Measuring Small Bowel Length in Bariatric Surgery: An Ex Vivo Laparoscopic Training Experiment.

INTRODUCTION: Determining limb length in gastric bypass procedures is a crucial step to ensure significant weight loss without risking malnutrition. This study investigated the effect of ex vivo training on the skills needed to determine limb lengths. MATERIALS AND METHODS: This was a single-center ex vivo training experiment in a teaching hospital in the Netherlands. We designed a training exercise with marked ropes in a laparoscopic trainer box. All ten surgical residents participated and practiced the skill of estimating limb length. Before and after the two-week period their results on a 150-centimeter limb length task were evaluated. RESULTS: Before training, 10 surgical residents estimated 150 centimeters of small bowel with an absolute deviation of 21% [range 9-30]. After the training experiment, the residents measured with 8% [2-20] deviation (P = .17). The 8 residents who trained sufficiently improved statistically significantly to an absolute deviation of 5% [2-17] (P = .012). Over 70% of the participants felt their skills had improved. CONCLUSIONS: With sufficient training, surgical residents' skills in measuring small bowel length improved when tested in an ex vivo model. Residents became more confident in their laparoscopic measurement skills. This ex vivo training model is a alternative and addition to on-site training.

Impact of 18FFDG-PET/CT and Laparoscopy in Staging of Locally Advanced Gastric Cancer: A Cost Analysis in the Prospective Multicenter PLASTIC-Study.

BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.

Prognostic value of Mandard score and nodal status for recurrence patterns and survival after multimodal treatment of oesophageal adenocarcinoma.

BACKGROUND: This study evaluated the association of pathological tumour response (tumour regression grade, TRG) and a novel scoring system, combining both TRG and nodal status (TRG-ypN score; TRG1-ypN0, TRG>1-ypN0, TRG1-ypN+ and TRG>1-ypN+), with recurrence patterns and survival after multimodal treatment of oesophageal adenocarcinoma. METHODS: This Dutch nationwide cohort study included patients treated with neoadjuvant chemoradiotherapy followed by oesophagectomy for distal oesophageal or gastro-oesophageal junctional adenocarcinoma between 2007 and 2016. The primary endpoint was the association of Mandard score and TRG-ypN score with recurrence patterns (rate, location, and time to recurrence). The secondary endpoint was overall survival. RESULTS: Among 2746 inclusions, recurrence rates increased with higher Mandard scores (TRG1 30.6%, TRG2 44.9%, TRG3 52.9%, TRG4 61.4%, TRG5 58.2%; P < 0.001). Among patients with recurrent disease, the distribution (locoregional versus distant) was the same for the different TRG groups. Patients with TRG1 developed more brain recurrences (17.7 versus 9.8%; P = 0.001) and had a longer mean overall survival (44 versus 35 months; P < 0.001) than those with TRG>1. The TRG>1-ypN+ group had the highest recurrence rate (64.9%) and worst overall survival (mean 27 months). Compared with the TRG>1-ypN0 group, patients with TRG1-ypN+ had a higher risk of recurrence (51.9 versus 39.6%; P < 0.001) and worse mean overall survival (33 versus 41 months; P < 0.001). CONCLUSION: Improved tumour response to neoadjuvant therapy was associated with lower recurrence rates and higher overall survival rates. Among patients with recurrent disease, TRG1 was associated with a higher incidence of brain recurrence than TRG>1. Residual nodal disease influenced prognosis more negatively than residual disease at the primary tumour site.

A New Procedure-Based Assessment of Operative Skills in Gastric Bypass Surgery, Evaluated by Video Fragment Rating.

PURPOSE: Feedback on technical and procedural skills is essential during the training of residents and fellows. The aim of this study was to assess the performance of a newly created instrument for the assessment of operative skills using laparoscopic Roux-en-Y gastric bypass (LRYGB) video fragments. MATERIALS AND METHODS: A new procedure-based assessment (PBA) was created by combining LRYGB key steps with a 5-point independence scale. LRYGB performed by residents and surgeons with different levels of expertise were video recorded. Fragments of the pouch creation, gastro-jejunostomy and jejunojejunostomy, were review by 12 expert bariatric surgeons and the operative skills assessed with the PBA, Objective Structured Assessment of Technical Skill (OSATS), and the Bariatric OSATS (BOSATS). The PBA was compared to the OSATS and BOSATS. Mean scores for all items of the different assessments were summarized and compared using a T-test. RESULTS: The scores of the procedural steps were combined and compared for all levels. The mean scores for beginner, intermediate, and expert level were 2.71, 3.70, and 3.90 for the PBA; for the OSATS 1.84, 2.86, and 3.44; and for the BOSATS 2.78, 3.56, and 4.19. Each of these assessments differentiated between the three skill levels (all p < 0.05). CONCLUSION: The PBA discriminates well between different levels of operative skills. Similar patterns were found for the OSATS and BOSATS, showing that the randomly selected video fragments are representative samples for assessing skill level. Future research will demonstrate whether these results can be extrapolated to clinical training, and which scores allow for procedure certification.

Dye-free visualisation of intestinal perfusion using laser speckle contrast imaging in laparoscopic surgery: a prospective, observational multi-centre study.

INTRODUCTION: Intraoperative perfusion imaging may help the surgeon in creating the intestinal anastomoses in optimally perfused tissue. Laser speckle contrast imaging (LSCI) is such a perfusion visualisation technique that is characterized by dye-free, real-time and continuous imaging. Our aim is to validate the use of a novel, dye-free visualization tool to detect perfusion deficits using laparoscopic LSCI. METHODS: In this multi-centre study, a total of 64 patients were imaged using the laparoscopic laser speckle contrast imager. Post-operatively, surgeons were questioned if the additional visual feedback would have led to a change in clinical decision-making. RESULTS: This study suggests that the laparoscopic laser speckle contrast imager PerfusiX-Imaging is able to image colonic perfusion. All images were clear and easy to interpret for the surgeon. The device is non-disruptive of the surgical procedure with an average added surgical time of 2.5 min and no change in surgical equipment. The potential added clinical value is accentuated by the 17% of operating surgeons indicating a change in anastomosis location. Further assessment and analysis of both white light and PerfusiX perfusion images by non-involved, non-operating surgeons showed an overall agreement of 80%. CONCLUSION: PerfusiX-Imaging is a suitable laparoscopic perfusion imaging system for colon surgery that can visualize perfusion in real-time with no change in surgical equipment. The additional visual feedback could help guide the surgeons in placing the anastomosis at the most optimal site.

Assessment methods in laparoscopic colorectal surgery: a systematic review of available instruments.

BACKGROUND: Laparoscopic surgery has become the golden standard for many procedures, requiring new skills and training methods. The aim of this review is to appraise literature on assessment methods for laparoscopic colorectal procedures and quantify these methods for implementation in surgical training. MATERIALS AND METHODS: PubMed, Embase and Cochrane Central Register of Controlled Trials databases were searched in October 2022 for studies reporting learning and assessment methods for laparoscopic colorectal surgery. Quality was scored using the Downs and Black checklist. Included articles were categorized in procedure-based assessment methods and non-procedure-based assessment methods. A second distinction was made between capability for formative and/or summative assessment. RESULTS: In this systematic review, nineteen studies were included. These studies showed large heterogeneity despite categorization. Median quality score was 15 (range 0-26). Fourteen studies were categorized as procedure-based assessment methods (PBA), and five as non-procedure-based assessment methods. Three studies were applicable for summative assessment. CONCLUSIONS: The results show a considerable diversity in assessment methods with varying quality and suitability. To prevent a sprawl of assessment methods, we argue for selection and development of available high-quality assessment methods. A procedure-based structure combined with an objective assessment scale and possibility for summative assessment should be cornerstones.

Towards best practice in developing motor skills: a systematic review on spacing in VR simulator-based psychomotor training for surgical novices.

OBJECTIVE: Repeated practice, or spacing, can improve various types of skill acquisition. Similarly, virtual reality (VR) simulators have demonstrated their effectiveness in fostering surgical skill acquisition and provide a promising, realistic environment for spaced training. To explore how spacing impacts VR simulator-based acquisition of surgical psychomotor skills, we performed a systematic literature review. METHODS: We systematically searched the databases PubMed, PsycINFO, Psychology and Behavioral Sciences Collection, ERIC and CINAHL for studies investigating the influence of spacing on the effectiveness of VR simulator training focused on psychomotor skill acquisition in healthcare professionals. We assessed the quality of all included studies using the Medical Education Research Study Quality Instrument (MERSQI) and the risk of bias using the Cochrane Collaboration's risk of bias assessment tool. We extracted and aggregated qualitative data regarding spacing interval, psychomotor task performance and several other performance metrics. RESULTS: The searches yielded 1662 unique publications. After screening the titles and abstracts, 53 publications were retained for full text screening and 7 met the inclusion criteria. Spaced training resulted in better performance scores and faster skill acquisition when compared to control groups with a single day (massed) training session. Spacing across consecutive days seemed more effective than shorter or longer spacing intervals. However, the included studies were too heterogeneous in terms of spacing interval, obtained performance metrics and psychomotor skills analysed to allow for a meta-analysis to substantiate our outcomes. CONCLUSION: Spacing in VR simulator-based surgical training improved skill acquisition when compared to massed training. The overall number and quality of available studies were only moderate, limiting the validity and generalizability of our findings.

Trends in Distal Esophageal and Gastroesophageal Junction Cancer Care: The Dutch Nationwide Ivory Study.

OBJECTIVE: This study evaluated the nationwide trends in care and accompanied postoperative outcomes for patients with distal esophageal and gastro-esophageal junction cancer. SUMMARY OF BACKGROUND DATA: The introduction of transthoracic esophagectomy, minimally invasive surgery, and neo-adjuvant chemo(radio)therapy changed care for patients with esophageal cancer. METHODS: Patients after elective transthoracic and transhiatal esophagectomy for distal esophageal or gastroesophageal junction carcinoma in the Netherlands between 2007-2016 were included. The primary aim was to evaluate trends in both care and postoperative outcomes for the included patients. Additionally, postoperative outcomes after transthoracic and tran-shiatal esophagectomy were compared, stratified by time periods. RESULTS: Among 4712 patients included, 74% had distal esophageal tumors and 87% had adenocarcinomas. Between 2007 and 2016, the proportion of transthoracic esophagectomy increased from 41% to 81%, and neo-adjuvant treatment and minimally invasive esophagectomy increased from 31% to 96%, and from 7% to 80%, respectively. Over this 10-year period, postoperative outcomes improved: postoperative morbidity decreased from 66.6% to 61.8% ( P = 0.001), R0 resection rate increased from 90.0% to 96.5% (P <0.001), median lymph node harvest increased from 15 to 19 ( P <0.001), and median survival increased from 35 to 41 months ( P = 0.027). CONCLUSION: In this nationwide cohort, a transition towards more neo-adju-vant treatment, transthoracic esophagectomy and minimally invasive surgery was observed over a 10-year period, accompanied by decreased postoperative morbidity, improved surgical radicality and lymph node harvest, and improved survival.

Endoscopy training in the Netherlands: a national survey among gastroenterology residents.

Background and study aims Training in endoscopy is a key objective of gastroenterology residency. There is currently no standardized or systematic training approach. This study evaluated and compared the current status of gastrointestinal endoscopy training programs in all teaching hospitals in the Netherlands from a resident perspective. Materials and methods A national online survey with open and closed questions on gastrointestinal endoscopy training was administered to all gastroenterology residents (N = 180) in the eight educational regions in the Netherlands. Results One hundred residents who had already started endoscopy training were included in the analyses. Sixty-five residents (65 %) were satisfied with their endoscopy training program. Participation in a preclinical endoscopy course was mandatory in seven of eight educational regions. Residents from the region without a mandatory endoscopy training course were significantly less likely to be satisfied with their endoscopy training program (32 %, P  = .011). Criteria used to determine the level of supervision differed greatly between teaching hospitals (e. g. assessed endoscopy competence, predefined period of time or number of procedures). Only 26 residents (26 %) reported uniformity in teaching methods and styles between different supervising gastroenterologists in their teaching hospital. Conclusions Although most gastroenterology residents were satisfied with the endoscopy training program and endoscopy supervision in their teaching hospital, this study identified considerable local and regional variability. Future studies should be conducted to evaluate the trainers' perspective and trainers' behavior during endoscopy training sessions, which might eventually lead to the development of best practices regarding endoscopy training, including standardization of training programs and supervision methods.

Recurrent Disease After Esophageal Cancer Surgery: A Substudy of The Dutch Nationwide Ivory Study.

OBJECTIVE: This study investigated the patterns, predictors, and survival of recurrent disease following esophageal cancer surgery. BACKGROUND: Survival of recurrent esophageal cancer is usually poor, with limited prospects of remission. METHODS: This nationwide cohort study included patients with distal esophageal and gastroesophageal junction adenocarcinoma and squamous cell carcinoma after curatively intended esophagectomy in 2007 to 2016 (follow-up until January 2020). Patients with distant metastases detected during surgery were excluded. Univariable and multivariable logistic regression were used to identify predictors of recurrent disease. Multivariable Cox regression was used to determine the association of recurrence site and treatment intent with postrecurrence survival. RESULTS: Among 4626 patients, 45.1% developed recurrent disease a median of 11 months postoperative, of whom most had solely distant metastases (59.8%). Disease recurrences were most frequently hepatic (26.2%) or pulmonary (25.1%). Factors significantly associated with disease recurrence included young age (≤65 y), male sex, adenocarcinoma, open surgery, transthoracic esophagectomy, nonradical resection, higher T-stage, and tumor positive lymph nodes. Overall, median postrecurrence survival was 4 months [95% confidence interval (95% CI): 3.6-4.4]. After curatively intended recurrence treatment, median survival was 20 months (95% CI: 16.4-23.7). Survival was more favorable after locoregional compared with distant recurrence (hazard ratio: 0.74, 95% CI: 0.65-0.84). CONCLUSIONS: This study provides important prognostic information assisting in the surveillance and counseling of patients after curatively intended esophageal cancer surgery. Nearly half the patients developed recurrent disease, with limited prospects of survival. The risk of recurrence was higher in patients with a higher tumor stage, nonradical resection and positive lymph node harvest.

Functional constipation in patients with hemorrhoids: a systematic review and meta-analysis.

Hemorrhoids are common anorectal pathology, with high recurrence rates after surgical treatment. It is hypothesized that high straining forces during paradoxical contractions and inadequate relaxation are causally related to hemorrhoids. This review aimed to assess the coprevalence of functional constipation and dyssynergic defecation in a population with hemorrhoids. Moreover, the effects of rubber band ligation (RBL) were analyzed. Sources included Pubmed, Embase and CENTRAL . Randomized trials, cohort and case-control studies that investigated the prevalence of constipation in patients with hemorrhoids or the prevalence of hemorrhoids in patients with constipation compared to healthy subjects were included. Manometric studies were also eligible. Quality assessment was performed by using the Newcastle Ottawa Quality Assessment Scale. The primary outcome was the prevalence of functional constipation or dyssynergic defecation in patients with hemorrhoids. Nineteen studies were included. Prevalence of constipation was significantly higher in patients with hemorrhoids compared to controls [OR (odds ratio), 2.09; 95% CI (confidence interval), 1.27-3.44]. No significant difference in the prevalence of hemorrhoids between patients with constipation compared to controls was found (OR, 2.37; 95% CI, 0.67-8.44). Anal pressures in patients with hemorrhoids were significantly higher compared to healthy controls in all manometric studies. After RBL, these pressures remained significantly higher in patients with hemorrhoids ( P = 0.001). Functional constipation, dyssynergic defecation and higher basal anal pressures are more prevalent in patients with hemorrhoids compared to controls. Improvement of therapy for functional constipation, especially dyssynergic defecation patterns, might lead to better long-term outcomes and reduce recurrence.

Boundary Objects as Dialogical Learning Accelerators for Social Change in Design for Health: Systematic Review.

BACKGROUND: Boundary objects can add value for innovative design and implementation research in health care through their organizational focus and the dynamic structure between ill-structured and tailored use. However, when innovation is approached as a boundary object, more attention will need to be paid to the preimplementation phase. Research and design thinking pay attention to the preimplementation stage but do not have a social or organizational focus per se. The integration of boundary objects in design methodologies can provide a more social and organizational focus in innovative design projects by mapping out the mechanisms that occur at boundaries during design. Four dialogical learning mechanisms that can be triggered at boundaries have been described in the literature: identification, coordination, reflection, and transformation. These mechanisms seem suitable for integration in innovative design research on health. OBJECTIVE: Focusing on innovation in health, this study aims to find out whether the different learning mechanisms can be linked to studies on health innovation that mention boundary objects as a concept and assess whether the related mechanisms provide insight into the stage of the design and implementation or change process. METHODS: The following 6 databases were searched for relevant abstracts: PubMed, Scopus, Education Resources Information Center, PsycINFO, Information Science and Technology Abstracts, and Embase. These databases cover a wide range of published studies in the field of health. RESULTS: Our initial search yielded 3102 records; after removing the duplicates, 2186 (70.47%) records were screened on the title and abstract, and 25 (0.81%) papers were included; of the 13 papers where we identified 1 mechanism, 5 (38%) described an innovation or innovative project, and of the 12 papers where we identified more mechanisms, 9 (75%) described the development or implementation of an innovation. The reflective mechanism was not identified solely but was present in papers describing a more successful development or implementation project of innovation. In these papers, the predetermined goals were achieved, and the process of integration was relatively smoother. CONCLUSIONS: The concept of boundary objects has found its way into health care. Although the idea of a boundary object was introduced to describe how specific artifacts can fulfill a bridging function between different sociocultural sites and thus have a social focus, the focus in the included papers was often on the boundary object itself rather than the social effect. The reflection and transformation mechanisms were underrepresented in the included studies but based on the findings in this review, pursuing to trigger the reflective mechanism in design, development, and implementation projects can lead to a more fluid and smooth integration of innovation into practice.

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.

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.

Procedure-based assessment for laparoscopic cholecystectomy can replace global rating scales.

INTRODUCTION: Global rating scales (GRSs) such as the Objective Structured Assessment of Technical Skills (OSATS) and Global Operative Assessment of Laparoscopic Surgery (GOALS) are assessment methods for surgical procedures. The aim of this study was to establish construct validity of Procedure-Based Assessment (PBA) and to compare PBA with GRSs for laparoscopic cholecystectomy. MATERIAL AND METHODS: OSATS and GOALS GRSs were compared with PBA in their ability to discriminate between levels of performance between trainees who can perform the procedure independently and those who cannot. Three groups were formed based on the number of procedures performed by the trainee: novice (1-10), intermediate (11-20) and experienced (>20). Differences between groups were assessed using the Kruskal-Wallis and Mann-Whitney U tests. RESULTS: Increasing experience correlated significantly with higher GRSs and PBA scores (all p < .001). Scores of novice and intermediate groups overlapped substantially on the OSATS (p = .1) and GOALS (p = .1), while the PBA discriminated between these groups (p = .03). The median score in the experienced group was higher with less dispersion for PBA (97.2[85.3-100]) compared to OSATS (82.1[60.7-100]) and GOALS (80[60-100]). CONCLUSION: For assessing skill level or the capability of performing a laparoscopic cholecystectomy independently, PBA has a higher discriminative ability compared to the GRSs.

18F-Fludeoxyglucose-Positron Emission Tomography/Computed Tomography and Laparoscopy for Staging of Locally Advanced Gastric Cancer: A Multicenter Prospective Dutch Cohort Study (PLASTIC).

Importance: The optimal staging for gastric cancer remains a matter of debate. Objective: To evaluate the value of 18F-fludeoxyglucose-positron emission tomography with computed tomography (FDG-PET/CT) and staging laparoscopy (SL) in addition to initial staging by means of gastroscopy and CT in patients with locally advanced gastric cancer. Design, Setting, and Participants: This multicenter prospective, observational cohort study included 394 patients with locally advanced, clinically curable gastric adenocarcinoma (≥cT3 and/or N+, M0 category based on CT) between August 1, 2017, and February 1, 2020. Exposures: All patients underwent an FDG-PET/CT and/or SL in addition to initial staging. Main Outcomes and Measures: The primary outcome was the number of patients in whom the intent of treatment changed based on the results of these 2 investigations. Secondary outcomes included diagnostic performance, number of incidental findings on FDG-PET/CT, morbidity and mortality after SL, and diagnostic delay. Results: Of the 394 patients included, 256 (65%) were men and mean (SD) age was 67.6 (10.7) years. A total of 382 patients underwent FDG-PET/CT and 357 underwent SL. Treatment intent changed from curative to palliative in 65 patients (16%) based on the additional FDG-PET/CT and SL findings. FDG-PET/CT detected distant metastases in 12 patients (3%), and SL detected peritoneal or locally nonresectable disease in 73 patients (19%), with an overlap of 7 patients (2%). FDG-PET/CT had a sensitivity of 33% (95% CI, 17%-53%) and specificity of 97% (95% CI, 94%-99%) in detecting distant metastases. Secondary findings on FDG/PET were found in 83 of 382 patients (22%), which led to additional examinations in 65 of 394 patients (16%). Staging laparoscopy resulted in a complication requiring reintervention in 3 patients (0.8%) without postoperative mortality. The mean (SD) diagnostic delay was 19 (14) days. Conclusions and Relevance: This study's findings suggest an apparently limited additional value of FDG-PET/CT; however, SL added considerably to the staging process of locally advanced gastric cancer by detection of peritoneal and nonresectable disease. Therefore, it may be useful to include SL in guidelines for staging advanced gastric cancer, but not FDG-PET/CT.

Updated protocol of the SANO trial: a stepped-wedge cluster randomised trial comparing surgery with active surveillance after neoadjuvant chemoradiotherapy for oesophageal cancer.

BACKGROUND: The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The last patient with a clinically complete response is expected to be included in May 2021. The purpose of this update is to present all amendments to the SANO trial protocol as approved by the Institutional Research Board (IRB) before accrual is completed. DESIGN: The SANO trial protocol has been published ( https://doi.org/10.1186/s12885-018-4034-1 ). In this ongoing, phase-III, non-inferiority, stepped-wedge, cluster randomised controlled trial, patients with cCR (i.e. after neoadjuvant chemoradiotherapy no evidence of residual disease in two consecutive clinical response evaluations [CREs]) undergo either active surveillance or standard oesophagectomy. In the active surveillance arm, CREs are repeated every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and yearly in the fourth and fifth year. In this arm, oesophagectomy is offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant metastases. The primary endpoint is overall survival. UPDATE: Amendments to the study design involve the first cluster in the stepped-wedge design being partially randomised as well and continued accrual of patients at baseline until the predetermined number of patients with cCR is reached. Eligibility criteria have been amended, stating that patients who underwent endoscopic treatment prior to neoadjuvant chemoradiotherapy cannot be included and that patients who have highly suspected residual tumour without histological proof can be included. Amendments to the study procedures include that patients proceed to the second CRE if at the first CRE the outcome of the pathological assessment is uncertain and that patients with a non-passable stenosis at endoscopy are not considered cCR. The sample size was recalculated following new insights on response rates (34% instead of 50%) and survival (expected 2-year overall survival of 75% calculated from the moment of reaching cCR instead of 3-year overall survival of 67% calculated from diagnosis). This reduced the number of required patients with cCR from 264 to 224, but increased the required inclusions from 480 to approximately 740 patients at baseline. CONCLUSION: Substantial amendments were made prior to closure of enrolment of the SANO trial. These amendments do not affect the outcomes of the trial compared to the original protocol. The first results are expected late 2023. If active surveillance plus surgery as needed after neoadjuvant chemoradiotherapy for oesophageal cancer leads to non-inferior overall survival compared to standard oesophagectomy, active surveillance can be implemented as a standard of care.

The Development of an Escape Room-Based Serious Game to Trigger Social Interaction and Communication Between High-Functioning Children With Autism and Their Peers: Iterative Design Approach.

BACKGROUND: Children with autism spectrum disorder (ASD) have social deficits that affect social interactions, communication, and relationships with peers. Many existing interventions focus mainly on improving social skills in clinical settings. In addition to the direct instruction-based programs, activity-based programs could be of added value, especially to bridge the relational gap between children with ASD and their peers. OBJECTIVE: The aim of this study is to describe an iterative design process for the development of an escape room-based serious game as a boundary object. The purpose of the serious game is to facilitate direct communication between high-functioning children with ASD and their peers, for the development of social skills on the one hand and strengthening relationships with peers through a fun and engaging activity on the other hand. METHODS: This study is structured around the Design Research Framework to develop an escape room through an iterative-incremental process. With a pool of 37 children, including 23 children diagnosed with ASD (5 girls) and 14 children (7 girls) attending special primary education for other additional needs, 4 testing sessions around different prototypes were conducted. The beta prototype was subsequently reviewed by experts (n=12). During the design research process, we examined in small steps whether the developed prototypes are feasible and whether they have the potential to achieve the formulated goals of different stakeholders. RESULTS: By testing various prototypes, several insights were found and used to improve the design. Insights were gained in finding a fitting and appealing theme for the children, composing the content, and addressing different constraints in applying the goals from the children's and therapeutic perspectives. Eventually, a multiplayer virtual escape room, AScapeD, was developed. Three children can play the serious game in the same room on tablets. The first test shows that the game enacts equal cooperation and communication among the children. CONCLUSIONS: This paper presents an iterative design process for AScapeD. AScapeD enacts equal cooperation and communication in a playful way between children with ASD and their peers. The conceptual structure of an escape room contributes to the natural emergence of communication and cooperation. The iterative design process has been beneficial for finding a constructive game structure to address all formulated goals, and it contributed to the design of a serious game as a boundary object that mediates the various objectives of different stakeholders. We present 5 lessons learned from the design process. The developed prototype is feasible and has the potential to achieve the goals of the serious game.

Design of a Digital Comic Creator (It's Me) to Facilitate Social Skills Training for Children With Autism Spectrum Disorder: Design Research Approach.

BACKGROUND: Children with autism spectrum disorder (ASD) often face difficulties in social situations and are often lagging in terms of social skills. Many interventions designed for children with ASD emphasize improving social skills. Although many interventions demonstrate that targeted social skills can be improved in clinical settings, developed social skills are not necessarily applied in children's daily lives at school, sometimes because classmates continue to show negative bias toward children with ASD. Children with ASD do not blame the difficult social situations they encounter on their lack of social skills; their main goal is to be accepted by peers. OBJECTIVE: This study aims to design a comic creator-It's me-that would create comics to serve as transformational boundary objects to facilitate and enact a horizontal interaction structure between high-functioning children with ASD and their peers, aiming to increase mutual understanding between children at school. METHODS: This research project and this study are structured around the Design Research Framework in order to develop the comic through an iterative-incremental process. Three test sessions, which included 13, 6, and 47 children, respectively, were initiated where the focus shifted in time from usability during the first two tests to the initial assessment of acceptance and feasibility in the third session. A stakeholder review, which included six experts, took place after the second test session. RESULTS: A digital comic creator, It's me, was produced within this study. Children can create their own personal comic by filling in a digital questionnaire. Based on concepts of peer support, psychoeducation, and horizontal interaction, It's me has a rigorous base of underlying concepts that have been translated into design. Based on the first test sessions, the comic has shown its potential to initiate personal conversations between children. Teachers are convinced that It's me can be of added value in their classrooms. CONCLUSIONS: It's me aims to initiate more in-depth conversations between peers, which should lead to more mutual understanding and better relationships between children with ASD and their peers. The first test sessions showed that It's me has the potential to enact horizontal interaction and greater understanding among peers. It's me was designed as a boundary object, aiming to connect the objectives of different stakeholders, and to trigger reflection and transformation learning mechanisms. The applied design research approach might be of added value in the acceptance and adoption of the intervention because children, professionals, and teachers see added value in the tool, each from their own perspectives.

Intestinal obstruction caused by pericecal internal herniation.

Intestinal obstruction caused by pericecal internal herniation are rare and only described in a few cases. This case describes an 80-year-old man presented with acute abdominal pain, nausea and vomiting, with no prior surgical history. Computed tomography was performed and showed a closed loop short bowel obstruction in the right lower quadrant and ascites. Laparoscopy revealed pericecal internal hernia. This is a viscous protrusion through a defect in the peritoneal cavity. Current operative treatment modalities include minimally invasive surgery. Laparoscopic repair of internal herniation is possible and feasible in experienced hands. It must be included in the differential diagnoses of every patient who presents with abdominal pain. When diagnosed act quick and thorough and expeditiously. Treatment preference should be a laparoscopic procedure.