Surgical treatment for locally advanced lower third rectal cancer after neoadjuvent chemoradiation with capecitabine: prospective phase II trial

<p>Abstract</p> <p>Introduction</p> <p>Treatment of rectal cancer requires a multidisciplinary approach with standardized surgical, pathological and radiotherapeutic procedures. Sphincter preserving surgery for cancer of the lower rectum needs a long-course of neoadjuvant treatments to reduce tumor volume, to induce down-staging that increases circumferential resection margin, and to facilitate surgery.</p> <p>Aim</p> <p>To evaluate the rate of anal sphincter preservation in low lying, resectable, locally advanced rectal cancer and the resectability rate in unresectable cases after neoadjuvent chemoradiation by oral Capecitabine.</p> <p>Patients and methods</p> <p>This trial included 43 patients with low lying (4–7 cm from anal verge) locally advanced rectal cancer, of which 33 were resectable. All patients received preoperative concurrent chemoradiation (45 Gy/25 fractions over 5 weeks with oral capecitabine 825 mg/m²twice daily on radiotherapy days), followed after 4–6 weeks by total mesorectal excision technique.</p> <p>Results</p> <p>Preoperative chemoradiation resulted in a complete pathologic response in 4 patients (9.3%; 95% CI 3–23.1) and an overall downstaging in 32 patients (74.4%; 95% CI 58.5–85). Sphincter sparing surgical procedures were done in 20 out of 43 patients (46.5%; 95% CI 31.5–62.2). The majority (75%) were of clinical T₃disease. Toxicity was moderate and required no treatment interruption. Grade II anemia occurred in 4 patients (9.3%, 95% CI 3–23.1), leucopenia in 2 patients (4.7%, 95% CI 0.8–17) and radiation dermatitis in 4 patients (9.3%, 95% CI 3–23.1) respectively.</p> <p>Conclusion</p> <p>In patients with low lying, locally advanced rectal cancer, preoperative chemoradiation using oral capecitabine 825 mg/m², twice a day on radiotherapy days, was tolerable and effective in downstaging and resulted in 46.5% anal sphincter preservation rate.</p

Disentangling molecular and clinical stratification patterns in beta-galactosidase deficiency

INTRODUCTION: This study aims to define the phenotypic and molecular spectrum of the two clinical forms of β-galactosidase (β-GAL) deficiency, GM1-gangliosidosis and mucopolysaccharidosis IVB (Morquio disease type B, MPSIVB). METHODS: Clinical and genetic data of 52 probands, 47 patients with GM1-gangliosidosis and 5 patients with MPSIVB were analysed. RESULTS: The clinical presentations in patients with GM1-gangliosidosis are consistent with a phenotypic continuum ranging from a severe antenatal form with hydrops fetalis to an adult form with an extrapyramidal syndrome. Molecular studies evidenced 47 variants located throughout the sequence of the GLB1 gene, in all exons except 7, 11 and 12. Eighteen novel variants (15 substitutions and 3 deletions) were identified. Several variants were linked specifically to early-onset GM1-gangliosidosis, late-onset GM1-gangliosidosis or MPSIVB phenotypes. This integrative molecular and clinical stratification suggests a variant-driven patient assignment to a given clinical and severity group. CONCLUSION: This study reports one of the largest series of b-GAL deficiency with an integrative patient stratification combining molecular and clinical features. This work contributes to expand the community knowledge regarding the molecular and clinical landscapes of b-GAL deficiency for a better patient management

American Society of Pain and Neuroscience Best Practice (ASPN) Guideline for the Treatment of Sacroiliac Disorders [Response to Letter]

Dawood Sayed,1 Timothy R Deer,2,3 Vinicius Tieppo Francio,1 Christopher M Lam,1 Kamil Sochacki,4 Nasir Hussain,5 Tristan E Weaver,5 Jay Karri,6,7 Vwaire Orhurhu,8,9 Natalie Holmes Strand,10 Jacqueline Soicher Weisbein,11 Jonathan M Hagedorn,12 Ryan S D&rsquo;Souza,12 Ryan R Budwany,2 Ahish Chitneni,13 Kasra Amirdelfan,14 Michael J Dorsi,15 Dan TD Nguyen,16 Christopher Bovinet,17 Alaa Abd-Elsayed18 1Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 2Pain Services, Spine and Nerve Center of the Virginias, Charleston, WV, USA; 3Anesthesiology and Pain Medicine, West Virginia University School of Medicine, Charleston, WV, USA; 4Department of Anesthesiology and Perioperative Medicine, Rutgers Robert Wood Johnson, New Brunswick, NJ, USA; 5Anesthesiology, the Ohio State University Wexner Medical Center, Columbus, OH, USA; 6Department of Orthopedic Surgery, University of Maryland School of Medicine, Baltimore, MD, USA; 7Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, USA; 8Department of Anesthesiology, University of Pittsburgh Medical Center, Williamsport, PA, USA; 9Pain Medicine, MVM Health, East Stroudsburg, PA, USA; 10Anesthesiology and Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 11Interventional Pain Management, Napa Valley Orthopaedic Medical Group, Napa, CA, USA; 12Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 13Department of Rehabilitation &amp; Regenerative Medicine, New York Presbyterian &ndash; Columbia &amp; Cornell, New York, NY, USA; 14Director of Clinical Research, Boomerang Healthcare, Walnut Creek, CA, USA; 15Neurosurgery, University of California Los Angeles, Los Angeles, CA, USA; 16Neuroradiology &amp; Pain Solutions of Oklahoma, Edmond, OK, USA; 17The Spine Center of SE Georgia, Brunswick, GA, USA; 18Anesthesiology, University of Wisconsin, Madison, WI, USACorrespondence: Dawood Sayed, Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA, Tel +1 785-550-5800, Email [email protected]

American Society of Pain and Neuroscience Best Practice (ASPN) Guideline for the Treatment of Sacroiliac Disorders

Dawood Sayed,1 Timothy R Deer,2,3 Vinicius Tieppo Francio,1 Christopher M Lam,1 Kamil Sochacki,4 Nasir Hussain,5 Tristan E Weaver,5 Jay Karri,6,7 Vwaire Orhurhu,8,9 Natalie Holmes Strand,10 Jacqueline Soicher Weisbein,11 Jonathan M Hagedorn,12 Ryan S D’Souza,12 Ryan R Budwany,2 Ahish Chitneni,13 Kasra Amirdelfan,14 Michael J Dorsi,15 Dan TD Nguyen,16 Christopher Bovinet,17 Alaa Abd-Elsayed18 1Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 2Pain Services, Spine and Nerve Center of the Virginias, Charleston, WV, USA; 3Anesthesiology and Pain Medicine, West Virginia University School of Medicine, Charleston, WV, USA; 4Department of Anesthesiology and Perioperative Medicine, Rutgers Robert Wood Johnson, New Brunswick, NJ, USA; 5Anesthesiology, the Ohio State University Wexner Medical Center, Columbus, OH, USA; 6Department of Orthopedic Surgery, University of Maryland School of Medicine, Baltimore, MD, USA; 7Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, USA; 8Department of Anesthesiology, University of Pittsburgh Medical Center, Williamsport, PA, USA; 9Pain Medicine, MVM Health, East Stroudsburg, PA, USA; 10Anesthesiology and Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 11Interventional Pain Management, Napa Valley Orthopaedic Medical Group, Napa, CA, USA; 12Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 13Department of Rehabilitation & Regenerative Medicine, New York Presbyterian – Columbia & Cornell, New York, NY, USA; 14Director of Clinical Research, Boomerang Healthcare, Walnut Creek, CA, USA; 15Neurosurgery, University of California Los Angeles, Los Angeles, CA, USA; 16Neuroradiology & Pain Solutions of Oklahoma, Edmond, OK, USA; 17The Spine Center of SE Georgia, Brunswick, GA, USA; 18Anesthesiology, University of Wisconsin, Madison, WI, USACorrespondence: Dawood Sayed, Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA, Tel +1 785-550-5800, Email [email protected]: Clinical management of sacroiliac disease has proven challenging from both diagnostic and therapeutic perspectives. Although it is widely regarded as a common source of low back pain, little consensus exists on the appropriate clinical management of sacroiliac joint pain and dysfunction. Understanding the biomechanics, innervation, and function of this complex load bearing joint is critical to formulating appropriate treatment algorithms for SI joint disorders. ASPN has developed this comprehensive practice guideline to serve as a foundational reference on the appropriate management of SI joint disorders utilizing the best available evidence and serve as a foundational guide for the treatment of adult patients in the United States and globally.Keywords: sacroiliac joint, sacroiliitis, chronic pain, best practices, radiofrequency ablation, sacroiliac joint fusio

Pooled analysis of who surgical safety checklist use and mortality after emergency laparotomy

Background: The World Health Organization (WHO) Surgical Safety Checklist has fostered safe practice for 10 years, yet its place in emergency surgery has not been assessed on a global scale. The aim of this study was to evaluate reported checklist use in emergency settings and examine the relationship with perioperative mortality in patients who had emergency laparotomy. Methods: In two multinational cohort studies, adults undergoing emergency laparotomy were compared with those having elective gastrointestinal surgery. Relationships between reported checklist use and mortality were determined using multivariable logistic regression and bootstrapped simulation. Results: Of 12 296 patients included from 76 countries, 4843 underwent emergency laparotomy. After adjusting for patient and disease factors, checklist use before emergency laparotomy was more common in countries with a high Human Development Index (HDI) (2455 of 2741, 89⋅6 per cent) compared with that in countries with a middle (753 of 1242, 60⋅6 per cent; odds ratio (OR) 0⋅17, 95 per cent c.i. 0⋅14 to 0⋅21, P &lt; 0⋅001) or low (363 of 860, 42⋅2 percent; OR 0⋅08, 0⋅07 to 0⋅10, P &lt; 0⋅001) HDI. Checklist use was less common in elective surgery than for emergency laparotomy in high-HDI countries (risk difference −9⋅4 (95 per cent c.i. −11⋅9 to −6⋅9) per cent; P &lt; 0⋅001), but the relationship was reversed in low-HDI countries (+12⋅1 (+7⋅0 to +17⋅3) per cent; P &lt; 0⋅001). In multivariable models, checklist use was associated with a lower 30-day perioperative mortality (OR 0⋅60, 0⋅50 to 0⋅73; P &lt; 0⋅001). The greatest absolute benefit was seen for emergency surgery in low-and middle-HDI countries. Conclusion: Checklist use in emergency laparotomy was associated with a significantly lower perioperative mortality rate. Checklist use in low-HDI countries was half that in high-HDI countries

Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study

Background Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. Methods This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231. Findings Between Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p<0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05–2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p<0·001). Interpretation Countries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication. Funding DFID-MRC-Wellcome Trust Joint Global Health Trial Development Grant, National Institute of Health Research Global Health Research Unit Grant

Global variation in anastomosis and end colostomy formation following left-sided colorectal resection

Background End colostomy rates following colorectal resection vary across institutions in high-income settings, being influenced by patient, disease, surgeon and system factors. This study aimed to assess global variation in end colostomy rates after left-sided colorectal resection. Methods This study comprised an analysis of GlobalSurg-1 and -2 international, prospective, observational cohort studies (2014, 2016), including consecutive adult patients undergoing elective or emergency left-sided colorectal resection within discrete 2-week windows. Countries were grouped into high-, middle- and low-income tertiles according to the United Nations Human Development Index (HDI). Factors associated with colostomy formation versus primary anastomosis were explored using a multilevel, multivariable logistic regression model. Results In total, 1635 patients from 242 hospitals in 57 countries undergoing left-sided colorectal resection were included: 113 (6·9 per cent) from low-HDI, 254 (15·5 per cent) from middle-HDI and 1268 (77·6 per cent) from high-HDI countries. There was a higher proportion of patients with perforated disease (57·5, 40·9 and 35·4 per cent; P < 0·001) and subsequent use of end colostomy (52·2, 24·8 and 18·9 per cent; P < 0·001) in low- compared with middle- and high-HDI settings. The association with colostomy use in low-HDI settings persisted (odds ratio (OR) 3·20, 95 per cent c.i. 1·35 to 7·57; P = 0·008) after risk adjustment for malignant disease (OR 2·34, 1·65 to 3·32; P < 0·001), emergency surgery (OR 4·08, 2·73 to 6·10; P < 0·001), time to operation at least 48 h (OR 1·99, 1·28 to 3·09; P = 0·002) and disease perforation (OR 4·00, 2·81 to 5·69; P < 0·001). Conclusion Global differences existed in the proportion of patients receiving end stomas after left-sided colorectal resection based on income, which went beyond case mix alone

The American Society of Pain and Neuroscience (ASPN) Guidelines for Radiofrequency Ablative Procedures in Patients with Implanted Devices

Timothy Sowder,1 Dawood Sayed,1 Tyler Concannon,1 Scott H Pew,2 Natalie H Strand,2 Alaa Abd-Elsayed,3 Christopher S Wie,2 Daniel E Gomez Ramos,4 Ahmed M Raslan,5 Timothy R Deer6 1Department of Anesthesiology, University of Kansas Medical Center, Kansas City, KS, USA; 2Department of Anesthesiology, Mayo Clinic, Phoenix, AZ, USA; 3Department of Anesthesiology, University of Wisconsin, Madison, WI, USA; 4Department of Neurology, Mayo Clinic, Phoenix, AZ, USA; 5Department of Neurological Surgery, Oregon Health and Science University, Portland, OR, USA; 6The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Timothy Sowder, Department of Anesthesiology, University of Kansas Medical Center, 3901 Rainbow Boulevard, Mail Stop 1034, Kansas City, KS, 66160, USA, Tel +1-913-588-6670, Fax +1-913-588-3365, Email [email protected]: Radiofrequency ablation (RFA) is a treatment modality used in interventional pain management to treat several conditions including chronic neck or back pain, sacroiliac joint pain, major joint pain, and pain from sites that can be isolated to a sensory nerve amenable to RFA. The goals of such procedures are to reduce pain, improve function, delay need for surgical intervention, and reduce pain medication consumption. As applications for RFA expand through novel techniques and nerve targets, there is concern with how RFA may impact patients with implanted medical devices. Specifically, the electrical currents used in RFA produce electromagnetic interference, which can result in unintentional energy transfer to implanted devices. This may also interfere with device function or cause damage to the device itself. As the number of patients with implanted devices increases, it is imperative to establish guidelines for the management of implanted devices during RFA procedures. This review aims to establish guidelines to assist physicians in the preoperative, intraoperative, and postoperative management of implanted devices in patients undergoing procedures using radiofrequency energy. Here, we provide physicians with background knowledge and a summary of current evidence to allow safe utilization of RFA treatment in patients with implanted devices such as cardiac implantable electronic devices, spinal cord stimulators, intrathecal pumps, and deep brain stimulators. While these guidelines are intended to be comprehensive, each patient should be assessed on an individual basis to optimize outcomes.Keywords: radiofrequency ablation, implanted medical devices, cardiac implantable electronic device, spinal cord stimulator, intrathecal pump, deep brain stimulato

Chronic Hepatitis C Patients with Obesity: Do We Need Two Operators for Accurate Evaluation of Liver Stiffness?

Introduction and aim. Transient elastography is gaining popularity as a non-invasive method for predicting liver fibrosis, but inter observer agreement and factors influencing reproducibility have not been adequately assessed.Material and methods. This cross-sectional study was conducted at Specialized Medical Hospital and the Egyptian Liver Foundation, Mansoura, Egypt. The inclusion criteria were: age older than 18 years and chronic infection by hepatitis C. The exclusion criteria were the presence of ascites, pacemaker or pregnancy. Three hundred and fifty-six patients participated in the study. Therefore, 356 pairs of exams were done by two operators on the same day.Results. The overall inter observer agreement ICC was 0.921. The correlation the two operators was excellent (Spearman’s value q = 0.808, p < 0.001). Inter-observer reliability values were κ = 0.557 (p < 0.001). A not negligible discordance of fibrosis staging between operators was observed (87 cases, 24.4%). Discordance of at least one stage and for two or more stages of fibrosis occurred in 60 (16.9%) and 27 cases (7.6%) respectively. Obesity (BMI ≥ 30 kg/m2) is the main factor associated with discordance (p = 0.002).Conclusion. Although liver stiffness measurement has had an excellent correlation between the two operators, TE presented an inter-observer variability that may not be negligible