Multimodal prehabilitation (Fit4Surgery) in high-impact surgery to enhance surgical outcomes: Study protocol of F4S PREHAB, a single center stepped wedge trial.

BACKGROUND: High-impact surgery imposes a significant physiological and functional burden and is associated with substantial postoperative morbidity. Multimodal prehabilitation has demonstrated a reduction in postoperative complications and enhanced functional recovery, mainly in abdominal cancer surgery. Common preoperative risk factors shared among patients undergoing high-impact surgery, extending beyond abdominal cancer surgery procedures, suggest the relevance of multimodal prehabilitation to a broader patient population. This stepped wedge trial primarily aims to examine the hospital-wide effect of multimodal prehabilitation, compared to standard preoperative care, on the occurrence and severity of postoperative complications. Secondary and tertiary endpoints include length of hospital stay, physical fitness, nutritional status, mental health, intoxications, and cost-effectiveness of the intervention. METHODS: The Fit4Surgery (F4S) PREHAB trial is a monocenter stepped wedge trial in an academic hospital. Adult patients, divided into 20 health clusters based on specific diagnoses, will be assessed for eligibility and receive usual preoperative care or multimodal prehabilitation. Patient enrollment commenced in March 2021 and continues up to and including April 2024. The intervention consists of a high-intensity exercise program, a nutritional intervention, psychological support, and smoking and alcohol cessation. The primary outcome will be measured by the Clavien-Dindo classification (grade II or higher) and the Comprehensive Complication Index (CCI). DISCUSSION: Multimodal prehabilitation potentially reduces postoperative complications and enhances functional recovery. This is the first study to determine the hospital-wide effect and cost-effectiveness of multimodal prehabilitation in patients across various surgical specialties.

Ferumoxtran-10-enhanced MRI for pre-operative metastatic lymph node detection in pancreatic, duodenal, or periampullary adenocarcinoma.

OBJECTIVES: To assess 3-Tesla (3-T) ultra-small superparamagnetic iron oxide (USPIO)-enhanced MRI in detecting lymph node (LN) metastases for resectable adenocarcinomas of the pancreas, duodenum, or periampullary region in a node-to-node validation against histopathology. METHODS: Twenty-seven consecutive patients with a resectable pancreatic, duodenal, or periampullary adenocarcinoma were enrolled in this prospective single expert centre study. Ferumoxtran-10-enhanced 3-T MRI was performed pre-surgery. LNs found on MRI were scored for suspicion of metastasis by two expert radiologists using a dedicated scoring system. Node-to-node matching from in vivo MRI to histopathology was performed using a post-operative ex vivo 7-T MRI of the resection specimen. Sensitivity and specificity were calculated using crosstabs. RESULTS: Eighteen out of 27 patients (median age 65 years, 11 men) were included in the final analysis (pre-surgery withdrawal n = 4, not resected because of unexpected metastases peroperatively n = 2, and excluded because of inadequate contrast-agent uptake n = 3). On MRI 453 LNs with a median size of 4.0 mm were detected, of which 58 (13%) were classified as suspicious. At histopathology 385 LNs with a median size of 5.0 mm were found, of which 45 (12%) were metastatic. For 55 LNs node-to-node matching was possible. Analysis of these 55 matched LNs, resulted in a sensitivity and specificity of 83% (95% CI: 36-100%) and 92% (95% CI: 80-98%), respectively. CONCLUSION: USPIO-enhanced MRI is a promising technique to preoperatively detect and localise LN metastases in patients with pancreatic, duodenal, or periampullary adenocarcinoma. CLINICAL RELEVANCE STATEMENT: Detection of (distant) LN metastases with USPIO-enhanced MRI could be used to determine a personalised treatment strategy that could involve neoadjuvant or palliative chemotherapy, guided resection of distant LNs, or targeted radiotherapy. REGISTRATION: The study was registered on clinicaltrials.gov NCT04311047. https://clinicaltrials.gov/ct2/show/NCT04311047?term=lymph+node&cond=Pancreatic+Cancer&cntry=NL&draw=2&rank=1 . KEY POINTS: LN metastases of pancreatic, duodenal, or periampullary adenocarcinoma cannot be reliably detected with current imaging. This technique detected LN metastases with a sensitivity and specificity of 83% and 92%, respectively. MRI with ferumoxtran-10 is a promising technique to improve preoperative staging in these cancers.

Qualitative flow metabolic phenotype of pancreatic cancer. A new prognostic biomarker?

BACKGROUND: Retrospective analysis to investigate the relationship between the flow-metabolic phenotype and overall survival (OS) of pancreatic ductal adenocarcinoma (PDAC) and its potential clinical utility. METHODS: Patients with histopathologically proven PDAC between 2005 and 2014 using tumor attenuation on routine pre-operative CECT as a surrogate for the vascularity and [18F]FDG-uptake as a surrogate for metabolic activity on [18F]FDG-PET. RESULTS: In total, 93 patients (50 male, 43 female, median age 63) were included. Hypoattenuating PDAC with high [18F]FDG-uptake has the poorest prognosis (median OS 7 ± 1 months), compared to hypoattenuating PDAC with low [18F]FDG-uptake (median OS 11 ± 3 months; p = 0.176), iso- or hyperattenuating PDAC with high [18F]FDG-uptake (median OS 15 ± 5 months; p = 0.004) and iso- or hyperattenuating PDAC with low [18F]FDG-uptake (median OS 23 ± 4 months; p = 0.035). In multivariate analysis, surgery combined with tumor differentiation, tumor stage, systemic therapy and flow metabolic phenotype remained independent predictors for overall survival. DISCUSSION: The novel qualitative flow-metabolic phenotype of PDAC using a combination of CECT and [18F]FDG-PET features, predicted significantly worse survival for hypoattenuating-high uptake pancreatic cancers compared to the other phenotypes.

Nationwide Outcome after Pancreatoduodenectomy in Patients at very High Risk (ISGPS-D) for Postoperative Pancreatic Fistula.

OBJECTIVE: To assess nationwide surgical outcome after pancreatoduodenectomy (PD) in patients at very high risk for postoperative pancreatic fistula (POPF), categorized as ISGPS-D. SUMMARY BACKGROUND DATA: Morbidity and mortality after ISGPS-D PD is perceived so high that a recent randomized trial advocated prophylactic total pancreatectomy (TP) as alternative aiming to lower this risk. However, current outcomes of ISGPS-D PD remain unknown as large nationwide series are lacking. METHODS: Nationwide retrospective analysis including consecutive patients undergoing ISGPS-D PD (i.e., soft texture and pancreatic duct ≤3 mm), using the mandatory Dutch Pancreatic Cancer Audit (2014-2021). Primary outcome was in-hospital mortality and secondary outcomes included major morbidity (i.e., Clavien-Dindo grade ≥IIIa) and POPF (ISGPS grade B/C). The use of prophylactic TP to avoid POPF during the study period was assessed. RESULTS: Overall, 1402 patients were included. In-hospital mortality was 4.1% (n=57), which decreased to 3.7% (n=20/536) in the last 2 years. Major morbidity occurred in 642 patients (45.9%) and POPF in 410 (30.0%), which corresponded with failure to rescue in 8.9% (n=57/642). Patients with POPF had increased rates of major morbidity (88.0% vs. 28.3%; P<0.001) and mortality (6.3% vs. 3.5%; P=0.016), compared to patients without POPF. Among 190 patients undergoing TP, prophylactic TP to prevent POPF was performed in 4 (2.1%). CONCLUSION: This nationwide series found a 4.1% in-hospital mortality after ISGPS-D PD with 45.9% major morbidity, leaving little room for improvement through prophylactic TP. Nevertheless, given the outcomes in 30% of patients who develop POPF, future randomized trials should aim to prevent and mitigate POPF in this high-risk category.

Impact of network treatment in patients with resected pancreatic cancer on use and timing of chemotherapy and survival.

BACKGROUND: Centralization of pancreatic cancer surgery aims to improve postoperative outcomes. Consequently, patients with pancreatic cancer may undergo pancreatic surgery in an expert centre and adjuvant chemotherapy in a local hospital (network treatment). The aim of this study was to assess whether network treatment has an impact on time to chemotherapy, failure to complete adjuvant chemotherapy, and survival. Second, whether these parameters varied between pancreatic networks was studied. METHODS: This retrospective study included all patients diagnosed with non-metastatic pancreatic ductal adenocarcinoma who underwent pancreatic surgery and adjuvant chemotherapy, registered in the Netherlands Cancer Registry (2015-2020). Time to chemotherapy was defined as the time between surgery and the start of adjuvant chemotherapy. Completion of adjuvant chemotherapy was defined as the receipt of 12 cycles of FOLFIRINOX or six cycles of gemcitabine. Analysis was performed with linear mixed models and multilevel logistic regression models. Cox regression analyses were performed for survival. RESULTS: In total, 1074 patients were included. Network treatment was observed in 468 patients (43.6 per cent) and was not associated with longer time to chemotherapy (0.77 days, standard error (s.e.) 1.14, P = 0.501), failure to complete adjuvant chemotherapy (odds ratio (OR) = 1.140, 95 per cent c.i. 0.86 to 1.52, P = 0.349), and overall survival (hazards ratio (HR) = 1.04, 95 per cent c.i. 0.88 to 1.22, P = 0.640). Significant variation between the networks was observed for time to chemotherapy (range 40.5-63 days, P < 0.0001) and completion of adjuvant chemotherapy (range 19-52 per cent, P = 0.030). Adjusted for case mix, time to chemotherapy significantly differed between networks. CONCLUSION: In this nationwide analysis, network treatment in patients with resected pancreatic cancer was not associated with longer time to chemotherapy, failure to complete adjuvant chemotherapy, and worse survival. Significant variation between pancreatic cancer networks was found for time to chemotherapy.

Multimodal Prehabilitation in Patients Undergoing Complex Colorectal Surgery, Liver Resection, and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): A Pilot Study on Feasibility and Potential Efficacy.

BACKGROUND: Surgery for complex primary and metastatic colorectal cancer (CRC), such as liver resection and hyperthermic intraperitoneal chemotherapy (HIPEC), in academic settings has led to improved survival but is associated with complications up to 75%. Prehabilitation has been shown to prevent complications in non-academic hospitals. This pilot study aimed to determine the feasibility and potential efficacy of a multimodal prehabilitation program in patients undergoing surgery in an academic hospital for complex primary and metastatic CRC. METHODS: All patients awaiting complex colorectal surgery, liver resection, or HIPEC from July 2019 until January 2020 were considered potentially eligible. Feasibility was measured by accrual rate, completion rate, adherence to the program, satisfaction, and safety. To determine potential efficacy, postoperative outcomes were compared with a historical control group. RESULTS: Sixteen out of twenty-five eligible patients (64%) commenced prehabilitation, and fourteen patients fully completed the intervention (88%). The adherence rate was 69%, as 11 patients completed >80% of prescribed supervised trainings. No adverse events occurred, and all patients expressed satisfaction with the program. The complication rate was significantly lower in the prehabilitation group (37.5%) than the control group (70.2%, p = 0.020). There was no difference in the type of complications. CONCLUSION: This pilot study illustrates that multimodal prehabilitation is feasible in the majority of patients undergoing complex colorectal cancer, liver resection, and HIPEC in an academic setting.

Self-efficacy and application of skills in the workplace after multidisciplinary trauma masterclass participation: a mixed methods survey and interview study.

PURPOSE: The most complex injuries are usually least often encountered by trauma team members, limiting learning opportunities at work. Identifying teaching formats that enhance trauma skills can guide future curricula. This study evaluates self-assessed technical and nontechnical trauma skills and their integration into novel work situations for multidisciplinary trauma masterclass participants. METHODS: This mixed methods study included participants of a multidisciplinary 3-day trauma masterclass. Ratings of trauma skills were collected through pre- and postcourse questionnaires with 1-year follow-up. Qualitative semi-structured interviews 9 months postcourse focused on the course format and self-perceived association with technical and nontechnical skills applied at work. RESULTS: Response rates of pre- and postcourse questionnaires after 1 day, 3 months, and 1 year were respectively 72% (51/71), 85% (60/71), 34% (24/71), and 14% (10/71). Respondents were surgeons (58%), anesthesiologists (31%), and scrub nurses (11%). Self-efficacy in nontechnical (mean 3.4, SD 0.6 vs. mean 3.8, SD 0.5) and technical (mean 2.9, SD 0.6 vs. mean 3.6, SD 0.6) skills significantly increased postcourse (n = 40, p < 0.001). Qualitative interviews (n = 11) demonstrated that increased self-efficacy in trauma skills was the greatest benefit experienced at work. Innovative application of skills and enhanced reflection demonstrate adaptive expertise. Small-group case discussions and the operative porcine laboratory were considered the most educational working formats. The experienced faculty and unique focus on multidisciplinary teamwork were highly valued. CONCLUSION: Course participants' self-assessed work performance mostly benefited from greater self-efficacy and nontechnical skills. Future trauma curricula should consider aligning the teaching strategies accordingly.

Impact of multicentre diagnostic workup in patients with pancreatic cancer on repeated diagnostic investigations, time-to-diagnosis and time-to-treatment: A nationwide analysis.

BACKGROUND: Due to the centralization of pancreatic surgery, patients with suspected pancreatic cancer may undergo diagnostic workup in both a non-pancreatic centre and a pancreatic centre, i.e. multicentre workup. This retrospective study assessed whether multicentre diagnostic workup is associated with repeated diagnostics, delayed time-to-diagnosis, delayed time-to-treatment, survival and whether variation existed among pancreatic cancer networks. METHODS: This nationwide study included all patients diagnosed with non-metastatic pancreatic ductal adenocarcinoma (PDAC) in 2015, registered by the Netherlands Cancer Registry. A delayed time-to-diagnosis was defined as ≥3 weeks from initial hospital visit to final diagnosis. A delayed time-to-treatment was defined as ≥6 weeks from the first hospital visit to start of first tumour treatment. Multilevel logistic regression analyses and survival analyses were performed. RESULTS: In total, 931 patients with non-metastatic PDAC were included. Overall, 175 patients (19%) underwent a multicentre diagnostic workup, which was significantly associated with repeated diagnostic investigations (OR = 6.31, 95% CI 4.13-9.64, P < 0.0001), a delayed time-to-diagnosis (OR = 2.66 95% CI 1.74-4.06, P < 0.001), and a delayed time-to-treatment (OR = 1.93 95% CI 1.12-3.31, P = 0.02), but not with decreased survival (HR = 1.09 95% CI 0.83-1.44; P = 0.532). Variation in outcomes per network was observed, especially for time-to-treatment, though the ICC was not statistically significant (P = 0.065). CONCLUSION: Multicentre diagnostic workup for patients with PDAC is associated with repeated diagnostic investigations, a delayed time-to-diagnosis and delayed time-to-treatment compared to patients with monocentre workup. To reduce costs and improve treatment times, efforts should be made to improve network coordination, for example via network care pathways.

Clinical relevance assessment of animal preclinical research (RAA) tool: development and explanation.

BACKGROUND: Only a small proportion of preclinical research (research performed in animal models prior to clinical trials in humans) translates into clinical benefit in humans. Possible reasons for the lack of translation of the results observed in preclinical research into human clinical benefit include the design, conduct, and reporting of preclinical studies. There is currently no formal domain-based assessment of the clinical relevance of preclinical research. To address this issue, we have developed a tool for the assessment of the clinical relevance of preclinical studies, with the intention of assessing the likelihood that therapeutic preclinical findings can be translated into improvement in the management of human diseases. METHODS: We searched the EQUATOR network for guidelines that describe the design, conduct, and reporting of preclinical research. We searched the references of these guidelines to identify further relevant publications and developed a set of domains and signalling questions. We then conducted a modified Delphi-consensus to refine and develop the tool. The Delphi panel members included specialists in evidence-based (preclinical) medicine specialists, methodologists, preclinical animal researchers, a veterinarian, and clinical researchers. A total of 20 Delphi-panel members completed the first round and 17 members from five countries completed all three rounds. RESULTS: This tool has eight domains (construct validity, external validity, risk of bias, experimental design and data analysis plan, reproducibility and replicability of methods and results in the same model, research integrity, and research transparency) and a total of 28 signalling questions and provides a framework for researchers, journal editors, grant funders, and regulatory authorities to assess the potential clinical relevance of preclinical animal research. CONCLUSION: We have developed a tool to assess the clinical relevance of preclinical studies. This tool is currently being piloted.

Identification of Cardiovascular Patient Groups at Risk for Poor Medication Adherence: A Cluster Analysis.

BACKGROUND: Poor medication adherence limits the secondary prevention of cardiovascular diseases (CVDs) and leads to increased morbidity, mortality, and costs. Identifying groups of patients at risk of poor adherence behavior could enable an intervention to be developed and target patients appropriately. OBJECTIVE: The first aim of this study was to identify homogeneous subgroups of cardiovascular outpatients based on their cardiovascular risk factors. Subsequently, differences in medication adherence between these groups were examined. METHODS: In this retrospective, observational study, patients with an established CVD were included. Well-known cardiovascular risk factors such as smoking, diet, exercise, blood lipid levels, blood pressure, and body mass index were collected. To identify patient subgroups, a 2-step cluster analytic procedure was performed. Differences between the groups on medication adherence were determined on the outcome of the Modified Morisky Scale. Data collection took place between October 2011 and January 2013. RESULTS: Cardiovascular risk factors of 530 patients were included in the cluster analysis. Three groups were identified. Compared with other clusters (clusters 1 and 2), cluster 3 contained significantly fewer patients who could be classified as highly adherent and more patients classified as medium adherent (23% and 57%, respectively; P = .024). This group was characterized by a younger age (53% were <55 years old) and using a relatively low number of different medications (41% used <4 different medications). Besides, in this subgroup the most smokers (37%), unhealthy alcohol users (27%), and patients with unhealthy eating habits (14%) were present. CONCLUSION: This study showed that cardiovascular patients who are relatively young and have an unhealthy lifestyle are at risk for nonadherent behavior.

Risk Prediction in Acute Calculous Cholecystitis: A Systematic Review and Meta-Analysis of Prognostic Factors and Predictive Models.

Background: Laparoscopic cholecystectomy is the main treatment of acute cholecystitis. Although considered relatively safe, it carries 6%-9% risk of major complications and 0.1%-1% risk of mortality. There is no consensus regarding the evaluation of the preoperative risks, and the management of patients with acute cholecystitis is usually guided by surgeon's personal preferences. We assessed the best method to identify patients with acute cholecystitis who are at high risk of complications and mortality. Methods: We performed a systematic review of studies that reported the preoperative prediction of outcomes in people with acute cholecystitis. We searched the Cochrane Library, MEDLINE, EMBASE, WHO ICTRP, ClinicalTrials.gov, and Science Citation Index Expanded until April 27, 2019. We performed a meta-analysis when possible. Results: Six thousand eight hundred twenty-seven people were included in one or more analyses in 12 studies. Tokyo guidelines 2013 (TG13) predicted mortality (two studies; Grade 3 versus Grade 1: odds ratio [OR] 5.08, 95% confidence interval [CI] 2.79-9.26). Gender predicted conversion to open cholecystectomy (two studies; OR 1.59, 95% CI 1.06-2.39). None of the factors reported in at least two studies had significant predictive ability of major or minor complications. Conclusion: There is significant uncertainty in the ability of prognostic factors and risk prediction models in predicting outcomes in people with acute calculous cholecystitis. Based on studies of high risk of bias, TG13 Grade 3 severity may be associated with greater mortality than Grade 1. Early referral of such patients to high-volume specialist centers should be considered. Further well-designed prospective studies are necessary.

Optimal respiratory-gated [18F]FDG PET/CT significantly impacts the quantification of metabolic parameters and their correlation with overall survival in patients with pancreatic ductal adenocarcinoma.

PURPOSE: Metabolic parameters are increasingly being used to characterize tumors. Motion artifacts due to patient respiration introduce uncertainties in quantification of metabolic parameters during positron emission tomography (PET) image acquisition. The present study investigates the impact of amplitude-based optimal respiratory gating (ORG) on quantification of PET-derived image features in patients with pancreatic ductal adenocarcinoma (PDAC), in correlation with overall survival (OS). METHODS: Sixty-nine patients with histologically proven primary PDAC underwent 2'-deoxy-2'-[18F]fluoroglucose ([18F]FDG) PET/CT imaging during diagnostic work-up. Standard image acquisition and reconstruction was performed in accordance with the EANM guidelines and ORG images were reconstructed with a duty cycle of 35%. PET-derived image features, including standard parameters, first- and second-order texture features, were calculated from the standard and corresponding ORG images, and correlation with OS was assessed. RESULTS: ORG significantly impacts the quantification of nearly all features; values of single-voxel parameters (e.g., SUVmax) showed a wider range, volume-based parameters (e.g., SUVmean) were reduced, and texture features were significantly changed. After correction for motion artifacts using ORG, some features that describe intra-tumoral heterogeneity were more strongly correlated to OS. CONCLUSIONS: Correction for respiratory motion artifacts using ORG impacts the quantification of metabolic parameters in PDAC lesions. The correlation of metabolic parameters with OS was significantly affected, in particular parameters that describe intra-tumor heterogeneity. Therefore, interpretation of single-voxel or average metabolic parameters in relation to clinical outcome should be done cautiously. Furthermore, ORG is a valuable tool to improve quantification of intra-tumoral heterogeneity in PDAC.

Development and implementation of a clinical pathway for cardiac surgery in the intensive care unit: Effects on protocol adherence.

RATIONALE, AIMS AND OBJECTIVES: Cardiac surgery (CS) is facilitated by multiple perioperative guidelines and protocols. Use of a clinical pathway (CP) may facilitate the care of these patients. METHODS: This is a pre-post design study in the ICU of a tertiary referral centre. A CP for CS patients in the ICU was developed by ICU-nurses and enabled them to execute proactively predefined actions in accordance with and within the preset boundaries which were part of a variance report. A tailored implementation strategy was used. Primary outcome measure was protocol adherence above 80% on the domains of blood pressure control, action on chest tube blood loss and electrolyte control within the CP. RESULTS: In a 4-month period, 84 consecutive CP patients were included and compared with 162 matched control patients admitted in the year before implementation; 3 patients were excluded. Propensity score was used as matching parameter. CP patients were more likely to receive early adequate treatment for derangements in electrolytes (96% vs 47%, P < .001), blood pressure (90% vs 49%, P < .001) and adequate treatment for chest tube blood loss (90% vs 10%, P < .001). We found no differences in hospital and ICU LOS, ICU readmission or mortality. CONCLUSION: Use of the CP improved postoperative ICU treatment for cardiac surgical patients. Implementation of a CP and the use of a special variance report could be a blueprint for the implementation and use of a CP in low-volume high complex surgery.

Implementation and Evaluation of a Clinical Pathway for Pancreaticoduodenectomy Procedures: a Prospective Cohort Study.

INTRODUCTION: Medical and nursing protocols in perioperative care for pancreaticoduodenectomy are mainly mono-disciplinary, limiting their integration and transparency in a continuous health care system. The aims of this study were to evaluate adherence to a multidisciplinary clinical pathway for all pancreaticoduodenectomy patients during their entire hospital stay and to determine if the use of this clinical pathway is associated with beneficial effects on clinical end points. MATERIALS AND METHODS: A prospective cohort study was conducted in 95 pancreaticoduodenectomy patients treated according to a clinical pathway, including a variance report, compared to a historical control group (n = 52) with a traditional treatment regime. RESULTS: Process evaluation of the clinical pathway group revealed that protocol adherence throughout all units was above 80%. Major complications according to Clavien-Dindo classification grade ≥3 decreased from 27 to 13%; p = 0.02. Hospital length of stay was significantly shorter in the clinical pathway group, median 10 days [IQR 8-15], compared with the control group, median 13 days [IQR 10-18]; p = 0.02. CONCLUSION: The use of a clinical pathway in pancreaticoduodenectomy patients was associated with high protocol adherence, improved outcome and shorter hospital length of stay. Variance report analysis and protocol adherence with a Prepare-Act-Reflect Cycle are essential in surveillance of outcome.

Chronic Localized Back Pain Due to Posterior Cutaneous Nerve Entrapment Syndrome (POCNES): A New Diagnosis.

Most patients with chronic back pain suffer from degenerative thoracolumbovertebral disease. However, the following case illustrates that a localized peripheral nerve entrapment must be considered in the differential diagnosis of chronic back pain. We report the case of a 26-year-old woman with continuous excruciating pain in the lower back area. Previous treatment for nephroptosis was to no avail. On physical examination the pain was present in a 2 x 2 cm area overlying the twelfth rib some 4 cm lateral to the spinal process. Somatosensory testing using swab and alcohol gauze demonstrated the presence of skin hypo- and dysesthesia over the painful area. Local pressure on this painful spot elicited an extreme pain response that did not irradiate towards the periphery. These findings were highly suggestive of a posterior version of the anterior cutaneous nerve entrapment syndrome (ACNES), a condition leading to a severe localized neuropathic pain in anterior portions of the abdominal wall. She demonstrated a beneficial albeit temporary response after lidocaine infiltration as dictated by an established diagnostic and treatment protocol for ACNES. She subsequently underwent a local neurectomy of the involved superficial branch of the intercostal nerve. This limited operation had a favorable outcome resulting in a pain-free return to normal activities up to this very day (follow-up of 24 months).We propose to name this novel syndrome "posterior cutaneous nerve entrapment syndrome" (POCNES). Each patient with chronic localized back pain should undergo simple somatosensory testing to detect the presence of overlying skin hypo- and dysesthesia possibly reflecting an entrapped posterior cutaneous nerve.Key words: Chronic pain, back pain, posterior cutaneous nerve entrapment, peripheral nerve entrapment, surgical treatment for pain, anterior cutaneous nerve entrapment.

Assessment of available evidence in the management of gallbladder and bile duct stones: a systematic review of international guidelines.

BACKGROUND: Gallstone disease is a frequent disorder in the Western world with a prevalence of 10-20%. Recommendations for the assessment and management of gallstones vary internationally. The aim of this systematic review was to assess quality of guideline recommendations for treatment of gallstones. METHODS: PubMed, EMBASE and websites of relevant associations were systematically searched. Guidelines without a critical appraisal of literature were excluded. Quality of guidelines was determined using the AGREE II instrument. Recommendations without consensus or with low level of evidence were considered to define problem areas and clinical research gaps. RESULTS: Fourteen guidelines were included. Overall quality of guidelines was low, with a mean score of 57/100 (standard deviation 19). Five of 14 guidelines were considered suitable for use in clinical practice without modifications. Ten recommendations from all included guidelines were based on low level of evidence and subject to controversy. These included major topics, such as definition of symptomatic gallstones, indications for cholecystectomy and intraoperative cholangiography. CONCLUSION: Only five guidelines on gallstones are evidence-based and of a high quality, but even in these controversy exists on important topics. High quality evidence is needed in specific areas before an international guideline can be developed and endorsed worldwide.

A Multifaceted Nurse- and Web-Based Intervention for Improving Adherence to Treatment in Patients With Cardiovascular Disease: Rationale and Design of the MIRROR Trial.

BACKGROUND: Poor adherence to medication is one of the limitations in the treatment of cardiovascular diseases, thereby increasing the risk of premature death, hospital admissions, and related costs. There is a need for simple and easy-to-implement interventions that are based on patients' perspectives, beliefs, and perceptions of their illness and medication. OBJECTIVE: The objective is to test the effectivity of this intervention to improve medication adherence in patients with established cardiovascular disease, that is, in secondary prevention. METHODS: In this study the effect of a personalized visualization of cardiovascular risk levels through a website aiming at supporting self management in combination with a group consultation and communication intervention by a nurse on adherence to treatment in 600 patients with manifest cardiovascular diseases will be assessed. The health belief model was chosen as main theoretical model for the intervention. RESULTS: Primary outcome is adherence to treatment calculated by refill data. Secondary outcomes include the Beliefs about Medication Questionnaire and the Modified Morisky Scale. Patients are followed for one year. Results are expected by 2015. CONCLUSIONS: This study assesses adherence to treatment in a high-risk cardiovascular population by applying an intervention that addresses patients' capacity and practical barriers as well as patients' beliefs and perceptions of their illness and medication. CLINICALTRIAL: ClinicalTrials.gov NCT01449695; https://clinicaltrials.gov/ct2/show/NCT01449695 (Archived by WebCite at http://www.webcitation.org/6kCzkIKH3).

What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review.

BACKGROUND: Laparoscopic surgery has several advantages when compared to open surgery, including faster postoperative recovery and lower pain scores. However, for laparoscopy, a pneumoperitoneum is required to create workspace between the abdominal wall and intraabdominal organs. Increased intraabdominal pressure may also have negative implications on cardiovascular, pulmonary, and intraabdominal organ functionings. To overcome these negative consequences, several trials have been performed comparing low- versus standard-pressure pneumoperitoneum. METHODS: A systematic review of all randomized controlled clinical trials and observational studies comparing low- versus standard-pressure pneumoperitoneum. RESULTS AND CONCLUSIONS: Quality assessment showed that the overall quality of evidence was moderate to low. Postoperative pain scores were reduced by the use of low-pressure pneumoperitoneum. With appropriate perioperative measures, the use of low-pressure pneumoperitoneum does not seem to have clinical advantages as compared to standard pressure on cardiac and pulmonary function. Although there are indications that low-pressure pneumoperitoneum is associated with less liver and kidney injury when compared to standard-pressure pneumoperitoneum, this does not seem to have clinical implications for healthy individuals. The influence of low-pressure pneumoperitoneum on adhesion formation, anastomosis healing, tumor metastasis, intraocular and intracerebral pressure, and thromboembolic complications remains uncertain, as no human clinical trials have been performed. The influence of pressure on surgical conditions and safety has not been established to date. In conclusion, the most important benefit of low-pressure pneumoperitoneum is lower postoperative pain scores, supported by a moderate quality of evidence. However, the quality of surgical conditions and safety of the use of low-pressure pneumoperitoneum need to be established, as are the values and preferences of physicians and patients regarding the potential benefits and risks. Therefore, the recommendation to use low-pressure pneumoperitoneum during laparoscopy is weak, and more studies are required.

Comparison of the effectiveness of low pressure pneumoperitoneum with profound muscle relaxation during laparoscopic donor nephrectomy to optimize the quality of recovery during the early post-operative phase: study protocol for a randomized controlled clinical trial.

BACKGROUND: Since technique modifications of laparoscopic donor nephrectomy, e.g. retroperitoneoscopic donor nephrectomy or hand-assistance, have not shown significant benefit regarding safety or improvement of recovery, further research should focus on improving postoperative recovery. The use of low pressure pneumoperitoneum has shown to significantly reduce postoperative pain after laparoscopy. To facilitate the use of low pressure pneumoperitoneum, deep neuromuscular block will be used. METHODS/DESIGN: This trial is a phase IV, single center, double-blind, randomized controlled clinical trial in which 64 patients will be randomized to: low pressure pneumoperitoneum (6 mmHg) and deep neuromuscular block or normal pressure pneumoperitoneum (12 mmHg) and deep neuromuscular block. Deep neuromuscular block is defined as post tetanic count < 5. Primary outcome measurement will be Quality of Recovery-40 questionnaire (overall score) on day 1. DISCUSSION: This study is the first randomized study to assess the combination of low pressure pneumoperitoneum in combination with deep neuromuscular block from a patients' perspective. The study findings may also be applicable for other laparoscopic procedures. TRIAL REGISTRATION: The trial was registered at trials.gov (NCT02146417) in July 2014.

Diclofenac causes anastomotic leakage in the proximal colon but not in the distal colon of the rat.

BACKGROUND: Nonsteroidal anti-inflammatory drugs have been associated with anastomotic leakage. It was studied if diclofenac affects anastomoses differently depending on the location in the gut. METHODS: Ninety-five rats were randomized to 6 groups with an anastomosis in either ileum (IL), proximal colon (PC), or distal colon (DC). Groups IL+ (n = 10), PC+ (n = 30), and DC+ (n = 10) received diclofenac (3 mg/kg/day) from day 0 until sacrifice on day 3. Group PC- (n = 15) did not receive diclofenac. Groups PC1+ and PC2+ (n = 15 each) were given diclofenac from day 1 to 4 and from day 2 to 5. RESULTS: Leak rates were 10/10 in group IL+, 22/30 in PC+, 1/10 in DC+, and 1/15 in PC-. Delayed administration of diclofenac by 1 or 2 days (6/15, P = .05) resulted in reduced leakage rates. Mechanical strength results corresponded with leak rates. CONCLUSIONS: Diclofenac causes leakage of anastomoses in rat IL and PC, but not in the DC. This suggests a role for the ileal and proximal colonic content in diclofenac-induced leakage.