Development of a reliable surgical quality assurance tool for gastrectomy in oncological trials.

BACKGROUND: Despite its recognized importance, there is currently no reliable tool for surgical quality assurance (SQA) of gastrectomy in surgical oncology. The aim of this study was to develop an SQA tool for gastrectomy and to apply this tool within the ADDICT Trial in order to assess the extent and completeness of lymphadenectomy. METHODS: The operative steps for D1+ and D2 gastrectomy have been previously described in the literature and ADDICT trial manual. Two researchers also performed fieldwork in the UK and Japan to document key operative steps through photographs and semi-structured interviews with expert surgeons. This provided the steps that were used as the framework for the SQA tool. Sixty-two photographic cases from the ADDICT Trial were rated by three independent surgeons. Generalizability (G) theory determined inter-rater reliability. D-studies examined the effect of varying the number of assessors and photographic series they rated. Chi-square assessed intra-rater reliability, comparing how the individual assessor's responses corresponded to their global rating for extent of lymphadenectomy. RESULTS: The tool comprised 20 items, including 19 anatomical landmarks and a global rating score. Overall reliability had G-coefficient of 0.557. Internal consistency was measured with a Cronbach's alpha score of 0.869 and Chi-square confirmed intra-rater reliability for each assessor as < 0.05. CONCLUSIONS: A photographic surgical quality assurance tool is presented for gastrectomy. Using this tool, the assessor can reliably determine not only the quality but also the extent of the lymphadenectomy performed based on remaining anatomy rather than the excised specimen.

Patient-reported outcomes after oesophagectomy in the multicentre LASER study.

BACKGROUND: Data on the long-term symptom burden in patients surviving oesophageal cancer surgery are scarce. The aim of this study was to identify the most prevalent symptoms and their interactions with health-related quality of life. METHODS: This was a cross-sectional cohort study of patients who underwent oesophageal cancer surgery in 20 European centres between 2010 and 2016. Patients had to be disease-free for at least 1 year. They were asked to complete a 28-symptom questionnaire at a single time point, at least 1 year after surgery. Principal component analysis was used to assess for clustering and association of symptoms. Risk factors associated with the development of severe symptoms were identified by multivariable logistic regression models. RESULTS: Of 1081 invited patients, 876 (81.0 per cent) responded. Symptoms in the preceding 6 months associated with previous surgery were experienced by 586 patients (66.9 per cent). The most common severe symptoms included reduced energy or activity tolerance (30.7 per cent), feeling of early fullness after eating (30.0 per cent), tiredness (28.7 per cent), and heartburn/acid or bile regurgitation (19.6 per cent). Clustering analysis showed that symptoms clustered into six domains: lethargy, musculoskeletal pain, dumping, lower gastrointestinal symptoms, regurgitation/reflux, and swallowing/conduit problems; the latter two were the most closely associated. Surgical approach, neoadjuvant therapy, patient age, and sex were factors associated with severe symptoms. CONCLUSION: A long-term symptom burden is common after oesophageal cancer surgery.

Variation in esophageal anastomosis technique-the role of collaborative learning.

Centralization of care has improved outcomes in esophagogastric (EG) cancer surgery. However, specialist surgical centers often work within clinical silos, with little transfer of knowledge and experience. Although variation exists in multiple dimensions of perioperative care, the differences in operative technique are rarely studied. An esophageal anastomosis workshop was held to identify areas of common and differing practice within the operative technique. Surgeons showed videos of their anastomosis technique by open and minimally invasive surgery. Each video was followed by a discussion. Surgeons from 10 different EG cancer centers attended. Eight key technical differences and learning points were identified and discussed: the optimum diameter of the gastric conduit; avoiding ischemia in the gastric conduit; minimizing esophageal trauma; the use of an esophageal mucosal collar; omental wrapping; intraoperative leak testing; ideal diameter of the circular stapler and the growing use of linear stapled anastomoses. The workshop received positive feedback from participants and on 2 years follow-up, 40% stated that they believed that the learning of tips and techniques during the workshop has contributed to lowering their anastomotic leak rate. Many differences exist in surgical technique. The reasons for, and crucially the significance of, these differences must be discussed and examined. Workshops provide a forum for peer-to-peer collaborative learning to reflect on one's own practice and improve surgical technique. These changes can, in turn, generate incremental improvements in patient care and postoperative outcomes.

Cardiorespiratory Comorbidity and Postoperative Complications following Esophagectomy: a European Multicenter Cohort Study.

BACKGROUND: The impact of cardiorespiratory comorbidity on operative outcomes after esophagectomy remains controversial. This study investigated the effect of cardiorespiratory comorbidity on postoperative complications for patients treated for esophageal or gastroesophageal junction cancer. PATIENTS AND METHODS: A European multicenter cohort study from five high-volume esophageal cancer centers including patients treated between 2010 and 2017 was conducted. The effect of cardiorespiratory comorbidity and respiratory function upon postoperative outcomes was assessed. RESULTS: In total 1590 patients from five centers were included; 274 (17.2%) had respiratory comorbidity, and 468 (29.4%) had cardiac comorbidity. Respiratory comorbidity was associated with increased risk of overall postoperative complications, anastomotic leak, pulmonary complications, pneumonia, increased Clavien-Dindo score, and critical care and hospital length of stay. After neoadjuvant chemoradiotherapy, respiratory comorbidity was associated with increased risk of anastomotic leak [odds ratio (OR) 1.83, 95% confidence interval (CI) 1.11-3.04], pneumonia (OR 1.65, 95% CI 1.10-2.47), and any pulmonary complication (OR 1.52, 95% CI 1.04-2.22), an effect which was not observed following neoadjuvant chemotherapy or surgery alone. Cardiac comorbidity was associated with increased risk of cardiovascular and pulmonary complications, respiratory failure, and Clavien-Dindo score ≥ IIIa. Among all patients, forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio > 70% was associated with reduced risk of overall postoperative complications, cardiovascular complications, atrial fibrillation, pulmonary complications, and pneumonia. CONCLUSIONS: The results of this study suggest that cardiorespiratory comorbidity and impaired pulmonary function are associated with increased risk of postoperative complications after esophagectomy performed in high-volume European centers. Given the observed interaction with neoadjuvant approach, these data indicate a potentially modifiable index of perioperative risk.

Incisional hernia and enterocutaneous fistula in patients with chronic intestinal failure: prevalence and risk factors in a cohort of patients referred to a tertiary centre.

AIM: This study aims to determine the prevalence of incisional hernia (IH) and enterocutaneous fistula (ECF) in patients with intestinal failure (IF) referred to a tertiary centre and to identify factors associated with their development. METHOD: A retrospective case note review was undertaken of a prospectively maintained database of all patients on home parenteral nutrition between 2011 and 2016 at a UK tertiary referral centre for IF. Risk factors were identified using binary logistic regression. RESULTS: The database search identified 447 patients, of whom 349 (78.1%) had surgery prior to developing IF. Eighty-one (23.2%) patients had an IH and 123 (35.2%) had an ECF at the time of referral. Of these, 51 (14.6%) had both IH and ECF. IH was associated with a high body mass index (P = 0.05), a history of a major surgical complication resulting in IF (P = 0.01), previous emergency surgery (P = 0.04), increasing number of operations (P = 0.02) and surgical site infection (SSI; P = 0.01). ECF was associated with complications relating to earlier surgery. (P ≤ .001), previous treatment with an open abdomen (P = 0.03), SSI (P = 0.001), intra-abdominal collection (P ≤ 0.001) and anastomotic leak (P = 0.02). CONCLUSION: In this series, patients with IF had a prevalence of IH which was more than double that expected following elective laparotomy (about 10%) and one in three had an ECF. Risk factors for IH and ECF are discussed.

2D versus 3D laparoscopic total mesorectal excision: a developmental multicentre randomised controlled trial.

AIMS: The role of laparoscopy in rectal cancer has been questioned. 3D laparoscopic systems are suggested to aid optimal surgical performance but have not been evaluated in advanced procedures. We hypothesised that stereoscopic imaging could improve the performance of laparoscopic total mesorectal excision (TME). METHODS: A multicentre developmental randomised controlled trial comparing 2D and 3D laparoscopic TME was performed (ISRCTN59485808). Trial surgeons were colorectal consultants that had completed their TME proficiency curve and underwent stereoscopic visual testing. Patients requiring elective laparoscopic TME with curative intent were centrally randomised (1:1) to 2D or 3D using Karl Storz IMAGE1 S D3-Link™ and 10-mm TIPCAM®1S 3D passive polarising laparoscopic systems. Outcomes were enacted adverse events as assessed by the observational clinical human reliability analysis technique, intraoperative data, 30-day patient outcomes, histopathological specimen assessment and surgeon cognitive load. RESULTS: 88 patients were included. There were no differences in patient or tumour demographics, surgeon stereopsis, case difficulty, cognitive load, operative time, blood loss or conversion between the trial arms. 1377 intraoperative adverse events were identified (median 18 per case, IQR 14-21, range 2-49) with no differences seen between the 2D and 3D arms (18 (95% CI 17-21) vs. 17 (95% CI 16-19), p = 0.437). 3D laparoscopy had non-significantly higher mesorectal fascial plane resections (94 vs. 77%, p = 0.059; OR 0.23 (95% CI 0.05-1.16)) but equal lymph node yield and circumferential margin distance and involvement. 30-day morbidity, anastomotic leak, re-operation, length of stay and readmission rates were equal between the 2D and 3D arms. CONCLUSION: Feasibility of performing multicentre 3D laparoscopic multicentre trials of specialist performed complex procedures is shown. 3D imaging did not alter the number of intraoperative adverse events; however, a potential improvement in mesorectal specimen quality was observed and should form the focus of future 3D laparoscopic TME trials.

Incidence and risk factors for esophageal cancer following achalasia treatment: national population-based case-control study.

The objective of this study is to identify the incidence of and risk factors associated with the development of esophageal cancer in treated achalasia patients in a national cohort. Patients with esophageal achalasia diagnosed and receiving a treatment between 2002 and 2012 were identified in England. Patient and treatment factors were compared between individuals who developed esophageal cancer and those that did not using univariate and multivariate analyses. A total of 7487 patients receiving an interventional treatment for esophageal achalasia were included and 101 patients (1.3%) developed esophageal cancer. The incidence of esophageal cancer was 205 cases per 100,000 patient years at risk. Patients who developed esophageal cancer were older and more commonly primarily treated with pneumatic dilation (82.2% vs. 60.3%; P < 0.001). In the esophageal cancer group, there was an increase in the number of patients requiring reinterventions (47.5% vs. 38.0%; P = 0.041) and the average total number of reinterventions per patient (1.2 vs. 0.8; P = 0.026). Multivariate analysis suggested associations between increased reintervention following both surgical myotomy (HR = 5.1; 95%CI 1.12-23.16) and pneumatic dilation (HR = 1.48; 95%CI 0.95-2.29), and esophageal cancer risk. Increasing patient age and reintervention following primary achalasia treatment are important potential risk factors for the development of esophageal cancer. Treated achalasia patients with symptom recurrence should be carefully evaluated for potential development of esophageal cancer prior to considering reintervention, and increased vigilance may help diagnose esophageal cancer in these individuals at an early stage.

Profile of exhaled-breath volatile organic compounds to diagnose pancreatic cancer.

BACKGROUND: Pancreatic cancer has a very poor prognosis as most patients are diagnosed at an advanced stage when curative treatments are not possible. Breath volatile organic compounds (VOCs) have shown potential as novel biomarkers to detect cancer. The aim of the study was to quantify differences in exhaled breath VOCs of patients with pancreatic cancers compared with cohorts without cancer. METHODS: Patients were recruited to an initial development cohort and a second validation cohort. The cancer group included patients with localized and metastatic cancers, whereas the control group included patients with benign pancreatic disease or normal pancreas. The reference test for comparison was radiological imaging using abdominal CT, ultrasound imaging or endoscopic ultrasonography, confirmed by histopathological examination as appropriate. Breath was collected from the development cohort with steel bags, and from the validation cohort using the ReCIVA™ system. Analysis was performed using gas chromatography-mass spectrometry. RESULTS: A total of 68 patients were recruited to the development cohort (25 with cancer, 43 no cancer) and 64 to the validation cohort (32 with cancer, 32 no cancer). Of 66 VOCs identified, 12 were significantly different between groups in the development cohort on univariable analysis. Receiver operating characteristic (ROC) curve analysis using significant volatile compounds and the validation cohort produced an area under the curve of 0·736 (sensitivity 81 per cent, specificity 58 per cent) for differentiating cancer from no cancer, and 0·744 (sensitivity 70 per cent, specificity 74 per cent) for differentiating adenocarcinoma from no cancer. CONCLUSION: Breath VOCs may distinguish patients with pancreatic cancer from those without cancer.

Population-based cohort study of surgical myotomy and pneumatic dilatation as primary interventions for oesophageal achalasia.

BACKGROUND: The aim of this national population-based cohort study was to compare rates of reintervention after surgical myotomy versus sequential pneumatic dilatation for the primary management of oesophageal achalasia. METHODS: Patients with oesophageal achalasia diagnosed between 2002 and 2012, and without an intervention in the preceding 5 years were identified from the Hospital Episode Statistics database. Patients were divided into two groups based on the primary treatment, and propensity score matching was used to compensate for differences in baseline characteristics. RESULTS: Some 14 705 patients were diagnosed with oesophageal achalasia, of whom 7487 (50·9 per cent) received interventional treatment: 1742 (23·3 per cent) surgical myotomy, 4534 (60·6 per cent) pneumatic dilatation and 1211 (16·2 per cent) endoscopic botulinum toxin injection. As age increased, the proportion of patients receiving myotomy decreased and the proportion undergoing dilatation increased. Patients who underwent surgical myotomy were younger (mean age 44·8 years versus 58·5 years among those who had pneumatic dilatation; P < 0·001), a greater proportion had a Charlson co-morbidity index score of 0 (90·1 versus 87·7 per cent; P = 0·003) and they were more commonly men (55·6 versus 51·8 per cent; P = 0·020). Following propensity score matching, the safety of the two initial treatment approaches was equivalent, with no difference in incidence of oesophageal perforation (1·3 and 1·4 per cent after myotomy and dilatation respectively; P = 0·750). However, dilatation was associated with increased need for reintervention (59·6 versus 13·8 per cent; P < 0·001) and frequency of reinterventions (mean 0·34 versus 0·06 per year; P < 0·001). CONCLUSION: Surgical myotomy was associated with a lower rate of reintervention and could be offered as primary treatment in patients with oesophageal achalasia who are fit for surgery. For those unfit for surgery, pneumatic dilatation may provide symptomatic relief with approximately 60 per cent of patients requiring reintervention.

Influence of national centralization of oesophagogastric cancer on management and clinical outcome from emergency upper gastrointestinal conditions.

BACKGROUND: In England in 2001 oesophagogastric cancer surgery was centralized. The aim of this study was to evaluate whether centralization of oesophagogastric cancer to high-volume centres has had an effect on mortality from different emergency upper gastrointestinal conditions. METHODS: The Hospital Episode Statistics database was used to identify patients admitted to hospitals in England (1997-2012). The influence of oesophagogastric high-volume cancer centre status (20 or more resections per year) on 30- and 90-day mortality from oesophageal perforation, paraoesophageal hernia and perforated peptic ulcer was analysed. RESULTS: Over the study interval, 3707, 12 441 and 56 822 patients with oesophageal perforation, paraoesophageal hernia and perforated peptic ulcer respectively were included. There was a passive centralization to high-volume cancer centres for oesophageal perforation (26·9 per cent increase), paraoesophageal hernia (19·5 per cent increase) and perforated peptic ulcer (23·0 per cent increase). Management of oesophageal perforation in high-volume centres was associated with a reduction in 30-day (HR 0·58, 95 per cent c.i. 0·45 to 0·74) and 90-day (HR 0·62, 0·49 to 0·77) mortality. High-volume cancer centre status did not affect mortality from paraoesophageal hernia or perforated peptic ulcer. Annual emergency admission volume thresholds at which mortality improved were observed for oesophageal perforation (5 patients) and paraoesophageal hernia (11). Following centralization, the proportion of patients managed in high-volume cancer centres that reached this volume threshold was 88·0 per cent for oesophageal perforation, but only 30·3 per cent for paraoesophageal hernia. CONCLUSION: Centralization of low incidence conditions such as oesophageal perforation to high-volume cancer centres provides a greater level of expertise and ultimately reduces mortality.

EAES classification of intraoperative adverse events in laparoscopic surgery.

BACKGROUND: Surgical outcomes are traditionally evaluated by post-operative data such as histopathology and morbidity. Although these outcomes are reported using accepted systems, their ability to influence operative performance is limited by their retrospective application. Interest in direct measurement of intraoperative events is growing but no available systems applicable to routine practice exist. We aimed to develop a structured, practical method to report intraoperative adverse events enacted during minimal access surgical procedures. METHODS: A structured mixed methodology approach was adopted. Current intraoperative adverse event reporting practices and desirable system characteristics were sought through a survey of the EAES executive. The observational clinical human reliability analysis method was applied to a series of laparoscopic total mesorectal excision (TME) case videos to identify intraoperative adverse events. In keeping with survey results, observed events were further categorised into non-consequential and consequential, which were further subdivided into four levels based upon the principle of therapy required to correct the event. A second survey phase explored usability, acceptability, face and content validity of the novel classification. RESULTS: 217 h of TME surgery were analysed to develop and continually refine the five-point hierarchical structure. 34 EAES expert surgeons (69%) responded. The lack of an accepted system was the main barrier to routine reporting. Simplicity, reproducibility and clinical utility were identified as essential requirements. The observed distribution of intraoperative adverse events was 60.1% grade I (non-consequential), 37.1% grade II (minor corrective action), 2.4% grade III (major correction or change in post-operative care) and 0.1% grade IV (life threatening). 84% agreed with the proposed classification (Likert scale 4.04) and 92% felt it was applicable to their practice and incorporated all desirable characteristics. CONCLUSION: A clinically applicable intraoperative adverse event classification, which is acceptable to expert surgeons, is reported and complements the objective assessment of minimal access surgical performance.

The influence of hospital volume upon clinical management and outcomes of esophageal achalasia: an English national population-based cohort study.

Management of achalasia is potentially complex. Previous studies have identified equivalence between pneumatic dilatation and surgical cardiomyotomy in terms of clinical outcomes. However, previous research has not investigated whether a management strategies and outcomes are different in high-volume achalasia centers. This national population-based cohort study aimed to identify the treatment modalities utilized in centers, which regularly manage achalasia and those which manage it infrequently. This study also assessed rates of re-intervention and complications to establish if a volume-outcome relationship exists for the management of achalasia in England. In this study, the Hospitals Episode Statistics database was used to identify all patients treated for achalasia in England from 2002 to 2012. Primary treatment was defined as surgical cardiomyotomy, sequential pneumatic dilatation, or botulinum toxin therapy. Primary outcome measure was reintervention. Centers were divided into regular achalasia centers (≥5.7 cases per annum) and infrequent achalasia centers (<5.7 cases per annum), and were analyzed according to tertiary cancer center status. In total, there were 7,487 patients treated for achalasia. Out of 1,947 cases (26%) were treated in regular achalasia centers, with 5,540 (74%) treated in infrequent centers. In binary logistic regression modeling regular centers treated a similar proportion of patients with primary surgical cardiomyotomy (OR: 1.11 (95% CI 0.98-1.27)) and had similar rates of re-intervention to infrequent achalasia centers (HR: 1.03 (0.94-1.12)). RA-CUSUM analysis demonstrated no relationship between total hospital volume and reintervention rates. Tertiary cancer centers treated more achalasia patients with primary surgical cardiomyotomy (OR: 1.51 (95% CI 1.31-1.73)) but there was no significant difference in reintervention rates (OR: 1.05 (95% CI 0.95-1.16)). In conclusion, this analysis failed to demonstrate a volume-outcome relationship in the management of achalasia in England. This study highlights that achalasia is treated infrequently by the majority of centers.

Effects of intraoperative pyloric stretch procedure on outcomes after esophagectomy.

Various methods have been described to aid pyloric drainage in patients undergoing esophagectomy with gastric reconstruction. These techniques are intended to prevent delayed gastric empting following esophagectomy that can be associated with early morbidity and long-term functional complaints. The current study aims to review the safety and efficacy of a pyloric stretch procedure performed at the time of esophagectomy. To achieve this, a retrospective review of 100 consecutive patients undergoing esophagectomy during the period 2011-2016 was performed. Until May 2013, no patients received intraoperative pyloric intervention. After May 2013, all patients (N = 50) underwent intraoperative pyloric stretch procedure that involved bidirectional mechanical dilatation of the pylorus. Postoperative outcomes including result of routine oral contrast swallow and early morbidity were evaluated. Intraoperative pyloric stretching was performed safely and without local complications in all patients. Delayed gastric emptying was observed significantly less frequently in patients who received intraoperative pyloric stretching (48% vs. 22%, P = 0.006). No significant differences were observed in postoperative outcomes. When considering all patients as a single cohort, the presence of delayed gastric emptying was associated with significantly higher rates of postoperative pneumonia (71% vs. 45%, P = 0.010), cardiac complications (57% vs. 25%, P = 0.001) as well as longer hospital say (12 vs. 15 days, P < 0.001) and delay to free oral fluid intake (7 vs. 9 days, < 0.001). Binary logistic regression identified age and postoperative delayed gastric emptying as independent risk factors for postoperative pneumonia. In conclusion, this study has demonstrated the safety and efficacy an intraoperative pyloric stretch procedure for the prevention of delayed gastric emptying following esophagectomy.

Effect of perioperative blood transfusion on the long-term survival of patients undergoing esophagectomy for esophageal cancer: a systematic review and meta-analysis.

Perioperative blood transfusion has been linked to poorer long-term survival in patients undergoing esophagectomy, presumably due to its potential immunomodulatory effects. This review aims to summarize existing evidence relating to the influence of blood transfusion on long-term survival following esophagectomy for esophageal cancer. A systematic literature search (up to February 2017) was conducted for studies reporting the effects of perioperative blood transfusion on survival following esophagectomy for esophageal cancer. Meta-analysis was used to summate survival outcomes. Twenty observational studies met the criteria for inclusion. Eighteen of these studies compared the outcomes of patients who received allogenic blood transfusion to patients who did not receive this intervention. Meta-analysis of outcomes revealed that allogenic blood transfusion significantly reduced long-term survival (HR = 1.49; 95% CI 1.26 to 1.76; P < 0.001). There appeared to be a dose-related response with patients who received ≥3 units of blood having lower long-term survival compared to patient who received between 0 and 2 units (HR = 1.59; 95% CI 1.31 to 1.93; P < 0.001). Two studies comparing patients who received allogenic versus autologous blood transfusion showed superior survival in the latter group. Factors associated with the requirement for perioperative blood transfusion included: intraoperative blood loss; preoperative hemoglobin; operative approach; operative time, and; presences of advanced disease. These findings indicate that perioperative blood transfusion is associated with significantly worse long-term survival in patients undergoing esophagectomy for esophageal cancer. Autologous donation of blood, meticulous intraoperative hemostasis, and avoidance of unnecessary transfusions may prevent additional deaths attributed to this intervention.

Multimodality treatment for esophageal adenocarcinoma: multi-center propensity-score matched study.

Background: The primary aim of this study was to compare survival from neoadjuvant chemoradiotherapy plus surgery (NCRS) versus neoadjuvant chemotherapy plus surgery (NCS) for the treatment of esophageal or junctional adenocarcinoma. The secondary aims were to compare pathological effects, short-term mortality and morbidity, and to evaluate the effect of lymph node harvest upon survival in both treatment groups. Methods: Data were collected from 10 European centers from 2001 to 2012. Six hundred and eight patients with stage II or III oesophageal or oesophago-gastric junctional adenocarcinoma were included; 301 in the NCRS group and 307 in the NCS group. Propensity score matching and Cox regression analyses were used to compensate for differences in baseline characteristics. Results: NCRS resulted in significant pathological benefits with more ypT0 (26.7% versus 5%; P < 0.001), more ypN0 (63.3% versus 32.1%; P < 0.001), and reduced R1/2 resection margins (7.7% versus 21.8%; P < 0.001). Analysis of short-term outcomes showed no statistically significant differences in 30-day or 90-day mortality, but increased incidence of anastomotic leak (23.1% versus 6.8%; P < 0.001) in NCRS patients. There were no statistically significant differences between the groups in 3-year overall survival (57.9% versus 53.4%; Hazard Ratio (HR)= 0.89, 95%C.I. 0.67-1.17, P = 0.391) nor disease-free survival (52.9% versus 48.9%; HR = 0.90, 95%C.I. 0.69-1.18, P = 0.443). The pattern of recurrence was also similar (P = 0.660). There was a higher lymph node harvest in the NCS group (27 versus 14; P < 0.001), which was significantly associated with a lower recurrence rate and improved disease free survival within the NCS group. Conclusion: The survival differences between NCRS and NCS maybe modest, if present at all, for the treatment of locally advanced esophageal or junctional adenocarcinoma. Future large-scale randomized trials must control and monitor indicators of the quality of surgery, as the extent of lymphadenectomy appears to influence prognosis in patients treated with NCS, from this large multi-center European study.

National proficiency-gain curves for minimally invasive gastrointestinal cancer surgery.

BACKGROUND: Minimal access surgery for gastrointestinal cancer has short-term benefits but is associated with a proficiency-gain curve. The aim of this study was to define national proficiency-gain curves for minimal access colorectal and oesophagogastric surgery, and to determine the impact on clinical outcomes. METHODS: All adult patients undergoing minimal access oesophageal, colonic and rectal surgery between 2002 and 2012 were identified from the Hospital Episode Statistics database. Proficiency-gain curves were created using risk-adjusted cumulative sum analysis. Change points were identified, and bootstrapping was performed with 1000 iterations to identify a confidence level. The primary outcome was 30-day mortality; secondary outcomes were 90-day mortality, reintervention, conversion and length of hospital stay. RESULTS: Some 1696, 15 008 and 16 701 minimal access oesophageal, rectal and colonic cancer resections were performed during the study period. The change point in the proficiency-gain curve for 30-day mortality for oesophageal, rectal and colonic surgery was 19 (confidence level 98·4 per cent), 20 (99·2 per cent) and three (99·5 per cent) procedures; the mortality rate fell from 4·0 to 2·0 per cent (relative risk reduction (RRR) 0·50, P = 0·033), from 2·1 to 1·2 per cent (RRR 0·43, P < 0·001) and from 2·4 to 1·8 per cent (RRR 0·25, P = 0·058) respectively. The change point in the proficiency-gain curve for reintervention in oesophageal, rectal and colonic resection was 19 (98·1 per cent), 32 (99·5 per cent) and 26 (99·2 per cent) procedures respectively. There were also significant proficiency-gain curves for 90-day mortality, conversion and length of stay. CONCLUSION: The introduction of minimal access gastrointestinal cancer surgery has been associated with a proficiency-gain curve for mortality and major morbidity at a national level. Unnecessary patient harm should be avoided by appropriate training and monitoring of new surgical techniques.

Validation of an oncoplastic breast simulator for assessment of technical skills in wide local excision.

BACKGROUND: Simulation enables safe practice and facilitates objective assessment of technical skills. However, simulation training in breast surgery is rare and assessment remains subjective. The primary aim was to evaluate the construct validity of technical skills assessments in wide local excision (WLE). METHODS: Surgeons of different grades performed a WLE of a 25-mm palpable tumour on an in-house synthetic breast simulator. Procedures were videotaped (blinded), reviewed retrospectively, and independently rated against a procedure-specific global rating scale by two consultant breast surgeons. Specimen radiographs were obtained and the macroscopic distance from the 'tumour' edge to the resection margin was recorded in four cardinal directions. Expert consensus was used to construct an Oncoplastic Deviation Score (ODS), assigning points for excessively wide (more than 10 mm) and, conversely, close (less than 5 mm) macroscopic margins. RESULTS: Thirty-four surgeons (12 consultant surgeons, 12 specialty trainees and 10 core trainees) participated in the study. Video-based rating scores varied hierarchically with operator expertise (P < 0.050). Inter-rater reliability was excellent (α ≥ 0.80, P < 0.050 for all scales), and inter-rater agreement was moderate (κ = 0.132-0.361, P < 0.050 for all scales). Statistically significant differences were observed on pairwise comparisons between each grade of surgeon in scores for 'exposure', 'skin flap development', 'glandular remodelling', 'skin closure' and 'final product review' (P < 0.050). Consultants received significantly fewer ODS points than specialty trainees (P = 0.012) and core trainees (P = 0.028). Compared with experts (median 9.0 mm), wider margins were observed amongst specialty trainees (median 12.0 mm) and narrower margins amongst core trainees (median 7.1 mm) (P = 0.001). CONCLUSION: Video ratings of performance and a proposed ODS differentiate surgeons based on technical skills in WLE and may be useful for objective assessment of breast surgery trainees.

Application of objective clinical human reliability analysis (OCHRA) in assessment of technical performance in laparoscopic rectal cancer surgery.

BACKGROUND: Laparoscopic rectal resection is technically challenging, with outcomes dependent upon technical performance. No robust objective assessment tool exists for laparoscopic rectal resection surgery. This study aimed to investigate the application of the objective clinical human reliability analysis (OCHRA) technique for assessing technical performance of laparoscopic rectal surgery and explore the validity and reliability of this technique. METHODS: Laparoscopic rectal cancer resection operations were described in the format of a hierarchical task analysis. Potential technical errors were defined. The OCHRA technique was used to identify technical errors enacted in videos of twenty consecutive laparoscopic rectal cancer resection operations from a single site. The procedural task, spatial location, and circumstances of all identified errors were logged. Clinical validity was assessed through correlation with clinical outcomes; reliability was assessed by test-retest. RESULTS: A total of 335 execution errors identified, with a median 15 per operation. More errors were observed during pelvic tasks compared with abdominal tasks (p < 0.001). Within the pelvis, more errors were observed during dissection on the right side than the left (p = 0.03). Test-retest confirmed reliability (r = 0.97, p < 0.001). A significant correlation was observed between error frequency and mesorectal specimen quality (r s = 0.52, p = 0.02) and with blood loss (r s = 0.609, p = 0.004). CONCLUSIONS: OCHRA offers a valid and reliable method for evaluating technical performance of laparoscopic rectal surgery.

Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial.

BACKGROUND: The optimal time of rectal resection after long-course chemoradiotherapy (CRT) remains unclear. A feasibility study was undertaken for a multi-centre randomized controlled trial evaluating the impact of the interval after chemoradiotherapy on the technical complexity of surgery. METHODS: Patients with rectal cancer were randomized to either a 6- or 12-week interval between CRT and surgery between June 2012 and May 2014 (ISRCTN registration number: 88843062). For blinded technical complexity assessment, the Observational Clinical Human Reliability Analysis technique was used to quantify technical errors enacted within video recordings of operations. Other measured outcomes included resection completeness, specimen quality, radiological down-staging, tumour cell density down-staging and surgeon-reported technical complexity. RESULTS: Thirty-one patients were enrolled: 15 were randomized to 6 and 16-12 weeks across 7 centres. Fewer eligible patients were identified than had been predicted. Of 23 patients who underwent resection, mean 12.3 errors were observed per case at 6 weeks vs. 10.7 at 12 weeks (p = 0.401). Other measured outcomes were similar between groups. CONCLUSIONS: The feasibility of measurement of operative performance of rectal cancer surgery as an endpoint was confirmed in this exploratory study. Recruitment of sufficient numbers of patients represented a challenge, and a proportion of patients did not proceed to resection surgery. These results suggest that interval after CRT may not substantially impact upon surgical technical performance.