TY - JOUR
AU1 - Evans, R P, T
AU2 - Singh,, P
AU3 - Nepogodiev,, D
AU4 - Bundred,, J
AU5 - Kamarajah,, S
AU6 - Jefferies,, B
AU7 - Siaw-Acheampong,, K
AU8 - Wanigasooriya,, K
AU9 - McKay,, S
AU1 - Mohamed,, I
AU1 - Whitehouse,, T
AU1 - Alderson,, D
AU1 - Gossage,, J
AU1 - , van Hillegersberg, R
AU1 - Vohra, R, S
AU1 - Griffiths, E, A
AB - SUMMARY Esophagectomy is a mainstay in curative treatment for esophageal cancer; however, the reported techniques and outcomes can vary greatly. Thirty-day mortality of patients with an intact anastomosis is 2–3% as compared to 17–35% in patients who have an anastomotic leak. The subsequent management of leaks postesophagectomy has great global variability with little consensus on a gold standard of practice. The aim of this multicentre prospective audit is to analyze current techniques of esophagogastric anastomosis to determine the effect on the anastomotic leak rate. Leak rates and leak management will be assessed to determine their impact on patient outcomes. A 12-month international multicentre prospective audit started in April 2018 and is coordinated by a team from the West Midlands Research Collaborative. This will include patients undergoing esophagectomy over 9 months and encompassing a 90-day follow-up period. A pilot data collection period occurred at four UK centers in 2017 to trial the data collection form. The audit standards will include anastomotic leak and the conduit necrosis rate should be less than 13% and major postoperative morbidity (Clavien–Dindo Grade III or more) should be less than 35%. The 30-day mortality rate should be less than 5% and the 90-day mortality rate should be less than 8%. This will be a trainee-led international audit of esophagectomy practice. Key support will be given by consultant colleagues and anesthetists. Individualized unit data will be distributed to the respective contributing sites. An overall anonymized report will be made available to contributing units. Results of the audit will be published in peer-reviewed journals with all collaborators fully acknowledged. The key information and results from the audit will be disseminated at relevant scientific meetings. INTRODUCTION Esophagectomy is a mainstay in the curative treatment of esophageal cancer; however, the outcome varies greatly.1,–3 There are many different techniques employed for esophagectomy, particularly regarding operative approach, the use of minimally invasive techniques, and methods of reconstruction. Furthermore, the indications for and types of multimodal neoadjuvant therapies add another layer of variation. Anastomotic leakage following esophagectomy is associated with high rates of morbidity and mortality. Thirty-day mortality in patients with a demonstrable leak can be as high as 17–35% whereas the 30-day mortality of patients with an intact anastomosis is 2–3%.2,4 In addition, anastomotic leakage is known to increase length of hospital stay, reduce quality of life, and be economically costly for the health service.5 There is also evidence that anastomotic leakage adversely affects long-term prognosis and is associated with reduced long-term survival and increased recurrence rates.6 Reported anastomotic leak rates are very variable between surgeons, units, and countries. Recent papers demonstrate rates between 1.8% and 34.6%.7,–17 The largest of the recent studies by Kassis et al. identified 7595 esophagectomies with a leak rate of 10.6% and Ryan et al. identified 7167 esophagectomies with a transthoracic esophagectomy leak rate of 9.8% and a transhiatal esophagectomy leak rate of 12%.7,8 However, until recently the definitions of anastomotic leakage and gastric conduit necrosis have not been standardized across the surgical literature. In 2015, the Esophagectomy Complications Consensus Group (ECCG) defined anastomotic leaks as ‘full-thickness defects involving the oesophagus, anastomosis, staple line or conduit’, irrespective of the presentation or method of identification. In this classification, leaks were divided into three types based on the management strategy.18 Gastric conduit necrosis has also been classified by the ECCG, and this is when the gastric conduit becomes ischemic and necrotic to varying degrees.18 The ECCG have recently published data on 2704 esophageal resections operated on between January 2015 and December 2016.19 This data was from 24 high-volume esophageal units in 14 countries. The indication for resection was malignancy in 95.6%, with neoadjuvant chemoradiation or neoadjuvant chemotherapy given in 46.1% and 29.5% of cases, respectively. In this dataset, the anastomotic leak rate was 11.4% and the rate of conduit necrosis was 1.3%.19 Approximately half (52.1%) of the esophagectomies were performed open. In a similar benchmarking study, from 13 high-volume units over a 5-year period, outcomes from totally minimally invasive esophagectomy (43.7% were 3-stage procedures) in low-risk patients were defined. Anastomotic leakage in this cohort was 15.9%.1 However, this data was from specialist centers and no specific information was collected on leak management or specific anastomotic leak–related outcomes. The main purpose of this international audit is to identify the incidence of leaks and analyze when they are diagnosed and how they are specifically managed (conservatively, endoscopically, surgically). An international multicenter audit will enable a large volume of patient data to be obtained over a short time period when changes in unit policies are likely to be minimized. It will potentially obtain a more general overview of the variations in practice across units and countries. In addition, data will come from a range of low- and high-volume centers with a range of resources (e.g., access to minimal access or robotic techniques). This audit seeks to provide up-to-date information on the international variations in surgical practice. METHODS Primary aim The primary aim of this audit is to determine the international variation in the rate of anastomotic leak following esophagectomy for esophageal cancer. Leak rates will be stratified by center volume and country income. These results will be benchmarked against audit standards that the anastomotic leak and conduit necrosis rate should be under 13%. Secondary aims 1 To determine the international variation in morbidity and mortality following esophagectomy for esophageal cancer, including major complications and mortality. These results will be benchmarked against audit standards that the major postoperative complication (Clavien–Dindo grade ≥3) rate should be under 35%, 30-day mortality should be under 5%, and 90-day mortality should be under 8%. 2 To assess the relationship between anastomotic technique and optimal patient outcome (discharge home eating and drinking orally) following esophagectomy for esophageal cancer. 3 To determine risk factors for anastomotic leak following esophagectomy for esophageal cancer.1,19,20 SUMMARY A global prospective audit of patients undergoing esophagectomy over a 9-month period from April 2018 to December 2018 will be performed. Patients will be followed up for 90 days after the date of surgical resection to collect outcome data. Registered units must include all patients undergoing esophagectomy for malignancy during the study period. A 2-month pilot of 4 centers within the UK was undertaken to finalize the detailed online case report forms. This will ensure that all relevant data is collected to achieve the goals of the audit. Data collection will be undertaken as per Appendix I. Inclusion criteria Eligible patients suitable for inclusion in the study will be identified from multidisciplinary team (MDT/tumor board) meetings, review of theatre scheduling systems and operating lists, and coordination with the lead surgeon for esophagogastric cancer resections and the Oesophageal Cancer Specialist nursing services. The inclusion criteria are: • All adult patients undergoing elective esophagectomy for malignancy with an esophagogastric anastomosis carried out during the study period. • Any approach (2-stage, 3-stage thoracoabdominal, transhiatal) using any technique of access (open, robotic, or standard minimal access) • Any anastomotic technique—handsewn, stapled (mechanical; circular/linear), combined handsewn and stapled. • Thoracic and cervical anastomotic locations. • Patients undergoing total gastrectomy, pharyngolaryngesophagectomy, or colonic interposition and small bowel jejunal interposition reconstructions are excluded. • Patients undergoing esophagectomy for benign or emergency indications will be excluded. Center eligibility All centers routinely performing elective esophagectomies for esophageal cancer are eligible to join the study. There is no minimum number of esophagectomies required to participate; however, all consecutive eligible cases during the study period should be submitted. Cancer surgery has been identified as a key ‘global surgery’ research priority; therefore, given the lack of high-quality published data on esophagectomy in low- and middle-income countries (LMICs), centers anywhere in the world will be eligible.21 To address anticipated heterogeneity between centers in different settings, analyses will be stratified by country income (high- versus low- and middle-income countries). LMICs will be identified based on the Organisation for Economic Co-operation and Development (OECD) Official Development Assistance (ODA) list. Each unit will be required to register prior to the start date for data collection. Each unit will be responsible for obtaining local hospital approval before commencement of the audit. Each unit must ensure they have appropriate staff that will be able to ensure a >95% completeness of data entry before the closing date of the study. Patient follow-up The study design aims to ensure that no additional patient follow-up or intervention is required that would deviate from the normal patient journey. For the purposes of accurate data entry, follow-up will require investigators to collate information from electronic and paper records. This will enable adequate analysis of the pre-, intra-, and postoperative patient outcomes. The data collection period will be for 90 days after the index operation involving the patient's resection. Data completion and organization Data input will be via a dedicated encrypted server through the Research Electronic Data Capture (REDCap) web application. No patient identifiable information will be inputted into the database. REDCap will provide an ID number for each patient entered. Locally held records containing corresponding REDCap ID numbers and local patient identifiers must be stored securely. This will facilitate patient data entry at different time points by different team members and enable cross-checking of data entry by different team members to ensure accuracy of data collection. Data can be entered directly into the REDCap system via the secure website via a computer or on a smart phone. Printable data collection forms will be made available to enable participants to record data as required that can be uploaded to REDCap when a computer/device is available. Patient data will be entered into case report forms (CRFs) that are designed not to deviate from safe patient care. CRFs will only record patient events and not instigate any form of intervention. Intra-operative detail must be entered by a surgeon present at the time of the operation. However, if a nominated member of the audit is not present at the operation, he/she must take instruction from a surgeon who was present at the time of the operation. This will minimize error and ensure accurate operative data recording that may be absent in the operation note records. All other data such as demographics or outcomes may be inputted by any member of the audit team. Missing data may be entered any time during the study period. Units with >5% missing data will be excluded from the study. The Birmingham Surgical Trials Consortium, University of Birmingham, will host the REDCap system. All data will be stored securely on encrypted and certified servers. Data collection form Please see Appendix I for our detailed data collection/case report form. Preoperative variables, including patient demographics, age, gender, smoking and alcohol history, preoperative blood results (albumin, hemoglobin, and creatinine), and co-morbidities, will be collected here. These can be completed prior to the date of the operation if desired. Data will also be collected on neoadjuvant therapy and preoperative tumor stage. Intra-operative variables, including the operation type, technique of the operation (open/laparoscopic/robotic), location of the anastomosis, type of anastomosis performed (handsewn, stapled, or combination of both) and any techniques to assess the anastomosis during the surgery will be documented here. Techniques to try to reduce anastomotic leakage, including wrapping the anastomosis in omentum or burying the anastomosis in the pleural, will be collected. Postoperative nutritional access will be assessed including placement of a nasojejunal tube or a feeding jejunostomy. Anesthetic variables will include information on single lung ventilation (double lumen tube/bronchial blocker), intra-operative infusion of fluids and blood, and administration of vasopressors by bolus or infusion in the intra-operative period. Pre- and postprocedural pain management techniques including the use of epidural/spinal anesthesia, paravertebral blocks, and patient-controlled anesthesia will be recorded. The postprocedure lactate level and whether the patient was extubated on the same day as the operation will also be recorded. Postoperative/complications variables will mainly focus on the ECCG definitions of anastomotic leak and conduit necrosis (Appendix II) and complications according to other organ systems (respiratory, cardiac, renal, chyle leak, etc.). Whether the anastomosis was formally assessed for integrity (by endoscopy/computed tomography, CT, or contrast study) during the postoperative period will be recorded. In addition, if an anastomotic leak or conduit necrosis does occur, the management strategy for the patient will be recorded. This could change between the primary (first), secondary (second), and tertiary (third) management options—for example, nonoperative, operative (re-thoracotomy), radiological, and endoscopic (stenting or endoVAC therapy)—in any order depending on what actually occurs to the patient. Final outcome data such as whether the patient was discharged eating and drinking normally, total length of stay, 30- and 90-day mortality, and readmission will also be collected. Unit Survey will focus on the resources within specific units, such as variability in surgeon number and type and whether there are agreed operative strategies. It will also assess access to services out of hours and the role and uptake of Enhanced Recovery After Surgery (ERAS). Local approvals All data collected will measure current practice, with no changes made to normal treatment. As such, this study should be registered as an audit of current practice at each participating center. Authorship Each individual unit may have up to five co-authors. Manuscripts arising from this study will be published under a single corporate authorship ‘Oesophagogastric Anastomosis Study Group, West Midlands Research Collaborative’, with co-authors listed in an appendix and PubMed-citable. Pilot Pilot data collection was undertaken at four UK hospitals (Queen Elizabeth Hospital Birmingham, St. Thomas’ Hospital, Queen's Medical Centre Nottingham, and University Hospital of North Midlands) prior to the commencement of the full global study. Each center tested the feasibility of collection of the proposed data points using the REDCap online case report forms. The forms’ clarity was tested to ensure there were no ambiguous data points. Based on the feedback received, the data collection tool was streamlined prior to commencement of the main study. Data publication and governance Data will be published as pooled data. It is important to emphasize that no identifiable surgeon or identifiable unit specific data will be published. Local units may request their own specific data at the end of the study. The ‘Oesophagogastric Anastomosis Study Group, West Midlands Research Collaborative’ welcome the use of the data for further research. All requests will be assessed on an individual basis with a strong emphasis on safeguarding of data. All subsequent publications using the dataset must recognize the Oesophagogastric Anastomosis Study Group, West Midlands Research Collaborative, and be published under the principles of shared authorship with a single corporate author. Data reporting The report of the audit will be prepared in accordance with the guidelines as set by the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement for observational studies and STROCSS (Strengthening the Reporting of Cohort Studies in Surgery).22,23 Statistical analysis Initially, univariable analyses will be performed to identify factors associated with anastomotic leaks. Comparisons between patients with and without leaks will be performed using t-tests for normally distributed variables, Mann–Whitney tests for nonnormal and ordinal variables and chi-square tests for nominal variables. Multivariable analyses will then be performed, in order to identify those factors that are independently predictive of anastomotic leak. For ordinal and continuous factors, goodness of fit testing will initially be performed using Hosmer–Lemeshow tests. Variables for which a significantly poor fit is detected will be divided into groups for analysis, either based on clinically relevant categories or using the percentiles of the distribution. All factors will then be considered for inclusion in a multivariable binary logistic regression model. In order to minimize the impact of multicollinearity, a stepwise approach to variable selection will also be used, to reduce the number of factors included in the model. Sensitivity analyses will also be performed in which any factors with large quantities of missing data will be excluded from analysis, in order to assess the potential impact of any selection bias. The relative performance of the individual (anonymized) centers will then be considered using both unadjusted and risk-adjusted funnel plots. DISCUSSION Historically esophageal cancer surgery has been associated with a significant morbidity and mortality.24,25 Patient factors will strongly influence outcomes post esophagectomy and despite improvements in the recognition and optimization of co-morbidity these factors are often relatively fixed.6,26 The method by which one performs an esophagectomy can vary greatly. At present, there is no agreed gold standard of practice and surgeons across many nations will vary their operative techniques in search of the ‘textbook outcome’.27 The parameters of a textbook outcome can vary, however. Busweiler et al. set forth standards such as complete tumor resection with a minimum of 15 nodes in the specimen and subsequent uneventful postoperative course without readmission. In this study, only 29.7% of patients undergoing an esophagectomy achieved a textbook outcome.27 Numerous studies have advocated varying techniques comparing handsewn and mechanical options for anastomoses.28,29 There is some evidence to show that a mechanical anastomosis using a linear stapler has a reduced leak rate and reduced stricture rate as compared to a handsewn anastomosis; however, results vary markedly between surgeons and units.30,31 There is evidence to suggest that cervical anastomoses are associated with an increased leak rate as compared to thoracic anastomoses.8,29,32 Prompt recognition of anastomotic leakage can potentially expedite clinical intervention and improve patient outcome. CT with oral and intravenous contrast in combination with endoscopy to assess the gastric pull up is advocated to diagnose a potential leak.33,–35 The clinical management of leaks is controversial and depends on the site of the leak, size of the defect, perfusion of the gastric conduit, and the clinical status of the patient. Small contained anastomotic leaks can be managed nonoperatively, where patients are kept nil by mouth and given antibiotics and nasogastric drainage. Leaks that are not localized or that cause greater systemic upset are generally considered to be those that require some form of active intervention such as radiological drainage or treatment with either endoluminal VAC therapy, covered esophageal stenting, or rethoracotomy. There is little evidence of superiority of one technique over another. Large anastomotic leaks, especially if associated with severe sepsis or gastric conduit necrosis, usually require rethoracotomy resection of the anastomosis and esophageal diversion with cervical esophagostomy.36 This paper presents the protocol for a prospective international multicentre audit that will seek to document the spectrum of esophagectomy techniques with particular focus on the anastomotic technique in an attempt to identify a correlation between a particular anastomotic technique and an improved patient outcome. Anastomotic leak is associated with a marked increase in mortality as compared with an intact anastomosis. Similarly with operative technique, the strategies employed to manage a leak are hugely varied. The audit will also focus on trying to document the global variations in leak management and in turn identify strategies that minimize mortality. It is anticipated that the Oesophago-Gastric Anastomosis Audit group will use data from this prospective cohort study to develop further ideas for further interventional studies in the future to improve esophagectomy outcomes. Recruitment of international centers and the initial data capture will set the building blocks of this aim and provide data for accurate power analyses for future randomized trials. Strengths: • A multicentre prospective study with protocolized data collection • Capture of practice in esophageal units (high-, middle-, and low-volume units) throughout the UK, Europe, and international centers performing esophagectomy for cancer. • Data from a range of hospitals will allow the assessment of variation in practice and outcome of esophagogastric anastomosis and leak management. • Data capture will be performed with a Standardised Complications Grading system developed by the ECCG.18 Limitations: • Details on anastomotic complications occurring after 90 days will not be collected. • Nine-month data collection will only provide a snapshot of the practice. On behalf of the West Midlands Research Collaborative Guarantor of the article: Ewen Griffiths Specific author contributions: Conception, design, writing, and editing of the protocol: Richard Evans, Pritam Singh, Ewen Griffiths; Design and writing of the protocol: Derek Alderson, Ravinder Vohra, James Gossage, Tony Whitehouse, Richard van Hillegersberg, Dmitri Nepogodiev, James Bundred, Sivesh Kamarajah, Siobhan McKay, Imran Mohamed, Benjamin Jefferies, Kasun Wanigasooriya, Kwabena Siaw-Acheampong; All authors read and approved the final manuscript. Financial support: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The patient support group Oesophageal Patients Association (Queen Elizabeth Hospital Branch) kindly paid for the website hosting (www.ogaa.org.uk). Potential competing interests: None. References 1 Schmidt H M Gisbertz S S Moons J et al. Defining benchmarks for transthoracic esophagectomy . 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Google Scholar Crossref Search ADS PubMed WorldCat Appendix I: Preoperative data collection Gender Male/Female Age (in Years) Smoking history Height (cm) Weight (kg) ASA 1 A normal healthy patient 2 A patient with mild systemic disease 3 A patient with severe systemic disease 4 A patient with severe systemic disease that is a constant threat to life Eastern Cooperative Oncology Group (ECOG)/WHO/Zubrod Score26 0—Fully active, able to carry on all predisease performance without restriction 1—Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2—Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of working hours 3—Capable of only limited self-care; confined to bed or chair >50% of waking hours 4—Completely disabled; cannot carry on any self-care; totally confined to bed or chair Charlson Comorbidity Index27 Myocardial infarction Yes/No Congestive heart failure Yes/No Peripheral vascular disease (includes aortic aneurysm >6 cm) Yes/No Cerebrovascular disease: CVA with mild or no residual weakness or TIA Yes/No Dementia Yes/No Chronic pulmonary disease Yes/No Connective tissue disease Yes/No Peptic ulcer disease Yes/No Mild liver disease (without portal hypertension, includes chronic hepatitis) Yes/No Diabetes without end organ damage (excludes diet controlled alone) Yes/No Hemiplegia Yes/No Moderate or severe renal disease Yes/No Diabetes with end organ damage (retinopathy, neuropathy, or brittle diabetes) Yes/No Tumor without metastasis (exclude if >5 years from diagnosis) Yes/No Leukaemia (acute or chronic) Lymphoma Yes/No Moderate or severe liver disease Yes/No Metastatic solid tumour Yes/No AIDS (not just HIV +ve) Yes/No Yes/No Preop bloods at start of surgery (or last recorded level, within previous 2 weeks) _____ g/L or mmol/L Albumin Haemoglobin (g/L) Serum Creatinine units Micromol/L Mg/dl Malignancy details Tumour type Adeno/SCC/Other—please specify Location of tumour Upper thoracic approx. 20–25 cm Middle thoracic approx. 25–30 cm Distal thoracic—approx. 30cm—greater than 5 cm proximal to the anatomical squamocolumnar junction or Z-line Siewert 1—between 5 and 1 cm proximal to the anatomical squamocolumnar junction or Z-line Siewert 2—between 1 cm proximal and 2 cm distal to the anatomical Z-line Siewert 3—between 2 and 5 cm distal to the anatomical Z-line Overall preoperative staging TNM 7th Neo-adjuvant therapy None/Chemotherapy/Chemoradiotherapy Chemotherapy regimen None/Chemotherapy/Chemoradiotherapy CF—Cisplatin, 5FU/ECF—Epirubicin, Cisplatin, 5FU/ECX—Epirubicin, Cisplatin, Capecitabine/EOX—Epirubicin, Oxaliplatin, Capecitabine/FLOT–5FU, Oxaliplatin, Gender Male/Female Age (in Years) Smoking history Height (cm) Weight (kg) ASA 1 A normal healthy patient 2 A patient with mild systemic disease 3 A patient with severe systemic disease 4 A patient with severe systemic disease that is a constant threat to life Eastern Cooperative Oncology Group (ECOG)/WHO/Zubrod Score26 0—Fully active, able to carry on all predisease performance without restriction 1—Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2—Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of working hours 3—Capable of only limited self-care; confined to bed or chair >50% of waking hours 4—Completely disabled; cannot carry on any self-care; totally confined to bed or chair Charlson Comorbidity Index27 Myocardial infarction Yes/No Congestive heart failure Yes/No Peripheral vascular disease (includes aortic aneurysm >6 cm) Yes/No Cerebrovascular disease: CVA with mild or no residual weakness or TIA Yes/No Dementia Yes/No Chronic pulmonary disease Yes/No Connective tissue disease Yes/No Peptic ulcer disease Yes/No Mild liver disease (without portal hypertension, includes chronic hepatitis) Yes/No Diabetes without end organ damage (excludes diet controlled alone) Yes/No Hemiplegia Yes/No Moderate or severe renal disease Yes/No Diabetes with end organ damage (retinopathy, neuropathy, or brittle diabetes) Yes/No Tumor without metastasis (exclude if >5 years from diagnosis) Yes/No Leukaemia (acute or chronic) Lymphoma Yes/No Moderate or severe liver disease Yes/No Metastatic solid tumour Yes/No AIDS (not just HIV +ve) Yes/No Yes/No Preop bloods at start of surgery (or last recorded level, within previous 2 weeks) _____ g/L or mmol/L Albumin Haemoglobin (g/L) Serum Creatinine units Micromol/L Mg/dl Malignancy details Tumour type Adeno/SCC/Other—please specify Location of tumour Upper thoracic approx. 20–25 cm Middle thoracic approx. 25–30 cm Distal thoracic—approx. 30cm—greater than 5 cm proximal to the anatomical squamocolumnar junction or Z-line Siewert 1—between 5 and 1 cm proximal to the anatomical squamocolumnar junction or Z-line Siewert 2—between 1 cm proximal and 2 cm distal to the anatomical Z-line Siewert 3—between 2 and 5 cm distal to the anatomical Z-line Overall preoperative staging TNM 7th Neo-adjuvant therapy None/Chemotherapy/Chemoradiotherapy Chemotherapy regimen None/Chemotherapy/Chemoradiotherapy CF—Cisplatin, 5FU/ECF—Epirubicin, Cisplatin, 5FU/ECX—Epirubicin, Cisplatin, Capecitabine/EOX—Epirubicin, Oxaliplatin, Capecitabine/FLOT–5FU, Oxaliplatin, Open in new tab Gender Male/Female Age (in Years) Smoking history Height (cm) Weight (kg) ASA 1 A normal healthy patient 2 A patient with mild systemic disease 3 A patient with severe systemic disease 4 A patient with severe systemic disease that is a constant threat to life Eastern Cooperative Oncology Group (ECOG)/WHO/Zubrod Score26 0—Fully active, able to carry on all predisease performance without restriction 1—Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2—Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of working hours 3—Capable of only limited self-care; confined to bed or chair >50% of waking hours 4—Completely disabled; cannot carry on any self-care; totally confined to bed or chair Charlson Comorbidity Index27 Myocardial infarction Yes/No Congestive heart failure Yes/No Peripheral vascular disease (includes aortic aneurysm >6 cm) Yes/No Cerebrovascular disease: CVA with mild or no residual weakness or TIA Yes/No Dementia Yes/No Chronic pulmonary disease Yes/No Connective tissue disease Yes/No Peptic ulcer disease Yes/No Mild liver disease (without portal hypertension, includes chronic hepatitis) Yes/No Diabetes without end organ damage (excludes diet controlled alone) Yes/No Hemiplegia Yes/No Moderate or severe renal disease Yes/No Diabetes with end organ damage (retinopathy, neuropathy, or brittle diabetes) Yes/No Tumor without metastasis (exclude if >5 years from diagnosis) Yes/No Leukaemia (acute or chronic) Lymphoma Yes/No Moderate or severe liver disease Yes/No Metastatic solid tumour Yes/No AIDS (not just HIV +ve) Yes/No Yes/No Preop bloods at start of surgery (or last recorded level, within previous 2 weeks) _____ g/L or mmol/L Albumin Haemoglobin (g/L) Serum Creatinine units Micromol/L Mg/dl Malignancy details Tumour type Adeno/SCC/Other—please specify Location of tumour Upper thoracic approx. 20–25 cm Middle thoracic approx. 25–30 cm Distal thoracic—approx. 30cm—greater than 5 cm proximal to the anatomical squamocolumnar junction or Z-line Siewert 1—between 5 and 1 cm proximal to the anatomical squamocolumnar junction or Z-line Siewert 2—between 1 cm proximal and 2 cm distal to the anatomical Z-line Siewert 3—between 2 and 5 cm distal to the anatomical Z-line Overall preoperative staging TNM 7th Neo-adjuvant therapy None/Chemotherapy/Chemoradiotherapy Chemotherapy regimen None/Chemotherapy/Chemoradiotherapy CF—Cisplatin, 5FU/ECF—Epirubicin, Cisplatin, 5FU/ECX—Epirubicin, Cisplatin, Capecitabine/EOX—Epirubicin, Oxaliplatin, Capecitabine/FLOT–5FU, Oxaliplatin, Gender Male/Female Age (in Years) Smoking history Height (cm) Weight (kg) ASA 1 A normal healthy patient 2 A patient with mild systemic disease 3 A patient with severe systemic disease 4 A patient with severe systemic disease that is a constant threat to life Eastern Cooperative Oncology Group (ECOG)/WHO/Zubrod Score26 0—Fully active, able to carry on all predisease performance without restriction 1—Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2—Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of working hours 3—Capable of only limited self-care; confined to bed or chair >50% of waking hours 4—Completely disabled; cannot carry on any self-care; totally confined to bed or chair Charlson Comorbidity Index27 Myocardial infarction Yes/No Congestive heart failure Yes/No Peripheral vascular disease (includes aortic aneurysm >6 cm) Yes/No Cerebrovascular disease: CVA with mild or no residual weakness or TIA Yes/No Dementia Yes/No Chronic pulmonary disease Yes/No Connective tissue disease Yes/No Peptic ulcer disease Yes/No Mild liver disease (without portal hypertension, includes chronic hepatitis) Yes/No Diabetes without end organ damage (excludes diet controlled alone) Yes/No Hemiplegia Yes/No Moderate or severe renal disease Yes/No Diabetes with end organ damage (retinopathy, neuropathy, or brittle diabetes) Yes/No Tumor without metastasis (exclude if >5 years from diagnosis) Yes/No Leukaemia (acute or chronic) Lymphoma Yes/No Moderate or severe liver disease Yes/No Metastatic solid tumour Yes/No AIDS (not just HIV +ve) Yes/No Yes/No Preop bloods at start of surgery (or last recorded level, within previous 2 weeks) _____ g/L or mmol/L Albumin Haemoglobin (g/L) Serum Creatinine units Micromol/L Mg/dl Malignancy details Tumour type Adeno/SCC/Other—please specify Location of tumour Upper thoracic approx. 20–25 cm Middle thoracic approx. 25–30 cm Distal thoracic—approx. 30cm—greater than 5 cm proximal to the anatomical squamocolumnar junction or Z-line Siewert 1—between 5 and 1 cm proximal to the anatomical squamocolumnar junction or Z-line Siewert 2—between 1 cm proximal and 2 cm distal to the anatomical Z-line Siewert 3—between 2 and 5 cm distal to the anatomical Z-line Overall preoperative staging TNM 7th Neo-adjuvant therapy None/Chemotherapy/Chemoradiotherapy Chemotherapy regimen None/Chemotherapy/Chemoradiotherapy CF—Cisplatin, 5FU/ECF—Epirubicin, Cisplatin, 5FU/ECX—Epirubicin, Cisplatin, Capecitabine/EOX—Epirubicin, Oxaliplatin, Capecitabine/FLOT–5FU, Oxaliplatin, Open in new tab Leucoverin, Docetaxel/MIC—Mitomycin, Ifosfamide, Cisplatin/CROSS—Carboplatin, Paclitaxel/Other—please specify Cycles of chemotherapy—Intended Cycles of chemotherapy—Completed If Radiotherapy give preop Total Gy ___________ Did the radiotherapy field include the gastric fundus—yes/no Pre-operative nutritional support None Oral supplements Enteral nutrition via NJ/NG/PEG/Jej etc. Parenteral nutrition Pre-operative gastric ischaemic preconditioning performed* Yes/No Leucoverin, Docetaxel/MIC—Mitomycin, Ifosfamide, Cisplatin/CROSS—Carboplatin, Paclitaxel/Other—please specify Cycles of chemotherapy—Intended Cycles of chemotherapy—Completed If Radiotherapy give preop Total Gy ___________ Did the radiotherapy field include the gastric fundus—yes/no Pre-operative nutritional support None Oral supplements Enteral nutrition via NJ/NG/PEG/Jej etc. Parenteral nutrition Pre-operative gastric ischaemic preconditioning performed* Yes/No *This is when laparoscopy and division of the left gastric vessels + − short gastric vessels are performed prior to oesophagectomy under a separate anaesthetic. Open in new tab Leucoverin, Docetaxel/MIC—Mitomycin, Ifosfamide, Cisplatin/CROSS—Carboplatin, Paclitaxel/Other—please specify Cycles of chemotherapy—Intended Cycles of chemotherapy—Completed If Radiotherapy give preop Total Gy ___________ Did the radiotherapy field include the gastric fundus—yes/no Pre-operative nutritional support None Oral supplements Enteral nutrition via NJ/NG/PEG/Jej etc. Parenteral nutrition Pre-operative gastric ischaemic preconditioning performed* Yes/No Leucoverin, Docetaxel/MIC—Mitomycin, Ifosfamide, Cisplatin/CROSS—Carboplatin, Paclitaxel/Other—please specify Cycles of chemotherapy—Intended Cycles of chemotherapy—Completed If Radiotherapy give preop Total Gy ___________ Did the radiotherapy field include the gastric fundus—yes/no Pre-operative nutritional support None Oral supplements Enteral nutrition via NJ/NG/PEG/Jej etc. Parenteral nutrition Pre-operative gastric ischaemic preconditioning performed* Yes/No *This is when laparoscopy and division of the left gastric vessels + − short gastric vessels are performed prior to oesophagectomy under a separate anaesthetic. Open in new tab Intra-operative data collection Training operation Yes/No Trainee performed abdominal phase Trainee performed chest dissection Trainee performed neck dissection Trainee performed anastomosis Yes/No Yes/No/Not applicable (not done) Yes/No/Not applicable (not done) Yes/No/Not applicable (not done) Abdominal phase Open/Laparoscopic/Lap converted to open/Robotic/Robotic converted to lap/Robotic converted to open Thoracic phase Open right chest/Open left chest/Thoracoabdominal/Thorascopic/Thorascopic converted to open/Transhiatal/Robotic/Robotic converted to thorascopic/Robotic converted to open Lymphadenectomy Abdominal only Abdominal and thoracic (2 field) Abdominal/Thoracic/Neck (3 field) Gastric tube Whole stomach, wide gastric tube >5 cm, Thin gastric tube <5cm Anastomotic technique Handsewn/Circular stapled/Linear stapled and sutured (Orringer style)/no anastomosis Anastomotic configuration End to end End to side Side to side Site of anastomosis Neck/Chest above azygous/at azygous/below azygous/Anastomosis not performed Anastomosis technique Handsewn Circular stapler Linear stapler Single layer/Two layer Interrupted/Continuous CDH (Ethicon)/CEEA (Covidien)/ECS (Ethicon) EEA (Covidien)/SDH (Ethicon)/OrVil/Other—please specify (size in mm) Endopath (Ethicon)/GIA (Covidien)/NTLC (Ethicon)/TA (Covidien)/TCT (Ethicon)/TL (Covidien)/TLC (Ethicon)/TX (Ethicon)/Other—please specify Was the anastomosis covered in omentum Yes/No Was the anastomosis buried in pleura Yes/No Was the anastomosis tested for integrity Not performed/NG air leak test/Intra-op endoscopy/Methylene blue/Indigocyanine green (IGC) assessment/Other method Nutritional feeding access None/Feeding jejunostomy/Nasojejunal tube Procedures on the pylorus None/Pyloromyotomy/Pyloroplasty/Botox/Dilatation Intra-op complications Major vessel injury Unable to perform anastomosis Unplanned splenectomy Enteric injury Airway injury Non-viable gastric conduit Gastric conduit unable to reach planned anastomosis site. Total operative duration (mins)(skin incision to skin closure) Please specify in minutes, e.g. 210 minutes not 3.5 hours Training operation Yes/No Trainee performed abdominal phase Trainee performed chest dissection Trainee performed neck dissection Trainee performed anastomosis Yes/No Yes/No/Not applicable (not done) Yes/No/Not applicable (not done) Yes/No/Not applicable (not done) Abdominal phase Open/Laparoscopic/Lap converted to open/Robotic/Robotic converted to lap/Robotic converted to open Thoracic phase Open right chest/Open left chest/Thoracoabdominal/Thorascopic/Thorascopic converted to open/Transhiatal/Robotic/Robotic converted to thorascopic/Robotic converted to open Lymphadenectomy Abdominal only Abdominal and thoracic (2 field) Abdominal/Thoracic/Neck (3 field) Gastric tube Whole stomach, wide gastric tube >5 cm, Thin gastric tube <5cm Anastomotic technique Handsewn/Circular stapled/Linear stapled and sutured (Orringer style)/no anastomosis Anastomotic configuration End to end End to side Side to side Site of anastomosis Neck/Chest above azygous/at azygous/below azygous/Anastomosis not performed Anastomosis technique Handsewn Circular stapler Linear stapler Single layer/Two layer Interrupted/Continuous CDH (Ethicon)/CEEA (Covidien)/ECS (Ethicon) EEA (Covidien)/SDH (Ethicon)/OrVil/Other—please specify (size in mm) Endopath (Ethicon)/GIA (Covidien)/NTLC (Ethicon)/TA (Covidien)/TCT (Ethicon)/TL (Covidien)/TLC (Ethicon)/TX (Ethicon)/Other—please specify Was the anastomosis covered in omentum Yes/No Was the anastomosis buried in pleura Yes/No Was the anastomosis tested for integrity Not performed/NG air leak test/Intra-op endoscopy/Methylene blue/Indigocyanine green (IGC) assessment/Other method Nutritional feeding access None/Feeding jejunostomy/Nasojejunal tube Procedures on the pylorus None/Pyloromyotomy/Pyloroplasty/Botox/Dilatation Intra-op complications Major vessel injury Unable to perform anastomosis Unplanned splenectomy Enteric injury Airway injury Non-viable gastric conduit Gastric conduit unable to reach planned anastomosis site. Total operative duration (mins)(skin incision to skin closure) Please specify in minutes, e.g. 210 minutes not 3.5 hours Open in new tab Training operation Yes/No Trainee performed abdominal phase Trainee performed chest dissection Trainee performed neck dissection Trainee performed anastomosis Yes/No Yes/No/Not applicable (not done) Yes/No/Not applicable (not done) Yes/No/Not applicable (not done) Abdominal phase Open/Laparoscopic/Lap converted to open/Robotic/Robotic converted to lap/Robotic converted to open Thoracic phase Open right chest/Open left chest/Thoracoabdominal/Thorascopic/Thorascopic converted to open/Transhiatal/Robotic/Robotic converted to thorascopic/Robotic converted to open Lymphadenectomy Abdominal only Abdominal and thoracic (2 field) Abdominal/Thoracic/Neck (3 field) Gastric tube Whole stomach, wide gastric tube >5 cm, Thin gastric tube <5cm Anastomotic technique Handsewn/Circular stapled/Linear stapled and sutured (Orringer style)/no anastomosis Anastomotic configuration End to end End to side Side to side Site of anastomosis Neck/Chest above azygous/at azygous/below azygous/Anastomosis not performed Anastomosis technique Handsewn Circular stapler Linear stapler Single layer/Two layer Interrupted/Continuous CDH (Ethicon)/CEEA (Covidien)/ECS (Ethicon) EEA (Covidien)/SDH (Ethicon)/OrVil/Other—please specify (size in mm) Endopath (Ethicon)/GIA (Covidien)/NTLC (Ethicon)/TA (Covidien)/TCT (Ethicon)/TL (Covidien)/TLC (Ethicon)/TX (Ethicon)/Other—please specify Was the anastomosis covered in omentum Yes/No Was the anastomosis buried in pleura Yes/No Was the anastomosis tested for integrity Not performed/NG air leak test/Intra-op endoscopy/Methylene blue/Indigocyanine green (IGC) assessment/Other method Nutritional feeding access None/Feeding jejunostomy/Nasojejunal tube Procedures on the pylorus None/Pyloromyotomy/Pyloroplasty/Botox/Dilatation Intra-op complications Major vessel injury Unable to perform anastomosis Unplanned splenectomy Enteric injury Airway injury Non-viable gastric conduit Gastric conduit unable to reach planned anastomosis site. Total operative duration (mins)(skin incision to skin closure) Please specify in minutes, e.g. 210 minutes not 3.5 hours Training operation Yes/No Trainee performed abdominal phase Trainee performed chest dissection Trainee performed neck dissection Trainee performed anastomosis Yes/No Yes/No/Not applicable (not done) Yes/No/Not applicable (not done) Yes/No/Not applicable (not done) Abdominal phase Open/Laparoscopic/Lap converted to open/Robotic/Robotic converted to lap/Robotic converted to open Thoracic phase Open right chest/Open left chest/Thoracoabdominal/Thorascopic/Thorascopic converted to open/Transhiatal/Robotic/Robotic converted to thorascopic/Robotic converted to open Lymphadenectomy Abdominal only Abdominal and thoracic (2 field) Abdominal/Thoracic/Neck (3 field) Gastric tube Whole stomach, wide gastric tube >5 cm, Thin gastric tube <5cm Anastomotic technique Handsewn/Circular stapled/Linear stapled and sutured (Orringer style)/no anastomosis Anastomotic configuration End to end End to side Side to side Site of anastomosis Neck/Chest above azygous/at azygous/below azygous/Anastomosis not performed Anastomosis technique Handsewn Circular stapler Linear stapler Single layer/Two layer Interrupted/Continuous CDH (Ethicon)/CEEA (Covidien)/ECS (Ethicon) EEA (Covidien)/SDH (Ethicon)/OrVil/Other—please specify (size in mm) Endopath (Ethicon)/GIA (Covidien)/NTLC (Ethicon)/TA (Covidien)/TCT (Ethicon)/TL (Covidien)/TLC (Ethicon)/TX (Ethicon)/Other—please specify Was the anastomosis covered in omentum Yes/No Was the anastomosis buried in pleura Yes/No Was the anastomosis tested for integrity Not performed/NG air leak test/Intra-op endoscopy/Methylene blue/Indigocyanine green (IGC) assessment/Other method Nutritional feeding access None/Feeding jejunostomy/Nasojejunal tube Procedures on the pylorus None/Pyloromyotomy/Pyloroplasty/Botox/Dilatation Intra-op complications Major vessel injury Unable to perform anastomosis Unplanned splenectomy Enteric injury Airway injury Non-viable gastric conduit Gastric conduit unable to reach planned anastomosis site. Total operative duration (mins)(skin incision to skin closure) Please specify in minutes, e.g. 210 minutes not 3.5 hours Open in new tab Anesthetic data collection Single lung ventilation Yes/No If Yes—double lumen Tube or bronchial blocker If Yes—duration of one lung ventilation (mins) Intra-operative vasopressor support required (e.g., noradrenaline, metaraminol, ephredrine, phenylephredrine, etc.) Yes—bolus Yes—continuous infusion No Total IV fluid (mls) given intra-operatively __________mls crystalloid __________mls colloid Intra-operative blood transfusion Yes/No If Yes—number of units transfused_______ Postoperative blood transfusion Yes/No If Yes—number of units transfused_______ Analgesia technique Epidural Thoracic paravertebral block Intrathecal morphine Patient-controlled analgesia (PCA) Ketamine Abdominal pain catheter Lactate level immediately postoperative ______mmol/L Was the patient extubated the same day as resectional surgery? Yes/No Single lung ventilation Yes/No If Yes—double lumen Tube or bronchial blocker If Yes—duration of one lung ventilation (mins) Intra-operative vasopressor support required (e.g., noradrenaline, metaraminol, ephredrine, phenylephredrine, etc.) Yes—bolus Yes—continuous infusion No Total IV fluid (mls) given intra-operatively __________mls crystalloid __________mls colloid Intra-operative blood transfusion Yes/No If Yes—number of units transfused_______ Postoperative blood transfusion Yes/No If Yes—number of units transfused_______ Analgesia technique Epidural Thoracic paravertebral block Intrathecal morphine Patient-controlled analgesia (PCA) Ketamine Abdominal pain catheter Lactate level immediately postoperative ______mmol/L Was the patient extubated the same day as resectional surgery? Yes/No Open in new tab Single lung ventilation Yes/No If Yes—double lumen Tube or bronchial blocker If Yes—duration of one lung ventilation (mins) Intra-operative vasopressor support required (e.g., noradrenaline, metaraminol, ephredrine, phenylephredrine, etc.) Yes—bolus Yes—continuous infusion No Total IV fluid (mls) given intra-operatively __________mls crystalloid __________mls colloid Intra-operative blood transfusion Yes/No If Yes—number of units transfused_______ Postoperative blood transfusion Yes/No If Yes—number of units transfused_______ Analgesia technique Epidural Thoracic paravertebral block Intrathecal morphine Patient-controlled analgesia (PCA) Ketamine Abdominal pain catheter Lactate level immediately postoperative ______mmol/L Was the patient extubated the same day as resectional surgery? Yes/No Single lung ventilation Yes/No If Yes—double lumen Tube or bronchial blocker If Yes—duration of one lung ventilation (mins) Intra-operative vasopressor support required (e.g., noradrenaline, metaraminol, ephredrine, phenylephredrine, etc.) Yes—bolus Yes—continuous infusion No Total IV fluid (mls) given intra-operatively __________mls crystalloid __________mls colloid Intra-operative blood transfusion Yes/No If Yes—number of units transfused_______ Postoperative blood transfusion Yes/No If Yes—number of units transfused_______ Analgesia technique Epidural Thoracic paravertebral block Intrathecal morphine Patient-controlled analgesia (PCA) Ketamine Abdominal pain catheter Lactate level immediately postoperative ______mmol/L Was the patient extubated the same day as resectional surgery? Yes/No Open in new tab Postoperative data collection Was assessment of anastomosis performed in the postop period? Endoscopy Plain film contrast swallow CT contrast swallow Other What day post operatively did this occur? Yes/No Yes/No Yes/No Yes/No Please specify Post-op Day_____________ Post-operative complications Anastomotic leak Number of days after surgery leak was diagnosed Conduit necrosis Number of days after surgery conduit necrosis was diagnosed Yes/No/Grade 1/2/3 No. of days _________________ Yes/No/Grade 1/2/3 No. of days _________________ Primary treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Primary treatment strategy of leak/conduit necrosis operative Operative technique Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair— no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Was assessment of anastomosis performed in the postop period? Endoscopy Plain film contrast swallow CT contrast swallow Other What day post operatively did this occur? Yes/No Yes/No Yes/No Yes/No Please specify Post-op Day_____________ Post-operative complications Anastomotic leak Number of days after surgery leak was diagnosed Conduit necrosis Number of days after surgery conduit necrosis was diagnosed Yes/No/Grade 1/2/3 No. of days _________________ Yes/No/Grade 1/2/3 No. of days _________________ Primary treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Primary treatment strategy of leak/conduit necrosis operative Operative technique Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair— no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Open in new tab Was assessment of anastomosis performed in the postop period? Endoscopy Plain film contrast swallow CT contrast swallow Other What day post operatively did this occur? Yes/No Yes/No Yes/No Yes/No Please specify Post-op Day_____________ Post-operative complications Anastomotic leak Number of days after surgery leak was diagnosed Conduit necrosis Number of days after surgery conduit necrosis was diagnosed Yes/No/Grade 1/2/3 No. of days _________________ Yes/No/Grade 1/2/3 No. of days _________________ Primary treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Primary treatment strategy of leak/conduit necrosis operative Operative technique Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair— no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Was assessment of anastomosis performed in the postop period? Endoscopy Plain film contrast swallow CT contrast swallow Other What day post operatively did this occur? Yes/No Yes/No Yes/No Yes/No Please specify Post-op Day_____________ Post-operative complications Anastomotic leak Number of days after surgery leak was diagnosed Conduit necrosis Number of days after surgery conduit necrosis was diagnosed Yes/No/Grade 1/2/3 No. of days _________________ Yes/No/Grade 1/2/3 No. of days _________________ Primary treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Primary treatment strategy of leak/conduit necrosis operative Operative technique Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair— no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Open in new tab Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a secondary management strategy of leak/conduit necrosis used? Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition (NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Secondary leak treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Secondary treatment strategy of leak/conduit necrosis operative Operative technique Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a tertiary management strategy of leak/conduit necrosis used? Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair—no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition (NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a secondary management strategy of leak/conduit necrosis used? Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition (NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Secondary leak treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Secondary treatment strategy of leak/conduit necrosis operative Operative technique Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a tertiary management strategy of leak/conduit necrosis used? Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair—no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition (NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Open in new tab Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a secondary management strategy of leak/conduit necrosis used? Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition (NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Secondary leak treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Secondary treatment strategy of leak/conduit necrosis operative Operative technique Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a tertiary management strategy of leak/conduit necrosis used? Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair—no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition (NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a secondary management strategy of leak/conduit necrosis used? Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition (NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Secondary leak treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Secondary treatment strategy of leak/conduit necrosis operative Operative technique Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a tertiary management strategy of leak/conduit necrosis used? Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair—no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition (NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Open in new tab Tertiary leak treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Tertiary treatment strategy of leak/conduit necrosis operative Operative technique Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a further management strategy of leak/conduit used? Please describe this further leak/conduit necrosis management strategy. Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck. Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair—no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition(NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Gastrointestinal complication Nil Ileus defined as small bowel dysfunction preventing or delaying enteral feeding Small bowel obstruction Feeding J-tube complication Pyloromyotomy/pyloroplasty complication. Clostridium difficile infection Gastrointestinal bleeding requiring intervention or transfusion Delayed conduit emptying requiring intervention or delaying discharge or requiring maintenance of NG drainage >7 d postoperatively Pancreatitis Liver dysfunction Chyle leak Grade (1—enteric dietary modification, 2—total parenteral nutrition, 3—interventional or surgical therapy) Chyle leak volume Nil Grade 1/2/3 Type A (<1 Litre in 24 hours) Type B (>1 Litre in 24 hours) Vocal cord injury/Palsy Nil Type 1: Transient injury requiring no therapy Type 2: Injury requiring elective surgical procedure Type 3: Injury requiring acute surgical intervention (due to aspiration or respiratory issues Unilateral/Bilateral Tertiary leak treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Tertiary treatment strategy of leak/conduit necrosis operative Operative technique Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a further management strategy of leak/conduit used? Please describe this further leak/conduit necrosis management strategy. Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck. Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair—no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition(NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Gastrointestinal complication Nil Ileus defined as small bowel dysfunction preventing or delaying enteral feeding Small bowel obstruction Feeding J-tube complication Pyloromyotomy/pyloroplasty complication. Clostridium difficile infection Gastrointestinal bleeding requiring intervention or transfusion Delayed conduit emptying requiring intervention or delaying discharge or requiring maintenance of NG drainage >7 d postoperatively Pancreatitis Liver dysfunction Chyle leak Grade (1—enteric dietary modification, 2—total parenteral nutrition, 3—interventional or surgical therapy) Chyle leak volume Nil Grade 1/2/3 Type A (<1 Litre in 24 hours) Type B (>1 Litre in 24 hours) Vocal cord injury/Palsy Nil Type 1: Transient injury requiring no therapy Type 2: Injury requiring elective surgical procedure Type 3: Injury requiring acute surgical intervention (due to aspiration or respiratory issues Unilateral/Bilateral Open in new tab Tertiary leak treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Tertiary treatment strategy of leak/conduit necrosis operative Operative technique Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a further management strategy of leak/conduit used? Please describe this further leak/conduit necrosis management strategy. Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck. Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair—no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition(NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Gastrointestinal complication Nil Ileus defined as small bowel dysfunction preventing or delaying enteral feeding Small bowel obstruction Feeding J-tube complication Pyloromyotomy/pyloroplasty complication. Clostridium difficile infection Gastrointestinal bleeding requiring intervention or transfusion Delayed conduit emptying requiring intervention or delaying discharge or requiring maintenance of NG drainage >7 d postoperatively Pancreatitis Liver dysfunction Chyle leak Grade (1—enteric dietary modification, 2—total parenteral nutrition, 3—interventional or surgical therapy) Chyle leak volume Nil Grade 1/2/3 Type A (<1 Litre in 24 hours) Type B (>1 Litre in 24 hours) Vocal cord injury/Palsy Nil Type 1: Transient injury requiring no therapy Type 2: Injury requiring elective surgical procedure Type 3: Injury requiring acute surgical intervention (due to aspiration or respiratory issues Unilateral/Bilateral Tertiary leak treatment of leak/conduit necrosis Postoperative day of start of treatment _____ Tertiary treatment strategy of leak/conduit necrosis operative Operative technique Conservative (noninterventional) strategy (This means radiological drains/endoscopically placed stents/EndoVac/sponge were not used) Conservative management strategy Radiological drainage Number of radiologically sited drains at initial intervention Was an esophageal stent used to treat the leak? Esophageal stent type Complications from esophageal stenting Total number of stents used EndoVac/Endosponge placed Total number of vac changes Other endoscopic methods of leak management Was a further management strategy of leak/conduit used? Please describe this further leak/conduit necrosis management strategy. Yes/No Minimal access chest/Minimal access abdomen/Minimal access converted to open chest/Minimal access converted to open abdomen/Open chest/Open abdomen/Open neck. Washout only/Drainage (T-tube/Foley catheter)/Anastomotic repair—no resection/Anastomotic repair—no resection, with muscle flap/Resection of anastomosis and refashioning/Disconnection and cervical esophagostomy Yes/No Nil by mouth Antibiotics Antifungals Parenteral nutrition Enteral nutrition(NG/NJ/feeding jejunostomy) Yes/No Yes/No Covered plastic/Covered metal/Covered biodegradable/other Displacement/Erosion/Failure to occlude leak/Other Yes/No Haemostatic clips/Fibrin glue/Over the scope clips (OTSCs) Yes/No Gastrointestinal complication Nil Ileus defined as small bowel dysfunction preventing or delaying enteral feeding Small bowel obstruction Feeding J-tube complication Pyloromyotomy/pyloroplasty complication. Clostridium difficile infection Gastrointestinal bleeding requiring intervention or transfusion Delayed conduit emptying requiring intervention or delaying discharge or requiring maintenance of NG drainage >7 d postoperatively Pancreatitis Liver dysfunction Chyle leak Grade (1—enteric dietary modification, 2—total parenteral nutrition, 3—interventional or surgical therapy) Chyle leak volume Nil Grade 1/2/3 Type A (<1 Litre in 24 hours) Type B (>1 Litre in 24 hours) Vocal cord injury/Palsy Nil Type 1: Transient injury requiring no therapy Type 2: Injury requiring elective surgical procedure Type 3: Injury requiring acute surgical intervention (due to aspiration or respiratory issues Unilateral/Bilateral Open in new tab Pneumonia Nil Pneumonia Pleural effusion requiring additional drainage procedure Pneumothorax requiring treatment Atelectasis mucous plugging requiring bronchoscopy Respiratory failure requiring reintubation Acute respiratory distress syndrome (Berlin definition) Acute aspiration Tracheobronchial injury Chest tube maintenance for air leak for >10 d postoperative Tracheostomy Cardiac complication Nil Cardiac arrest requiring CPR Myocardial infarction (Definition: World Health Organization) Dysrhythmia atrial requiring treatment Dysrhythmia ventricular requiring treatment Congestive heart failure requiring treatment Pericarditis requiring treatment Wound/Diaphragmatic complication Nil Thoracic wound dehiscence Acute abdominal wall dehiscence/hernia Acute diaphragmatic hernia Urologic/Renal complication Nil Acute renal insufficiency (defined as doubling of baseline creatinine) Acute renal failure requiring dialysis Urinary tract infection Urinary retention requiring reinsertion of urinary catheter, delaying discharge, or discharge with urinary catheter Thromboembolic complication Nil Deep venous thrombosis Pulmonary embolus Stroke (CVA) Peripheral thrombophlebitis Infection Nil Wound infection requiring opening wound or antibiotics Central IV line infection requiring removal or antibiotics Intrathoracic/intra-abdominal abscess Generalized sepsis (Definition: CDC) Other infections requiring antibiotics Did the patient return to theatre for any surgical procedure under general anesthetic? Local anesthetic/endoscopic and ICU procedures are excluded. Yes/No Complication not otherwise specified Final histology23,24 T stage Number of nodes examined Number of nodes positive for malignancy Surgical margins M stage Complete path response/HGD/1/2/3/4 No. of nodes_______________ No. of nodes_______________ Proximal—clear/involved (<1 mm) Distal—clear/involved (<1 mm) CRM—clear/involved (<1 mm) 0/1 Outcomes Overall Clavien–Dindo classification (at the time of discharge)28 *Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. Grade 1 also includes wound infections opened at the bedside. Grade 1—Any deviation from the normal postoperative course* without need for pharmacological treatments or surgical, endoscopic, and radiological interventions Grade 2—Requiring pharmacological therapy with drugs other than such allowed for grade 1 complications. Blood transfusions and total parenteral nutrition are also included. Grade 3a—Requiring surgical, endoscopic, or radiological intervention NOT under general anaesthesia 3b—Requiring surgical, endoscopic, or radiological intervention UNDER general anaesthesia Pneumonia Nil Pneumonia Pleural effusion requiring additional drainage procedure Pneumothorax requiring treatment Atelectasis mucous plugging requiring bronchoscopy Respiratory failure requiring reintubation Acute respiratory distress syndrome (Berlin definition) Acute aspiration Tracheobronchial injury Chest tube maintenance for air leak for >10 d postoperative Tracheostomy Cardiac complication Nil Cardiac arrest requiring CPR Myocardial infarction (Definition: World Health Organization) Dysrhythmia atrial requiring treatment Dysrhythmia ventricular requiring treatment Congestive heart failure requiring treatment Pericarditis requiring treatment Wound/Diaphragmatic complication Nil Thoracic wound dehiscence Acute abdominal wall dehiscence/hernia Acute diaphragmatic hernia Urologic/Renal complication Nil Acute renal insufficiency (defined as doubling of baseline creatinine) Acute renal failure requiring dialysis Urinary tract infection Urinary retention requiring reinsertion of urinary catheter, delaying discharge, or discharge with urinary catheter Thromboembolic complication Nil Deep venous thrombosis Pulmonary embolus Stroke (CVA) Peripheral thrombophlebitis Infection Nil Wound infection requiring opening wound or antibiotics Central IV line infection requiring removal or antibiotics Intrathoracic/intra-abdominal abscess Generalized sepsis (Definition: CDC) Other infections requiring antibiotics Did the patient return to theatre for any surgical procedure under general anesthetic? Local anesthetic/endoscopic and ICU procedures are excluded. Yes/No Complication not otherwise specified Final histology23,24 T stage Number of nodes examined Number of nodes positive for malignancy Surgical margins M stage Complete path response/HGD/1/2/3/4 No. of nodes_______________ No. of nodes_______________ Proximal—clear/involved (<1 mm) Distal—clear/involved (<1 mm) CRM—clear/involved (<1 mm) 0/1 Outcomes Overall Clavien–Dindo classification (at the time of discharge)28 *Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. Grade 1 also includes wound infections opened at the bedside. Grade 1—Any deviation from the normal postoperative course* without need for pharmacological treatments or surgical, endoscopic, and radiological interventions Grade 2—Requiring pharmacological therapy with drugs other than such allowed for grade 1 complications. Blood transfusions and total parenteral nutrition are also included. Grade 3a—Requiring surgical, endoscopic, or radiological intervention NOT under general anaesthesia 3b—Requiring surgical, endoscopic, or radiological intervention UNDER general anaesthesia Open in new tab Pneumonia Nil Pneumonia Pleural effusion requiring additional drainage procedure Pneumothorax requiring treatment Atelectasis mucous plugging requiring bronchoscopy Respiratory failure requiring reintubation Acute respiratory distress syndrome (Berlin definition) Acute aspiration Tracheobronchial injury Chest tube maintenance for air leak for >10 d postoperative Tracheostomy Cardiac complication Nil Cardiac arrest requiring CPR Myocardial infarction (Definition: World Health Organization) Dysrhythmia atrial requiring treatment Dysrhythmia ventricular requiring treatment Congestive heart failure requiring treatment Pericarditis requiring treatment Wound/Diaphragmatic complication Nil Thoracic wound dehiscence Acute abdominal wall dehiscence/hernia Acute diaphragmatic hernia Urologic/Renal complication Nil Acute renal insufficiency (defined as doubling of baseline creatinine) Acute renal failure requiring dialysis Urinary tract infection Urinary retention requiring reinsertion of urinary catheter, delaying discharge, or discharge with urinary catheter Thromboembolic complication Nil Deep venous thrombosis Pulmonary embolus Stroke (CVA) Peripheral thrombophlebitis Infection Nil Wound infection requiring opening wound or antibiotics Central IV line infection requiring removal or antibiotics Intrathoracic/intra-abdominal abscess Generalized sepsis (Definition: CDC) Other infections requiring antibiotics Did the patient return to theatre for any surgical procedure under general anesthetic? Local anesthetic/endoscopic and ICU procedures are excluded. Yes/No Complication not otherwise specified Final histology23,24 T stage Number of nodes examined Number of nodes positive for malignancy Surgical margins M stage Complete path response/HGD/1/2/3/4 No. of nodes_______________ No. of nodes_______________ Proximal—clear/involved (<1 mm) Distal—clear/involved (<1 mm) CRM—clear/involved (<1 mm) 0/1 Outcomes Overall Clavien–Dindo classification (at the time of discharge)28 *Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. Grade 1 also includes wound infections opened at the bedside. Grade 1—Any deviation from the normal postoperative course* without need for pharmacological treatments or surgical, endoscopic, and radiological interventions Grade 2—Requiring pharmacological therapy with drugs other than such allowed for grade 1 complications. Blood transfusions and total parenteral nutrition are also included. Grade 3a—Requiring surgical, endoscopic, or radiological intervention NOT under general anaesthesia 3b—Requiring surgical, endoscopic, or radiological intervention UNDER general anaesthesia Pneumonia Nil Pneumonia Pleural effusion requiring additional drainage procedure Pneumothorax requiring treatment Atelectasis mucous plugging requiring bronchoscopy Respiratory failure requiring reintubation Acute respiratory distress syndrome (Berlin definition) Acute aspiration Tracheobronchial injury Chest tube maintenance for air leak for >10 d postoperative Tracheostomy Cardiac complication Nil Cardiac arrest requiring CPR Myocardial infarction (Definition: World Health Organization) Dysrhythmia atrial requiring treatment Dysrhythmia ventricular requiring treatment Congestive heart failure requiring treatment Pericarditis requiring treatment Wound/Diaphragmatic complication Nil Thoracic wound dehiscence Acute abdominal wall dehiscence/hernia Acute diaphragmatic hernia Urologic/Renal complication Nil Acute renal insufficiency (defined as doubling of baseline creatinine) Acute renal failure requiring dialysis Urinary tract infection Urinary retention requiring reinsertion of urinary catheter, delaying discharge, or discharge with urinary catheter Thromboembolic complication Nil Deep venous thrombosis Pulmonary embolus Stroke (CVA) Peripheral thrombophlebitis Infection Nil Wound infection requiring opening wound or antibiotics Central IV line infection requiring removal or antibiotics Intrathoracic/intra-abdominal abscess Generalized sepsis (Definition: CDC) Other infections requiring antibiotics Did the patient return to theatre for any surgical procedure under general anesthetic? Local anesthetic/endoscopic and ICU procedures are excluded. Yes/No Complication not otherwise specified Final histology23,24 T stage Number of nodes examined Number of nodes positive for malignancy Surgical margins M stage Complete path response/HGD/1/2/3/4 No. of nodes_______________ No. of nodes_______________ Proximal—clear/involved (<1 mm) Distal—clear/involved (<1 mm) CRM—clear/involved (<1 mm) 0/1 Outcomes Overall Clavien–Dindo classification (at the time of discharge)28 *Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. Grade 1 also includes wound infections opened at the bedside. Grade 1—Any deviation from the normal postoperative course* without need for pharmacological treatments or surgical, endoscopic, and radiological interventions Grade 2—Requiring pharmacological therapy with drugs other than such allowed for grade 1 complications. Blood transfusions and total parenteral nutrition are also included. Grade 3a—Requiring surgical, endoscopic, or radiological intervention NOT under general anaesthesia 3b—Requiring surgical, endoscopic, or radiological intervention UNDER general anaesthesia Open in new tab Total length of ITU/HDU stay (non-ward-based care)(in days) Was the patient eating and drinking on discharge? Total length of stay in hospital Destination on discharge Readmission within 30 days of discharge Number of days after discharge the patient was readmitted Location of readmission Cause for readmission 90-day mortality How many days postop did the patient die? Location of death Grade 4a—Life-threatening complication (including CNS complications) requiring ICU management: SINGLE organ dysfunction Grade 4b—Life-threatening complication (including CNS complications) requiring ICU management: MULTI-organ dysfunction Grade 5—Death of a patient Home Other medical facility, e.g. secondary hospital, rehabilitation center, nursing facility Yes/No Primary/Secondary hospital Yes/No In hospital Out of hospital Total length of ITU/HDU stay (non-ward-based care)(in days) Was the patient eating and drinking on discharge? Total length of stay in hospital Destination on discharge Readmission within 30 days of discharge Number of days after discharge the patient was readmitted Location of readmission Cause for readmission 90-day mortality How many days postop did the patient die? Location of death Grade 4a—Life-threatening complication (including CNS complications) requiring ICU management: SINGLE organ dysfunction Grade 4b—Life-threatening complication (including CNS complications) requiring ICU management: MULTI-organ dysfunction Grade 5—Death of a patient Home Other medical facility, e.g. secondary hospital, rehabilitation center, nursing facility Yes/No Primary/Secondary hospital Yes/No In hospital Out of hospital Open in new tab Total length of ITU/HDU stay (non-ward-based care)(in days) Was the patient eating and drinking on discharge? Total length of stay in hospital Destination on discharge Readmission within 30 days of discharge Number of days after discharge the patient was readmitted Location of readmission Cause for readmission 90-day mortality How many days postop did the patient die? Location of death Grade 4a—Life-threatening complication (including CNS complications) requiring ICU management: SINGLE organ dysfunction Grade 4b—Life-threatening complication (including CNS complications) requiring ICU management: MULTI-organ dysfunction Grade 5—Death of a patient Home Other medical facility, e.g. secondary hospital, rehabilitation center, nursing facility Yes/No Primary/Secondary hospital Yes/No In hospital Out of hospital Total length of ITU/HDU stay (non-ward-based care)(in days) Was the patient eating and drinking on discharge? Total length of stay in hospital Destination on discharge Readmission within 30 days of discharge Number of days after discharge the patient was readmitted Location of readmission Cause for readmission 90-day mortality How many days postop did the patient die? Location of death Grade 4a—Life-threatening complication (including CNS complications) requiring ICU management: SINGLE organ dysfunction Grade 4b—Life-threatening complication (including CNS complications) requiring ICU management: MULTI-organ dysfunction Grade 5—Death of a patient Home Other medical facility, e.g. secondary hospital, rehabilitation center, nursing facility Yes/No Primary/Secondary hospital Yes/No In hospital Out of hospital Open in new tab Unit Survey Country Number of consultant surgeons performing esophagectomy Total No. Number of esophagectomies performed in 2017 (01/01/2017–31/12/2017) Speciality of surgeons performing esophagectomy Thoracic/Esophagogastric/General surgeon/Surgical oncologist Size of institution Total number of beds Total number of ICU beds 24-hour on-call rota for esophageal emergencies None/Weekdays 8–5/Weekdays 24 hours/Every day 8–5/24hours every day 24-hour on-call availability for interventional radiology None/Weekdays 8–5/Weekdays 24 hours/Every day 8–5/24hours every day Where do esophagectomy patients routinely go postoperatively? Ward/HDU/ICU/Dedicated GI HDU/Other (High-dependency units (level 2 care) are an intermediary level of care between a general surgical ward and intensive care units. They have 1 nurse assigned to 2 patients (1:2 nurse to patient ratio). ERAS (enhanced recovery after surgery) protocol for esophagectomy patients ERAS nurse Physio input Yes/No Yes/No Nil dedicated/Daily weekdays/Twice daily weekdays/Daily every day/Twice daily every day Does your unit perform gastric ischemic preconditioning? Yes—routinely Yes—selectively No If Yes—how many days prior to surgery Does your unit have an agreed approach to esophagectomy for lower 1/3 adenocarcinoma? No Yes Open 2-stage transthoracic esophagectomy Open left thoracoabdominal esophagectomy Open transhiatal esophagectomy Laparoscopic transhiatal esophagectomy Hybrid transthoracic esophagectomy (Lap abdominal mobilization/open chest) Hybrid transthoracic esophagectomy (Open abdominal mobilization/thorascopic chest) 2-stage minimal access esophagectomy 3-stage minimal access esophagectomy (Lap abdomen, open neck & chest) 3-stage minimal access esophagectomy (Open abdomen & chest, thorascopic chest) Robotic esophagectomy Other Does your unit have an agreed approach to esophagectomy for lower 1/3 squamous cell carcinoma? No Yes No operative approach Open 2-stage transthoracic esophagectomy Open left thoracoabdominal esophagectomy Open transhiatal esophagectomy Laparoscopic transhiatal esophagectomy Hybrid transthoracic esophagectomy (Lap abdominal mobilization/open chest) Hybrid transthoracic esophagectomy (Open abdominal mobilization/Thorascopic chest) 2-stage minimal access esophagectomy 3-stage minimal access esophagectomy (Lap abdomen, open neck & chest) 3-stage minimal access esophagectomy (Open abdomen & chest, thorascopic chest) Robotic esophagectomy Other Does you unit have an agreed technique to perform intrathoracic anastomosis? No Yes Handsew Circular stapled OrVil Stapled side to side with suturing (Orringer style) Other Country Number of consultant surgeons performing esophagectomy Total No. Number of esophagectomies performed in 2017 (01/01/2017–31/12/2017) Speciality of surgeons performing esophagectomy Thoracic/Esophagogastric/General surgeon/Surgical oncologist Size of institution Total number of beds Total number of ICU beds 24-hour on-call rota for esophageal emergencies None/Weekdays 8–5/Weekdays 24 hours/Every day 8–5/24hours every day 24-hour on-call availability for interventional radiology None/Weekdays 8–5/Weekdays 24 hours/Every day 8–5/24hours every day Where do esophagectomy patients routinely go postoperatively? Ward/HDU/ICU/Dedicated GI HDU/Other (High-dependency units (level 2 care) are an intermediary level of care between a general surgical ward and intensive care units. They have 1 nurse assigned to 2 patients (1:2 nurse to patient ratio). ERAS (enhanced recovery after surgery) protocol for esophagectomy patients ERAS nurse Physio input Yes/No Yes/No Nil dedicated/Daily weekdays/Twice daily weekdays/Daily every day/Twice daily every day Does your unit perform gastric ischemic preconditioning? Yes—routinely Yes—selectively No If Yes—how many days prior to surgery Does your unit have an agreed approach to esophagectomy for lower 1/3 adenocarcinoma? No Yes Open 2-stage transthoracic esophagectomy Open left thoracoabdominal esophagectomy Open transhiatal esophagectomy Laparoscopic transhiatal esophagectomy Hybrid transthoracic esophagectomy (Lap abdominal mobilization/open chest) Hybrid transthoracic esophagectomy (Open abdominal mobilization/thorascopic chest) 2-stage minimal access esophagectomy 3-stage minimal access esophagectomy (Lap abdomen, open neck & chest) 3-stage minimal access esophagectomy (Open abdomen & chest, thorascopic chest) Robotic esophagectomy Other Does your unit have an agreed approach to esophagectomy for lower 1/3 squamous cell carcinoma? No Yes No operative approach Open 2-stage transthoracic esophagectomy Open left thoracoabdominal esophagectomy Open transhiatal esophagectomy Laparoscopic transhiatal esophagectomy Hybrid transthoracic esophagectomy (Lap abdominal mobilization/open chest) Hybrid transthoracic esophagectomy (Open abdominal mobilization/Thorascopic chest) 2-stage minimal access esophagectomy 3-stage minimal access esophagectomy (Lap abdomen, open neck & chest) 3-stage minimal access esophagectomy (Open abdomen & chest, thorascopic chest) Robotic esophagectomy Other Does you unit have an agreed technique to perform intrathoracic anastomosis? No Yes Handsew Circular stapled OrVil Stapled side to side with suturing (Orringer style) Other Open in new tab Country Number of consultant surgeons performing esophagectomy Total No. Number of esophagectomies performed in 2017 (01/01/2017–31/12/2017) Speciality of surgeons performing esophagectomy Thoracic/Esophagogastric/General surgeon/Surgical oncologist Size of institution Total number of beds Total number of ICU beds 24-hour on-call rota for esophageal emergencies None/Weekdays 8–5/Weekdays 24 hours/Every day 8–5/24hours every day 24-hour on-call availability for interventional radiology None/Weekdays 8–5/Weekdays 24 hours/Every day 8–5/24hours every day Where do esophagectomy patients routinely go postoperatively? Ward/HDU/ICU/Dedicated GI HDU/Other (High-dependency units (level 2 care) are an intermediary level of care between a general surgical ward and intensive care units. They have 1 nurse assigned to 2 patients (1:2 nurse to patient ratio). ERAS (enhanced recovery after surgery) protocol for esophagectomy patients ERAS nurse Physio input Yes/No Yes/No Nil dedicated/Daily weekdays/Twice daily weekdays/Daily every day/Twice daily every day Does your unit perform gastric ischemic preconditioning? Yes—routinely Yes—selectively No If Yes—how many days prior to surgery Does your unit have an agreed approach to esophagectomy for lower 1/3 adenocarcinoma? No Yes Open 2-stage transthoracic esophagectomy Open left thoracoabdominal esophagectomy Open transhiatal esophagectomy Laparoscopic transhiatal esophagectomy Hybrid transthoracic esophagectomy (Lap abdominal mobilization/open chest) Hybrid transthoracic esophagectomy (Open abdominal mobilization/thorascopic chest) 2-stage minimal access esophagectomy 3-stage minimal access esophagectomy (Lap abdomen, open neck & chest) 3-stage minimal access esophagectomy (Open abdomen & chest, thorascopic chest) Robotic esophagectomy Other Does your unit have an agreed approach to esophagectomy for lower 1/3 squamous cell carcinoma? No Yes No operative approach Open 2-stage transthoracic esophagectomy Open left thoracoabdominal esophagectomy Open transhiatal esophagectomy Laparoscopic transhiatal esophagectomy Hybrid transthoracic esophagectomy (Lap abdominal mobilization/open chest) Hybrid transthoracic esophagectomy (Open abdominal mobilization/Thorascopic chest) 2-stage minimal access esophagectomy 3-stage minimal access esophagectomy (Lap abdomen, open neck & chest) 3-stage minimal access esophagectomy (Open abdomen & chest, thorascopic chest) Robotic esophagectomy Other Does you unit have an agreed technique to perform intrathoracic anastomosis? No Yes Handsew Circular stapled OrVil Stapled side to side with suturing (Orringer style) Other Country Number of consultant surgeons performing esophagectomy Total No. Number of esophagectomies performed in 2017 (01/01/2017–31/12/2017) Speciality of surgeons performing esophagectomy Thoracic/Esophagogastric/General surgeon/Surgical oncologist Size of institution Total number of beds Total number of ICU beds 24-hour on-call rota for esophageal emergencies None/Weekdays 8–5/Weekdays 24 hours/Every day 8–5/24hours every day 24-hour on-call availability for interventional radiology None/Weekdays 8–5/Weekdays 24 hours/Every day 8–5/24hours every day Where do esophagectomy patients routinely go postoperatively? Ward/HDU/ICU/Dedicated GI HDU/Other (High-dependency units (level 2 care) are an intermediary level of care between a general surgical ward and intensive care units. They have 1 nurse assigned to 2 patients (1:2 nurse to patient ratio). ERAS (enhanced recovery after surgery) protocol for esophagectomy patients ERAS nurse Physio input Yes/No Yes/No Nil dedicated/Daily weekdays/Twice daily weekdays/Daily every day/Twice daily every day Does your unit perform gastric ischemic preconditioning? Yes—routinely Yes—selectively No If Yes—how many days prior to surgery Does your unit have an agreed approach to esophagectomy for lower 1/3 adenocarcinoma? No Yes Open 2-stage transthoracic esophagectomy Open left thoracoabdominal esophagectomy Open transhiatal esophagectomy Laparoscopic transhiatal esophagectomy Hybrid transthoracic esophagectomy (Lap abdominal mobilization/open chest) Hybrid transthoracic esophagectomy (Open abdominal mobilization/thorascopic chest) 2-stage minimal access esophagectomy 3-stage minimal access esophagectomy (Lap abdomen, open neck & chest) 3-stage minimal access esophagectomy (Open abdomen & chest, thorascopic chest) Robotic esophagectomy Other Does your unit have an agreed approach to esophagectomy for lower 1/3 squamous cell carcinoma? No Yes No operative approach Open 2-stage transthoracic esophagectomy Open left thoracoabdominal esophagectomy Open transhiatal esophagectomy Laparoscopic transhiatal esophagectomy Hybrid transthoracic esophagectomy (Lap abdominal mobilization/open chest) Hybrid transthoracic esophagectomy (Open abdominal mobilization/Thorascopic chest) 2-stage minimal access esophagectomy 3-stage minimal access esophagectomy (Lap abdomen, open neck & chest) 3-stage minimal access esophagectomy (Open abdomen & chest, thorascopic chest) Robotic esophagectomy Other Does you unit have an agreed technique to perform intrathoracic anastomosis? No Yes Handsew Circular stapled OrVil Stapled side to side with suturing (Orringer style) Other Open in new tab Does you unit have an agreed technique to perform neck anastomosis? No Yes Handsew Circular stapled OrVil Stapled side to side with suturing (Orringer style) Other Does your unit have access to Indigo-Cynanine Green assessment of the anastomosis or gastric conduit? Yes/No Does your unit have a policy of performing routine postoperative assessment of the anastomosis? No Yes—barium or water soluble contrast swallow Yes—endoscopy Yes—CT If your unit routinely assess the anastomosis in the postoperative period, what day is this generally performed? Postop day______________ Does your unit have access to the following for the treatment of esophageal anastomotic leak? TPN—Yes/No Endoscopic clips—Yes/No Endoscopic or radiologically placed covered esophageal stents—Yes/No EndoVAC/Endosponge therapy—Yes/No Interventional guided drainage of abdominal or thoracic collections—Yes/No Does you unit have an agreed technique to perform neck anastomosis? No Yes Handsew Circular stapled OrVil Stapled side to side with suturing (Orringer style) Other Does your unit have access to Indigo-Cynanine Green assessment of the anastomosis or gastric conduit? Yes/No Does your unit have a policy of performing routine postoperative assessment of the anastomosis? No Yes—barium or water soluble contrast swallow Yes—endoscopy Yes—CT If your unit routinely assess the anastomosis in the postoperative period, what day is this generally performed? Postop day______________ Does your unit have access to the following for the treatment of esophageal anastomotic leak? TPN—Yes/No Endoscopic clips—Yes/No Endoscopic or radiologically placed covered esophageal stents—Yes/No EndoVAC/Endosponge therapy—Yes/No Interventional guided drainage of abdominal or thoracic collections—Yes/No Open in new tab Does you unit have an agreed technique to perform neck anastomosis? No Yes Handsew Circular stapled OrVil Stapled side to side with suturing (Orringer style) Other Does your unit have access to Indigo-Cynanine Green assessment of the anastomosis or gastric conduit? Yes/No Does your unit have a policy of performing routine postoperative assessment of the anastomosis? No Yes—barium or water soluble contrast swallow Yes—endoscopy Yes—CT If your unit routinely assess the anastomosis in the postoperative period, what day is this generally performed? Postop day______________ Does your unit have access to the following for the treatment of esophageal anastomotic leak? TPN—Yes/No Endoscopic clips—Yes/No Endoscopic or radiologically placed covered esophageal stents—Yes/No EndoVAC/Endosponge therapy—Yes/No Interventional guided drainage of abdominal or thoracic collections—Yes/No Does you unit have an agreed technique to perform neck anastomosis? No Yes Handsew Circular stapled OrVil Stapled side to side with suturing (Orringer style) Other Does your unit have access to Indigo-Cynanine Green assessment of the anastomosis or gastric conduit? Yes/No Does your unit have a policy of performing routine postoperative assessment of the anastomosis? No Yes—barium or water soluble contrast swallow Yes—endoscopy Yes—CT If your unit routinely assess the anastomosis in the postoperative period, what day is this generally performed? Postop day______________ Does your unit have access to the following for the treatment of esophageal anastomotic leak? TPN—Yes/No Endoscopic clips—Yes/No Endoscopic or radiologically placed covered esophageal stents—Yes/No EndoVAC/Endosponge therapy—Yes/No Interventional guided drainage of abdominal or thoracic collections—Yes/No Open in new tab Appendix II: Esophagectomy Complications Consensus Group Definitions (18) Anastomotic Leak Defined as: Full thickness GI defect involving esophagus, anastomosis, staple line, or conduit irrespective of presentation or method of identification Type I: Local defect requiring no change in therapy or treated medically or with dietary modification Type II: Localized defect requiring interventional but not surgical therapy, for example, interventional radiology drain, stent or bedside opening, and packing of incision Type III: Localized defect requiring surgical therapy Conduit Necrosis Type I: Conduit necrosis focal Identified endoscopically TreatmentAdditional monitoring or non-surgical therapy Type II: Conduit necrosis focal Identified endoscopically and not associated with free anastomotic or conduit leak TreatmentSurgical therapy not involving esophageal diversion Type III: Conduit necrosis extensive TreatmentTreated with conduit resection with diversion © The Author(s) 2019. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)
TI - Study protocol for a multicenter prospective cohort study on esophagogastric anastomoses and anastomotic leak (the Oesophago-Gastric Anastomosis Audit/OGAA)
JF - Diseases of the Esophagus
DO - 10.1093/dote/doz007
DA - 2020-01-16
UR - https://www.deepdyve.com/lp/oxford-university-press/study-protocol-for-a-multicenter-prospective-cohort-study-on-0VB79YVzW0
VL - 33
IS - 1
DP - DeepDyve
ER -