Stoma-free Survival After Rectal Cancer Resection With Anastomotic Leakage: Development and Validation of a Prediction Model in a Large International Cohort.

OBJECTIVE: To develop and validate a prediction model (STOMA score) for 1-year stoma-free survival in patients with rectal cancer (RC) with anastomotic leakage (AL). BACKGROUND: AL after RC resection often results in a permanent stoma. METHODS: This international retrospective cohort study (TENTACLE-Rectum) encompassed 216 participating centres and included patients who developed AL after RC surgery between 2014 and 2018. Clinically relevant predictors for 1-year stoma-free survival were included in uni and multivariable logistic regression models. The STOMA score was developed and internally validated in a cohort of patients operated between 2014 and 2017, with subsequent temporal validation in a 2018 cohort. The discriminative power and calibration of the models' performance were evaluated. RESULTS: This study included 2499 patients with AL, 1954 in the development cohort and 545 in the validation cohort. Baseline characteristics were comparable. One-year stoma-free survival was 45.0% in the development cohort and 43.7% in the validation cohort. The following predictors were included in the STOMA score: sex, age, American Society of Anestesiologist classification, body mass index, clinical M-disease, neoadjuvant therapy, abdominal and transanal approach, primary defunctioning stoma, multivisceral resection, clinical setting in which AL was diagnosed, postoperative day of AL diagnosis, abdominal contamination, anastomotic defect circumference, bowel wall ischemia, anastomotic fistula, retraction, and reactivation leakage. The STOMA score showed good discrimination and calibration (c-index: 0.71, 95% CI: 0.66-0.76). CONCLUSIONS: The STOMA score consists of 18 clinically relevant factors and estimates the individual risk for 1-year stoma-free survival in patients with AL after RC surgery, which may improve patient counseling and give guidance when analyzing the efficacy of different treatment strategies in future studies.

Learning Curve of Laparoscopic Gastrectomy: A Multicenter Study.

OBJECTIVE: To evaluate the learning curve of laparoscopic gastrectomy (LG) after an implementation program. BACKGROUND: Although LG is increasingly being performed worldwide, little is known about the learning curve. METHODS: Consecutive patients who underwent elective LG for gastric adenocarcinoma with curative intent in each of the 5 highest-volume centers in the Netherlands were enrolled. Generalized additive models and a 2-piece model with a break point were used to determine the learning curve length. Analyses were corrected for casemix and were performed for LG and for the subgroups distal gastrectomy (LDG) and total gastrectomy (LTG). The learning curve effect was assessed for (1) anastomotic leakage; and (2) the occurrence of postoperative complications, conversions to open surgery, and short-term oncological parameters. RESULTS: In total 540 patients were included for analysis, 108 patients from each center; 268 patients underwent LDG and 272 underwent LTG. First, for LG, no learning effect regarding anastomotic leakage could be identified: the rate of anastomotic leakage initially increased, then reached a plateau after 36 cases at 10% anastomotic leakage. Second, the level of overall complications reached a plateau after 20 cases, at 38% overall complications, and at 5% conversions. For both LDG and LTG, each considered separately, fluctuations in secondary outcomes and anastomotic leakage followed fluctuations in casemix. CONCLUSION: On the basis of our study of the first 108 procedures of LG in 5 high-volume centers with well-trained surgeons, no learning curve effect could be identified regarding anastomotic leakage. A learning curve effect was found with respect to overall complications and conversion rate.

Treatment of anastomotic leak after oesophagectomy for oesophageal cancer: large, collaborative, observational TENTACLE cohort study.

BACKGROUND: Anastomotic leak is a severe complication after oesophagectomy. Anastomotic leak has diverse clinical manifestations and the optimal treatment strategy is unknown. The aim of this study was to assess the efficacy of treatment strategies for different manifestations of anastomotic leak after oesophagectomy. METHODS: A retrospective cohort study was performed in 71 centres worldwide and included patients with anastomotic leak after oesophagectomy (2011-2019). Different primary treatment strategies were compared for three different anastomotic leak manifestations: interventional versus supportive-only treatment for local manifestations (that is no intrathoracic collections; well perfused conduit); drainage and defect closure versus drainage only for intrathoracic manifestations; and oesophageal diversion versus continuity-preserving treatment for conduit ischaemia/necrosis. The primary outcome was 90-day mortality. Propensity score matching was performed to adjust for confounders. RESULTS: Of 1508 patients with anastomotic leak, 28.2 per cent (425 patients) had local manifestations, 36.3 per cent (548 patients) had intrathoracic manifestations, 9.6 per cent (145 patients) had conduit ischaemia/necrosis, 17.5 per cent (264 patients) were allocated after multiple imputation, and 8.4 per cent (126 patients) were excluded. After propensity score matching, no statistically significant differences in 90-day mortality were found regarding interventional versus supportive-only treatment for local manifestations (risk difference 3.2 per cent, 95 per cent c.i. -1.8 to 8.2 per cent), drainage and defect closure versus drainage only for intrathoracic manifestations (risk difference 5.8 per cent, 95 per cent c.i. -1.2 to 12.8 per cent), and oesophageal diversion versus continuity-preserving treatment for conduit ischaemia/necrosis (risk difference 0.1 per cent, 95 per cent c.i. -21.4 to 1.6 per cent). In general, less morbidity was found after less extensive primary treatment strategies. CONCLUSION: Less extensive primary treatment of anastomotic leak was associated with less morbidity. A less extensive primary treatment approach may potentially be considered for anastomotic leak. Future studies are needed to confirm current findings and guide optimal treatment of anastomotic leak after oesophagectomy.

Stoma-free survival after anastomotic leak following rectal cancer resection: worldwide cohort of 2470 patients.

BACKGROUND: The optimal treatment of anastomotic leak after rectal cancer resection is unclear. This worldwide cohort study aimed to provide an overview of four treatment strategies applied. METHODS: Patients from 216 centres and 45 countries with anastomotic leak after rectal cancer resection between 2014 and 2018 were included. Treatment was categorized as salvage surgery, faecal diversion with passive or active (vacuum) drainage, and no primary/secondary faecal diversion. The primary outcome was 1-year stoma-free survival. In addition, passive and active drainage were compared using propensity score matching (2 : 1). RESULTS: Of 2470 evaluable patients, 388 (16.0 per cent) underwent salvage surgery, 1524 (62.0 per cent) passive drainage, 278 (11.0 per cent) active drainage, and 280 (11.0 per cent) had no faecal diversion. One-year stoma-free survival rates were 13.7, 48.3, 48.2, and 65.4 per cent respectively. Propensity score matching resulted in 556 patients with passive and 278 with active drainage. There was no statistically significant difference between these groups in 1-year stoma-free survival (OR 0.95, 95 per cent c.i. 0.66 to 1.33), with a risk difference of -1.1 (95 per cent c.i. -9.0 to 7.0) per cent. After active drainage, more patients required secondary salvage surgery (OR 2.32, 1.49 to 3.59), prolonged hospital admission (an additional 6 (95 per cent c.i. 2 to 10) days), and ICU admission (OR 1.41, 1.02 to 1.94). Mean duration of leak healing did not differ significantly (an additional 12 (-28 to 52) days). CONCLUSION: Primary salvage surgery or omission of faecal diversion likely correspond to the most severe and least severe leaks respectively. In patients with diverted leaks, stoma-free survival did not differ statistically between passive and active drainage, although the increased risk of secondary salvage surgery and ICU admission suggests residual confounding.

Crowd-sourced and expert video assessment in minimally invasive esophagectomy.

BACKGROUND: Video-based assessment by experts may structurally measure surgical performance using procedure-specific competency assessment tools (CATs). A CAT for minimally invasive esophagectomy (MIE-CAT) was developed and validated previously. However, surgeon's time is scarce and video assessment is time-consuming and labor intensive. This study investigated non-procedure-specific assessment of MIE video clips by MIE experts and crowdsourcing, collective surgical performance evaluation by anonymous and untrained laypeople, to assist procedure-specific expert review. METHODS: Two surgical performance scoring frameworks were used to assess eight MIE videos. First, global performance was assessed with the non-procedure-specific Global Operative Assessment of Laparoscopic Skills (GOALS) of 64 procedural phase-based video clips < 10 min. Each clip was assessed by two MIE experts and > 30 crowd workers. Second, the same experts assessed procedure-specific performance with the MIE-CAT of the corresponding full-length video. Reliability and convergent validity of GOALS for MIE were investigated using hypothesis testing with correlations (experience, blood loss, operative time, and MIE-CAT). RESULTS: Less than 75% of hypothesized correlations between GOALS scores and experience of the surgical team (r < 0.3), blood loss (r = - 0.82 to 0.02), operative time (r = - 0.42 to 0.07), and the MIE-CAT scores (r = - 0.04 to 0.76) were met for both crowd workers and experts. Interestingly, experts' GOALS and MIE-CAT scores correlated strongly (r = 0.40 to 0.79), while crowd workers' GOALS and experts' MIE-CAT scores correlations were weak (r = - 0.04 to 0.49). Expert and crowd worker GOALS scores correlated poorly (ICC ≤ 0.42). CONCLUSION: GOALS assessments by crowd workers lacked convergent validity and showed poor reliability. It is likely that MIE is technically too difficult to assess for laypeople. Convergent validity of GOALS assessments by experts could also not be established. GOALS might not be comprehensive enough to assess detailed MIE performance. However, expert's GOALS and MIE-CAT scores strongly correlated indicating video clip (instead of full-length video) assessments could be useful to shorten assessment time.

Performance of a consensus-based algorithm for diagnosing anastomotic leak after minimally invasive esophagectomy for esophageal cancer.

Anastomotic leak (AL) is a common and severe complication after esophagectomy. This study aimed to assess the performance of a consensus-based algorithm for diagnosing AL after minimally invasive esophagectomy. This study used data of the ICAN trial, a multicenter randomized clinical trial comparing cervical and intrathoracic anastomosis, in which a predefined diagnostic algorithm was used to guide diagnosing AL. The algorithm identified patients suspected of AL based on clinical signs, blood C-reactive protein (cut-off value 200 mg/L), and/or drain amylase (cut-off value 200 IU/L). Suspicion of AL prompted evaluation with contrast swallow computed tomography and/or endoscopy to confirm AL. Primary outcome measure was algorithm performance in terms of sensitivity, specificity, and positive and negative predictive values (PPV, NPV), respectively. AL was defined according to the definition of the Esophagectomy Complications Consensus Group. 245 patients were included, and 125 (51%) patients were suspected of AL. The algorithm had a sensitivity of 62% (95% confidence interval [CI]: 46-75), a specificity of 97% (95% CI: 89-100), and a PPV and NPV of 94% (95% CI: 79-99) and 77% (95% CI: 66-86), respectively, on initial assessment. Repeated assessment in 19 patients with persisting suspicion of AL despite negative or inconclusive initial assessment had a sensitivity of 100% (95% CI: 77-100). The algorithm showed poor performance because the low sensitivity indicates the inability of the algorithm to confirm AL on initial assessment. Repeated assessment using the algorithm was needed to confirm remaining leaks.

Predicting mortality in patients with anastomotic leak after esophagectomy: development of a prediction model using data from the TENTACLE-Esophagus study.

Anastomotic leak (AL) is a common but severe complication after esophagectomy, and over 10% of patients with AL suffer mortality. Different prognostic factors in patients with AL are known, but a tool to predict mortality after AL is lacking. This study aimed to develop a prediction model for postoperative mortality in patients with AL after esophagectomy. TENTACLE-Esophagus is an international retrospective cohort study, which included 1509 patients with AL after esophagectomy. The primary outcome was 90-day postoperative mortality. Previously identified prognostic factors for mortality were selected as predictors: patient-related (e.g. comorbidity, performance status) and leak-related predictors (e.g. leucocyte count, overall gastric conduit condition). The prediction model was developed using multivariable logistic regression and validated internally using bootstrapping. Among the 1509 patients with AL, 90-day mortality was 11.7%. Sixteen predictors were included in the prediction model. The model showed good performance after internal validation: the c-index was 0.79 (95% confidence interval 0.75-0.83). Predictions for mortality by the internally validated model aligned well with observed 90-day mortality rates. The prediction model was incorporated in an online tool for individual use and can be found at: https://www.tentaclestudy.com/prediction-model. The developed prediction model combines patient-related and leak-related factors to accurately predict postoperative mortality in patients with AL after esophagectomy. The model is useful for clinicians during counselling of patients and their families and may aid identification of high-risk patients at diagnosis of AL. In the future, the tool may guide clinical decision-making; however, external validation of the tool is warranted.

Learning Curves of Ivor Lewis Totally Minimally Invasive Esophagectomy by Hospital and Surgeon Characteristics: A Retrospective Multinational Cohort Study.

OBJECTIVE: To describe the pooled learning curves of Ivor Lewis totally minimally invasive esophagectomy (TMIE) in hospitals stratified by predefined hospital- and surgeon-related factors. BACKGROUND: Ivor Lewis (TMIE is known to have a long learning curve which is associated with considerable learning associated morbidity. It is unknown whether hospital and surgeon characteristics are associated with more efficient learning. METHODS: A retrospective analysis of prospectively collected data of consecutive Ivor Lewis TMIE patients in 14 European hospitals was performed. Outcome parameters used as proxy for efficient learning were learning curve length, learning associated morbidity, and the plateau level regarding anastomotic leakage and textbook outcome. Pooled incidences were plotted for the factor-based subgroups using generalized additive models and 2-phase models. Casemix predicted outcomes were plotted and compared with observed outcomes. The investigated factors included annual volume, TMIE experience, clinic visits, courses and fellowships followed, and proctor supervision. RESULTS: This study included 2121 patients. The length of the learning curve was shorter for centers with an annual volume >50 compared to centers with an annual volume <50. Analysis with an annual volume cut-off of 30 cases showed similar but less pronounced results. No outcomes suggesting more efficient learning were found for longer experience as consultant, visiting an expert clinic, completing a minimally invasive esophagectomy fellowship or implementation under proctor supervision. CONCLUSIONS: More efficient learning was observed in centers with higher annual volume. Visiting an expert clinic, completing a fellowship, or implementation under a proctor's supervision were not associated with more efficient learning.

Severity of oEsophageal Anastomotic Leak in patients after oesophagectomy: the SEAL score.

BACKGROUND: Anastomotic leak (AL) is a common but severe complication after oesophagectomy. It is unknown how to determine the severity of AL objectively at diagnosis. Determining leak severity may guide treatment decisions and improve future research. This study aimed to identify leak-related prognostic factors for mortality, and to develop a Severity of oEsophageal Anastomotic Leak (SEAL) score. METHODS: This international, retrospective cohort study in 71 centres worldwide included patients with AL after oesophagectomy between 2011 and 2019. The primary endpoint was 90-day mortality. Leak-related prognostic factors were identified after adjusting for confounders and were included in multivariable logistic regression to develop the SEAL score. Four classes of leak severity (mild, moderate, severe, and critical) were defined based on the risk of 90-day mortality, and the score was validated internally. RESULTS: Some 1509 patients with AL were included and the 90-day mortality rate was 11.7 per cent. Twelve leak-related prognostic factors were included in the SEAL score. The score showed good calibration and discrimination (c-index 0.77, 95 per cent c.i. 0.73 to 0.81). Higher classes of leak severity graded by the SEAL score were associated with a significant increase in duration of ICU stay, healing time, Comprehensive Complication Index score, and Esophagectomy Complications Consensus Group classification. CONCLUSION: The SEAL score grades leak severity into four classes by combining 12 leak-related predictors and can be used to the assess severity of AL after oesophagectomy.

International expert opinion on optimal treatment of anastomotic leakage after rectal cancer resection: a case-vignette study.

PURPOSE: Little is known about the optimal treatment of anastomotic leakage after low anterior resection (LAR) for rectal cancer and whether treatment strategy depends on leakage features and patient characteristics. The objective of this study was to determine which treatment principles are used by expert colorectal surgeons worldwide. METHODS: In this international case-vignette study, participants completed a survey on their preferred treatment for 11 clinical cases with varying leakage features and two patient scenarios depending on surgical risk (a total of 22 cases). RESULTS: In total, 42 of 64 invited surgeons completed the survey from 18 countries worldwide. The majority worked at a university training hospital (62%) and had more than 15 years of experience performing LAR for rectal cancer (52%). Early leaks in septic patients were preferably treated by major salvage surgery, to some extent depending on the patient scenario. In early leaks in non-septic patients, drainage and faecal diversion were the cornerstones of the proposed treatment. Endoscopic vacuum therapy was more often proposed than percutaneous drainage. A minority proposed anastomotic reconstruction, more often for larger defects. Treatment of late leaks ranged from watchful waiting, drainage, or transanal repair to major (non-)restorative salvage surgery, with minimal influence of the degree of symptoms on the proposed strategy. Leaks of the blind loop and rectovaginal fistulae showed high variability in the proposed treatment strategy. CONCLUSION: This TENTACLE-Rectum case-vignette study demonstrates tailored treatment strategies depending on the clinical type of leak and patient characteristics, with variable degrees of consensus and knowledge gaps which should be addressed in future studies.

European consensus on essential steps of Minimally Invasive Ivor Lewis and McKeown Esophagectomy through Delphi methodology.

BACKGROUND: Minimally invasive esophagectomy (MIE) is a complex and technically demanding procedure with a long learning curve, which is associated with increased morbidity and mortality. To master MIE, training in essential steps is crucial. Yet, no consensus on essential steps of MIE is available. The aim of this study was to achieve expert consensus on essential steps in Ivor Lewis and McKeown MIE through Delphi methodology. METHODS: Based on expert opinion and peer-reviewed literature, essential steps were defined for Ivor Lewis (IL) and McKeown (McK) MIE. In a round table discussion, experts finalized the lists of steps and an online Delphi questionnaire was sent to an international expert panel (7 European countries) of minimally invasive upper GI surgeons. Based on replies and comments, steps were adjusted and rephrased and sent in iterative fashion until consensus was achieved. RESULTS: Two Delphi rounds were conducted and response rates were 74% (23 out of 31 experts) for the first and 81% (27 out of 33 experts) for the second round. Consensus was achieved on 106 essential steps for both the IL and McK approach. Cronbach's alpha in the first round was 0.78 (IL) and 0.78 (McK) and in the second round 0.92 (IL) and 0.88 (McK). CONCLUSIONS: Consensus among European experts was achieved on essential surgical steps for both Ivor Lewis and McKeown minimally invasive esophagectomy.

Treatment of anastomotic leak after esophagectomy: insights of an international case vignette survey and expert discussions.

Anastomotic leak (AL) is a severe complication after esophagectomy. Clinical presentation of AL is diverse and there is large practice variation regarding treatment of AL. This study aimed to explore different AL treatment strategies and their underlying rationale. This mixed-methods study consisted of an international survey among upper gastro-intestinal (GI) surgeons and focus groups with expert upper GI surgeons. The survey included 10 case vignettes and data sources were integrated after separate analysis. The survey was completed by 188 respondents (completion rate 69%) and 6 focus groups were conducted with 20 international experts. Prevention of mortality was the most important goal of primary treatment. Goals of secondary treatment were to promote tissue healing, return to oral feeding and safe hospital discharge. There was substantial variation in the preferred treatment principles (e.g. drainage or defect closure) and modalities (e.g. stent or endoVAC) within different presentations of AL. Patients with local symptoms were treated by supportive means only or by non-surgical drainage and/or defect closure. Drainage was routinely performed in patients with intrathoracic collections and often combined with defect closure. Patients with conduit necrosis were predominantly treated by resection and reconstruction of the anastomosis or by esophageal diversion. This mixed-methods study shows that overall treatment strategies for AL are determined by vitality of the conduit and presence of intrathoracic collections. There is large variation in preferred treatment principles and modalities. Future research may investigate optimal treatment for specific AL presentations and aim to develop consensus-based treatment guidelines for AL after esophagectomy.

Trends in risk factors of anastomotic leakage after colorectal cancer surgery (2011-2019): A Dutch population-based study.

AIM: Anastomotic leakage (AL) after colon cancer (CC) and rectal cancer (RC) surgery often requires reintervention. Prevalence and morbidity may change over time with evolutions in treatment strategies and changes in patient characteristics. This nationwide study aimed to evaluate changes in the incidence, risk factors and mortality from AL during the past nine years. METHODS: Data of CC and RC resections with primary anastomosis were extracted from the Dutch Colorectal Audit (2011-2019). AL was registered if requiring reintervention. Three consecutive cohorts were compared using logistic regression analysis. RESULTS: Incidence of AL after CC surgery decreased from 6.6% in 2011-2013 to 4.8% in 2017-2019 and increased from 8.6% to 11.9% after RC surgery. In 2011-2013, male sex, ASA ≥3, (y)pT3-4, neoadjuvant therapy, emergency surgery and multivisceral resection were identified as risk factors for AL after CC surgery. In 2017-2019, only male sex and ASA ≥3 were risk factors for AL. For RC patients, male sex and neoadjuvant therapy were a risk factor for AL in 2011-2013. In 2017-2019, transanal approach was also a risk factor for AL. Postoperative mortality rate after AL was 12% (CC) and 2% (RC) in 2017-2019, without significant changes over time. CONCLUSION: Contradictory trends in incidence and mortality for AL were observed among CC and RC surgery with changing risk factors over the past 9 years. High mortality after AL is only observed after CC surgery and remains unchanged. Continued efforts should be made to improve early detection and treatment of AL for these patients.

Treatment of anastomotic leakage after rectal cancer resection: The TENTACLE-Rectum study.

AIM: Anastomotic leakage is a severe complication after low anterior resection (LAR) for rectal cancer and occurs in up to 20% of patients. Most research focuses on reducing its incidence and finding predictive factors for anastomotic leakage. There are no robust data on severity and treatment strategies with associated outcomes. The aims of this work were (1) to investigate the factors that contribute to severity of anastomotic leakage and to compose an anastomotic leakage severity score and (2) to evaluate the effects of different treatment approaches on prespecified outcome parameters, stratified for severity score and other leakage characteristics. METHOD: TENTACLE-Rectum is an international multicentre retrospective cohort study. Patients with anastomotic leakage after LAR for primary rectal cancer between 1 January 2014 and 31 December 2018 will be included by each centre. We aim to include 1246 patients in this study. The primary outcome is 1-year stoma-free survival (i.e. patients alive at 1 year without a stoma). Secondary outcomes include number of reinterventions and unplanned readmissions within 1 year, total length of hospital stay, total time with a stoma, the type of stoma present at 1 year (defunctioning, permanent), complications related to secondary leakage and mortality. For aim (1) regression models will be used to create an anastomotic leakage severity score. For aim (2) the effectiveness of different treatment strategies for leakage will be tested after correction for severity score and leakage characteristics, in addition to other potential related confounders. CONCLUSION: TENTACLE-Rectum will be an important step towards drawing up evidence-based recommendations and improving outcomes for patients who experience severe treatment-related morbidity.

Outcomes of Patients with Anastomotic Leakage After Transhiatal, McKeown or Ivor Lewis Esophagectomy: A Nationwide Cohort Study.

BACKGROUND: Anastomotic leakage has a great impact on clinical outcomes after esophagectomy. It has never been studied whether anastomotic leakage is of equal severity between different types of esophagectomy (i.e., transhiatal, McKeown and Ivor Lewis) in terms of postoperative mortality and morbidity. METHODS: All esophageal cancer patients with anastomotic leakage after transhiatal, McKeown or Ivor Lewis esophagectomy between 2011 and 2019 were selected from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) registry. The primary outcome was 30-day/in-hospital mortality. Secondary outcomes included postoperative complications, re-operation and ICU readmission rate. RESULTS: Data from 1030 patients with anastomotic leakage after transhiatal (n=287), McKeown (n=397) and Ivor Lewis esophagectomy (n=346) were evaluated. The 30-day/in-hospital mortality rate was 4.5% in patients with leakage after transhiatal esophagectomy, 8.1% after McKeown and 8.1% after Ivor Lewis esophagectomy (P=0.139). After correction for confounders, leakage after transhiatal resection was associated with lower mortality (OR 0.152-0.699, P=0.004), but mortality after McKeown and Ivor Lewis esophagectomy was similar. Re-operation rate was 24.0% after transhiatal, 40.6% after McKeown and 41.3% after Ivor Lewis esophagectomy (P<0.001). ICU readmission rate was 24.0% after transhiatal, 37.8% after McKeown and 43.4% after Ivor Lewis esophagectomy (P<0.001). CONCLUSION: This study in patients with anastomotic leakage confirms a strong association between severity of clinical consequences and different types of esophagectomy. It supports the hypothesis that cervical leakage is generally less severe than intrathoracic leakage. The clinical impact of anastomotic leakage should be taken into account, in addition to its incidence, when different types of esophagectomy are compared by clinicians or researchers.

Propensity Score-Matched Analysis Comparing Minimally Invasive Ivor Lewis Versus Minimally Invasive Mckeown Esophagectomy.

INTRODUCTION: Totally minimally invasive esophagectomy (TMIE) is increasingly used in treatment of patients with esophageal carcinoma. However, it is currently unknown if McKeown TMIE or Ivor Lewis TMIE should be preferred for patients in whom both procedures are oncologically feasible. METHODS: The study was performed in 4 high-volume Dutch esophageal cancer centers between November 2009 and April 2017. Prospectively collected data from consecutive patients with esophageal cancer localized in the distal esophagus or gastroesophageal junction undergoing McKeown TMIE or Ivor Lewis TMIE were included. Patients were propensity score matched for age, body mass index, sex, American Society of Anesthesiologists classification, Charlson Comorbidity Index, tumor type, tumor location, clinical stage, neoadjuvant treatment, and the hospital of surgery. The primary outcome parameter was anastomotic leakage requiring reintervention or reoperation. Secondary outcome parameters were operation characteristics, pathology results, complications, reinterventions, reoperations, length of stay, and mortality. RESULTS: Of all 787 included patients, 420 remained after matching. The incidence of anastomotic leakage requiring reintervention or reoperation was 23.3% after McKeown TMIE versus 12.4% after Ivor Lewis TMIE (P = 0.003). Ivor Lewis TMIE was significantly associated with a lower incidence of pulmonary complications (46.7% vs 31.9%), recurrent laryngeal nerve palsy (9.5% vs 0.5%), reoperations (18.6% vs 11.0%), 90-day mortality (7.1% vs 2.9%), shorter median intensive care unit length of stay (2 days vs 1 day) and shorter median hospital length of stay (12 vs 11 days) (all P < 0.05). R0 resection rate was similar between the groups. The median number of examined lymph nodes was 21 after McKeown TMIE and 25 after Ivor Lewis TMIE (P < 0.001). CONCLUSIONS: Ivor Lewis TMIE is associated with a lower incidence of anastomotic leakage, 90-day mortality and other postoperative morbidity compared to McKeown TMIE in patients in whom both procedures are oncologically feasible.

Robot assisted versus laparoscopic suturing learning curve in a simulated setting.

BACKGROUND: Compared to conventional laparoscopy, robot assisted surgery is expected to have most potential in difficult areas and demanding technical skills like minimally invasive suturing. This study was performed to identify the differences in the learning curves of laparoscopic versus robot assisted suturing. METHOD: Novice participants performed three suturing tasks on the EoSim laparoscopic augmented reality simulator or the RobotiX robot assisted virtual reality simulator. Each participant performed an intracorporeal suturing task, a tilted plane needle transfer task and an anastomosis needle transfer task. To complete the learning curve, all tasks were repeated up to twenty repetitions or until a time plateau was reached. Clinically relevant and comparable parameters regarding time, movements and safety were recorded. Intracorporeal suturing time and cumulative sum analysis was used to compare the learning curves and phases. RESULTS: Seventeen participants completed the learning curve laparoscopically and 30 robot assisted. Median first knot suturing time was 611 s (s) for laparoscopic versus 251 s for robot assisted (p < 0.001), and this was 324 s versus 165 (sixth knot, p < 0.001) and 257 s and 149 s (eleventh knot, p < 0.001) respectively on base of the found learning phases. The percentage of 'adequate surgical knots' was higher in the laparoscopic than in the robot assisted group. First knot: 71% versus 60%, sixth knot: 100% versus 83%, and eleventh knot: 100% versus 73%. When assessing the 'instrument out of view' parameter, the robot assisted group scored a median of 0% after repetition four. In the laparoscopic group, the instrument out of view increased from 3.1 to 3.9% (left) and from 3.0 to 4.1% (right) between the first and eleventh knot (p > 0.05). CONCLUSION: The learning curve of minimally invasive suturing shows a shorter task time curve using robotic assistance compared to the laparoscopic curve. However, laparoscopic outcomes show good end results with rapid outcome improvement.

Totally minimally invasive esophagectomy versus hybrid minimally invasive esophagectomy: systematic review and meta-analysis.

Minimally invasive esophagectomy is increasingly performed for the treatment of esophageal cancer, but it is unclear whether hybrid minimally invasive esophagectomy (HMIE) or totally minimally invasive esophagectomy (TMIE) should be preferred. The objective of this study was to perform a meta-analysis of studies comparing HMIE with TMIE. A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Articles comparing HMIE and TMIE were included. The Newcastle-Ottawa scale was used for critical appraisal of methodological quality. The primary outcome was pneumonia. Sensitivity analysis was performed by analyzing outcome for open chest hybrid MIE versus total TMIE and open abdomen MIE versus TMIE separately. Therefore, subgroup analysis was performed for laparoscopy-assisted HMIE versus TMIE, thoracoscopy-assisted HMIE versus TMIE, Ivor Lewis HMIE versus Ivor Lewis TMIE, and McKeown HMIE versus McKeown TMIE. There were no randomized controlled trials. Twenty-nine studies with a total of 3732 patients were included. Studies had a low to moderate risk of bias. In the main analysis, the pooled incidence of pneumonia was 19.0% after HMIE and 9.8% after TMIE which was not significantly different between the groups (RR: 1.46, 95% CI: 0.97-2.20). TMIE was associated with a lower incidence of wound infections (RR: 1.81, 95% CI: 1.13-2.90) and less blood loss (SMD: 0.78, 95% CI: 0.34-1.22) but with longer operative time (SMD:-0.33, 95% CI: -0.59--0.08). In subgroup analysis, laparoscopy-assisted HMIE was associated with a higher lymph node count than TMIE, and Ivor Lewis HMIE was associated with a lower anastomotic leakage rate than Ivor Lewis TMIE. In general, TMIE was associated with moderately lower morbidity compared to HMIE, but randomized controlled evidence is lacking. The higher leakage rate and lower lymph node count that was found after TMIE in sensitivity analysis indicate that TMIE can also have disadvantages. The findings of this meta-analysis should be considered carefully by surgeons when moving from HMIE to TMIE.

Learning Curve and Associated Morbidity of Minimally Invasive Esophagectomy: A Retrospective Multicenter Study.

OBJECTIVE: To investigate the morbidity that is associated with the learning curve of minimally invasive esophagectomy. BACKGROUND: Although learning curves have been described, it is currently unknown how much extra morbidity is associated with the learning curve of technically challenging surgical procedures. METHODS: Prospectively collected data were retrospectively analyzed of all consecutive patients undergoing minimally invasive Ivor Lewis esophagectomy in 4 European expert centers. The primary outcome parameter was anastomotic leakage. Secondary outcome parameters were operative time and textbook outcome ("optimal outcome"). Learning curves were plotted using weighted moving average and CUSUM analysis was used to determine after how many cases the plateau was reached. Learning associated morbidity was calculated with area under the curve analysis. RESULTS: This study included 646 patients. Three of the 4 hospitals reached the plateau of 8% anastomotic leakage. The length of the learning curve was 119 cases. The mean incidence of anastomotic leakage decreased from 18.8% during the learning phase to 4.5% after the plateau had been reached (P < 0.001). Thirty-six extra patients (10.1% of all patients operated on during the learning curve) experienced learning associated anastomotic leakage, that could have been avoided if patients were operated by surgeons who had completed the learning curve. The incidence of textbook outcome increased from 28% to 53% and the mean operative time decreased from 344 minutes to 270 minutes. CONCLUSIONS: A considerable number of 36 extra patients (10.1%) experienced learning associated anastomotic leakage. More research is urgently needed to investigate how learning associated morbidity can be reduced to increase patient safety during learning curves.

Surgeon Volume and Surgeon Age in Relation to Proficiency Gain Curves for Prognosis Following Surgery for Esophageal Cancer.

BACKGROUND: Surgery proficiency gain curves must be shortened to reduce patient harm during esophagectomy learning. OBJECTIVE: This study aimed to test whether surgeon volume and surgeon age influenced the length of period of surgical proficiency gain. METHODS: This population-based cohort study included 1384 patients with esophageal cancer who underwent esophagectomy by any of the 36 highest-volume surgeons in Sweden between 1987 and 2010, with follow-up until 2016. Annual surgeon volume was dichotomized by the median values into 'higher-volume surgeons' (≥ 4 cases per year) and 'lower-volume surgeons' (< 4 cases per year), and surgeon age at the start of practicing esophagectomies into 'younger surgeons' (aged < 45 years) and 'older surgeons' (aged ≥ 45 years). Proficiency gain curves were constructed using risk-adjusted cumulative sum analysis for 1- to 5-year mortality (main outcome) and secondary outcomes (presented below). The results were adjusted for all established prognostic factors. RESULTS: For 1- to 5-year mortality, the change point was at 14 cases among 'higher-volume surgeons', while 'lower-volume surgeons' had a later change point at 31 cases. The corresponding change points were at 13 cases among 'younger surgeons' and at 48 cases among 'older surgeons'. Similar patterns of differences in the proficiency gain curves were seen for the secondary outcomes of 30-day mortality and resection margin status (tumor involvement). CONCLUSION: Higher-volume- and younger surgeons seem to have a substantially shorter period of proficiency gain for long-term mortality and other outcomes following surgery for esophageal cancer. This indicates a value of intensified training of younger surgeons for these complex operations.