Complications and predictors associated with moderate to severe obstructive sleep apnoea in bariatric surgery: Evaluation of routine obstructive sleep apnoea screening.

PURPOSE: Obstructive sleep apnoea (OSA) is a breathing disorder resulting in blockage of airflow and hypo-oxygenation. The incidence of OSA in patients with class 2 or 3 obesity (Body Mass index, BMI >35) is 60-70%. Unfortunately, most bariatric patients are unaware they suffer from OSA. Untreated OSA can lead to perioperative cardiopulmonary complications. The aim of this study was to identify predictors associated with moderate to severe OSA and asses the incidence of OSA-related complications in a large cohort of patients who underwent OSA-screening and treatment if indicated before bariatric surgery. METHODS: All consecutive patients who underwent primary bariatric surgery between September 2013 and September 2019 were included. Univariable and multivariable logistic regression analysis was performed to identify potential predictors for moderate to severe OSA using sleep studies. RESULTS: A total of 2872 patients who underwent bariatric surgery were included for analysis. Overall, OSA was identified in 62.5% of all patients and moderate to severe OSA (AHI ≥15) in 28.6%. Independent predictors for moderate to severe OSA were male gender (p < 0.001), age (p < 0.001), preoperative BMI (p < 0.001), preoperative waist circumference (p < 0.001), hypertension (p < 0.001), and dyslipidaemia (p = 0.046). The incidence of OSA-related complications was low (0.8%) and not significantly different among the different OSA severity classes. CONCLUSION: This is the largest study to assess OSA presence and OSA-related complications in patients undergoing bariatric surgery. The incidence of potential OSA-related complications was low (0.8%). We believe focus could be shifted towards more cost-efficient strategies where OSA screening is omitted such as perioperative continuous monitoring.

The effect of selective decontamination on the intestinal microbiota as measured with IS-pro: a taxonomic classification tool applicable for direct evaluation of intestinal microbiota in clinical routine.

Selective decontamination of the digestive tract (SDD) is aimed at elimination of potential pathogenic microorganisms. In this study, the effect of SDD on gut microbiota was evaluated in a large homogenous group of elective colorectal cancer surgery patients. Rectal swabs were taken from 118 patients undergoing colorectal surgery. These patients were randomly assigned to receive perioperative SDD or to the control group (no SDD). Rectal swabs were taken prior to surgery, 3 days after commencing administration of SDD. Gut microbial profiles were obtained with the IS-pro technique, a standardized microbiota profiling assay applicable in clinical routine. Differences in abundance for different taxonomical groups and diversity between the groups were assessed. Unsupervised and supervised classification techniques were used to assess microbial signatures, differentiating between the SDD group and the control group. Patients in the SDD group had different gut microbial signatures than in the control group, also in phyla that are not a target for SDD. Escherichia coli, Sutterella spp., Faecalibacterium prausnitzii, and Streptococcus spp. were the species that differed the most between the two groups. The SDD group showed clustering into two subgroups. In one subgroup, a decrease in Proteobacteria was observed, whereas the other subgroup showed a shift in Proteobacteria species. This study shows that SDD not only decreases colonization of the gastrointestinal tract with potential pathogenic Gram-negative microorganisms, but also reduces the abundance of normal colonizers of our gastrointestinal system and leads to a shift in total microbiota composition.

The learning curve of transanal total mesorectal excision for rectal cancer is associated with local recurrence: results from a multicentre external audit.

AIM: Transanal total mesorectal excision (TaTME) has been suggested as a potential solution for the resection of challenging mid and low rectal cancer. This relatively complex procedure has been implemented in many centres over the last years, despite the absence of long-term safety data. Recently, concern has arisen because of an increase in local recurrence in the implementation phase. The aim of this study was to assess the correlation between accumulated experience and local recurrences. METHOD: An independent clinical researcher performed an external audit of consecutive series of all TaTME procedures in six centres in the Netherlands. Kaplan-Meier estimated local recurrence rates were calculated and multivariate Cox proportional hazards regression analysis performed to assess risk factors for local recurrence. Primary outcome was the local recurrence rate in the initial implementation (cases 1-10), continued adoption (cases 11-40) and prolonged experience (case 41 onward). RESULTS: Six hundred and twenty-four consecutive patients underwent TaTME for rectal cancer with a median follow-up of 27 months (range 1-82 months). The estimated 2- and 3-year local recurrence rates were 4.6% and 6.6%, respectively. Cox proportional hazards regression revealed procedural experience to be an independent factor in multivariate analysis next to advanced stage (ycMRF+, pT3-4, pN+) and pelvic sepsis. Corrected analysis projected the 3-year local recurrence rates to be 9.7%, 3.3% and 3.5% for the implementation, continued adoption and prolonged experience cohorts, respectively. CONCLUSION: This multicentre study shows a high local recurrence rate (12.5%) after implementation of TaTME which lowers to an acceptable rate (3.4%) when experience increases. Therefore, intensified proctoring and further precautions must be implemented to reduce the unacceptably high risk of local recurrence at units starting this technique.

Predicting return to work among patients with colorectal cancer.

BACKGROUND: The increase in prevalence of colorectal cancer among young patients coupled with an older retirement age in developed countries means that more patients are being diagnosed with colorectal cancer while still at work. The aim of this study was to develop prediction models for return to work by 1 and 2 years after the start of sick leave. METHODS: This was a retrospective registry-based cohort study of data from a nationwide occupational health service in the Netherlands. Only employed patients with colonic or rectal cancer treated with curative intent were included. Two predictor variable models were developed using multivariable logistic regression with backward selection. Calibration, discrimination and explained variance were used to assess model performance, and internal validation by bootstrapping was performed. RESULTS: Median time to return to work for 317 included patients was 423 (95 per cent c.i. 379 to 467) days. Two-thirds of patients had returned to work by 2 years after the start of the sick leave. Presence of metastases, adjuvant treatment, stoma, emotional distress and postoperative complications were predictors of not returning to work in the 1-year model. In the 2-year model, presence of metastases, emotional distress, postoperative complications, company size and the trajectory of the return-to-work process were predictors. CONCLUSION: Almost 70 per cent of patients with colorectal cancer in this population returned to work within 2 years after the start of sick leave. The models can be used to guide patients early in colorectal cancer treatment about the likelihood of returning to work, and to identify and modify barriers that could facilitate this.

ANTECEDENTES: El aumento de la prevalencia del cáncer colorrectal (colorectal cancer, CCR) en pacientes jóvenes, junto con una edad de jubilación más avanzada en los países desarrollados, significa un mayor número de pacientes en edad laboral diagnosticados de CCR. El objetivo de este estudio fue desarrollar modelos de predicción del regreso al trabajo uno y dos años después del inicio de la baja por enfermedad para el tratamiento de CCR. MÉTODOS: Se trata de un estudio de cohortes retrospectivo basado en el registro de datos nacionales de salud laboral en los Países Bajos. Solo se incluyeron pacientes con cáncer de colon o recto tratados con intención curativa. Se desarrollaron dos modelos de variables de predicción utilizando regresión logística multivariante con selección de variables hacia atrás. Para evaluar el rendimiento del modelo se utilizaron la calibración, la discriminación y la varianza explicada y se realizó la validación interna mediante bootstrap. RESULTADOS: La mediana de tiempo de regreso al trabajo de 317 pacientes incluidos fue de 423 días (i.c. del 95%: 378,6-467,4). Dos tercios de los pacientes habían regresado al trabajo dos años después del inicio del período de baja por enfermedad. La presencia de metástasis, el tratamiento adyuvante, el estoma, la angustia emocional y las complicaciones postoperatorias fueron factores predictivos de no volver a trabajar en el modelo de un año. En el modelo de dos años, la presencia de metástasis, la angustia emocional, las complicaciones postoperatorias, el tamaño de la empresa y la trayectoria del proceso de retorno al trabajo fueron factores predictores del regreso laboral. CONCLUSIÓN: Casi el 70% de los pacientes con CCR en esta población volvieron a trabajar dentro de los dos años posteriores al inicio del periodo de baja por enfermedad. Los modelos se pueden usar para guiar a los pacientes con CCR al inicio de su tratamiento sobre su probabilidad de regresar al trabajo, así como para identificar y modificar las barreras que podrían facilitarlo.

Locoregional recurrences after transanal total mesorectal excision of rectal cancer during implementation.

BACKGROUND: Transanal total mesorectal excision (TaTME) has been proposed as an approach in patients with mid and low rectal cancer. The TaTME procedure has been introduced in the Netherlands in a structured training pathway, including proctoring. This study evaluated the local recurrence rate during the implementation phase of TaTME. METHODS: Oncological outcomes of the first ten TaTME procedures in each of 12 participating centres were collected as part of an external audit of procedure implementation. Data collected from a cohort of patients treated over a prolonged period in four centres were also collected to analyse learning curve effects. The primary outcome was the presence of locoregional recurrence. RESULTS: The implementation cohort of 120 patients had a median follow up of 21·9 months. Short-term outcomes included a positive circumferential resection margin rate of 5·0 per cent and anastomotic leakage rate of 17 per cent. The overall local recurrence rate in the implementation cohort was 10·0 per cent (12 of 120), with a mean(s.d.) interval to recurrence of 15·2(7·0) months. Multifocal local recurrence was present in eight of 12 patients. In the prolonged cohort (266 patients), the overall recurrence rate was 5·6 per cent (4·0 per cent after excluding the first 10 procedures at each centre). CONCLUSION: TaTME was associated with a multifocal local recurrence rate that may be related to suboptimal execution rather than the technique itself. Prolonged proctoring, optimization of the technique to avoid spillage, and quality control is recommended.

ANTECEDENTES: La escisión total del mesorrecto por vía transanal (Transanal Total Mesorectal Excision, TaTME) se ha propuesto como abordaje quirúrgico en pacientes con cáncer de recto medio e inferior. La técnica TaTME se ha introducido en los Países Bajos mediante un proceso de formación estructurado que incluye la supervisión. Este estudio evaluó el porcentaje de recidiva local durante la fase de implementación de TaTME. MÉTODOS: Se recogieron los resultados oncológicos de los primeros 10 procedimientos realizados mediante TaTME en cada uno de los 12 centros participantes como parte de una auditoría externa de implementación del procedimiento. Se reunió una cohorte más amplia de pacientes procedentes de 4 centros para analizar los efectos de la curva de aprendizaje. El criterio de valoración principal fue la presencia de recidiva locorregional. RESULTADOS: La cohorte de implementación de 120 pacientes tuvo una mediana de seguimiento de 21,9 meses. Los resultados a corto plazo incluyeron una tasa del margen de resección circunferencial positivo del 5% y una tasa de fuga anastomótica del 17,4%. La tasa global de recidiva local en la cohorte de implementación fue del 10% (12/120) con un intervalo medio de recidiva de 15,2 (DE 7) meses. El patrón de recidiva local fue multifocal en 8 de 12 casos (67%). En la cohorte ampliada (n = 266), la tasa global de recidiva fue del 5,6% (4,0%, excluyendo a los primeros 10 pacientes). CONCLUSIÓN: TaTME se asoció con un porcentaje de recidiva local multifocal que puede relacionarse con una ejecución subóptima, más que con la técnica en sí. Se recomienda una supervisión prolongada, la optimización de la técnica para evitar la diseminación tumoral, así como un control de calidad.

Structured training pathway and proctoring; multicenter results of the implementation of transanal total mesorectal excision (TaTME) in the Netherlands.

BACKGROUND: Transanal total mesorectal excision (TaTME) is a new complex technique with potential to improve the quality of surgical mesorectal excision for patients with mid and low rectal cancer. The procedure is technically challenging and has shown to be associated with a relative long learning curve which might hamper widespread adoption. Therefore, a national structured training pathway for TaTME has been set up in the Netherlands to allow safe implementation. The aim of this study was to monitor safety and efficacy of the training program with 12 centers. METHODS: Short-term outcomes of the first ten TaTME procedures were evaluated in 12 participating centers in the Netherlands within the national structured training pathway. Consecutive patients operated during and after the proctoring program for rectal carcinoma with curative intent were included. Primary outcome was the incidence of intraoperative complications, secondary outcomes included postoperative complications and pathological outcomes. RESULTS: In October 2018, 12 hospitals completed the training program and from each center the first 10 patients were included for evaluation. Intraoperative complications occurred in 4.9% of the cases. The clinicopathological outcome reported 100% for complete or nearly complete specimen, 100% negative distal resection margin, and the circumferential resection margin was positive in 5.0% of patients. Overall postoperative complication rate was 45.0%, with 19.2% Clavien-Dindo ≥ III and an anastomotic leak rate of 17.3%. CONCLUSIONS: This study shows that the nationwide structured training program for TaTME delivers safe implementation of TaTME in terms of intraoperative and pathology outcomes within the first ten consecutive cases in each center. However, postoperative morbidity is substantial even within a structured training pathway and surgeons should be aware of the learning curve of this new technique.

Randomized clinical trial of selective decontamination of the digestive tract in elective colorectal cancer surgery (SELECT trial).

BACKGROUND: Infectious complications and anastomotic leakage affect approximately 30 per cent of patients after colorectal cancer surgery. The aim of this multicentre randomized trial was to investigate whether selective decontamination of the digestive tract (SDD) reduces these complications of elective colorectal cancer surgery. METHODS: The effectiveness of SDD was evaluated in a multicentre, open-label RCT in six centres in the Netherlands. Patients with colorectal cancer scheduled for elective curative surgery with a primary anastomosis were eligible. Oral colistin, tobramycin and amphotericin B were administered to patients in the SDD group to decontaminate the digestive tract. Both treatment and control group received intravenous cefazolin and metronidazole for perioperative prophylaxis. Mechanical bowel preparation was given for left-sided colectomies, sigmoid and anterior resections. Anastomotic leakage was the primary outcome; infectious complications and mortality were secondary outcomes. RESULTS: The outcomes for 228 patients randomized to the SDD group and 227 randomized to the control group were analysed. The trial was stopped after interim analysis demonstrated that superiority was no longer attainable. Effective SDD was confirmed by interspace DNA profiling analysis of rectal swabs. Anastomotic leakage was observed in 14 patients (6·1 per cent) in the SDD group and in 22 patients (9·7 per cent) in the control group (odds ratio (OR) 0·61, 95 per cent c.i. 0·30 to 1·22). Fewer patients in the SDD group had one or more infectious complications than patients in the control group (14·9 versus 26·9 per cent respectively; OR 0·48, 0·30 to 0·76). Multivariable analysis indicated that SDD reduced the rate of infectious complications (OR 0·47, 0·29 to 0·76). CONCLUSION: SDD reduces infectious complications after colorectal cancer resection but did not significantly reduce anastomotic leakage in this trial. Registration number: NCT01740947 ( https://www.clinicaltrials.gov).

Perioperative PET/CT lymphoscintigraphy and fluorescent real-time imaging for sentinel lymph node mapping in early staged colon cancer.

PURPOSE: Using current optical imaging techniques and gamma imaging modalities, perioperative sentinel lymph node (SLN) identification in colon cancer can be difficult when the SLN is located near the primary tumour or beneath a thick layer of (fat) tissue. Sentinel lymph node mapping using PET/CT lymphoscintigraphy combined with real-time visualization of the SLN using near-infrared imaging has shown promising results in several types of cancer and may facilitate the successful identification of the number and location of the SLN in early colon cancer. METHODS: Clinical feasibility of PET/CT lymphoscintigraphy using preoperative endoscopically injected [89Zr]Zr-Nanocoll and intraoperative injection of the near-infrared (NIR) tracer Indocyanine Green (ICG) was evaluated in ten early colon cancer patients. Three preoperative PET/CT scans and an additional ex vivo scan of the specimen were performed after submucosal injection of [89Zr]Zr-Nanocoll. All SLNs and other lymph nodes underwent extensive pathological examination for metastases. A histopathological proven lymph node visible at preoperative PET/CT and identified at PET/CT of the specimen was defined as SLN. RESULTS: A total of 27 SLNs were harvested in seven out of eight patients with successful injection of both tracers. In one patient no SLNs were assigned preoperatively. In two patients injection of [89Zr]Zr-Nanocoll failed due to incorrect needle positioning. Twenty-one (78%) SLNs were found intraoperatively using NIR-imaging. Eleven of the 27 (41%) SLNs were located near the primary tumour (< 2 cm). Those six SLNs not found intraoperatively with NIR-imaging were all located close to the tumour. In all seven patients at least one SLN could be assigned at preoperative imaging 24 h after tracer administration. One SLN contained metastases detected by immunohistochemistry. No metastases were found in the non-SLNs. CONCLUSIONS: This study shows the potential of preoperative PET/CT lymphoscintigraphy to inform the surgeon about the number and location of SLNs in patients with early colon cancer. The additional use of NIR-imaging allows for intraoperative identification of these SLNs which are invisible with conventional white light imaging. Further research is necessary to improve and simplify the technique. We recommend perioperative SLN identification using a preoperative lymphoscintigraphy scan just before surgery approximately 24 h after injection. Additionally a postoperative scan of the specimen combined with intraoperative real-time NIR-imaging should be performed.

Short-term outcomes of transanal completion total mesorectal excision (cTaTME) for rectal cancer: a case-matched analysis.

BACKGROUND: Local excision of early rectal tumors as a rectal preserving treatment is gaining popularity, especially since bowel cancer screening programs result in a shift towards the diagnosis of early stage rectal cancers. However, unfavorable histological features predicting high risk for recurrence within the "big biopsy" may mandate completion total mesorectal excision (cTME). Completion surgery is associated with higher morbidity, poorer specimen quality, and less favorable oncological outcomes compared to primary TME. Transanal approach potentially improves outcome of completion surgery for rectal cancer. The aim of this study was to compare radical completion surgery after local excision for rectal cancer by the transanal approach (cTaTME) with conventional abdominal approach (cTME). METHODS: All consecutive patients who underwent cTaTME for rectal cancer between 2012 and 2017 were case-matched with cTME patients, according to gender, tumor height, preoperative radiotherapy, and tumor stage. Surgical, pathological, and short-term postoperative outcomes were evaluated. RESULTS: In total, 25 patients underwent completion TaTME and were matched with 25 patients after cTME. Median time from local excision to completion surgery was 9 weeks in both groups. In the cTaTME and cTME groups, perforation of the rectum occurred in 4 and 28% of patients, respectively (p = 0.049), leading to poor specimen quality in these patients. Number of harvested lymph nodes was higher after cTaTME (median 15; range 7-47) than after cTME (median 10; range 0-17). No significant difference was found in end colostomy rate between the two groups. Major 30-day morbidity (Clavien-Dindo≥ III) was 20 and 32%, respectively (p = 0.321). Hospital stay was significantly longer after cTME. CONCLUSION: TaTME after full-thickness excision is a promising technique with a significantly lower risk of perforation of the rectum and better specimen quality compared to conventional completion TME.

Residual mesorectum on postoperative magnetic resonance imaging following transanal total mesorectal excision (TaTME) and laparoscopic total mesorectal excision (LapTME) in rectal cancer.

BACKGROUND: The standard treatment for mid- and low-rectal cancer is total mesorectal excision. Incomplete excision is an important predictor of local recurrence after rectal cancer surgery. Transanal TME (TaTME) is a new treatment option in which the rectum is approached with both laparoscopic and transanal endoscopic techniques. The aim of the present study was to determine the prevalence and localisation of residual mesorectal tissue by postoperative magnetic resonance imaging (MRI) of the pelvis and compare this between TaTME and laparoscopic TME (LapTME) patients. In addition, we assessed correspondence with histopathological quality. METHODS: Two groups of patients with cT1-T3 rectal cancer who underwent TME surgery with primary anastomosis were included, each group consisting of 32 patients. Postoperative T2-weighted MRI of the pelvis was performed at least 6 months after TME surgery and evaluated by two radiologists independently. Residual mesorectum was defined as any residual mesorectal tissue detectable after TME. Localisation of the tissue was categorised in relation to height in the pelvis and position of the level of anastomosis. RESULTS: Residual mesorectal tissue was detected in 3.1% of TaTME patients and of 46.9% in LapTME patients (p < 0.001). Multivariate analysis identified only type of surgery as a significant risk factor for leaving residual mesorectum. Other known risk factors for incomplete TME, such as body mass index (BMI) and male gender, were not significant. No relation was seen between specimen quality and prevalence of residual mesorectum. CONCLUSIONS: The completeness of mesorectal excision was significantly better with TaTME than with standard laparoscopic technique.

Lateral Pelvic Lymph Node Metastases in Rectal Cancer: A Systematic Review.

BACKGROUND: Synchronous lateral pelvic lymph node (LPLN) involvement occurs in a significant number of patients with rectal cancer. The aim of this study is to determine the rate of LPLN metastases in rectal cancer patients with LPLN suspicious for metastases (LPLNSM) on pretreatment imaging, treated with neoadjuvant chemoradiotherapy (nCRT). Additionally, the influence of LPLN responsiveness to nCRT as determined by post-nCRT restaging scan was investigated. METHODS: A systematic review was conducted to identify studies on patients with author-defined LPLNSM that reported the pathological outcomes after total mesorectal excision (TME) with lateral pelvic lymph node dissection (LPLD). MEDLINE, EMBASE, Web of Science and the Cochrane Library were searched. The primary outcome was the percentage of pathologically confirmed LPLN metastases. RESULTS: A total of 462 patients from eleven studies were identified. The number of pathologically confirmed LPLN metastases in 361 patients that underwent uni- or bilateral LPLD ranged from 21.9 to 61.1%. The LPLD resulted in pathologically confirmed metastases in a range from 0 to 20.4% of patients with responsive LPLNSM and in a range from 25.0 to 83.3% of patients with persistent nodes. However, radiologic cutoff criteria for the evaluation of LPLN differed between studies. CONCLUSIONS: In a large number of patients with LPLNSM on initial imaging, metastatic LPLN are present after nCRT and surgical treatment. Even in LPLN that are considered responsive on restaging, significant rates of pathologically confirmed metastases are reported.

The value of force and torque measurements in transanal total mesorectal excision (TaTME).

BACKGROUND: Transanal total mesorectal excision (TaTME) is associated with a relatively long learning curve. Force, motion, and time parameters are increasingly used for objective assessment of skills to enhance laparoscopic training efficacy. The aim of this study was to identify relevant metrics for accurate skill assessment in more complex transanal purse-string suturing. METHODS: A box trainer was designed for TaTME and equipped with two custom made multi-DOF force/torque sensors. These sensors measured the applied forces in the axial direction of the instruments (Fz), instrument load orientation expressed in torque (Mx and My) on the entrance port, and the full tissue interaction force (Fft) at the intestine fixation point. In a construct validity study, novices for TaTME performed a purse-string suture to investigate which parameters can be used best to identify meaningful events during tissue manipulation and instrument handling. RESULTS: Significant differences exist between pre- and post-training assessment for the mean axial force at the entrance port Fz (p = 0.01), mean torque in the entrance port Mx (p = 0.03) and mean force on the intestine during suturing Fft (p = 0.05). Furthermore, force levels during suturing exceed safety threshold values, potentially leading to dangerous complications such as rupture of the rectum. CONCLUSIONS: Forces and torque measured at the entrance port, and the tissue interaction force signatures provide detailed insight into instrument handling, instrument loading, and tissue handling during purse-string suturing in a TaTME training setup. This newly developed training setup for single-port laparoscopy that enables objective feedback has the potential to enhance surgical training in TaTME.

Near-infrared fluorescence imaging for sentinel lymph node identification in colon cancer: a prospective single-center study and systematic review with meta-analysis.

BACKGROUND: Near-infrared (NIR) fluorescence imaging has the potential to overcome the current drawbacks of sentinel lymph node mapping (SLNM) in colon cancer. Our aim was to provide an overview of current SLNM performance and of factors influencing successful sentinel lymph node (SLN) identification using NIR fluorescence imaging in colon cancer. METHODS: A systematic review and meta-analysis was conducted to identify currently used methods and results. Additionally, we performed a single-center study using indocyanine green (ICG) as SLNM dye in colon cancer patients scheduled for a laparoscopic colectomy. SLNs were analyzed with conventional hematoxylin-and-eosin staining and additionally with serial sectioning and immunohistochemistry (extended histopathological assessment). A true-positive procedure was defined as a tumor-positive SLN either by conventional hematoxylin-and-eosin staining or by extended histopathological assessment, independently of regional lymph node status. SLN procedures were determined to be true negatives if SLNs and regional lymph nodes revealed no metastases after conventional and advanced histopathology. SLN procedures yielding tumor-negative SLNs in combination with tumor-positive regional lymph nodes were classified as false negatives. Sensitivity, negative predictive value and detection rate were calculated. RESULTS: This systematic review and meta-analysis included 8 studies describing 227 SLN procedures. A pooled sensitivity of 0.63 (95% CI 0.51-0.74), negative predictive value 0.81 (95% CI 0.73-0.86) and detection rate of 0.94 (95% CI 0.85-0.97) were found. Upstaging as a result of extended histopathological assessment was 0.15 (95% CI 0.07-0.25). In our single-center study, we included 30 patients. Five false-negative SLNs were identified, resulting in a sensitivity of 44% and negative predictive value of 80%, with a detection rate of 89.7%. Eight patients had lymph node metastases, in three cases detected after extended pathological assessment, resulting in an upstaging of 13% (3 of 23 patients with negative nodes by conventional hematoxylin and eosin staining). CONCLUSIONS: Several anatomical and technical difficulties make SLNM with NIR fluorescence imaging in colon cancer particularly challenging when compared to other types of cancer. As a consequence, reports of SLNM accuracy vary widely. Future studies should try to standardize the SLNM procedure and focus on early-stage colon tumors, validation of tracer composition, injection mode and improvement of real-time optical guidance.

Cancer survivors' needs during various treatment phases after multimodal treatment for colon cancer - is there a role for eHealth?

BACKGROUND: More colon cancer patients are expected to fully recover after treatment due to earlier detection of cancer and improvements in general health- and cancer care. The objective of this study was to gather participants' experiences with full recovery in the different treatment phases of multimodal treatment and to identify their needs during these phases. The second aim was to propose and evaluate possible solutions for unmet needs by the introduction of eHealth. METHODS: A qualitative study based on two focus group discussions with 22 participants was performed. The validated Supportive Care Needs Survey and the Cancer Treatment Survey were used to form the topic list. The verbatim transcripts were analyzed with Atlas.ti. 7th version comprising open, axial and selective coding. The guidelines of the consolidated criteria for reporting qualitative research (COREQ) were used. RESULTS: Experiences with the treatment for colon cancer were in general positive. Most important unmet needs were 'receiving information about the total duration of side effects', 'receiving information about the minimum amount of chemo needed to overall survival' and 'receiving a longer aftercare period (with additional attention for psychological guidance)'. More provision of information online, a chat function with the oncological nurse specialist via a website, and access to scientific articles regarding the optimal dose of chemotherapy were often mentioned as worthwhile additions to the current health care for colon cancer. CONCLUSIONS: Many of the unmet needs of colon cancer survivors occur during the adjuvant treatment phase and thereafter. To further optimize recovery and cancer care, it is necessary to have more focus on these unmet needs. More attention for identifying patients' problems and side-effects during chemotherapy; and identifying patients' supportive care needs after finishing chemotherapy are necessary. For some of these needs, eHealth in the form of blended care will be a possible solution.

EAES classification of intraoperative adverse events in laparoscopic surgery.

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

Transanal total mesorectal excision for rectal cancer: evaluation of the learning curve.

BACKGROUND: Transanal total mesorectal excision (TaTME) provides an excellent view of the resection margins for rectal cancer from below, but is challenging due to few anatomical landmarks. During implementation of this technique, patient safety and optimal outcomes need to be ensured. The aim of this study was to evaluate the learning curve of TaTME in patients with rectal cancer in order to optimize future training programs. METHODS: All consecutive patients after TaTME for rectal cancer between February 2012 and January 2017 were included in a single-center database. Influence of surgical experience on major postoperative complications, leakage rate and operating time was evaluated using cumulative sum charts and the splitting model. Correction for potential case-mix differences was performed. RESULTS: Over a period of 60 months, a total of 138 patients were included in this study. Adjusted for case-mix, improvement in postoperative outcomes was clearly seen after the first 40 patients, showing a decrease in major postoperative complications from 47.5 to 17.5% and leakage rate from 27.5 to 5%. Mean operating time (42 min) and conversion rate (from 10% to zero) was lower after transition to a two-team approach, but neither endpoint decreased with experience. Readmission and reoperation rates were not influenced by surgical experience. CONCLUSIONS: The learning curve of TaTME affected major (surgical) postoperative complications for the first 40 patients. A two-team approach decreased operative time and conversion rate. When implementing this new technique, a thorough teaching and supervisory program is recommended to shorten the learning curve and improve the clinical outcomes of the first patients.

Safety in the operating room during orthopedic trauma surgery-incidence of adverse events related to technical equipment and logistics.

BACKGROUND: Safety in the operating room is widely debated. Adverse events during surgery are potentially dangerous for the patient and staff. The incidence of adverse events during orthopedic trauma surgery is unknown. Therefore, we performed a study to quantify the incidence of these adverse events. Primary objective was to determine the incidence of adverse events related to technical equipment and logistics. The secondary objective was to evaluate the consequences of these adverse events. METHODS: We completed a cross-sectional observational study to assess the incidence, consequences and preventability of adverse events related to technical equipment and logistics during orthopedic trauma surgery. During a 10 week period, all orthopedic trauma operations were evaluated by an observer. Six types of procedures were differentiated: osteosynthesis; arthroscopy; removal of hardware; joint replacement; bone grafting and other. Adverse events were divided in six categories: staff dependent factors; patient dependent factors; anaesthesia; imaging equipment; operation room equipment and instruments and implants. Adverse events were defined as any factor affecting the surgical procedure in a negative way. RESULTS: Hundred-fifty operative procedures were included. In 54% of the procedures, at least one adverse event occurred. In total, 147 adverse events occurred, with a range of 1-5 per procedure. Most adverse events occurred during joint replacement procedures. Thirty-seven percent of the incidents concerned defect, incorrect connected or absent instruments. In 36% of the procedures adverse events resulted in a prolonged operation time with a median prolongation of 10.0 min. CONCLUSION: In more than half of orthopedic trauma surgical procedures adverse events related to technical equipment and logistics occurred, most of them could easily be prevented. These adverse events could endanger the safety of the patient and staff and should therefore be reduced. LEVEL OF EVIDENCE: 4.

Transanal total mesorectal excision (TaTME) for rectal cancer: effects on patient-reported quality of life and functional outcome.

BACKGROUND: Transanal total mesorectal excision (TaTME) has rapidly become an important component of the treatment of rectal cancer surgery. Cohort studies have shown feasibility concerning procedure, specimen quality and morbidity. However, concerns exist about quality of life and ano(neo)rectal function. The aim of this study was to prospectively evaluate quality of life in patients following TaTME for rectal cancer with anastomosis. METHODS: Consecutive patients who underwent restorative TaTME surgery for rectal adenocarcinoma in an academic teaching center with tertiary referral function were evaluated. Validated questionnaires were prospectively collected. Quality of life was assessed by the EuroQol 5D (EQ-5D), European Organization for Research and Treatment of Cancer's QLQ-C30 and QLQ-CR29 and low anterior resection syndrome (LARS) scale. Outcomes of the questionnaires at 1 and 6 months were compared with preoperative (baseline) values. RESULTS: Thirty patients after restorative TaTME for rectal cancer were included. Deterioration for all domains was mainly observed at 1 month after surgery compared to baseline, but most outcomes had returned to baseline at 6 months. Social function and anal pain remained significantly worse at 6 months. Major LARS (score >30) was 33% at 6 months after ileostomy closure. No end colostomies were required. CONCLUSIONS: TaTME is associated with acceptable quality of life and functional outcome at 6 months after surgery comparable to published results after conventional laparoscopic low anterior resection.

Angiogenesis-Related Markers and Prognosis After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Metastatic Colorectal Cancer.

BACKGROUND: Patients presenting with peritoneal metastases (PM) of colorectal cancer (CRC) can be curatively treated with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). Angiogenesis is under control of multiple molecules of which HIF1a, SDF1, CXCR4, and VEGF are key players. We investigated these angiogenesis-related markers and their prognostic value in patients with PM arising from CRC treated with CRS and HIPEC. PATIENTS AND METHODS: Clinicopathological data and tissue specimens were collected in 2 tertiary referral centers from 52 patients who underwent treatment for isolated PM of CRC. Whole tissue specimens were subsequently analyzed for protein expression of HIF1a, SDF1, CXCR4, and VEGF by immunohistochemistry. Microvessel density (MVD) was analyzed by CD31 immunohistochemistry. The relationship between overall survival (OS) and protein expression as well as other clinicopathological characteristics was analyzed. RESULTS: Univariate analysis showed that high peritoneal cancer index (PCI), resection with residual disease and high expression of VEGF were negatively correlated with OS after treatment with CRS and HIPEC (P < 0.01, P < 0.01, and P = 0.02, respectively). However, no association was found between the other markers and OS (P > 0.05). Multivariate analysis showed an independent association between OS and PCI, resection outcome and VEGF expression (multivariate HR: 6.1, 7.8 and 3.8, respectively, P ≤ 0.05). CONCLUSIONS: An independent association was found between high VEGF expression levels and worse OS after CRS and HIPEC. The addition of VEGF expression to the routine clinicopathological workup could help to identify patients at risk for early treatment failure. Furthermore, VEGF may be a potential target for adjuvant treatment in these patients.

Transanal total mesorectal excision for rectal carcinoma: short-term outcomes and experience after 80 cases.

BACKGROUND: Low anterior resection for distal and mid-rectal cancer is associated with high positive resection margins. Transanal total mesorectal excision (TaTME) is a new treatment in which the rectum is dissected transanally according to TME principles. The short-term results and oncological follow-up of the first 80 patients were described. METHODS: Between June 2012 and September 2014, all patients in the Gelderse Vallei Hospital and the VU University Medical Center with histologically proven distal or mid-rectal carcinomas without evidence of distant metastases underwent TaTME. Patients with T4 tumors were excluded. Transanal mobilization was performed with the aid of a single port and endoscopic instruments according to TME criteria. RESULTS: Eighty patients were operated in a period of 2 years. Laparotomy was recommended and performed in four patients. Postoperative morbidity was 39%. Ten (12%) complications were graded as severe (Clavien-Dindo grade 3, 4 and 5) and needed re-intervention. Median operative time was 204 min (range 91-447). Median hospital stay was 8 days (range 3-41). Specimens were graded as complete in 88% of the patients, nearly complete in 9% and incomplete in 3%. A positive circumferential resection margin (<2 mm) was observed in two patients. During the two and half years study period, a local recurrence was observed in two patients. CONCLUSION: TaTME is a safe alternative to standard laparoscopic TME in selected low-risk patients with rectal carcinoma when treated by an experienced colorectal team. In the future, randomized trials are necessary to prove its oncological safety.