative complications and the patient was discharged on the eighth day. Histology confirmed gastric submucosal lipoma. DISCUSSION: As technology improves more complex procedures are possible by single port laparoscopic surgery. In this case, flexible tipped cameras and unidirectional barbed sutures have facilitated an intracorporal hand-sewn two layer end-to-end anastomosis. Experience will allow such techniques to become mainstream.

Experiences of a "COVID protected" robotic surgical centre for colorectal and urological cancer in the COVID-19 pandemic.

The recent COVID-19 pandemic led to the cancellation of elective surgery across the United Kingdom. Re-establishing elective surgery in a manner that ensures patient and staff safety has been a priority. We report our experience and patient outcomes from setting up a "COVID protected" robotic unit for colorectal and renal surgery that housed both the da Vinci Si (Intuitive, Sunnyvale, CA, USA) and the Versius (CMR Surgical, Cambridge, UK) robotic systems. "COVID protected" robotic surgery was undertaken in a day-surgical unit attached to the main hospital. A standard operating procedure was developed in collaboration with the trust COVID-19 leadership team and adapted to national recommendations. 60 patients underwent elective robotic surgery in the initial 10-weeks of the study. This included 10 colorectal procedures and 50 urology procedures. Median length of stay was 4 days for rectal cancer procedures, 2 days less than prior to the COVID period, and 1 day for renal procedures. There were no instances of in-patient coronavirus transmission. Six rectal cancer patients waited more than 62 days for their surgery because of the initial COVID peak but none had an increase T-stage between pre-operative staging and post-operative histology. Robotic surgery can be undertaken in "COVID protected" units within acute hospitals in a safe way that mitigates the increased risk of undergoing major surgery in the current pandemic. Some benefits were seen such as reduced length of stay for colorectal patients that may be associated with having a dedicated unit for elective robotic surgical services.

Qualitative analysis of stakeholder interviews to identify the barriers and facilitators to the adoption of point-of-care diagnostic tests in the UK.

OBJECTIVES: This study investigated the barriers and facilitators to the adoption of point-of-care tests (POCTs). DESIGN: Qualitative study incorporating a constant comparative analysis of stakeholder responses to a series of interviews undertaken to design the Point-of-Care Key Evidence Tool. SETTING: The study was conducted in relation to POCTs used in all aspects of healthcare. PARTICIPANTS: Forty-three stakeholders were interviewed including clinicians (incorporating laboratory staff and members of trust POCT committees), commissioners, industry, regulators and patients. RESULTS: Thematic analysis highlighted 32 barriers in six themes and 28 facilitators in eight themes to the adoption of POCTs. Six themes were common to both barriers and facilitators (clinical, cultural, evidence, design and quality assurance, financial and organisational) and two themes contained facilitators alone (patient factors and other (non-financial) resource use). CONCLUSIONS: Findings from this study demonstrate the complex motivations of stakeholders in the adoption of POCT. Most themes were common to both barriers and facilitators suggesting that good device design, stakeholder engagement and appropriate evidence provision can increase the likelihood of a POCT device adoption. However, it is important to realise that while the majority of identified barriers may be perceived or mitigated some may be absolute and if identified early in device development further investment should be carefully considered.

Development and validation of ester impregnated pH strips for locating nasogastric feeding tubes in the stomach-a multicentre prospective diagnostic performance study.

BACKGROUND: NG (nasogastric) tubes are used worldwide as a means to provide enteral nutrition. Testing the pH of tube aspirates prior to feeding is commonly used to verify tube location before feeding or medication. A pH at or lower than 5.5 was taken as evidence for stomach intubation. However, the existing standard pH strips lack sensitivity, especially in patients receiving feeding and antacids medication. We developed and validated a first-generation ester-impregnated pH strip test to improve the accuracy towards gastric placements in adult population receiving routine NG-tube feeding. The sensitivity was improved by its augmentation with the action of human gastric lipase (HGL), an enzyme specific to the stomach. METHODS: We carried out a multi-centred, prospective, two-gate diagnostic accuracy study on patients who require routine NG-tube feeding in 10 NHS hospitals comparing the sensitivity of the novel pH strip to the standard pH test, using either chest X-rays or, in its absence, clinical observation of the absence of adverse events as the reference standard. We also tested the novel pH strips in lung aspirates from patients undergoing oesophageal cancer surgeries using visual inspection as the reference standard. We simulated health economics using a decision analytic model and carried out adoption studies to understand its route to commercialisation. The primary end point is the sensitivity of novel and standard pH tests at the recommended pH cut-off of 5.5. RESULTS: A total of 6400 ester-impregnated pH strips were prepared based on an ISO13485 quality management system. A total of 376 gastric samples were collected from adult patients in 10 NHS hospitals who were receiving routine NG-tube feeding. The sensitivities of the standard and novel pH tests were respectively 49.2% (95% CI 44.1­54.3%) and 70.2% (95% CI 65.6­74.8%) under pH cut-off of 5.5 and the novel test has a lung specificity of 89.5% (95% CI 79.6%, 99.4%). Our simulation showed that using the novel test can potentially save 132 unnecessary chest X-rays per check per every 1000 eligible patients, or direct savings of £4034 to the NHS. CONCLUSIONS: The novel pH test correctly identified significantly more patients with tubes located inside the stomach compared to the standard pH test used widely by the NHS. TRIAL REGISTRATION: http://www.isrctn.com/ISRCTN11170249 , Registered 21 June 2017-retrospectively registered.

A rare case of acute congestive ischaemic colitis related to combined superior and inferior mesenteric arteriovenous malformations.

Visceral arteriovenous malformations (AVMs) are extremely rare with only a few cases described within the literature. To date, no cases of ischaemic colitis related to arteriovenous malformations affecting both superior and inferior mesenteric arteries have been reported. We report the first case of acute ischaemic colitis caused by venous congestion and reduced arterial flow due to combined AVMs in the territory of superior and inferior mesenteric arteries in a 51-year-old patient. After a multidisciplinary meeting, interventional radiology embolization was considered to be of unlikely benefit due to extensive varicosities; therefore, surgical treatment in the form of open subtotal colectomy and end ileostomy was performed. This case report demonstrates the severity and the complexity in the management of AVM-related ischaemic colitis, together with a review of the literature.

[Not Available].

Laparoscopic cholecystectomy is the gold standard method for treating gallstone related disease. Despite its widespread and well established application, clear consensus is not arrived at regarding the comparative risks and benefits of acute versus interval cholecystectomy. The complications of this technique are well known, with respect to both the operative intervention and the technique used. This case describes a case of cholecystitis in a 76-year-old man, who underwent acute laparoscopic cholecystectomy for cholecystitis refractory to antibiotic therapy. Postoperative complications included subhepatic collections bilaterally, eventually leading to the formation of an enterocutaneous fistula to the left chest wall - a previously undocumented phenomenon. The protracted course of the disease is discussed, with reference to investigations performed and the eventual successful outcome.

Pancreaticoduodenectomy for the Management of Pancreatic or Duodenal Metastases from Primary Sarcoma.

BACKGROUND/AIM: Sarcomas are rare and heterogeneous solid tumours of mesenchymal origin and frequently have an aggressive course. The mainstay of management for localized disease is surgical excision. Following excision there is approximately 30-50% risk of developing distant metastases. The role of pancreatic resection for metastatic sarcoma is unclear. Therefore, the aim of this study was to asses the outcome of patients with pancreatic metastases of sarcoma treated with surgical resection. PATIENTS AND METHODS: A retrospective analysis of a prospectively maintained single-surgeon, single-centre database was undertaken. Seven patients were identified who underwent pancreaticoduodenectomy for the management of metastatic disease from sarcoma between 2006-2016. RESULTS: The median age was 59 (range=19-73) years, and there were six females and one male. The primary sites included the uterus, broad ligament, femur and inferior vena cava. One patient died in the early postoperative period. The remaining six patients developed further recurrent disease, with a median disease-free interval of 11 (range=4-27) months and median overall survival of 21 months (range=4 days to 86 months). CONCLUSION: To our knowledge, this is the largest series of patients with pancreatic metastases of sarcoma treated with surgical resection. Despite optimal resection with R0 margins, in the absence of effective adjuvant systemic therapies, the benefit of such an approach in metastatic disease remains unclear.

Usability study of pH strips for nasogastric tube placement.

AIMS: (1) To model the process of use and usability of pH strips (2) to identify, through simulation studies, the likelihood of misreading pH strips, and to assess professional's acceptance, trust and perceived usability of pH strips. METHODS: This study was undertaken in four phases and used a mixed method approach (an audit, a semi-structured interview, a survey and simulation study). The three months audit was of 24 patients, the semi-structured interview was performed with 19 health professionals and informed the process of use of pH strips. A survey of 134 professionals and novices explored the likelihood of misinterpreting pH strips. Standardised questionnaires were used to assess professionals perceived usability, trust and acceptance of pH strip use in a simulated study. RESULTS: The audit found that in 45.7% of the cases aspiration could not be achieved, and that 54% of the NG-tube insertions required x-ray confirmation. None of those interviewed had received formal training on pH strips use. In the simulated study, participants made up to 11.15% errors in reading the strips with important implications for decision making regarding NG tube placement. No difference was identified between professionals and novices in their likelihood of misinterpreting the pH value of the strips. Whilst the overall experience of usage is poor (47.3%), health professionals gave a positive level of trust in both the interview (62.6%) and the survey (68.7%) and acceptance (interview group 65.1%, survey group 74.7%). They also reported anxiety in the use of strips (interview group 29.7%, survey group 49.7%). CONCLUSIONS: Significant errors occur when using pH strips in a simulated study. Manufacturers should consider developing new pH strips, specifically designed for bedside use, that are more usable and less likely to be misread.

Does use of point-of-care testing improve cost-effectiveness of the NHS Health Check programme in the primary care setting? A cost-minimisation analysis.

OBJECTIVE: To determine if use of point of care testing (POCT) is less costly than laboratory testing to the National Health Service (NHS) in delivering the NHS Health Check (NHSHC) programme in the primary care setting. DESIGN: Observational study and theoretical mathematical model with microcosting approach. SETTING: We collected data on NHSHC delivered at nine general practices (seven using POCT; two not using POCT). PARTICIPANTS: We recruited nine general practices offering NHSHC and a pathology services laboratory in the same area. METHODS: We conducted mathematical modelling with permutations in the following fields: provider type (healthcare assistant or nurse), type of test performed (total cholesterol with either lab fasting glucose or HbA1c), cost of consumables and variable uptake rates, including rate of non-response to invite letter and rate of missed [did not attend (DNA)] appointments. We calculated total expected cost (TEC) per 100 invites, number of NHSHC conducted per 100 invites and costs for completed NHSHC for laboratory and POCT-based pathways. A univariate and probabilistic sensitivity analysis was conducted to account for uncertainty in the input parameters. MAIN OUTCOME MEASURES: We collected data on cost, volume and type of pathology services performed at seven general practices using POCT and a pathology services laboratory. We collected data on response to the NHSHC invitation letter and DNA rates from two general practices. RESULTS: TEC of using POCT to deliver a routine NHSHC is lower than the laboratory-led pathway with savings of £29 per 100 invited patients up the point of cardiovascular disease risk score presentation. Use of POCT can deliver NHSHC in one sitting, whereas the laboratory pathway offers patients several opportunities to DNA appointment. CONCLUSIONS: TEC of using POCT to deliver an NHSHC in the primary care setting is lower than the laboratory-led pathway. Using POCT minimises DNA rates associated with laboratory testing and enables completion of NHSHC in one sitting.