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

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 <0001) or low (363 of 860, 422 per cent; OR 008, 007 to 010, P <0.001) HDI. Checklist use was less common in elective surgery than for emergency laparotomy in high-HDI countries (risk difference -94 (95 per cent c.i. -11.9 to -6.9) per cent; P <0001), but the relationship was reversed in low-HDI countries (+121 (+7.0 to +173) per cent; P <0001). In multivariable models, checklist use was associated with a lower 30-day perioperative mortality (OR 0.60, 0.50 to 073; P <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.Peer reviewe

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

Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation: A Proposal for Standardization in Fellowship and Training Programs

Scott G Pritzlaff,1 Johnathan H Goree,2 Jonathan M Hagedorn,3 David W Lee,4 Kenneth B Chapman,5 Sandy Christiansen,6 Andrew Dudas,7 Alexander Escobar,8 Christopher J Gilligan,9 Maged Guirguis,10 Amitabh Gulati,11 Jessica Jameson,12 Christopher J Mallard,13 Melissa Murphy,14 Kiran V Patel,15 Raj G Patel,16 Samir J Sheth,17 Stephanie Vanterpool,18 Vinita Singh,19 Gregory Smith,2 Natalie H Strand,20 Chau M Vu,21 Tolga Suvar,22 Krishnan Chakravarthy,23 Leonardo Kapural,24 Michael S Leong,25 Timothy R Lubenow,22 Alaa Abd-Elsayed,26 Jason E Pope,21 Dawood Sayed,27 Timothy R Deer28 1Department of Anesthesiology and Pain Medicine, University of California, Davis, Sacramento, CA, USA; 2Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 3Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Mayo Clinic, Rochester, MN, USA; 4Fullerton Orthopedic Surgery Medical Group, Fullerton, CA, USA; 5The Spine & Pain Institute of New York, New York, NY, USA; 6Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA; 7Mays & Schnapp Neurospine and Pain, Memphis, TN, USA; 8Department of Anesthesiology, University of Toledo, Toledo, OH, USA; 9Division of Pain Medicine, Brigham and Women’s Hospital Harvard Medical School, Boston, MA, USA; 10Division of Pain Management, Ochsner Health, New Orleans, LA, USA; 11Department of Anesthesiology and Critical Care, Memorial Sloan Kettering Cancer Center, New York, NY, USA; 12Axis Spine Center, Coeur D’Alene, ID, USA; 13Department of Anesthesiology, University of Kentucky, Lexington, KY, USA; 14North Texas Orthopedics and Spine Center, Grapevine, TX, USA; 15Department of Anesthesiology and Pain Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, NY, USA; 16Capitol Pain Institute, Austin, TX, USA; 17Interventional Pain Management, Sutter Health, Roseville, CA, USA; 18Department of Anesthesiology, University of Tennessee, Knoxville, TN, USA; 19Department of Anesthesiology, Emory University, Atlanta, GA, USA; 20Interventional Pain Management, Mayo Clinic, Scottsdale, AZ, USA; 21Evolve Restorative Center, Santa Rosa, CA, USA; 22Department of Anesthesiology and Pain Medicine, Rush University Medical Center, Chicago, IL, USA; 23Coastal Pain and Spinal Diagnostics Medical Group, San Diego, CA, USA; 24Carolinas Pain Institute, Winston-Salem, NC, USA; 25Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, CA, USA; 26Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; 27Department of Anesthesiology, Pain and Perioperative Medicine, University of Kansas, Kansas City, KS, USA; 28The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Scott G Pritzlaff, University of California, Davis, 4860 Y Street, Suite 3020, Sacramento, CA, 95817, USA, Tel +1 916 734-6824, Fax +1 916 734-6827, Email [email protected]: The need to be competent in neuromodulation is and should be a prerequisite prior to completing a fellowship in interventional pain medicine. Unfortunately, many programs lack acceptable candidates for these advanced therapies, and fellows may not receive adequate exposure to neuromodulation procedures. The American Society of Pain and Neuroscience (ASPN) desires to create a consensus of experts to set a minimum standard of competence for neurostimulation procedures, including spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRG-S), and peripheral nerve stimulation (PNS). The executive board of ASPN accepted nominations for colleagues with excellence in the subject matter of neuromodulation and physician education. This diverse group used peer-reviewed literature and, based on grading of evidence and expert opinion, developed critical consensus guides for training that all accredited fellowship programs should adopt. For each consensus point, transparency and recusal were used to eliminate bias, and an author was nominated for evidence grading oversight and bias control. Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation sets a standard for neuromodulation training in pain fellowship training programs. The consensus panel has determined several recommendations to improve care in the United States for patients undergoing neuromodulation. As neuromodulation training in the United States has evolved dramatically, these therapies have become ubiquitous in pain medicine. Unfortunately, fellowship programs and the Accreditation Council for Graduate Medical Education (ACGME) pain program requirements have not progressed training to match the demands of modern advancements. PEAK sets a new standard for fellowship training and presents thirteen practice areas vital for physician competence in neuromodulation.Keywords: neuromodulation, pain education, spinal cord stimulation, dorsal root ganglion stimulation, peripheral nerve stimulation, fellowship trainin