The effect of a three-dimensional instructional video on performance of a spatially complex procedure in surgical residents in relation to their visual-spatial abilities.

BACKGROUND: The effect of three-dimensional (3D) vs. two-dimensional (2D) video on performance of a spatially complex procedure and perceived cognitive load were examined among residents in relation to their visual-spatial abilities (VSA). METHODS: In a randomized controlled trial, 108 surgical residents performed a 5-Flap Z-plasty on a simulation model after watching the instructional video either in a 3D or 2D mode. Outcomes included perceived cognitive load measured by NASA-TLX questionnaire, task performance assessed using Observational Clinical Human Reliability Analysis and the percentage of achieved safe lengthening of the scar. RESULTS: No significant differences were found between groups. However, when accounted for VSA, safe lengthening was achieved significantly more often in the 3D group and only among individuals with high VSA (OR = 6.67, 95%CI: 1.23-35.9, p = .027). CONCLUSIONS: Overall, 3D instructional videos are as effective as 2D videos. However, they can be effectively used to enhance learning in high VSA residents.

Global versus task-specific postoperative feedback in surgical procedure learning.

BACKGROUND: Task-specific checklists and global rating scales are both recommended assessment tools to provide constructive feedback on surgical performance. This study evaluated the most effective feedback tool by comparing the effects of the Observational Clinical Human Reliability Analysis (OCHRA) and the Objective Structured Assessment of Technical Skills (OSATS) on surgical performance in relation to the visual-spatial ability of the learners. METHODS: In a randomized controlled trial, medical students were allocated to either the OCHRA (n = 25) or OSATS (n = 25) feedback group. Visual-spatial ability was measured by a Mental Rotation Test. Participants performed an open inguinal hernia repair procedure on a simulation model twice. Feedback was provided after the first procedure. Improvement in performance was evaluated blindly using a global rating scale (performance score) and hand-motion analysis (time and path length). RESULTS: Mean improvement in performance score was not significantly different between the OCHRA and OSATS feedback groups (P = .100). However, mean improvement in time (371.0 ± 223.4 vs 274.6 ± 341.6; P = .027) and path length (53.5 ± 42.4 vs 34.7 ± 39.0; P = .046) was significantly greater in the OCHRA feedback group. When stratified by mental rotation test scores, the greater improvement in time (P = .032) and path length (P = .053) was observed only among individuals with low visual-spatial abilities. CONCLUSION: A task-specific (OCHRA) feedback is more effective in improving surgical skills in terms of time and path length in novices compared to a global rating scale (OSATS). The effects of a task-specific feedback are present mostly in individuals with lower visual-spatial abilities.

One Step at a Time: Step by Step Versus Continuous Video-Based Learning to Prepare Medical Students for Performing Surgical Procedures.

OBJECTIVE: The objective of this study was to compare the effects of cognitive load and surgical performance in medical students that performed the open inguinal hernia repair after preparation with step-by-step video-demonstration versus continuous video-demonstration. Hypothetically, the step-by-step group will perceive lower extraneous load during the preparation of the surgical procedure compared to the continuous group. Subsequently, fewer errors will be made in the surgical performance assessment by the step-by-step group, resulting in better surgical performance. DESIGN: In this prospective study, participants were randomly assigned to the step-by-step or continuous video-demonstration. They completed questionnaires regarding perceived cognitive load during preparation (10-point Likert scale). Their surgical performance was assessed on a simulation hernia model using the Observational Clinical Human Reliability Assessment. SETTING: Erasmus University Medical Center, Rotterdam, the Netherlands. PARTICIPANTS: Participants included medical students who were enrolled in extracurricular anatomy courses. RESULTS: Forty-three students participated; 23 students in the step-by-step group and 20 in the continuous group. As expected, the step-by-step group perceived a lower extraneous cognitive load (2.92 ± 1.21) compared to the continuous group (3.91 ± 1.67, p = 0.030). The surgical performance was not statistically significantly different between both groups; however, in subanalyses on a selection of students that prepared for 1 to 2 hours, the step-by-step group made less procedural errors, 1.67 ± 1.11, compared to the continuous group, 3.06 ± 1.91, p = 0.018. CONCLUSIONS: Our results suggest that preparation using step-by-step video-based learning results in lower extraneous cognitive load and subsequently fewer procedural errors during the surgical performance. For learning purposes, demonstration videos of surgical procedures should be presented in a segmented format.

Improvement of Care in Patients With Colorectal Cancer: Influence of the Introduction of Standardized Structured Reporting for Pathology.

PURPOSE: The use of standardized structured reporting (SSR) can improve communication between cancer specialists, which might improve clinical care; however, there are no reliable data on whether the introduction of SSR is associated with improvements in clinical outcome. PATIENTS AND METHODS: We performed a retrospective cohort study in the Netherlands, including all patients with colorectal cancer (CRC) from 2009 to 2014. As a reference, cohorts of 2007 and 2008 were included. Data from the Netherlands Cancer Registry were used and combined with data from the Dutch Pathology Registry (PALGA) and the Dutch ColoRectal Audit. We tested the preformulated hypothesis that use of SSR improves the care of patients with CRC by improving the completeness of the pathology reports, the quality of the pathology evaluation, and patient outcomes with respect to treatment and survival. RESULTS: We included 72,859 patients with CRC (23.8% reference, 32.9% SSR, and 43.3% narrative reports). Use of SSR increased over time, which resulted in more complete pathology reports (95.8% v 89.8%; P < .001). Risk assessment in stage II colon cancer was more adequate and resulted in an increased delivery of adjuvant therapy in patients with SSR (19.6% v 15.1%; P = .001). Risk of death for patients in the SSR group was significantly lowered (corrected hazard ratio, 0.94; 95% CI 0.90 to 0.97). CONCLUSION: We demonstrate that use of SSR improved patient care in those with CRC by providing more complete reports of higher quality, which had significant effects on the delivery of adjuvant therapy and patient outcomes.

Definition of the Rectum: An International, Expert-based Delphi Consensus.

BACKGROUND: The wide global variation in the definition of the rectum has led to significant inconsistencies in trial recruitment, clinical management, and outcomes. Surgical technique and use of preoperative treatment for a cancer of the rectum and sigmoid colon are radically different and dependent on the local definitions employed by the clinical team. A consensus definition of the rectum is needed to standardise treatment. METHODS: The consensus was conducted using the Delphi technique with multidisciplinary colorectal experts from October, 2017 to April, 2018. RESULTS: Eleven different definitions for the rectum were used by participants in the consensus. Magnetic resonance imaging (MRI) was the most frequent modality used to define the rectum (67%), and the preferred modality for 72% of participants. The most agreed consensus landmark (56%) was "the sigmoid take-off," an anatomic, image-based definition of the junction of the mesorectum and mesocolon. In the second round, 81% of participants agreed that the sigmoid take-off as seen on computed tomography or MRI achieved consensus, and that it could be implemented in their institution. Also, 87% were satisfied with the sigmoid take-off as the consensus landmark. CONCLUSION: An international consensus definition for the rectum is the point of the sigmoid take-off as visualized on imaging. The sigmoid take-off can be identified as the mesocolon elongates as the ventral and horizontal course of the sigmoid on axial and sagittal views respectively on cross-sectional imaging. Routine application of this landmark during multidisciplinary team discussion for all patients will enable greater consistency in tumour localisation.

The rectosigmoid problem.

The lack of consensus over the transition point for the end of the sigmoid and beginning of the rectum is a problem for the colorectal multidisciplinary team. In this review, we survey the wide number of landmarks for the rectosigmoid junction, and describe the theoretical and evidence-based strengths and weaknesses of each one. Without a reliable definition of the rectum, sigmoid and rectal cancers will be classified inconsistently. As the treatment strategies for sigmoid and rectal cancers are radically different, incorrect tumour localisation has a substantial impact on patient management, leading to under or over treatment. Inconsistent classification will confound investigation of metastatic patterns and treatment outcomes. Now that the rectosigmoid junction has been recognised as a distinct segment of colon by the International Classification of Diseases, further heterogeneity in management and outcomes could result to the detriment of patients and research. We describe a bespoke, anatomical and reliable landmark for the rectosigmoid junction; the sigmoid take-off.

Laparoscopic conversion in colorectal cancer surgery; is there any improvement over time at a population level?

Conversion of laparoscopic colorectal cancer resection has been associated with worse outcome, but this might have been related to a learning curve effect. This study aimed to evaluate incidence, predictive factors and outcomes of laparoscopic conversion after the implementation phase of laparoscopic surgery at a population level. Patients undergoing elective resection of non-locally advanced, non-metastatic colorectal cancer between 2011 and 2015 were included. Data were extracted from the Dutch Surgical Colorectal Audit. Patients were grouped as laparoscopic completed (LR), laparoscopic converted (CONV) with further specification of timing (within or after 30 min) as registered in the DSCA, and open resection (OR). Uni- and multi-variate analyses were used to determine predictors of conversion and outcome (complicated course and mortality), with evaluation of trends over time. A total of 23,044 patients with colon cancer and 11,324 with rectal cancer were included. Between 2011 and 2015, use of laparoscopy increased from 55 to 84% in colon cancer, and from 49 to 89% in rectal cancer. Conversion rates decreased from 11.8 to 8.6% and from 13 to 8.0%, respectively. Laparoscopic hospital volume was independently associated with conversion rate. Only for colon cancer, the rate of complicated course was significantly higher after CONV compared to OR (adjusted odds ratio 1.486; 95% CI 1.298-1.702), and significantly higher after late (> 30 min) compared to early conversion (adjusted odds ratio 1.341; 1.046-1.719). There was no impact of CONV on mortality in both colon and rectal cancer. The use of laparoscopic colorectal cancer surgery increased to more than 80% at a national level, accompanied by a decrease in conversion which is significantly related to the laparoscopic hospital volume. Conversion was only associated with complicated course in colon cancer, especially when the reason for conversion consisted of an intra-operative complication, without affecting mortality.

Psychological effects of the intensified follow-up of the CEAwatch trial after treatment for colorectal cancer.

BACKGROUND: The aim of the study was to evaluate psychological effects of the state-of-art intensified follow-up protocol for colorectal cancer patients in the CEAwatch trial. METHOD: At two time points during the CEAwatch trial questionnaires regarding patients' attitude towards follow-up, patients' psychological functioning and patients' experiences and expectations were sent to participants by post. Linear mixed models were fitted to assess the influences and secular trends of the intensified follow-up on patients' attitude towards follow-up and psychological functioning. As secondary outcome, odds ratios were calculated using ordinal logistic mixed model to compare patients' experiences to their expectations, as well as their experiences at two different time points. RESULTS: No statistical significant effects of the intensified follow-up were found on patients' attitude towards the follow-up and psychological functioning variables. Patients had high expectations of the intensified follow-up and their experiences at the second time point were more positive compared to the scores at the first time point. CONCLUSION: The intensified follow-up protocol posed no adverse effects on patients' attitude towards follow-up and psychological functioning. In general, patients were more nervous and anxious at the start of the new follow-up protocol, had high expectations of the new follow-up protocol and were troubled by the nuisances of the blood sample testing. As they spent more time in the follow-up and became more adapted to it, the nervousness and anxiety decreased and the preference for the frequent blood test became high in replacement of conversations with the doctors.

Level of Digitization in Dutch Hospitals and the Lengths of Stay of Patients with Colorectal Cancer.

A substantial amount of research has been published on the association between the use of electronic medical records (EMRs) and quality outcomes in U.S. hospitals, while limited research has focused on the Western European experience. The purpose of this study is to explore the association between the use of EMR technologies in Dutch hospitals and length of stay after colorectal cancer surgery. Two data sets were leveraged for this study; the HIMSS Analytics Electronic Medical Record Adoption Model (EMRAMSM) and the Dutch surgical colorectal audit (DSCA). The HIMSS Analytics EMRAM score was used to define a Dutch hospital's electronic medical records (EMR) capabilities while the DSCA was used to profile colorectal surgery quality outcomes (specifically total length of stay (LOS) in the hospital and the LOS in ICU). A total of 73 hospitals with a valid EMRAM score and associated DSCA patients (n = 30.358) during the study period (2012-2014) were included in the comparative set. A multivariate regression method was used to test differences adjusted for case mix, year of surgery, surgical technique and for complications, as well as stratifying for academic affiliated hospitals and general hospitals. A significant negative association was observed to exist between the total LOS (relative median LOS 0,974, CI 95% 0.959-0,989) of patients treated in advanced EMR hospitals (high EMRAM score cohort) versus patients treated at less advanced EMR care settings, once the data was adjusted for the case mix, year of surgery and type of surgery (laparoscopy or laparotomy). Adjusting for complications in a subgroup of general hospitals (n = 39) yielded essentially the same results (relative median LOS 0,934, CI 95% 0,915-0,954). No consistent significant associations were found with respect to LOS on the ICU. The findings of this study suggest advanced EMR capabilities support a healthcare provider's efforts to achieve desired quality outcomes and efficiency in Western European hospitals.

Locally Advanced Colon Cancer: Evaluation of Current Clinical Practice and Treatment Outcomes at the Population Level.

Background: The goal of this study was to evaluate current clinical practice and treatment outcomes regarding locally advanced colon cancer (LACC) at the population level. Methods: Data were used from the Dutch Surgical Colorectal Audit from 2009 to 2014. A total of 34,527 patients underwent resection for non-LACC and 6,918 for LACC, which was defined as cT4 and/or pT4 stage. LACC was divided into those with multivisceral resection (LACC-MV; n=3,385) and without (LACC-noMV; n=1,595). Guideline adherence, treatment strategy, and short-term outcomes were evaluated. Results: Guideline adherence was >90% regarding preoperative imaging and ≥80% regarding preoperative multidisciplinary team (MDT) discussion. In the elective setting, neoadjuvant chemoradiotherapy (chemoRT) was applied in 6.2% of the cT4 cases, and neoadjuvant chemotherapy in 4.0%. R0 resection rates were 99%, 91%, and 87% in patients with non-LACC, LACC-noMV, and LACC-MV, respectively (P<.001). A postoperative complicated course occurred in 17%, 25%, and 29% of patients (P<.001), and the 30-day/in-hospital mortality rate was 3.6%, 6.0%, and 5.4% (P<.001) in the non-LACC, LACC-noMV, and LACC-MV groups, respectively. Discussion/Conclusions: This population-based study suggests that there is room for improvement in the treatment of LACC, with regard to short-term surgical outcomes and oncologic outcomes (ie, radicality of resection). Improvement might be expected from optimized preoperative imaging, routine MDT discussions, and further specialization and centralization of care. Optimized use of neoadjuvant treatment strategies based on already available and upcoming evidence is likely to result in a better margin status and thereby a better long-term prognosis. Furthermore, lower R0 resection rates in an emergency setting suggest a potential role for bridging strategies in order to enable optimal staging, neoadjuvant treatment, and elective surgery by a surgical team most optimally qualified for the procedure.

Predictive performance of TPA testing for recurrent disease during follow-up after curative intent surgery for colorectal carcinoma.

BACKGROUND: The aim of the present study was to investigate the predictive performance of serial tissue polypeptide antigen (TPA) testing after curative intent resection for detection of recurrence of colorectal malignancy. METHODS: Serum samples were obtained in 572 patients from three different hospitals during follow-up after surgery. Test characteristics of serial TPA testing were assessed using a cut-off value of 75 U/L. The relation with American Joint Committee on Cancer stage and the potential additive value of tissue polypeptide antigen testing upon standard carcinoembryonic antigen (CEA) testing were investigated. RESULTS: The area under the receiver operating characteristic curve of TPA for recurrent disease was 0.70, indicating marginal usefulness as a predictive test. Forty percent of cases that were detected by CEA testing would have been missed by TPA testing alone, whilst most cases missed by CEA were also not detected by TPA testing. In the subpopulation of patients with stage III disease predictive performance was good (area under the curve 0.92 within 30 days of diagnosing recurrent disease). In this group of patients, 86% of cases that were detected by CEA were also detected by TPA. CONCLUSIONS: Overall, TPA is a relatively poor predictor for recurrent disease during follow-up. When looking at the specific subpopulation of patients with stage III disease predictive performance of TPA was good. However, TPA testing was not found to be superior to CEA testing in this specific subpopulation.

The analysis of terminal endpoint events in stepped wedge designs.

The stepped wedge design is a unique clinical trial design that allows for a sequential introduction of an intervention. However, the statistical analysis is unclear when this design is applied in survival data. The time-dependent introduction of the intervention in combination with terminal endpoints and interval censoring makes the analysis more complicated. In this paper, a time-on-study scale discrete survival model was constructed. Simulations were conducted primarily to study the performance of our model for different settings of the stepped wedge design. Secondary, we compared our approach to continuous Cox proportional hazard model. The results show that the discrete survival model estimates the intervention effects unbiasedly. If the length of the censoring interval is increased, the precision of the estimates is decreased. Without left truncation and late entry, the number of steps improves the precision of the estimates, whereas in combination of left truncation and late entry, the number of steps decreases the precision. Given the same number of participants and clusters, a parallel group design has higher precision than a stepped wedge design. Copyright © 2016 John Wiley & Sons, Ltd.

Long Term Outcomes of a Geriatric Liaison Intervention in Frail Elderly Cancer Patients.

BACKGROUND: The aim of this study was to evaluate the long term effects after discharge of a hospital-based geriatric liaison intervention to prevent postoperative delirium in frail elderly cancer patients treated with an elective surgical procedure for a solid tumour. In addition, the effect of a postoperative delirium on long term outcomes was examined. METHODS: A three month follow-up was performed in participants of the Liaison Intervention in Frail Elderly study, a multicentre, prospective, randomized, controlled trial. Patients were randomized to standard treatment or a geriatric liaison intervention. The intervention consisted of a preoperative geriatric consultation, an individual treatment plan targeted at risk factors for delirium and daily visits by a geriatric nurse during the hospital stay. The long term outcomes included: mortality, rehospitalisation, Activities of Daily Living (ADL) functioning, return to the independent pre-operative living situation, use of supportive care, cognitive functioning and health related quality of life. RESULTS: Data of 260 patients (intervention n = 127, Control n = 133) were analysed. There were no differences between the intervention group and usual-care group for any of the outcomes three months after discharge. The presence of postoperative delirium was associated with: an increased risk of decline in ADL functioning (OR: 2.65, 95% CI: 1.02-6.88), an increased use of supportive assistance (OR: 2.45, 95% CI: 1.02-5.87) and a decreased chance to return to the independent preoperative living situation (OR: 0.18, 95% CI: 0.07-0.49). CONCLUSIONS: A hospital-based geriatric liaison intervention for the prevention of postoperative delirium in frail elderly cancer patients undergoing elective surgery for a solid tumour did not improve outcomes 3 months after discharge from hospital. The negative effect of a postoperative delirium on late outcome was confirmed. TRIAL REGISTRATION: Nederlands Trial Register, Trial ID NTR 823.

[Web-based education: learning surgical procedures step-by-step with 3D visualization]. / Web-based onderwijs: stapsgewijs chirurgische procedures leren met visualisatie in 3D.

There is a need for more uniform, structured education focused on surgical procedures. We offer a standardized, step-by-step, web-based procedural training method with which surgeons can train more interns efficiently. The basis of this learning method is formed by 3D films in which surgical procedures are performed in clearly defined steps and the anatomic structures behind the surgical operating planes are further dissected. This basis is supported by online modules in which, aside from the operation, preparation and postoperative care are also addressed. Registrars can test their knowledge with exams. Trainers can see what the registrars studied, how they scored and how they progressed with their clinical skills. With the online portfolio we offer building blocks for certification and accreditation. With this clearly structured research method of constant quality, registrars are less dependent on the local trainer. In addition, through better preparation, the operation capacity can be used more efficiently for the training.

Involving patients in a multidisciplinary European consensus process and in the development of a 'patient summary of the consensus document for colon and rectal cancer care'.

CONTEXT: High-quality cancer care should be accessible for patients and healthcare professionals. Involvement of patients as partners in guideline formation and consensus processes is still rarely found. EURECCA, short for European Registration of Cancer Care, is the platform to improve outcomes of cancer care by reducing variation in the diagnostic and treatment process. EURECCA acknowledges the important role of patients in implementation of consensus information in clinical practice. OBJECTIVE: The aim of this article is to describe the process of involving patients in the consensus process and in developing the patient summary of the consensus for colon and rectal cancer care. METHODS: The Delphi method for achieving consensus was used. Three online voting rounds and one tele-voting round were offered to an expert panel of oncology professionals and patient representatives. At four different stages, patients and/or patient representatives were involved in the process: (1) during the consensus process, (2) lecturing about the role of the patient, (3) development of the patient summary, and (4) testing the patient summary. RESULTS: Representatives were invited to the voting and commenting rounds of this process and given an equal vote. Although patients were not consulted during the planning stages of this process, patient involvement increased following the panel's discussion of the implementation of the consensus among the patient population. After the consensus meeting, the patient summary was written by patient representatives, oncologists and nurses. A selection of proactive patients reviewed the draft patient summary; responses were positive and several patient-reported outcomes were added. Questionnaires to evaluate the use and implementation of the patient summary in daily practice are currently being developed and tested. Patient consultation will be needed in future planning for selection of topics. DISCUSSION: The present study may function as a model for future consensus processes to involve patients at different stages and to implement both patient and healthcare professional versions in daily practice.

Laparoscopic versus open total mesorectal excision for rectal cancer.

BACKGROUND: Colorectal cancer including rectal cancer is the third most common cause of cancer deaths in the western world. For colon carcinoma, laparoscopic surgery is proven to result in faster postoperative recovery, fewer complications and better cosmetic results with equal oncologic results. These short-term benefits are expected to be similar for laparoscopic rectal cancer surgery. However, the oncological safety of laparoscopic surgery for rectal cancer remained controversial due to the lack of definitive long-term results. Thus, the expected short-term benefits can only be of interest when oncological results are at least equal. OBJECTIVES: To evaluate the differences in short- and long-term results after elective laparoscopic total mesorectal excision (LTME) for the resection of rectal cancer compared with open total mesorectal excision (OTME). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2013, Issue 2), MEDLINE (January 1990 to February 2013), EMBASE (January 1990 to February 2013), ClinicalTrials.gov (February 2013) and Current Controlled Trials (February 2013). We handsearched the reference lists of the included articles for missed studies. SELECTION CRITERIA: Only randomised controlled trials (RCTs) comparing LTME and OTME, reporting at least one of our outcome measures, was considered for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality according to the CONSORT statement, and resolved disagreements by discussion. We rated the quality of the evidence using GRADE methods. MAIN RESULTS: We identified 45 references out of 953 search results, of which 14 studies met the inclusion criteria involving 3528 rectal cancer patients. We did not consider the risk of bias of the included studies to have impacted on the quality of the evidence. Data were analysed according to an intention-to-treat principle with a mean conversion rate of 14.5% (range 0% to 35%) in the laparoscopic group.There was moderate quality evidence that laparoscopic and open TME had similar effects on five-year disease-free survival (OR 1.02; 95% CI 0.76 to1.38, 4 studies, N = 943). The estimated effects of laparoscopic and open TME on local recurrence and overall survival were similar, although confidence intervals were wide, both with moderate quality evidence (local recurrence: OR 0.89; 95% CI 0.57 to1.39 and overall survival rate: OR 1.15; 95% CI 0.87 to1.52). There was moderate to high quality evidence that the number of resected lymph nodes and surgical margins were similar between the two groups.For the short-term results, length of hospital stay was reduced by two days (95% CI -3.22 to -1.10), moderate quality evidence), and the time to first defecation was shorter in the LTME group (-0.86 days; 95% CI -1.17 to -0.54). There was moderate quality evidence that 30 days morbidity were similar in both groups (OR 0.94; 95% CI 0.8 to 1.1). There were fewer wound infections (OR 0.68; 95% CI 0.50 to 0.93) and fewer bleeding complications (OR 0.30; 95% CI 0.10 to 0.93) in the LTME group.There was no clear evidence of any differences in quality of life after LTME or OTME regarding functional recovery, bladder and sexual function. The costs were higher for LTME with differences up to GBP 2000 for direct costs only. AUTHORS' CONCLUSIONS: We have found moderate quality evidence that laparoscopic total mesorectal excision (TME) has similar effects to open TME on long term survival outcomes for the treatment of rectal cancer. The quality of the evidence was downgraded due to imprecision and further research could impact on our confidence in this result. There is moderate quality evidence that it leads to better short-term post-surgical outcomes in terms of recovery for non-locally advanced rectal cancer. Currently results are consistent in showing a similar disease-free survival and overall survival, and for recurrences after at least three years and up to 10 years, although due to imprecision we cannot rule out superiority of either approach. We await long-term data from a number of ongoing and recently completed studies to contribute to a more robust analysis of long-term disease free, overall survival and local recurrence.

Strengths and weaknesses of a stepped wedge cluster randomized design: its application in a colorectal cancer follow-up study.

OBJECTIVES: To determine the advantages and disadvantages of a stepped wedge design for a specific clinical application. STUDY DESIGN AND SETTING: The clinical application was a pragmatic cluster randomized surgical trial intending to find an increased percentage of curable recurrences in patients in follow-up after colorectal cancer. Advantages and disadvantages of the stepped wedge design were evaluated, and for this application, new advantages and disadvantages were presented. RESULTS: A main advantage of the stepped wedge design was that the intervention rolls out to all participants, motivating patients and doctors, and a large number of patients who were included in this study. The stepped wedge design increased the complexity of the data analysis, and there were concerns regarding the informed consent procedure. The repeated measurements may bring burden to patients in terms of quality of life, satisfaction, and costs. CONCLUSION: The stepped wedge design is a strong alternative for pragmatic cluster randomized trials. The known advantages hold, whereas most of the disadvantages were not applicable to this application. The main advantage was that we were able to include a large number of patients. Main disadvantages were that the informed consent procedure can be problematic and that the analysis of the data can be complex.

EURECCA colorectal: multidisciplinary management: European consensus conference colon & rectum.

BACKGROUND: Care for patients with colon and rectal cancer has improved in the last 20years; however considerable variation still exists in cancer management and outcome between European countries. Large variation is also apparent between national guidelines and patterns of cancer care in Europe. Therefore, EURECCA, which is the acronym of European Registration of Cancer Care, is aiming at defining core treatment strategies and developing a European audit structure in order to improve the quality of care for all patients with colon and rectal cancer. In December 2012, the first multidisciplinary consensus conference about cancer of the colon and rectum was held. The expert panel consisted of representatives of European scientific organisations involved in cancer care of patients with colon and rectal cancer and representatives of national colorectal registries. METHODS: The expert panel had delegates of the European Society of Surgical Oncology (ESSO), European Society for Radiotherapy & Oncology (ESTRO), European Society of Pathology (ESP), European Society for Medical Oncology (ESMO), European Society of Radiology (ESR), European Society of Coloproctology (ESCP), European CanCer Organisation (ECCO), European Oncology Nursing Society (EONS) and the European Colorectal Cancer Patient Organisation (EuropaColon), as well as delegates from national registries or audits. Consensus was achieved using the Delphi method. For the Delphi process, multidisciplinary experts were invited to comment and vote three web-based online voting rounds and to lecture on the subjects during the meeting (13th-15th December 2012). The sentences in the consensus document were available during the meeting and a televoting round during the conference by all participants was performed. This manuscript covers all sentences of the consensus document with the result of the voting. The consensus document represents sections on diagnostics, pathology, surgery, medical oncology, radiotherapy, and follow-up where applicable for treatment of colon cancer, rectal cancer and metastatic colorectal disease separately. Moreover, evidence based algorithms for diagnostics and treatment were composed which were also submitted to the Delphi process. RESULTS: The total number of the voted sentences was 465. All chapters were voted on by at least 75% of the experts. Of the 465 sentences, 84% achieved large consensus, 6% achieved moderate consensus, and 7% resulted in minimum consensus. Only 3% was disagreed by more than 50% of the members. CONCLUSIONS: Multidisciplinary consensus on key diagnostic and treatment issues for colon and rectal cancer management using the Delphi method was successful. This consensus document embodies the expertise of professionals from all disciplines involved in the care for patients with colon and rectal cancer. Diagnostic and treatment algorithms were developed to implement the current evidence and to define core treatment guidance for multidisciplinary team management of colon and rectal cancer throughout Europe.

Safety of elective colorectal cancer surgery: non-surgical complications and colectomies are targets for quality improvement.

BACKGROUND: Mortality following severe complications (failure-to-rescue, FTR) is targeted in surgical quality improvement projects. Rates may differ between colon- and rectal cancer resections. METHODS: Analysis of patients undergoing elective colon and rectal cancer resections registered in the Dutch Surgical Colorectal Audit in 2011-2012. Severe complication- and FTR rates were compared between the groups in univariate and multivariate analysis. RESULTS: Colon cancer (CC) patients (n = 10,184) were older and had more comorbidity. Rectal cancer (RC) patients (n = 4,906) less often received an anastomosis and had more diverting stomas. Complication rates were higher in RC patients (24.8% vs. 18.3%, P < 0.001). However, FTR rates were higher in CC patients (18.6% vs. 9.4%, P < 0.001). Particularly, FTR associated with anastomotic leakage, postoperative bleeding, and infections was higher in CC patients. Adjusted for casemix, CC patients had a twofold risk of FTR compared to RC patients (OR 1.89, 95% CI 1.06-3.37). CONCLUSIONS: Severe complication rates were lower in CC patients than in RC patients; however, the risk of dying following a severe complication was twice as high in CC patients, regardless of differences in characteristics between the groups. Efforts should be made to improve recognition and management of postoperative (non-)surgical complications, especially in colon cancer surgery.