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Background The presence of lymph node metastases remains the most reliable prognostic predictor and the gold indicator for adjuvant treatment in colon cancer (CC). In spite of a potentially curative resection, 20 to 30% of CC patients testing negative for lymph node metastases (i.e. pN0) will subsequently develop locoregional and/or systemic metastases within 5 years. The presence of occult nodal isolated tumor cells (ITCs) and/or micrometastases (MMs) at the time of resection predisposes CC patients to high risk for disease recurrence. These pN0 micro+ patients harbouring occult micrometastases may benefit from adjuvant treatment. The purpose of the present study is to delineate the subset of pN0 patients with micrometastases (pN0 micro+ ) and evaluate the benefits from adjuvant chemotherapy in pN0 micro+ CC patients. Methods/design EnRoute+ is an open label, multicenter, randomized controlled clinical trial. All CC patients (age above 18 years) without synchronous locoregional lymph node and/or systemic metastases (clinical stage I-II disease) and operated upon with curative intent are eligible for inclusion. All resected specimens of patients are subject to an ex vivo sentinel lymph node mapping procedure (SLNM) following curative resection. The investigation for micrometastases in pN0 patients is done by extended serial sectioning and immunohistochemistry for pan-cytokeratin in sentinel lymph nodes which are tumour negative upon standard pathological examination. Patients with ITC/MM-positive sentinel lymph nodes (pN0 micro+ ) are randomized for adjuvant chemotherapy following the CAPOX treatment scheme or observation. The primary endpoint is 3-year disease free survival (DFS). Discussion The EnRoute+ study is designed to improve prognosis in high-risk stage I/II pN0 micro+ CC patients by reducing disease recurrence by adjuvant chemotherapy. Trial Registration ClinicalTrials.gov: NCT01097265

Background Hartmann’s procedure for perforated diverticulitis can be characterised by high morbidity and mortality rates. While the scientific community focuses on laparoscopic lavage as an alternative for laparotomy, the option of laparoscopic sigmoidectomy seems overlooked. We compared morbidity and hospital stay following acute laparoscopic sigmoidectomy (LS) and open sigmoidectomy (OS) for perforated diverticulitis. Methods This retrospective cohort parallel to the Ladies trial included patients from 28 Dutch academic or teaching hospitals between July 2010 and July 2014. Patients with LS were matched 1:2 to OS using the propensity score for age, gender, previous laparotomy, CRP level, gastrointestinal surgeon, and Hinchey classification. Results The propensity-matched cohort consisted of 39 patients with LS and 78 patients with OS, selected from a sample of 307 consecutive patients with purulent or faecal perforated diverticulitis. In both groups, 66 % of the patients had Hartmann’s procedure and 34 % had primary anastomosis. The hospital stay was shorter following LS (LS 7 vs OS 9 days; P  = 0.016), and the postoperative morbidity rate was lower following LS (LS 44 % vs OS 66 %; P  = 0.016). Mortality was low in both groups (LS 3 % vs OS 4 %; P  = 0.685). The stoma reversal rate after Hartmann’s procedure was higher following laparoscopy, with a probability of being stoma-free at 12 months of 88 and 62 % in the laparoscopic and open groups, respectively ( P  = 0.019). After primary anastomosis, the probability of reversal was 100 % in both groups. Conclusions In this propensity score-matched cohort, laparoscopic sigmoidectomy is superior to open sigmoidectomy for perforated diverticulitis with regard to postoperative morbidity and hospital stay.

Background: Laparoscopic colorectal surgery results in less post-operative pain, faster recovery, shorter length of stay and reduced morbidity compared with open procedures. Less or minimally invasive techniques have been developed to further minimise surgical trauma and to decrease the size and number of incisions. This study describes the safety and feasibility of using an umbilical multi-instrument access (MIA) port (Olympus TriPort+) device with the placement of just one 12-mm suprapubic trocar in laparoscopic (double-port) abdominoperineal resections (APRs) in rectal cancer patients. Patients and Methods: The study included 20 patients undergoing double-port APRs for rectal cancer between June 2011 and August 2013. Preoperative data were gathered in a prospective database, and post-operative data were collected retrospectively. Results: The 20 patients (30% female) had a median age of 67 years (range 46-80 years), and their median body mass index (BMI) was 26 kg/m2 (range 20-31 kg/m2). An additional third trocar was placed in 2 patients. No laparoscopic procedures were converted to an open procedure. Median operating time was 195 min (range 115-306 min). A radical resection (R0 resection) was achieved in all patients, with a median of 14 lymph nodes harvested. Median length of stay was 8 days (range 5-43 days). Conclusion: Laparoscopic APR using a MIA trocar is a feasible and safe procedure. A MIA port might be of benefit as an extra option in the toolbox of the laparoscopic surgeon to further minimise surgical trauma.

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. This study aimed to further develop the \"ikherstel\" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. 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. 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. 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. Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.

Background and purpose Single-port laparoscopy (SPL) is a relatively new technique, used in various procedures. There is limited knowledge about the cost effectiveness and the learning curve of this technique. The primary aim of this study was to compare hospital costs between SPL and conventional laparoscopic resections (CLR) for colorectal cancer; the secondary aim was to identify a learning curve of SPL. Methods All elective colorectal cancer SPL and CLR performed in a major teaching hospital between 2011 and 2012 that were registered in the Dutch Surgical Colorectal Audit were included ( n  = 267). The economic evaluation was conducted from a hospital perspective, and costs were calculated using time-driven activity-based costing methodology up to 90 days after discharge. When looking at SPL only, the introduction year (2011) was compared to the next year (2012). Results SPL ( n  = 78) was associated with lower mortality, lower reintervention rates, and more complications as compared to CLR ( n  = 189); however, none of these differences were statistically significant. A significant shorter operating time was seen in the SPL. Total costs were higher for SPL group as compared to CLR; however, this difference was not statistically significant. For the SPL group, most clinical outcomes improved between 2011 and 2012; moreover, total hospital costs for SPL in 2012 became comparable to CLR. Conclusion No significant differences in financial outcomes between SPL and CLR were identified. After the introduction period, SPL showed similar results as compared to CLR. Conclusions are based on a small single-port group and the conclusions of this manuscript should be an impetus for further research.

We investigated whether in vivo closed-chest left ventricular pressure-volume measurements would yield similar values for LV hemodynamics compared with open-chest PV measurements under several anesthetics. The right common carotid of C57Bl/6 mice was cannulated with a combined pressure-conductance catheter and inserted retrogradely into the left ventricle in the closed-chest model. The open-chest model consisted of an abdominal approach involving the opening of the thoracic cavity by transverse opening of the diaphragm and ventricular catheterization by apical stab. Measurements were performed under urethane or pentobarbital intraperitoneal injection anesthesia. Cardiac function in the open-chest model was characterized by larger ejection fraction and stroke volume with a leftward shift in ventricular volume compared to the closed-chest model. Further observed characteristics include low end-systolic pressure and arterial-ventricular coupling mismatch in the open-chest model. Arrhythmias were not detected in either model. Murine cardiac function determination via open-chest or closed-chest protocols is sensitive, reproducible and comparable. The choice for open- or closed-chest pressure-volume measurements in mice depends on the aims of the study.

In patients with colorectal cancer liver metastases (CRLM), resection of the primary tumour and local treatment of liver metastases may offer a chance of cure or long-term survival. Most patients however present with unresectable CRLM. Hepatic arterial infusion pump (HAIP) therapy with floxuridine (FUDR) combined with systemic therapy (SYST) could enhance conversion to resectable CRLM, reduce recurrences and therefore, probably prolong survival. The aim of this trial is to investigate whether intensifying induction treatment with HAIP-SYST prolongs survival in chemotherapy-naive patients with initially unresectable CRLM as compared to systemic therapy alone. This multicentre, phase 3 randomised controlled trial will be conducted in 20 Dutch liver centres and 306 patients will be included. Eligible participants are chemotherapy-naive patients with synchronous unresectable CRLM without extrahepatic disease and with suitable hepatic arterial anatomy to allow for potential pump placement. Unresectability is assessed by a liver expert panel of radiologists and surgeons based on predefined criteria. Patients randomised to the control arm receive induction systemic therapy according to standard clinical practice. Patients in the experimental arm undergo surgery for pump placement and resection of the primary tumour before start of HAIP-SYST. Treatment response and conversion to local treatment of CRLM is evaluated by the expert panel every 8-9 weeks during induction treatment. Primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS), hepatic PFS, conversion-to-resection rates, R0/R1 resection rates, radiological and pathological response, surgical complications, toxicity, quality of life and cost-effectiveness. The PUMP-IT RCT is the first prospective randomised trial to investigate HAIP-SYST as first line treatment for initially unresectable CRLM. This Dutch multicentre trial is open for accrual as of November 2024. PUMP-IT RCT is registered at EU Clinical Trials (EU CT): 2023-506,194-35-00, at CCMO: NL86326.041.24 and at ClinicalTrials.gov: NCT06857773, August 1, 2024. version 3.1, 29- 04-2026.

Ductal carcinoma in situ (DCIS) is a non-invasive breast neoplasia that accounts for 25% of all screen-detected breast cancers diagnosed annually. Neoplastic cells in DCIS are confined to the ductal system of the breast, although they can escape and progress to invasive breast cancer in a subset of patients. A key concern of DCIS is overtreatment, as most patients screened for DCIS and in whom DCIS is diagnosed will not go on to exhibit symptoms or die of breast cancer, even if left untreated. However, differentiating low-risk, indolent DCIS from potentially progressive DCIS remains challenging. In this Review, we summarize our current knowledge of DCIS and explore open questions about the basic biology of DCIS, including those regarding how genomic events in neoplastic cells and the surrounding microenvironment contribute to the progression of DCIS to invasive breast cancer. Further, we discuss what information will be needed to prevent overtreatment of indolent DCIS lesions without compromising adequate treatment for high-risk patients.‘Ductal carcinoma in situ’ (DCIS) describes abnormal cells in the milk ducts. DCIS is often non-invasive, although a small proportion of cases leave the ducts and progress to invasive breast cancer. This Review discusses the existing data for distinguishing progressive and non-progressive DCIS, with a focus on informing current disease management strategies.

Early recognition and management of postoperative complications, before they become clinically relevant, can improve postoperative outcomes for patients, especially for high-risk procedures such as pancreatic resection. We did an open-label, nationwide, stepped-wedge cluster-randomised trial that included all patients having pancreatic resection during a 22-month period in the Netherlands. In this trial design, all 17 centres that did pancreatic surgery were randomly allocated for the timing of the crossover from usual care (the control group) to treatment given in accordance with a multimodal, multidisciplinary algorithm for the early recognition and minimally invasive management of postoperative complications (the intervention group). Randomisation was done by an independent statistician using a computer-generated scheme, stratified to ensure that low–medium-volume centres alternated with high-volume centres. Patients and investigators were not masked to treatment. A smartphone app was designed that incorporated the algorithm and included the daily evaluation of clinical and biochemical markers. The algorithm determined when to do abdominal CT, radiological drainage, start antibiotic treatment, and remove abdominal drains. After crossover, clinicians were trained in how to use the algorithm during a 4-week wash-in period; analyses comparing outcomes between the control group and the intervention group included all patients other than those having pancreatic resection during this wash-in period. The primary outcome was a composite of bleeding that required invasive intervention, organ failure, and 90-day mortality, and was assessed by a masked adjudication committee. This trial was registered in the Netherlands Trial Register, NL6671. From Jan 8, 2018, to Nov 9, 2019, all 1805 patients who had pancreatic resection in the Netherlands were eligible for and included in this study. 57 patients who underwent resection during the wash-in phase were excluded from the primary analysis. 1748 patients (885 receiving usual care and 863 receiving algorithm-centred care) were included. The primary outcome occurred in fewer patients in the algorithm-centred care group than in the usual care group (73 [8%] of 863 patients vs 124 [14%] of 885 patients; adjusted risk ratio [RR] 0·48, 95% CI 0·38–0·61; p<0·0001). Among patients treated according to the algorithm, compared with patients who received usual care there was a decrease in bleeding that required intervention (47 [5%] patients vs 51 [6%] patients; RR 0·65, 0·42–0·99; p=0·046), organ failure (39 [5%] patients vs 92 [10%] patients; 0·35, 0·20–0·60; p=0·0001), and 90-day mortality (23 [3%] patients vs 44 [5%] patients; 0·42, 0·19–0·92; p=0·029). The algorithm for the early recognition and minimally invasive management of complications after pancreatic resection considerably improved clinical outcomes compared with usual care. This difference included an approximate 50% reduction in mortality at 90 days. The Dutch Cancer Society and UMC Utrecht.