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Currently, accurate biomarkers differentiating simple (phlegmonous) from complex (gangrenous and/or perforated) appendicitis in children are lacking. However, both types may potentially require different treatment strategies, and the search for diagnostic modalities remains warranted. Previously, we demonstrated a distinct microbiota (both an increased bacterial diversity and abundance) in the appendix of children with complex compared to simple appendicitis. From the same cohort of patients we have collected 35 rectal swabs under general anesthesia prior to appendectomy and microbiota analysis was performed by IS-pro, a 16S-23S rDNA–based clinical microbiota profiling technique. Using the obtained IS-profiles, we performed cluster analyses (UPGMA), comparison of diversity (Shannon Diversity Index) and intensity (abundance in relative fluorescence units) on phylum level, and comparison on species level of bacteria between simple and complex appendicitis. Regarding these analyses, we observed no clear differences between simple and complex appendicitis. However, increased similarity of the microbial composition of the appendix and rectal swab was found within children with complex compared to simple appendicitis. Furthermore, PLS-DA regression analysis provided clear visual differentiation between simple and complex appendicitis, but the diagnostic power was low (highest AUC 0.65). Conclusion: Microbiota analysis of rectal swabs may be viable to differentiate between simple and complex appendicitis prior to surgery as a supervised classification model allowed for discrimination of both types. However, the current diagnostic power was low and further validation studies are needed to assess the value of this method. What is Known:• Simple and complex appendicitis in children may require different treatment strategies, but accurate preoperative biomarkers are lacking.• Clear differentiation can be made between both types in children based upon the microbial composition in the appendix. What is New:• Increased similarity was found between the microbial composition of the appendix and rectal swab within children with complex compared to simple appendicitis.• Using a supervised classification model rectal swabs may be viable to discriminate between simple and complex appendicitis, but the diagnostic power was low.

Background Necrotizing soft tissue infections (NSTI) affect long-term quality of life in survivors. Different approaches to debridement may influence quality of life. The aim of this study was to assess the current practice of the debridement of NSTI in the Netherlands. Methods An animated, interactive online survey was distributed among general surgeons and plastic surgeons in the Netherlands. Two NSTI-cases were presented, followed by questions regarding the preferred surgical approach. Case one described a woman with a swollen, red leg, with signs of sepsis and without visible necrosis. Case two described an immunocompromised man with septic shock syndrome and extensive necrosis. Results In total 232 responses were included (143 general surgeons, 89 plastic surgeons). In case one, 32% chose to preserve all skin, while 17% chose to resect all skin above the affected fascia, including normal-looking skin. In case two, all participants resected necrotic skin, and most (88%) also blue discolored skin. While 32% did not resect more than blue discolored and necrotic skin, 35% also resected red-colored skin, and 21% all skin overlying the affected fascia, including normal colored skin. Respondents working in a hospital with a burn center tended to preserve more skin, whereas plastic surgeons chose more often for skin resection compared to general surgeons. Conclusions By using a novel approach to a survey, the authors demonstrate the existence of extensive practice variety regarding the approach to debridement of NSTI among Dutch general and plastic surgeons. Consensus is needed, followed by targeted education of surgeons.

BACKGROUND Preoperative weight loss (WL) is associated with higher postoperative WL at 1- to 2-year follow-up in patients who undergo laparoscopic Roux-en-Y gastric bypass (LRYGB). OBJECTIVE To evaluate the possible association between preoperative and postoperative WL at 3-year follow-up and identify risk factors for insufficient WL. SETTING A single-center prospective cohort study in the Netherlands. METHODS Patients undergoing primary LRYGB and laparoscopic conversion from band to bypass (redo LRYGB) were instructed to lose weight preoperatively. Follow-up data were collected 1, 2, and 3 years postoperatively. WL was described as percentage total weight loss (%TWL) and percentage excess body mass index (BMI) loss. Patients were divided into 2 groups: group A lost any amount of weight; group B did not lose any weight or gained weight preoperatively. RESULTS Group A consisted of 230 patients (median preoperative %TWL, 4.8%), and group B consisted of 46 patients (median preoperative %TWL, -1.3%). Median BMI at intake was 44.1 kg/m2. Baseline characteristics were similar. The %TWL and BMI for group A and B in the patients who underwent primary LRYGB at 1, 2, and 3 years was 32.2% (BMI, 28.6 kg/m2) versus 23.9% (BMI, 32.2 kg/m2), 31.8% (BMI, 28.9 kg/m2) versus 25.2% (BMI, 31.9 kg/m2), and 33.3% (BMI, 29.7 kg/m2) versus 21.9% (BMI, 34 kg/m2), respectively, all P < .05. In patients who underwent redo LRYGB no clinically significant differences in postoperative BMI were found. CONCLUSIONS Preoperative WL in primary patients who undergo LRYGB can be useful to identify those at risk of inadequate postoperative WL. In patients who undergo redo LRYGB different risk factors should be considered for prediction of inadequate postoperative WL.

BACKGROUND: The LIR!C trial showed that laparoscopic ileocaecal resection is a cost-effective treatment that has similar quality-of-life outcomes to treatment with infliximab, an anti-tumour necrosis factor (TNF) drug. We aimed to compare long-term outcomes of both interventions and identify baseline factors associated with the duration of treatment effect in each group.METHODS: In this retrospective follow-up study, we collected data from patients who participated in the LIR!C trial, a multicentre randomised controlled trial that compared quality of life after surgical resection versus infliximab in adult patients with non-stricturing and immunomodulator-refractory ileocaecal Crohn's disease. From Jan 1 to May 1, 2018, we collected follow-up data from the time from enrolment in the LIR!C trial until the last visit at either the gastrointestinal surgeon or gastroenterologist. In this study, outcomes of interest were need for surgery or repeat surgery or anti-TNF therapy, duration of treatment effect, and identification of factors associated with the duration of treatment effect. Duration of treatment effect was defined as the time without need for additional Crohn's disease-related treatment (corticosteroids, immunomodulators, biologics, or surgery).FINDINGS: We collected long-term follow-up data for 134 (94%) of 143 patients included in the LIR!C trial, of whom 69 were in the resection group and 65 were in the infliximab group. Median follow-up was 63·5 months (IQR 39·0-94·5). In the resection group, 18 (26%) of 69 patients started anti-TNF therapy and none required a second resection. 29 (42%) patients in the resection group did not require additional Crohn's disease-related medication, although 14 (48%) of these patients were given prophylactic immunomodulator therapy. In the infliximab group, 31 (48%) of 65 patients had a Crohn's disease-related resection, and the remaining 34 patients maintained, switched, or escalated their anti-TNF therapy. Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52). In both groups, therapy with an immunomodulator, in addition to the allocated treatment, was associated with duration of treatment effect (hazard ratio for resection group 0·34 [95% CI 0·16-0·69] and for infliximab group 0·49 [0·26-0·93]).INTERPRETATION: These findings further support laparoscopic ileocaecal resection as a treatment option in patients with Crohn's disease with limited (affected segment ≤40 cm) and predominantly inflammatory terminal ileitis for whom conventional treatment is not successful.FUNDING: None.

BACKGROUND: An adequate erythrocyte function is vital for tissue oxygenation and wound healing. The erythrocyte membrane phospholipid composition plays an important role in erythrocyte function and administration of omega-3 fatty acids may provide a means to improve it. OBJECTIVE: To investigate peri-operative erythrocyte function and effects of oral omega-3 fatty acids in morbidly obese women undergoing gastric bypass surgery METHODS: Fifty-six morbidly obese women undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery were randomized between a low calorie diet (LCD) during 2 weeks or oral omega-3 poly-unsaturated fatty acids (n-3 PUFAs) and a normal diet during 4 weeks. Peri-operative blood samples were analyzed with the Lorrca MaxSIS Ektacytometer for erythrocyte deformability and aggregability. RESULTS: There were no significant differences in erythrocyte function between the groups at any time point. Only erythrocyte aggregability parameters were affected by surgery. At six month follow-up, aggregation index (AI) and cholesterol, glucose and insulin were significantly improved. CONCLUSIONS: In this study, oral Omega-3 supplementation did not affect erythrocyte function compared to a LCD. Six months after surgery a significant improvement in AI and metabolic parameters was observed in both groups, contributing to a reduction in the risk at thromboembolic and cardiovascular complications.

Background: Anastomotic leakage (AL) remains a severe complication following colorectal surgery, having a negative impact on both short- and long-term outcomes. Since timely detection could enable early intervention, there is a need for the development of novel and accurate, preferably, non-invasive markers. The aim of this study was to investigate whether urinary intestinal fatty acid binding protein (I-FABP) could serve as such a marker. Methods: This prospective multicenter cross-sectional phase two diagnostic study was conducted at four centers in the Netherlands between March 2015 and November 2016. Urine samples of 15 patients with confirmed colorectal AL and 19 patients without colorectal AL on postoperative day 3 were included. Urinary I-FABP levels were determined using enzyme-linked immunosorbent assays and adjusted for urinary creatinine to compensate for renal dysfunction. Results: Urinary I-FABP levels were significantly elevated in patients with confirmed AL compared to patients without AL on postoperative day 3 (median: 2.570 ng/ml vs 0.809 ng/ml, p = 0.006). The area under the receiver operating characteristics curve (AUROC) was 0.775, yielding a sensitivity of 80% and specificity of 74% at the optimal cutoff point (> 1.589 ng/ml). This difference remained significant after calculation of I-FABP/creatinine ratios (median: 0.564 ng/µmol vs. 0.158 ng/µmol, p = 0.040), with an AUROC of 0.709, sensitivity of 60% and specificity of 90% at the optimal cutoff point (> 0.469 ng/µmol). Conclusions: Levels of urinary I-FABP and urinary I-FABP/creatinine were significantly elevated in patients with confirmed AL following colorectal surgery, suggesting their potential as a non-invasive biomarker for colorectal anastomotic leakage.

Background: Postoperative bleeding remains a relatively common complication following bariatric surgery and may lead to morbidity and even mortality. Objective: To develop a prediction model to identify patients at risk for postoperative bleeding. Setting: Rode Kruis Ziekenhuis, Beverwijk, the Netherlands. Based on Dutch nationwide obesity audit data. Methods: Patients undergoing primary bariatric surgery were selected from January 2015 to December 2020 from the Dutch Audit for Treatment of Obesity. The primary outcome was postoperative bleeding within 30 days. Assessed predictors included patient factors and operative data. A prediction model was developed using backward stepwise logistic regression. Internal validation was performed using bootstrapping techniques. Results: A total of 59,055 patients were included; 13,399 underwent a sleeve gastrectomy, and 45,656 underwent a gastric bypass procedure. Postoperative bleeding occurred in 1.5%. The following predictors were identified: male patients (odds ratio [OR] = 1.40; 95% confidence interval [CI]: 1.21–1.63), patients >45 years of age (OR = 1.50; 95% CI: 1.29–1.76), body mass index 2 (OR = 1.22; 95% CI: 1.06–1.41), cardiovascular disease (OR = 1.36; 95% CI: 1.17–1.57), and sleeve gastrectomy (OR = 1.43; 95% CI: 1.24–1.67). Area under the curve for the model was .612. Following bootstrapping for internal validation, a correction of .9817 was applied. Conclusion: A clinical decision rule was designed to assess the risk of postoperative bleeding in patients undergoing bariatric surgery. If 3 or more risk factors are present, there is an increased risk for postoperative bleeding. The model can aid in clinical decision-making: implementing extra preventative measures in high-risk patients. External validation is needed to further develop the model.

BACKGROUND: Nearly a quarter of patients with locally advanced (T4 stage) or perforated colon cancer are at risk of developing peritoneal metastases, often without curative treatment options. We aimed to determine the efficacy of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with locally advanced colon cancer.METHODS: This multicentre, open-label trial was done in nine hospitals that specialised in HIPEC in the Netherlands. Patients with clinical or pathological T4N0-2M0-stage tumours or perforated colon cancer were randomly assigned (1:1), with a web-based randomisation application, before resection of the primary tumour, to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy (experimental group) or to adjuvant systemic chemotherapy alone (control group). Patients were stratified by tumour characteristic (T4 or perforation), age (FINDINGS: Between April 1, 2015, and Feb 20, 2017, 204 patients were randomly assigned to treatment (102 in each group). In the HIPEC group, two patients withdrew consent after randomisation. In this group, 19 (19%) of 100 patients were diagnosed with peritoneal metastases: nine (47%) during surgical exploration preceding intentional adjuvant HIPEC, eight (42%) during routine follow-up, and two (11%) during diagnostic laparoscopy at 18-months. In the control group, 23 (23%) of 102 patients were diagnosed with peritoneal metastases, of whom seven (30%) were diagnosed by laparoscopy at 18-months and 16 during regular follow-up (therefore making them ineligible for diagnostic laparoscopy). In the intention-to-treat analysis (n=202), there was no difference in peritoneal-free survival at 18-months (80·9% [95% CI 73·3-88·5] for the experimental group vs 76·2% [68·0-84·4] for the control group, log-rank one-sided p=0·28). 12 (14%) of 87 patients who received adjuvant HIPEC developed postoperative complications and one (1%) encapsulating peritoneal sclerosis.INTERPRETATION: In patients with T4 or perforated colon cancer, treatment with adjuvant HIPEC with oxaliplatin did not improve peritoneal metastasis-free survival at 18 months. Routine use of adjuvant HIPEC is not advocated on the basis of this trial.FUNDING: Organization for Health Research and Development and the Dutch Cancer Society.

Background: In the Netherlands, patients only qualify for bariatric surgery when they have followed a 6-month mandatory weight loss program (MWP), also called the "last resort" criterion. One of the rationales for this is that MWPs result in greater weight loss.Objectives: To determine weight loss during MWPs and the effect of delayed versus immediate qualification on weight loss 3 years after bariatric surgery.Setting: Outpatient clinic.Methods: This is a nationwide, retrospective study with prospectively collected data. All patients who underwent a primary bariatric procedure in 2016 were included. We compared weight loss between patients who did not qualify according to the last resort criterion at screening (delayed group) with patients that qualified (immediate group).Results: In total 2628 patients were included. Mean age was 44.4 years, 81.3% were female, and baseline BMI was 42.3 kg/m(2). Roux-en-Y gastric bypass (RYGB) was the most frequently performed surgery (77.0%), followed by sleeve gastrectomy (15.8%) and banded RYGB (7.3%). The delayed group (n = 831; 32%) compared with immediate group (n = 1797; 68%), showed less percentage of total weight loss (%TWL) during the MWP (1.7% versus 3.9%, P < .001) and time between screening and surgery was longer (42.3 versus 17.5 wk, P < .001). Linear mixed model analysis showed no significant difference in %TWL at 18- (P = .291, n = 2077), 24- (P = .580, n = 1993) and 36-month (P = .325, n = 1743) follow-up.Conclusion: This study shows that delayed qualification for bariatric surgery compared with immediate qualification does not have a clinically relevant impact on postoperative weight loss 3 years after bariatric surgery. (C) 2020 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

To determine the effect of an orogastric tube for calibration of the gastric pouch on percentage excess weight loss (%EWL) and percentage total weight loss (%TWL) after laparoscopic Roux-en-Y gastric bypass (LRYGB). A retrospective case-matched control study in 132 patients. Group A (a 40 French orogastric tube was used to calibrate the gastric pouch) was compared to group B (no orogastric tube was used). All other surgical steps were identical in both groups. Postoperative %EWL and %TWL were recorded at 3, 6, 9, 12, and 24 months postoperatively. Baseline characteristics and comorbidities were similar for both groups; a mean age of 43.6 years, 84% of the patients were female and mean initial BMI was 44 kg/m2. At 24 months, 9% of the patients were lost to follow-up. At 1-year follow-up, %EWL and %TWL were 80% and 33.3% in group A versus 70% and 28.6% in group B with p = 0.013 and p = 0.007 respectively. At 2 years, EWL% and %TWL were 79.5% and 32.8% in group A and 67.18% and 28.1% in group B with a p value of 0.019 and 0.001 respectively. The use of a calibration tube, initial BMI, and age predicted the %TWL best with R squared at 30.7%. The use of a calibration tube for creating the gastric pouch may lead to a higher %EWL and %TWL at 2-year follow-up. The standardization of the technique for LRYGB is desirable to achieve the maximum success rate in the surgical therapy of morbid obesity.

Aim:\ud Inflammatory markers such as serum C‐reactive protein (CRP) are used as routine markers to detect anastomotic leakage following colorectal surgery. However, CRP is characterized by a relatively low predictive value, emphasizing the need for the development of novel diagnostic approaches. Volatile organic compounds (VOCs) are gaseous metabolic products deriving from all conceivable bodily excrements and reflect (alterations in) the patient's physical status. Therefore, VOCs are increasingly considered as potential non‐invasive diagnostic biomarkers. The aim of this study was to assess the diagnostic accuracy of urinary VOCs for colorectal anastomotic leakage.\ud \ud Methods:\ud In this explorative multicentre study, urinary VOC profiles of 22 patients with confirmed anastomotic leakage and 27 uneventful control patients following colorectal surgery were analysed by field asymmetric ion mobility spectrometry (FAIMS).\ud \ud Results:\ud Urinary VOCs of patients with anastomotic leakage could be distinguished from those of control patients with high accuracy: area under the receiver operating characteristics curve 0.91 (95% CI 0.81–1.00, P < 0.001), sensitivity 86% and specificity 93%. Serum CRP was significantly increased in patients with a confirmed anastomotic leak but with lower diagnostic accuracy compared to VOC analysis (area under the receiver operating characteristics curve 0.82, 95% CI 0.68–0.95, P < 0.001). Combining VOCs and CRP did not result in a significant improvement of the diagnostic performance compared to VOCs alone.\ud \ud Conclusion:\ud Analysis by FAIMS allowed for discrimination between urinary VOC profiles of patients with a confirmed anastomotic leak and control patients following colorectal surgery. A superior accuracy compared to CRP and apparently high specificity was observed, underlining the potential as a non‐invasive biomarker for the detection of colorectal anastomotic leakage.

Background Treatment of patients with ileocaecal Crohn's disease who have not responded to conventional therapy is commonly scaled up to biological agents, but surgery can also offer excellent short-term and long-term results. We compared laparoscopic ileocaecal resection with infliximab to assess how they affect health-related quality of life. Methods In this randomised controlled, open-label trial, in 29 teaching hospitals and tertiary care centres in the Netherlands and the UK, adults with non-stricturing, ileocaecal Crohn's disease, in whom conventional therapy has failed were randomly allocated (1:1) by an internet randomisation module with biased-coin minimisation for participating centres and perianal fistula to receive laparoscopic ileocaecal resection or infliximab. Eligible patients were aged 18–80 years, had active Crohn's disease of the terminal ileum, and had not responded to at least 3 months of conventional therapy with glucocorticosteroids, thiopurines, or methotrexate. Patients with diseased terminal ileum longer than 40 cm or abdominal abscesses were excluded. The primary outcome was quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) at 12 months. Secondary outcomes were general quality of life, measured by the Short Form-36 (SF-36) health survey and its physical and mental component subscales, days unable to participate in social life, days on sick leave, morbidity (additional procedures and hospital admissions), and body image and cosmesis. Analyses of the primary outcome were done in the intention-to-treat population, and safety analyses were done in the per-protocol population. This trial is registered at the Dutch Trial Registry (NTR1150). Findings Between May 2, 2008, and October 14, 2015, 73 patients were allocated to have resection and 70 to receive infliximab. Corrected for baseline differences, the mean IBDQ score at 12 months was 178·1 (95% CI 171·1–185·0) in the resection group versus 172·0 (164·3–179·6) in the infliximab group (mean difference 6·1 points, 95% CI −4·2 to 16·4; p=0·25). At 12 months, the mean SF-36 total score was 112·1 (95% CI 108·0–116·2) in the resection group versus 106·5 (102·1–110·9) in the infliximab group (mean difference 5·6, 95% CI −0·4 to 11·6), the mean physical component score was 47·7 (45·7–49·7) versus 44·6 (42·5–46·8; mean difference 3·1, 4·2 to 6·0), and the mean mental component score was 49·5 (47·0–52·1) versus 46·1 (43·3–48·9; mean difference 3·5, −0·3 to 7·3). Mean numbers of days of sick leave were 3·4 days (SD 7·1) in the resection group versus 1·4 days (4·7) in the infliximab group (p

Contains fulltext : 215610.pdf (Publisher’s version ) (Open Access) BACKGROUND: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. CONCLUSIONS: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.

PURPOSE: To identify available clinical prediction rules (CPRs) and investigate their ability to rule out appendicitis in children presenting with abdominal pain at the emergency department, and accordingly select CPRs that could be useful in a future prospective cohort study.METHODS: A literature search was conducted to identify available CPRs. These were subsequently tested in a historical cohort from a general teaching hospital, comprising all children (RESULTS: Twelve CPRs were tested in a cohort of 291 patients, of whom 87 (29.9%) suffered from acute appendicitis. The Ohmann score, Alvarado score, modified Alvarado score, Pediatric Appendicitis score, Low-Risk Appendicitis Rule Refinement, Christian score, and Low Risk Appendicitis Rule had a negative likelihood ratio 0.1. Three CPRs were excluded because the score could not be calculated for at least 50% of patients.CONCLUSION: This study identified seven CPRs that could be used in a prospective cohort study to compare their ability to rule out appendicitis in children and investigate if clinical monitoring and re-evaluation instead of performing additional investigations (i.e., ultrasound) is a safe treatment strategy in case there is low suspicion of appendicitis.

Purpose: Weight loss before bariatric surgery with a low-calorie diet (LCD) has several advantages, including reduction of liver volume and an improved access to the lesser sac. Disadvantages include performing surgery in a state of undernutrition, side effects, costs and patient compliance. Omega-3 fatty acids may serve as an alternative to reduce liver steatosis. Materials and Methods: A randomised controlled open-label trial was done to compare the effects of a LCD with Modifast (800 kcal/day) during 2 weeks with 2 g of omega-3 fatty acids a day and a normal diet (2000 kcal/day) during 4 weeks. Total liver volume (TLV) and volume of the left liver lobe (LLL), visceral fat area (VFA) and muscle area (SMA) at the L3–L4 level were measured with MRI before and after preoperative treatment. Results: Sixty-two morbidly obese women undergoing laparoscopic Roux-en-Y gastric bypass surgery (LRYGB) were recruited. In both groups, there was a significant decrease in LLL, TLV and VFA. For LLL and TLV reduction, the LCD had a significantly larger effect (p < 0.05). Only in the LCD group was there a significant decrease in SMA with significantly more side effects and worse compliance. Conclusion: Both the LCD and omega-3 diet reduced LLL, TLV and VFA. The LCD outperformed the omega-3 diet in LLL and TLV reduction, but induced significant loss of SMA and had worse compliance due to more side effects. Omega-3 fatty acids may provide a safe and more patient-friendly alternative for a LCD and further research is indicated. Trial Registration: The study is registered at www.clinicaltrials.gov (NCT02206256).

BACKGROUND Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention (“ikherstel” intervention or “I recover” intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE This study aimed to further develop the “ikherstel” eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS The IM protocol was used to guide further development of the “ikherstel” intervention. First, patients’ needs were identified using (1) the information of a process evaluation of the earlier performed “ikherstel” study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as “achieving earlier recovery including return to normal activities and work.” The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. CONCLUSIONS The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. CLINICALTRIAL Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686

Studies suggest that postoperative complications are a risk factor for venous thromboembolism (VTE) after bariatric surgery. Knowledge of factors associated with a higher risk of VTE after bariatric surgery may be essential to select patients who may benefit from either prolonged or intensified thrombosis prophylaxis. The aim of this study is to determine the relationship between postoperative complications and VTE after bariatric surgery and other classical risk factors. A retrospective multicenter case-control study was performed in patients who had bariatric surgery between January 2008 and September 2011. VTE until 6 months after surgery was registered, and patients were contacted to ascertain the results. For every case of VTE after surgery, 6 control patients were selected who were matched for gender, age, participating center and type of surgery. Risk factors for VTE before and after surgery and postoperative complications were registered. A total of 2,064 surgeries were included. In 12 patients, VTE occurred within 6 months after bariatric surgery (incidence 0.58 %, 95 % confidence interval (CI) = 0.25–0.93). There was a strong association of complications after surgery (cases 91.7 %, controls 15.3 %, odds ratio (OR) 61.0; 95 % CI = 7.1–521.3) or intensive care admission (cases 50.0 %, controls 11.1 %, OR = 8.0; 95 % CI = 2.1–30.8) with VTE. The majority of postoperative complications were anastomotic leak, abdominal abscess, and infection. We could not detect an association between classical thrombosis risk factors and postoperative VTE. The incidence of VTE is low after bariatric surgery using thrombosis prophylaxis. However, there is a strong association between postoperative complications and VTE. These patients may benefit from more intensive thrombosis prophylaxis.

Strict follow-up after bariatric surgery is an important factor in achieving and maintaining weight loss, whereas regaining weight is the most important threat in long-term follow-up. Stagnation in weight loss or weight regain can be signals of early treatment failure. The aim of this study is to assess the possibility of obtaining frequent objective weight measurements using an Internet-connected home weighing scale. Internet-connected home weighing scales were used to perform weekly follow-up in bariatric surgery patients during the first postoperative year. For each patient, weight measurements were registered and excess body weight loss was calculated. This follow-up method was deemed successful if weight measurements were available for 80 % of all weeks in the first year. A total of 14 patients started the protocol. Seven patients (50 %) performed weekly weight measurements for at least 80 % of all weeks in the first year. One-year follow-up was available for 11 patients. Excess weight loss was >50 % in nine (82 %) of these patients and >40 % in the remaining two. Using an Internet-connected weighing scale at home is feasible in postsurgery bariatric patients. It can provide the treating physicians with valuable information about weight loss over time. This could possibly offer opportunities for timely interventions during follow-up in case of insufficient weight loss or weight regain.

To investigate which perioperative treatment, ie, laparoscopic or open surgery combined with fast track (FT) or standard care, is the optimal approach for patients undergoing segmental resection for colon cancer. Important developments in elective colorectal surgery are the introduction of laparoscopy and implementation of FT care, both focusing on faster recovery. In a 9-center trial, patients eligible for segmental colectomy were randomized to laparoscopic or open colectomy, and to FT or standard care, resulting in 4 treatment groups. Primary outcome was total postoperative hospital stay (THS). Secondary outcomes were postoperative hospital stay (PHS), morbidity, reoperation rate, readmission rate, in-hospital mortality, quality of life at 2 and 4 weeks, patient satisfaction and in-hospital costs. Four hundred patients were required to find a minimum difference of 1 day in hospital stay. Median THS in the laparoscopic/FT group was 5 (interquar-tile range: 4-8) days; open/FT 7 (5-11) days; laparoscopic/standard 6 (4.5-9.5) days, and open/standard 7 (6-13) days (P < 0.001). Median PHS in the laparoscopic/FT group was 5 (4-7) days; open/FT 6 (4.5-10) days; laparoscopic/standard 6 (4-8.5) days and open/standard 7 (6-10.5) days (P < 0.001). Secondary outcomes did not differ significantly among the groups. Regression analysis showed that laparoscopy was the only independent predictive factor to reduce hospital stay and morbidity. Optimal perioperative treatment for patients requiring segmental colectomy for colon cancer is laparoscopic resection embedded in a FT program. If open surgery is applied, it is preferentially done in FT care. This study was registered under NTR222 (www.trialregister.nl)

Background Fast track surgery accelerates recovery, reduces morbidity and shortens hospital stay. It is unclear what the effects are of laparoscopic or open surgery within a fast track programme. The aim of this systematic review was to review the existing evidence. Method A systematic review was performed of all randomized (RCTs) and controlled clinical trials (CCTs) on laparoscopic and open surgery within a fast track setting. Primary endpoints were primary and overall hospital stay, readmission rate, morbidity and mortality. Study selection, quality assessment and data extraction were performed independently by two observers. Results Only two RCTs and three CCTs were eligible for final analysis, which reported on 400 patients. Data could not be pooled because of clinical heterogeneity. One RCT and one CCT stated a shorter primary hospital stay in the laparoscopic group of 3 and 2 days, respectively. In one RCT, the readmission rate was lower in the laparoscopic group; absolute risk reduction (ARR) 21.4% [95% confidence interval (CI): 6–42.3%] resulting in a number needed to treat (NNT) of 4.7 patients (95% CI: 2.4–176). Another study showed a 23% difference in favour of the laparoscopic group with regard to morbidity (95% CI: 6.3–39.1%), i.e. an NNT of 4.4 patients (95% CI: 2.6–15.9). There were no significant differences in mortality rates. Conclusion Due to the present lack of data, no robust conclusions can be made. A large randomized controlled trial is required to compare laparoscopic with open surgery within a fast track setting.

OBJECTIVE: There are few prospective data on the effects of prolonged intensive care unit stay on the quality of life and long-term survival of a homogeneous patient population. Therefore, the aims of this prospective study were a) to describe the quality of life in patients after having a transthoracic esophageal resection; and b) to analyze the influences of a prolonged intensive care unit stay on quality of life and survival in patients after esophageal cancer resection who survived to hospital discharge. DESIGN: Prospective study. SETTING: Medical center. PATIENTS: The study population consisted of 109 patients undergoing a transthoracic resection for adenocarcinoma of the middistal esophagus or gastric cardia between April 1994 and February 2000. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A comparison was made between patients staying or=6 days in the intensive care unit and also or=14 days. Quality of life was assessed in all patients by mailed self-report questionnaires at baseline (preoperatively), at 5 wks, and at 3, 6, 9, 12, 18, 24, 30, and 36 months after surgery. Daily physical, emotional, and social functioning was assessed with the generic Medical Outcome Studies Short Form-20. Disease-specific quality of life was measured by an adapted Rotterdam Symptom Check List. Quality of life data were gathered between July 1994 and March 2003. Five of the 109 patients died in the hospital and were excluded from the analysis. All five of them were in the intensive care unit >or=6 days. Of the remaining 104 patients, 92 provided baseline scores. The data of the 92 patients were used for the quality of life analyses. For the clinicopathologic and survival analysis, the data of 104 hospital survivors were used. Patients spent a median of 5.5 days (range 0-71) in the intensive care unit. The Medical Outcome Studies Short Form-20 and the Rotterdam Symptom Check List measurements showed no clear differences in long-term quality of life between patients after a short vs. a prolonged postoperative intensive care unit period. The median overall survival in all patients was 2.0 yrs (range 0.1-8.0). Median overall survival in patients staying in the intensive care unit or=6 days (p = .9, log-rank test). Median overall survival in patients staying in the intensive care unit or=14 days (p = .74, log-rank test). CONCLUSIONS: For patients who survived to hospital discharge after transthoracic esophagectomy, there was no difference in long-term quality of life or survival between those submitted to the intensive care unit for a short period vs. a long period

Background: Postoperative complications after open transthoracic esophagectomy could possibly be reduced if the abdominal phase is performed laparoscopically. The aim of this study was to investigate the feasibility of laparoscopic mobilization of the stomach and gastric tube formation in patients undergoing an open transthoracic esophagectomy for cancer. Methods: Thirteen patients underwent an open transthoracic esophagectomy with extended en bloc lymphadenectomy combined with laparoscopic gastric tube formation. Clinicopathological data were derived from a prospective database and patient files. Results: The median operation time was 484 min (range 347–573) and the median intraoperative blood loss was 1,500 ml (range 250–3,700). In 2 patients the laparoscopic procedure was converted to a laparotomy because of technical difficulties. Median postoperative stay in the ICU was 3 days (range 1–8) and median hospital stay was 29 days (range 12–104). One patient died in the hospital. Postoperatively 3 patients suffered from anastomotic leakage, 5 from pneumonia and 3 from vocal cord palsy. Conclusions: The complication rate was high in this series of patients undergoing an open extended transthoracic esophagectomy with laparoscopic mobilization of the stomach and gastric tube formation. Laparoscopic mobilization of the stomach and gastric tube formation are feasible, but need carefully guided testing before this technique can be applied routinely.

Background The extent to which adenocarcinoma of the cardia with lymph node metastasis in the upper mediastinum is amenable to cure by radical surgery is open to debate. It remains unclear whether these relatively distant metastases have an effect on long-term survival. The aim of this study was to identify the incidence of such positive nodes and evaluate their prognostic significance. Methods Some 50 patients with adenocarcinoma of the gastric cardia and substantial invasion of the oesophagus (junctional type II), who underwent an extended transthoracic oesophagectomy as part of a prospective randomized trial between 1994 and 2000, were studied. Results Eleven patients (22 per cent) had lymph node metastasis in the proximal field of the chest. These patients had more positive nodes overall (P = 0·020) and a shorter median survival (P = 0·009) than those without such metastasis. Multivariate analysis identified positive nodes in the proximal field as an independent predictor of poor survival. Conclusion Lymph node metastasis in the proximal field of the chest is common and is an indicator of poor prognosis in patients with adenocarcinoma of the cardia.

Background After esophagectomy for cancer, the first choice for reconstruction of the gastrointestinal continuity is by gastric tube. When this is not feasible, a reconstruction by colon interposition can be performed. The aim of this study was to assess the quality of life in patients at least 6 months after esophageal cancer resection and colon interposition without signs of recurrent disease. The results were compared with previously published data of patients after esophageal cancer resection and gastric tube reconstruction. Patients and Methods Between January 1993 and January 2002, 36 patients underwent esophageal cancer resection and gastrointestinal reconstruction by colon interposition. A one-time Quality of Life assessment was carried out in 14 patients who were still disease free after a median follow-up of 21 months (mean 35, range 7–97). The patients were visited at home and asked to fill in questionnaires which consisted of the Short Form-36 (SF-36) Health Survey to assess general quality of life, an adapted Rotterdam Symptom Checklist to assess disease-specific quality of life, a visual analogue scale, and an additional questionnaire concerning other specific effects of the operation. Results All 14 patients returned the completed set of questionnaires. Compared to the previously published results of patients after gastric tube reconstruction patients with a colon interposition scored significantly (P ≤ 0.05) lower in five of the eight subscales of the SF-36 questionnaire (i.e. general health, physical role, vitality, social functioning, and mental health). The most frequent symptoms measured by the Rotterdam Symptom Checklist were early satiety after a meal, dysphagia, diarrhea, loss of sexual interest, and fatigue. Six patients could not independently run their housekeeping and four patients still needed artificial enteral nutrition. Conclusion Based on the SF-36 questionnaire, patients after colon interposition by necessity have a poor general quality of life. Even long after the operation they have a broad spectrum of persisting symptoms. Prior to surgery, patients should be informed about the disabling long-term functional outcome of a colon interposition. J. Surg. Oncol. 2004;88:32–38. © 2004 Wiley-Liss, Inc.

Background and Aims: Traditionally large, complex colorectal polyps were managed by surgical resection (SR), and in recent years endoscopic resection (ER) has progressed significantly. However, to what extent ER has replaced SR remains largely unknown. We performed a multicenter retrospective cohort study to assess the volume and volume changes of SR for benign colorectal polyps over the past decade. Methods: Patients who underwent SR for a benign colorectal polyp in the Netherlands between 2005 and 2015 were selected from the prospective nationwide Dutch Pathology Registry (PALGA database). Clinical characteristics were obtained from the charts of patients who underwent SR in the province of Noord-Holland. Results: A total of 5937 patients were treated with SR for a colorectal polyp and the absolute (454-739 per year) and relative volumes (0.20%-0.37% per colonoscopy per year) of SR remained stable. In the province of Noord-Holland, 928 patients (15.6%) underwent SR. In these patients, submucosal lifting and ER were attempted in 19.9% (n = 175) and 15.0% (n = 134). After 2010, patients were more likely to undergo lifting (27.7% vs 11.4%, P

Incisional hernia is a frequent complication of midline laparotomy and is associated with high morbidity, decreased quality of life, and high costs. We aimed to compare the large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions.We did this prospective, multicentre, double-blind, randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands. Patients aged 18 years or older who were scheduled to undergo elective abdominal surgery with midline laparotomy were randomly assigned (1:1), via a computer-generated randomisation sequence, to receive small tissue bites of 5 mm every 5 mm or large bites of 1 cm every 1 cm. Randomisation was stratified by centre and between surgeons and residents with a minimisation procedure to ensure balanced allocation. Patients and study investigators were masked to group allocation. The primary outcome was the occurrence of incisional hernia; we postulated a reduced incidence in the small bites group. We analysed patients by intention to treat. This trial is registered at Clinicaltrials.gov, number NCT01132209 and with the Nederlands Trial Register, number NTR2052.Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=284) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) patients completed follow-up and were included in the primary outcome analysis. Patients in the small bites group had fascial closures sutured with more stitches than those in the large bites group (mean number of stitches 45 [SD 12] vs 25 [10]; p0·0001), a higher ratio of suture length to wound length (5·0 [1·5] vs 4·3 [1·4]; p0·0001) and a longer closure time (14 [6] vs 10 [4] min; p0·0001). At 1 year follow-up, 57 (21%) of 277 patients in the large bites group and 35 (13%) of 268 patients in the small bites group had incisional hernia (p=0·0220, covariate adjusted odds ratio 0·52, 95% CI 0·31-0·87; p=0·0131). Rates of adverse events did not differ significantly between groups.Our findings show that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia in midline incisions and is not associated with a higher rate of adverse events. The small bites technique should become the standard closure technique for midline incisions.Erasmus University Medical Center and Ethicon.

Background After major abdominal surgery (MAS), 20 % of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein (CRP) as an early marker for postoperative complications, however clinical significance has yet to be determined. Methods A multicenter, stepped wedge, prospective clinical trial including all adult patients planned to undergo elective MAS. The first period consists of standard postoperative monitoring, which entails on demand additional examinations. This is followed by a period with implementation of postoperative control according to the PRECious protocol, which implicates standardized measurement of CRP levels. If CRP levels exceed 140 mg/L on postoperative day 3,4 or 5, an enhanced CT-scan is performed. Primary outcome in this study is a combined primary outcome, entailing all morbidity and mortality due to postoperative complications. Complications are graded according to the Clavien-Dindo classification. Secondary outcomes are hospital length of stay, patients reported outcome measures (PROMs) and cost-effectiveness. Data will be collected during admission, three months and one year postoperatively. Approval by the medical ethics committee of the VU University Medical Center was obtained (ID 2015.114). Discussion the PRECious trial is a stepped-wedge, multicenter, open label, prospective clinical trial to determine the effect of a standardized postoperative quality control algorithm on postoperative morbidity and mortality, and cost-effectiveness. Trial registration www.ClinicalTrials.gov, NCT02102217. Registered 5 February 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-0903-y) contains supplementary material, which is available to authorized users.

Background: In women with breast cancer for whom breast-conserving therapy (BCT) is not the best option, a nipple and areola complex-(NAC) sparing mastectomy with immediate reconstruction has been proposed as a good and safe alternative to conventional, more radical mastectomy. Surgeons hesitate to perform this operation for fear of recurrence of tumour in the NAC due to undetected nipple involvement (NI) of the tumour. In order to determine whether a NAC-sparing mastectomy is a viable option, the frequency and predictive factors of NI by the tumour were studied in the literature. Methods: A literature survey was performed by searching the Medline database. Other references were derived from the material perused. Results and Conclusions: NI is found in up to 58% of mastectomy specimens and correlates with tumour size, tumour–areola or tumour–nipple distance, positive lymph nodes and clinical suspicion. Best candidates for NAC-sparing mastectomy are patients with a small tumour (T1) at a large distance (>4–5 cm) from the nipple. However, in these patients BCT has excellent results with low complications and recurrence rates. Considering the incidence of NI in larger tumours (T2 average 33%, T3 average >50%) a NAC-sparing mastectomy may carry an unacceptable high risk for local relapse and should therefore not be advocated.

Fireworks injuries are common and often affect children. Such injuries should be considered high energy trauma in the emergency room and taken care of according to the principles of the Advanced Trauma Life Support (ATLS).A 7-year-old boy was a victim of an explosion when he set off illegal fireworks. During evaluation in the emergency department he presented with a superficial laceration on the belly and extensive hand injury. Upon examination he had small-intestinal perforation that required immediate resection. The patient recovered well, but suffered permanent damage to the hand.Potentially life threatening injuries may accompany hand injuries after modern illegal fireworks. Hand injuries are serious. Despite prolonged treatment, they often result in permanent disability. The structured approach to trauma according to ATLS was important in detecting an accompanying abdominal trauma in this case.

Background Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the ‘INCH-trial’, comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed. Methods/Design A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm. Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, recurrences, mortality and quality of life. Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair. A difference of two days is considered significant. One-hunderd-and-thirty-five patients are enrolled in each treatment arm. The economic evaluation will be performed from a societal perspective. Primary outcomes are costs per patient related to time-to-recovery and quality of life. The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through length of hospital stay and quality of life. Secondary endpoints are re-operation rate due to post-operative complications or recurrences, mortality and quality of life. Discussion The difference in time to full recovery between the two treatment strategies is thought to be in favor of laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is therefore expected to be a more cost-effective approach. Trial registration Netherlands Trial register: NTR2808

A 74-year-old male patient with a history of myelodysplastic syndrome (MDS) presented with an ulcerative skin lesion on his left lower leg. Recent blood and bone marrow counts indicated a transformation of MDS into an acute myelogenous leukemia (AML). Histopathological examination of biopsies of the lesion revealed a cutaneous localization of AML, a so-called 'chloroma' (granulocytic or myeloid sarcoma).

Insufficient weight loss after gastric band placement is generally linked to band-related complications or a persistently unhealthy diet.A 47-year-old woman with a history of gastric band placement presented with complaints of decreased mobility, dyspnoea, gastro-oesophageal reflux and a progressive increase in abdominal girth. Initially, these symptoms were attributed to an unhealthy diet. However, additional testing showed a large intra-abdominal multicystic lesion originating from the ovaries. The patient was operated and two large serous cystadenomas were removed, after which the symptoms disappeared almost immediately.Abdominal complaints after bariatric surgery can often be explained by surgical complications or unhealthy eating habits. Although the cause of certain complaints is sometimes obvious, alternative diagnoses need to be considered. If the abdominal girth in middle-aged women increases, ovarian disorders must always be considered in the differential diagnosis and appropriate additional diagnostic testing need to be carried out.

Evaluation of the long-term results of bariatric surgery with an adjustable gastric band for the treatment of morbid obesity.Retrospective, descriptive.From September 1991-September 1993, 30 patients (6 males, 24 females) received an adjustable gastric band because of morbid obesity, being the first group in the Netherlands. The long-term data on these patients: weight loss, band adjustments, complications, reoperations and patient satisfaction, were collected using a medical record survey and a questionnaire and then analysed.Before the operation, the mean BMI was 42.5 kg/m2 (SD: 5.7) and the mean excess body weight was 50.8 kg (SD: 16.7). The mean follow-up time for all patients was 15.3 years (SD: 5.4) and for the responders to the questionnaire, 17.7 years (SD: 0.7); three patients died during follow-up. After surgery, the mean BMI was reduced to 34.7 kg/m2 (SD: 6.4). The mean excess body weight loss of the entire group was 38.1% (SD: 67.8) and of the patients who still had a gastric band in situ, 27.9% (SD: 67.4). In 15 patients, the gastric band reservoir was replaced at least once. The gastric band was replaced in 18 patients due to complications and eventually permanently removed in 6 patients. Of the respondents, 62% were satisfied with the weight loss and 52% were satisfied with regard to possible side effects and complications.The treatment of morbid obesity with an adjustable gastric band in this very first group of patients has resulted in substantial weight loss, but also a high rate of complications and reoperations. Treatment of these kinds of complications is an important aspect of bariatric surgery today. The efficacy of gastric banding is therefore currently under debate.

The purpose of the present study was to evaluate the value of discussing rectal cancer patients in a multidisciplinary team (MDT). All treated rectal cancer patients (> T1M0) diagnosed in 2006-2008 were included. According to the national guidelines, neoadjuvant (chemo)radiotherapy should be given to all rectal cancer patients. Patients were scored as "discussed" (MDT+) only if documented proof was available. The primary endpoint was the number of positive circumferential resection margins (CRM a parts per thousand currency sign1 mm). Of the 275 patients included, 210 were analyzed (exclusions: (recto)sigmoid tumor, acute laparotomy, and inoperability). Neoadjuvant treatment was applied in 174 (83%) patients and followed by total mesorectal excision in 171 (81%) patients. Patients considered not to require downstaging, received short-course radiotherapy (SCRT) (n = 116) or no radiotherapy (no RT) (n = 36), whereas 58 more advanced patients received chemoradiotherapy (CRT). The MDT discussion took place in 116 cases (55%). In the MDT+ group an MRI was used more often (p = 0.001) and TNM staging was more complete (p < 0.001). The proportion of patients with advanced disease was higher in the MDT+ group (88% a parts per thousand yenT3/N+ versus 68%; p = 0.001). The overall CRM+ rate was 13% and did not differ between the MDT+ and the MDT- group (p = 0.392). In patients receiving SCRT or no RT, the CRM+ rate was 10%, whereas the rate was 20% for patients receiving CRT. Although no difference in CRM+ rate was found for those patients who were discussed and those who were not, our results demonstrate room for improvement, especially in the selection of patients for SCRT or no RT. We advocate standardized documentation of treatment decisions and pathology reports.

Background Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. Methods/design The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management). Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used. The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. Discussion Considering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214), may be gathered within one and a half year. Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation. Trial Registration (Trial register number: NTR1478)

Background Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. Methods A randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I) A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days). II) A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time-to-full recovery of 5 days or more with a power of 85% and a confidence level of 95%. With an estimated one percent of patients lost to follow up, a total of 533 patients will be included. Conclusion A clinically relevant difference of more than 5 days in time-to-full recovery between the two treatment strategies is not expected. The liberal strategy without antibiotics and without the strict requirement for hospital admission is anticipated to be more a more cost-effective approach. Trial registration Trial registration number: NCT01111253

One-stop surgery was developed for patients to undergo surgical evaluation, anesthesia, surgery, and discharge all within 1 day. This study aimed to assess the feasibility, patient satisfaction, and potential of one-stop endoscopic total extraperitoneal (TEP) inguinal hernia surgery. After general practitioners had been informed, prospectively selected patients with unilateral or bilateral inguinal hernia underwent one-stop surgery by TEP. Pre- and postoperative questionnaires were used to evaluate patient satisfaction. During 12 months, 52 patients were referred for one-stop surgery. There were no “no shows”. The general practitioner correctly diagnosed inguinal hernia in 51 patients. On the scheduled date, 50 patients successfully underwent surgery using TEP, and 49 of these patients were satisfied with the procedure and would repeat one-stop surgery when indicated. One-stop endoscopic TEP inguinal hernia surgery is feasible and safe. The majority of patients would give preference to a repeated procedure if necessary. This clinical pathway reduces the number of patient visits to the hospital for inguinal hernia repair and also suggests cost efficiency.

This study was undertaken to assess the feasibility of lymphoscintigraphy of the gastric cardia and to identify the incidence of paraesophageal lymphatic drainage, precluding total gastrectomy with esophagojejunostomy as a potentially curative therapy for gastric cardia cancer.Ten patients scheduled for esophagectomy with high-grade dysplasia or with esophageal cancer at least 3 cm above the esophagogastric junction were enrolled in this study. Preoperatively, 111 MBq of(99m)Tc-labeled nanocolloid (n = 5) or sulfur colloid (n = 5) were injected into the submucosa of the tumor-free cardia. Subsequently, lymphoscintigraphy in combination with CT was obtained. Locoregional lymph node stations were measured for radioactivity by a gamma-probe intraoperatively and ex vivo in the resection specimen.In each patient, at least 1 radioactive lymph node station was detected. In total, 42 radioactive lymph node stations were detected by gamma-probe. Of those 42 areas, 38 (90%) were visible at preoperative lymphoscintigraphy. In the group of 5 patients in whom nanocolloid was used, a median of 2 (range, 1-4) node stations per patient was identified, whereas when sulfur colloid was administered a median of 6 (range, 4-8) active lymph node stations per patient could be detected (P0.002). Paraesophageal drainage was identified in 1 patient.Lymphoscintigraphy of the gastric cardia is feasible and can accurately determine the location of radioactive lymph nodes. Early paraesophageal lymphatic drainage is rare.

Exposure of the mucosa of the upper aerodigestive tract to carcinogens can induce genetic changes resulting in various independent clones of neoplastic growth, a concept defined as "field cancerization." The risk of developing multiple tumors in this compartment of the body is well established. We studied 6 distinct tumors of the upper aerodigestive tract of a single patient for loss of heterozygosity (LOH), microsatellite instability (MSI), p53 mutations, and K-ras codon 12 point mutations. We detected a unique pattern of LOH and p53 mutations in all 6 tumors. No tumor showed a K-ras mutation or MSI. The results support the mechanism of "field cancerization" and illustrate the potential power of molecular techniques to elucidate pathogenesis.

Background The median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Recent clinical and experimental data showed a continuous suture technique with many small tissue bites in the aponeurosis only, is possibly more effective in the prevention of incisional hernia when compared to the common used large bite technique or mass closure. Methods/Design The STITCH trial is a double-blinded multicenter randomized controlled trial designed to compare a standardized large bite technique with a standardized small bites technique. The main objective is to compare both suture techniques for incidence of incisional hernia after one year. Secondary outcomes will include postoperative complications, direct costs, indirect costs and quality of life. A total of 576 patients will be randomized between a standardized small bites or large bites technique. At least 10 departments of general surgery and two departments of oncological gynaecology will participate in this trial. Both techniques have a standardized amount of stitches per cm wound length and suture length wound length ratio's are calculated in each patient. Follow up will be at 1 month for wound infection and 1 year for incisional hernia. Ultrasound examinations will be performed at both time points to measure the distance between the rectus muscles (at 3 points) and to objectify presence or absence of incisional hernia. Patients, investigators and radiologists will be blinded during follow up, although the surgeon can not be blinded during the surgical procedure. Conclusion The STITCH trial will provide level 1b evidence to support the preference for either a continuous suture technique with many small tissue bites in the aponeurosis only or for the commonly used large bites technique. Trial registration Clinicaltrials.gov NCT01132209

Bacterial translocation may occur during abdominal surgery. Intestinal ischemia impairs the intestinal barrier function, thereby enhancing intestinal permeability and bacterial translocation. Total colectomies are performed both open and laparoscopically. In open surgery devascularisation is performed after mobilization of the bowel, whereas the medial to lateral laparoscopic approach starts with left-sided (inferior mesenteric artery; IMA) or right-sided (ileocolic artery; ICA) devascularisation. Aim is to determine whether the type of approach, open or laparoscopic, and the order of devascularisation in laparoscopic colectomy, affects intestinal barrier function, local inflammatory response and clinical outcome. Elective colectomy patients were included from April 2006 to July 2008. After informed consent, 22 patients scheduled for laparoscopic colectomy were randomized to start with IMA or ICA devascularisation. Eigtheen patients scheduled for open surgery served as a prospective control group. To assess the intestinal barrier function polyethylene glycol recovery (PEG; marker of intestinal permeability) and release of intestinal fatty acid binding protein (IFABP; marker of mucosal ischemia) were measured preand postoperatively. Mesenteric lymph nodes were harvested to assess expression of inflammatory mediator-related genes using Multiplex Ligation Probe Amplification. Right-sided start of devascularisation significantly increased excretion of I-FABP over time (P=0.005). Compared to pre-operative values increased I-FABP levels were found on postoperative days 1 and 3 (P=0.009 and P=0.002, respectively). There were no differences in PEG recovery, expression of inflammatory mediator-related genes or post-operative morbidity among the groups. In conclusion, a rightsided start of devascularisation during laparoscopic colectomy is associated with more intestinal mucosal ischemia. For this reason devascularisation starting at the IMA during laparoscopic colectomy may be preferred. There are no clinical consequences demonstrated in this small series.

Contains fulltext : 69534.pdf (Publisher’s version ) (Open Access) BACKGROUND: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. METHODS/DESIGN: The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. DISCUSSION: The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease. TRIAL REGISTRATION: Nederlands Trial Register NTR1150.