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Sample records for surgery study protocol

  1. Patient profiling for success after weight loss surgery (GO Bypass study: An interdisciplinary study protocol

    Directory of Open Access Journals (Sweden)

    Bodil Just Christensen

    2018-06-01

    Full Text Available Despite substantial research efforts, the mechanisms proposed to explain weight loss after gastric bypass (RYGB and sleeve gastrectomy (SL do not explain the large individual variation seen after these treatments. A complex set of factors are involved in the onset and development of obesity and these may also be relevant for the understanding of why success with treatments vary considerably between individuals. This calls for explanatory models that take into account not only biological determinants but also behavioral, affective and contextual factors. In this prospective study, we recruited 47 women and 8 men, aged 25–56 years old, with a BMI of 45.8 ± 7.1 kg/m2 from the waiting list for RYGB and SL at Køge hospital, Denmark. Pre-surgery and 1.5, 6 and 18 months after surgery we assessed various endpoints spanning multiple domains. Endpoints were selected on basis of previous studies and include: physiological measures: anthropometrics, vital signs, biochemical measures and appetite hormones, genetics, gut microbiota, appetite sensation, food and taste preferences, neural sensitivity, sensory perception and movement behaviors; psychological measures: general psychiatric symptom-load, depression, eating disorders, ADHD, personality disorder, impulsivity, emotion regulation, attachment pattern, general self-efficacy, alexithymia, internalization of weight bias, addiction, quality of life and trauma; and sociological and anthropological measures: sociodemographic measures, eating behavior, weight control practices and psycho-social factors.Joining these many endpoints and methodologies from different scientific disciplines and creating a multi-dimensional predictive model has not previously been attempted. Data on the primary endpoint are expected to be published in 2018. Trial registration: Clinicaltrials. gov ID NCT02070081. Keywords: Gastric bypass (RYGB, Sleeve gastrectomy, Weight loss, Interdisciplinary, Study protocol

  2. Enhanced Recovery After Surgery Protocols in Major Urologic Surgery

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    Natalija Vukovic

    2018-04-01

    Full Text Available The purpose of the reviewThe analysis of the components of enhanced recovery after surgery (ERAS protocols in urologic surgery.Recent findingsERAS protocols has been studied for over 20 years in different surgical procedures, mostly in colorectal surgery. The concept of improving patient care and reducing postoperative complications was also applied to major urologic surgery and especially procedure of radical cystectomy. This procedure is technically challenging, due to a major surgical resection and high postoperative complication rate that may reach 65%. Several clinical pathways were introduced to improve perioperative course and reduce the length of hospital stay. These protocols differ from ERAS modalities in other surgeries. The reasons for this are longer operative time, increased risk of perioperative transfusion and infection, and urinary diversion achieved using transposed intestinal segments. Previous studies in this area analyzed the need for mechanical bowel preparation, postoperative nasogastric tube decompression, as well as the duration of urinary drainage. Furthermore, the attention has also been drawn to perioperative fluid optimization, pain management, and bowel function.SummaryNotwithstanding partial resemblance between the pathways in major urologic surgery and other pelvic surgeries, there are still scarce guidelines for ERAS protocols in urology, which is why further studies should assess the importance of preoperative medical optimization, implementation of thoracic epidural anesthesia and analgesia, and perioperative nutritional management.

  3. Early complication detection after colorectal surgery (CONDOR): study protocol for a prospective clinical diagnostic study

    NARCIS (Netherlands)

    Kornmann, Verena; van Ramshorst, Bert; van Dieren, Susan; van Geloven, Nanette; Boermeester, Marja; Boerma, Djamila

    2016-01-01

    Anastomotic leakage is one of the most feared complications following colorectal surgery with a high morbidity and mortality rate. Multiple risk factors have been identified, but leakage still occurs. Early detection is crucial in order to reduce morbidity and mortality. The aim of this study is to

  4. Antibiotic prophylaxis audit and questionnaire study: Traffic Light Poster improves adherence to protocol in gastrointestinal surgery.

    Science.gov (United States)

    Cameron, Michaella; Jones, Stacey; Adedeji, Olufunso

    2015-07-01

    To measure adherence to antibiotic prophylaxis (AP) protocol amongst surgeons and anesthetists and explore their understanding of AP prescribing in practice. A prospective audit of AP in gastrointestinal surgery and re-audit after intervention. A questionnaire survey of practice. 58 (38%- clean; 62%- clean contaminated) operations were audited and 73 (48%-clean; 51%-clean contaminated) operations were re-audited after intervention with "Traffic Light Poster" (TFP) .55 colleagues (32 consultants and 23 trainees) were recruited for questionnaire survey in three West Midlands hospitals. Audit and Re-Audits. Only 31% of procedures followed the protocol correctly in the initial audit and this increased to 73% in the re-audit. 73% of patients undergoing clean procedures received AP inappropriately in the initial audit but reduced significantly to 20% (p audit. In the initial audit, 62% of clean contaminated procedures did not receive the appropriate first line AP but this fell to 35% (p audit. Questionnaire Survey- Only 30% of respondents would not give AP in clean surgery as recommended. 45% would use appropriate AP for clean-contaminated wounds. 73% of respondents will give AP at induction, 20% 1 h pre op and 7% just before incision. There is poor compliance with AP protocols in gastrointestinal surgery in part due to general lack of awareness. An educational intervention in the form of a 'Traffic Light Poster' improved adherence to AP protocol two fold. There was improved rationalizing of AP. Clean procedures, in particular, had less inappropriate prescribing. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  5. The Protocol for the Early vs. Late Infantile Strabismus Surgery Study

    NARCIS (Netherlands)

    H.J. Simonsz (Huib)

    1993-01-01

    textabstractAbstract. The Early vs. Late Infantile Strabismus SurgerY Study Group is a group of strabismologists and orthoptists who investigate whether early or late surgery is preferable in infantile strabismus, in a non-randomized, prospective, multi-centre trial. Infants between 6 and 18 months

  6. Beyond repair - family and community reintegration after obstetric fistula surgery: study protocol.

    Science.gov (United States)

    Byamugisha, Josaphat; El Ayadi, Alison; Obore, Susan; Mwanje, Haruna; Kakaire, Othman; Barageine, Justus; Lester, Felicia; Butrick, Elizabeth; Korn, Abner; Nalubwama, Hadija; Knight, Sharon; Miller, Suellen

    2015-12-18

    Obstetric fistula is a debilitating birth injury that affects an estimated 2-3 million women globally, most in sub-Saharan Africa and Asia. The urinary and/or fecal incontinence associated with fistula affects women physically, psychologically and socioeconomically. Surgical management of fistula is available with clinical success rates ranging from 65-95 %. Previous research on fistula repair outcomes has focused primarily on clinical outcomes without considering the broader goal of successful reintegration into family and community. The objectives for this study are to understand the process of family and community reintegration post fistula surgery and develop a measurement tool to assess long-term success of post-surgical family and community reintegration. This study is an exploratory sequential mixed-methods design including a preliminary qualitative component comprising in-depth interviews and focus group discussions to explore reintegration to family and community after fistula surgery. These results will be used to develop a reintegration tool, and the tool will be validated within a small longitudinal cohort (n = 60) that will follow women for 12 months after obstetric fistula surgery. Medical record abstraction will be conducted for patients managed within the fistula unit. Ethical approval for the study has been granted. This study will provide information regarding the success of family and community reintegration among women returning home after obstetric fistula surgery. The clinical and research community can utilize the standardized measurement tool in future studies of this patient population.

  7. Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Barbero, Cristina; Ricci, Davide; Cura Stura, Erik; Pellegrini, Augusto; Marchetto, Giovanni; ElQarra, Suad; Boffini, Massimo; Passera, Roberto; Valentini, Maria Consuelo; Rinaldi, Mauro

    2017-02-21

    Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature. The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp. A prospective, blinded, randomized controlled study on the rate of neurological embolizations during MIMVS started at the University of Turin in June 2014. Major, minor and silent neurological events are being investigated through standard neurological evaluation and magnetic resonance imaging assessment. The magnetic resonance imaging protocol includes conventional sequences for the morphological and quantitative assessment and nonconventional sequences for the white matter microstructural evaluation. Imaging studies are performed before surgery as baseline assessment and on the third postoperative day and, in patients who develop postoperative ischemic lesions, after 6 months. Despite recent concerns raised about the endoaortic setting with retrograde perfusion, we expect to show equivalence in terms of neurological events of this technique compared with the transthoracic clamp in a selected cohort of patients. With the first results expected in December 2016 the findings would be of help in confirming the efficacy and safety of MIMVS. ClinicalTrials.gov, Identifier: NCT02818166 . Registered on 8 February 2016 - trial retrospectively registered.

  8. Study protocol

    DEFF Research Database (Denmark)

    Smith, Benjamin E; Hendrick, Paul; Bateman, Marcus

    2017-01-01

    avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach....... DISCUSSION: This study will evaluate the feasibility of running a definitive large-scale trial on patients with patellofemoral pain, within the NHS in the UK. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from...... this study will inform the design of a multicentre trial. TRIAL REGISTRATION: ISRCTN35272486....

  9. Progressive resistance training and stretching following surgery for breast cancer: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ward Leigh C

    2006-12-01

    Full Text Available Abstract Background Currently 1 in 11 women over the age of 60 in Australia are diagnosed with breast cancer. Following treatment, most breast cancer patients are left with shoulder and arm impairments which can impact significantly on quality of life and interfere substantially with activities of daily living. The primary aim of the proposed study is to determine whether upper limb impairments can be prevented by undertaking an exercise program of prolonged stretching and resistance training, commencing soon after surgery. Methods/design We will recruit 180 women who have had surgery for early stage breast cancer to a multicenter single-blind randomized controlled trial. At 4 weeks post surgery, women will be randomly assigned to either an exercise group or a usual care (control group. Women allocated to the exercise group will perform exercises daily, and will be supervised once a week for 8 weeks. At the end of the 8 weeks, women will be given a home-based training program to continue indefinitely. Women in the usual care group will receive the same care as is now typically provided, i.e. a visit by the physiotherapist and occupational therapist while an inpatient, and receipt of pamphlets. All subjects will be assessed at baseline, 8 weeks, and 6 months later. The primary measure is arm symptoms, derived from a breast cancer specific questionnaire (BR23. In addition, range of motion, strength, swelling, pain and quality of life will be assessed. Discussion This study will determine whether exercise commencing soon after surgery can prevent secondary problems associated with treatment of breast cancer, and will thus provide the basis for successful rehabilitation and reduction in ongoing problems and health care use. Additionally, it will identify whether strengthening exercises reduce the incidence of arm swelling. Trial Registration The protocol for this study is registered with the Australian Clinical Trials Registry (ACTRN012606000050550.

  10. Efficacy of a high-observation protocol in major head and neck cancer surgery: A prospective study.

    Science.gov (United States)

    Barber, Brittany; Harris, Jeffrey; Shillington, Cameron; Rychlik, Shannon; Dort, Joseph; Meier, Michael; Estey, Angela; Elwi, Adam; Wickson, Patty; Buss, Michael; Zygun, David; Ansari, Kal; Biron, Vincent; O'Connell, Daniel; Seikaly, Hadi

    2017-08-01

    The purpose of this study was to optimize an existing clinical care pathway (CCP) for head and neck cancer with a high-observation protocol (HOP) and to determine the effect on length of intensive care unit (ICU) admission and length of stay in hospital (LOS). The HOP mandated initiation of spontaneous breathing trials before the conclusion of the surgery, weaning of sedation, and limiting mechanical ventilation. All patients with head and neck cancer undergoing primary surgery on the HOP were compared to a historical cohort regarding length of ICU admission, ICU readmissions, and LOS. Ninety-six and 52 patients were observed in "historical" and "HOP" cohorts. The length of ICU admission (1.9 vs 1.2 days; p = .021), LOS (20.3 vs 14.1 days; p = .020), and ICU readmissions (10.4% vs 1.9%; p = .013) were significantly decreased in the "HOP" cohort. Rapid weaning of sedation and limiting mechanical ventilation may contribute to a shorter length of ICU admission and LOS, as well as decreased ICU readmissions. © 2017 Wiley Periodicals, Inc. Head Neck 39: 1689-1695, 2016. © 2017 Wiley Periodicals, Inc.

  11. Laparoscopic colorectal surgery in learning curve: Role of implementation of a standardized technique and recovery protocol. A cohort study

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    Luglio, Gaetano; De Palma, Giovanni Domenico; Tarquini, Rachele; Giglio, Mariano Cesare; Sollazzo, Viviana; Esposito, Emanuela; Spadarella, Emanuela; Peltrini, Roberto; Liccardo, Filomena; Bucci, Luigi

    2015-01-01

    Background Despite the proven benefits, laparoscopic colorectal surgery is still under utilized among surgeons. A steep learning is one of the causes of its limited adoption. Aim of the study is to determine the feasibility and morbidity rate after laparoscopic colorectal surgery in a single institution, “learning curve” experience, implementing a well standardized operative technique and recovery protocol. Methods The first 50 patients treated laparoscopically were included. All the procedures were performed by a trainee surgeon, supervised by a consultant surgeon, according to the principle of complete mesocolic excision with central vascular ligation or TME. Patients underwent a fast track recovery programme. Recovery parameters, short-term outcomes, morbidity and mortality have been assessed. Results Type of resections: 20 left side resections, 8 right side resections, 14 low anterior resection/TME, 5 total colectomy and IRA, 3 total panproctocolectomy and pouch. Mean operative time: 227 min; mean number of lymph-nodes: 18.7. Conversion rate: 8%. Mean time to flatus: 1.3 days; Mean time to solid stool: 2.3 days. Mean length of hospital stay: 7.2 days. Overall morbidity: 24%; major morbidity (Dindo–Clavien III): 4%. No anastomotic leak, no mortality, no 30-days readmission. Conclusion Proper laparoscopic colorectal surgery is safe and leads to excellent results in terms of recovery and short term outcomes, even in a learning curve setting. Key factors for better outcomes and shortening the learning curve seem to be the adoption of a standardized technique and training model along with the strict supervision of an expert colorectal surgeon. PMID:25859386

  12. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    de Groot, Jeanny Ja; Maessen, José Mc; Slangen, Brigitte Fm; Winkens, Bjorn; Dirksen, Carmen D; van der Weijden, Trudy

    2015-07-30

    Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands. All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary

  13. Accuracy of a Computer-Aided Surgical Simulation (CASS) Protocol for Orthognathic Surgery: A Prospective Multicenter Study

    Science.gov (United States)

    Hsu, Sam Sheng-Pin; Gateno, Jaime; Bell, R. Bryan; Hirsch, David L.; Markiewicz, Michael R.; Teichgraeber, John F.; Zhou, Xiaobo; Xia, James J.

    2012-01-01

    Purpose The purpose of this prospective multicenter study was to assess the accuracy of a computer-aided surgical simulation (CASS) protocol for orthognathic surgery. Materials and Methods The accuracy of the CASS protocol was assessed by comparing planned and postoperative outcomes of 65 consecutive patients enrolled from 3 centers. Computer-generated surgical splints were used for all patients. For the genioplasty, one center utilized computer-generated chin templates to reposition the chin segment only for patients with asymmetry. Standard intraoperative measurements were utilized without the chin templates for the remaining patients. The primary outcome measurements were linear and angular differences for the maxilla, mandible and chin when the planned and postoperative models were registered at the cranium. The secondary outcome measurements were: maxillary dental midline difference between the planned and postoperative positions; and linear and angular differences of the chin segment between the groups with and without the use of the template. The latter was measured when the planned and postoperative models were registered at mandibular body. Statistical analyses were performed, and the accuracy was reported using root mean square deviation (RMSD) and Bland and Altman's method for assessing measurement agreement. Results In the primary outcome measurements, there was no statistically significant difference among the 3 centers for the maxilla and mandible. The largest RMSD was 1.0mm and 1.5° for the maxilla, and 1.1mm and 1.8° for the mandible. For the chin, there was a statistically significant difference between the groups with and without the use of the chin template. The chin template group showed excellent accuracy with largest positional RMSD of 1.0mm and the largest orientational RSMD of 2.2°. However, larger variances were observed in the group not using the chin template. This was significant in anteroposterior and superoinferior directions, as in

  14. Preoperative vestibular assessment protocol of cochlear implant surgery: an analytical descriptive study.

    Science.gov (United States)

    Bittar, Roseli Saraiva Moreira; Sato, Eduardo Setsuo; Ribeiro, Douglas Jósimo Silva; Tsuji, Robinson Koji

    Cochlear implants are undeniably an effective method for the recovery of hearing function in patients with hearing loss. To describe the preoperative vestibular assessment protocol in subjects who will be submitted to cochlear implants. Our institutional protocol provides the vestibular diagnosis through six simple tests: Romberg and Fukuda tests, assessment for spontaneous nystagmus, Head Impulse Test, evaluation for Head Shaking Nystagmus and caloric test. 21 patients were evaluated with a mean age of 42.75±14.38 years. Only 28% of the sample had all normal test results. The presence of asymmetric vestibular information was documented through the caloric test in 32% of the sample and spontaneous nystagmus was an important clue for the diagnosis. Bilateral vestibular areflexia was present in four subjects, unilateral arreflexia in three and bilateral hyporeflexia in two. The Head Impulse Test was a significant indicator for the diagnosis of areflexia in the tested ear (p=0.0001). The sensitized Romberg test using a foam pad was able to diagnose severe vestibular function impairment (p=0.003). The six clinical tests were able to identify the presence or absence of vestibular function and function asymmetry between the ears of the same individual. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  15. Study protocol

    DEFF Research Database (Denmark)

    Thorsteinsson, Troels; Helms, Anne Sofie; Adamsen, Lis

    2013-01-01

    , and problems related to interaction with peers. Methods/design The RESPECT study is a nationwide population-based prospective, controlled, mixed-methods intervention study looking at children aged 6-18 years newly diagnosed with cancer in eastern Denmark (n = 120) and a matched control group in western Denmark......, and one year after the cessation of treatment. The study is powered to quantify the impact of the combined educational, physical, and social intervention programs. Discussion RESPECT is the first population-based study to examine the effect of early rehabilitation for children with cancer, and to use...

  16. Effects of a surgical ward care protocol following open colon surgery as part of an enhanced recovery after surgery programme.

    Science.gov (United States)

    Kim, BoYeoul; Park, SungHee; Park, KyuJoo; Ryoo, SeungBum

    2017-11-01

    To investigate the effects of a standardised care protocol as part of an enhanced recovery after surgery programme on the management of patients who underwent open colon surgery at the University Hospital, South Korea. Patients who undergo open colon surgery often have concerns about their care as they prepare for hospitalisation. By shortening hospital stay lengths, enhanced recovery after surgery programmes could reduce the number of opportunities for patient education and communication with nurses. Therefore, our surgical team developed an enhanced recovery after surgery programme, applied using a care protocol for patients with colorectal cancer, that spans the entire recovery process. A retrospective, comparative study was conducted using a care protocol as part of an enhanced recovery after surgery programme. Comparisons were made before and after the implementation of an enhanced recovery after surgery programme with a care protocol. Records of 219 patients who underwent open colon surgery were retrospectively audited. The records were grouped according to the care protocol used (enhanced recovery after surgery programme with a care protocol or traditional care programme). The outcomes, including postoperative bowel function recovery, postoperative pain control, recovery time and postoperative complications, were compared between two categories. Patients who were managed using the programme with a care protocol had shorter hospital stays, fewer complications, such as postoperative ileus wound infections, and emergency room visits than those who were managed using the traditional care programme. The findings can be used to facilitate the implementation of an enhanced recovery after surgery programme with a care protocol following open colon surgery. We present a care protocol that enables effective management using consistent and standardised education providing bedside care for patients who undergo open colon surgery. This care protocol empowers long

  17. Redundant systematic reviews on the same topic in surgery: a study protocol for a meta-epidemiological investigation.

    Science.gov (United States)

    Katsura, Morihiro; Kuriyama, Akira; Tada, Masafumi; Yamamoto, Kazumichi; Furukawa, Toshi A

    2017-08-21

    We are witnessing an explosive increase in redundant and overlapping publications of systematic reviews and meta-analyses (SRs/MAs) on the same topic, which often present conflicting results and interpretations, in the current medical literature. They represent wasted efforts on the part of investigators and peer reviewers and may confuse and possibly mislead clinicians and policymakers. Here, we present a protocol for a meta-epidemiological investigation to describe how often there are overlapping SRs/MAs on the same topic, to assess the quality of these multiple publications, and to investigate the causes of discrepant results between multiple SRs/MAs in the field of major surgery. We will use MEDLINE/PubMed to identify all SRs/MAs of randomised controlled trials (RCTs) published in 2015 regarding major surgical interventions. After identifying the 'benchmark' SRs/MAs published in 2015, a process of screening in MEDLINE will be carried out to identify the previous SRs/MAs of RCTs on the same topic that were published within 5 years of the 'benchmark' SRs/MAs. We will tabulate the number of previous SRs/MAs on the same topic of RCTs, and then describe their variations in numbers of RCTs included, sample sizes, effect size estimates and other characteristics. We will also assess the differences in quality of each SR/MA using A Measurement Tool to Assess Systematic Reviews (AMSTAR) score. Finally, we will investigate the potential reasons to explain the discrepant results between multiple SRs/MAs. No formal ethical approval and informed consent are required because this study will not collect primary individual data. The intended audiences of the findings include clinicians, healthcare researchers and policymakers. We will publish our findings as a scientific report in a peer-reviewed journal. In PROSPERO CRD42017059077, March 2017. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial

  18. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  19. Normothermic versus hypothermic cardiopulmonary bypass in children undergoing open heart surgery (thermic-2): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Baos, Sarah; Sheehan, Karen; Culliford, Lucy; Pike, Katie; Ellis, Lucy; Parry, Andrew J; Stoica, Serban; Ghorbel, Mohamed T; Caputo, Massimo; Rogers, Chris A

    2015-05-25

    During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body ("perfusion") while the heart is stopped. Typically the blood is cooled during this procedure ("hypothermia") and warmed to normal body temperature once the operation has been completed. The main rationale for "whole body cooling" is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body's metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery ("normothermia"). However, the two techniques have not been extensively compared in children. The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of

  20. Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.

    Science.gov (United States)

    Abdullah, Hairil Rizal; Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang

    2017-08-04

    Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. NCT02921932 (ClinicalTrials.gov). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  1. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Spieth, Peter M; Güldner, Andreas; Uhlig, Christopher; Bluth, Thomas; Kiss, Thomas; Schultz, Marcus J; Pelosi, Paolo; Koch, Thea; Gama de Abreu, Marcelo

    2014-05-02

    General anesthesia usually requires mechanical ventilation, which is traditionally accomplished with constant tidal volumes in volume- or pressure-controlled modes. Experimental studies suggest that the use of variable tidal volumes (variable ventilation) recruits lung tissue, improves pulmonary function and reduces systemic inflammatory response. However, it is currently not known whether patients undergoing open abdominal surgery might benefit from intraoperative variable ventilation. The PROtective VARiable ventilation trial ('PROVAR') is a single center, randomized controlled trial enrolling 50 patients who are planning for open abdominal surgery expected to last longer than 3 hours. PROVAR compares conventional (non-variable) lung protective ventilation (CV) with variable lung protective ventilation (VV) regarding pulmonary function and inflammatory response. The primary endpoint of the study is the forced vital capacity on the first postoperative day. Secondary endpoints include further lung function tests, plasma cytokine levels, spatial distribution of ventilation assessed by means of electrical impedance tomography and postoperative pulmonary complications. We hypothesize that VV improves lung function and reduces systemic inflammatory response compared to CV in patients receiving mechanical ventilation during general anesthesia for open abdominal surgery longer than 3 hours. PROVAR is the first randomized controlled trial aiming at intra- and postoperative effects of VV on lung function. This study may help to define the role of VV during general anesthesia requiring mechanical ventilation. Clinicaltrials.gov NCT01683578 (registered on September 3 3012).

  2. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Barone Mark A

    2012-03-01

    Full Text Available Abstract Background A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. Methods/Design This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT comparing the new proposed short-term (7 day urethral catheterization to longer-term (14 day urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and

  3. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  4. Multidisciplinary perioperative protocol in patients undergoing acute high-risk abdominal surgery

    DEFF Research Database (Denmark)

    Tengberg, L. T.; Bay-Nielsen, M.; Bisgaard, T.

    2017-01-01

    Background: Acute high-risk abdominal (AHA) surgery carries a very high risk of morbidity and mortality and represents a massive healthcare burden. The aim of the present study was to evaluate the effect of a standardized multidisciplinary perioperative protocol in patients undergoing AHA surgery...... = 0·004). Conclusion: The introduction of a multidisciplinary perioperative protocol was associated with a significant reduction in postoperative mortality in patients undergoing AHA surgery. NCT01899885 (http://www.clinicaltrials.gov)....

  5. Study Protocol: Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma (Gamma-GBM).

    Science.gov (United States)

    Brehmer, Stefanie; Grimm, Mario Alexander; Förster, Alex; Seiz-Rosenhagen, Marcel; Welzel, Grit; Stieler, Florian; Wenz, Frederik; Groden, Christoph; Mai, Sabine; Hänggi, Daniel; Giordano, Frank Anton

    2018-04-24

    Glioblastoma (GBM) is the most common malignant brain tumor in adult patients. Tumor recurrence commonly occurs around the resection cavity, especially after subtotal resection (STR). Consequently, the extent of resection correlates with overall survival (OS), suggesting that depletion of postoperative tumor remnants will improve outcome. To assess safety and efficacy of adding stereotactic radiosurgery (SRS) to the standard treatment of GBM in patients with postoperative residual tumor. Gamma-GBM is a single center, open-label, prospective, single arm, phase II study that includes patients with newly diagnosed GBM (intraoperative via frozen sections) who underwent STR (residual tumor will be identified by native and contrast enhanced T1-weighted magnetic resonance imaging scans). All patients will receive SRS with 15 Gy (prescribed to the 50% isodose enclosing all areas of residual tumor) early (within 24-72 h) after surgery. Thereafter, all patients undergo standard-of-care therapy for GBM (radiochemotherapy with 60 Gy external beam radiotherapy [EBRT] plus concomitant temozolomide and 6 cycles of adjuvant temozolomide chemotherapy). The primary outcome is median progression-free survival, secondary outcomes are median OS, occurrence of radiation induced acute (3 mo post-SRS) neurotoxicity and incidence of symptomatic radionecrosis. We expect to detect efficacy and safety signals by the immediate application of SRS to standard-of-care therapy in newly diagnosed GBM. Early postoperative SRS to areas of residual tumor could bridge the therapeutic gap between surgery and adjuvant therapies.

  6. A novel protocol for antibiotic prophylaxis based on preoperative kidney function in patients undergoing open heart surgery under cardiopulmonary bypass.

    Science.gov (United States)

    Odaka, Mizuho; Minakata, Kenji; Toyokuni, Hideaki; Yamazaki, Kazuhiro; Yonezawa, Atsushi; Sakata, Ryuzo; Matsubara, Kazuo

    2015-08-01

    This study aimed to develop and assess the effectiveness of a protocol for antibiotic prophylaxis based on preoperative kidney function in patients undergoing open heart surgery. We established a protocol for antibiotic prophylaxis based on preoperative kidney function in patients undergoing open heart surgery. This novel protocol was assessed by comparing patients undergoing open heart surgery before (control group; n = 30) and after its implementation (protocol group; n = 31) at Kyoto University Hospital between July 2012 and January 2013. Surgical site infections (SSIs) were observed in 4 control group patients (13.3 %), whereas no SSIs were observed in the protocol group patients (P open heart surgery.

  7. Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults

    DEFF Research Database (Denmark)

    Skou, Soren Thorgaard; Lind, Martin; Holmich, Per

    2017-01-01

    INTRODUCTION: Arthroscopic surgery is a very common orthopaedic procedure. While several trials have investigated the effect of knee arthroscopy for middle-aged and older patients with meniscal tears, there is a paucity of trials comparing meniscal surgery with non-surgical treatment for younger...... adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears. METHODS AND ANALYSIS......: This is a protocol for a multicentre, parallel-group RCT conducted at six hospitals across all five healthcare regions in Denmark. 140 patients aged 18-40 years with a clinical history and symptoms consistent with a meniscal tear, verified on MRI, found eligible for meniscal surgery by an orthopaedic surgeon...

  8. Laparoscopic colorectal surgery in learning curve: Role of implementation of a standardized technique and recovery protocol. A cohort study

    Directory of Open Access Journals (Sweden)

    Gaetano Luglio

    2015-06-01

    Conclusion: Proper laparoscopic colorectal surgery is safe and leads to excellent results in terms of recovery and short term outcomes, even in a learning curve setting. Key factors for better outcomes and shortening the learning curve seem to be the adoption of a standardized technique and training model along with the strict supervision of an expert colorectal surgeon.

  9. [Effect of a multidisciplinar protocol on the clinical results obtained after bariatric surgery].

    Science.gov (United States)

    Cánovas Gaillemin, B; Sastre Martos, J; Moreno Segura, G; Llamazares Iglesias, O; Familiar Casado, C; Abad de Castro, S; López Pardo, R; Sánchez-Cabezudo Muñoz, M A

    2011-01-01

    Bariatric surgery has been shown to be an effective therapy for weight loss in patients with severe obesity, and the implementation of a multidisciplinar management protocol is recommended. To assess the usefulness of the implementation of a management protocol in obesity surgery based on the Spanish Consensus Document of the SEEDO. Retrospective comparative study of the outcomes in patients previously operated (51 patients) and after the implementation of the protocol (66 patients). The following data were gathered: anthropometry, pre-and post-surgery comorbidities, post-surgical nutritional and surgical complications, validated Quality of Life questionnaire, and dietary habits. Withdrawals (l7.6%) and alcoholism (5.8%) were higher in patients pre- versus post-implementation of the protocol (4.5% vs. 3%, respectively), the differences being statistically significant. The mortality rate was 2% in the pre-protocol group and 0% in the postprotocol group. The dietary habits were better in the post-protocol group, the pre-protocol group presenting a higher percentage of feeding-behavior disorders (5.1%) although not reaching a statistical significance. The improvement in quality of life was higher in the post-protocol group for all items, but only reaching statistical significance in sexual activity (p = 0.004). In the pre-protocol group, 70.5% of the patients had more than one nutritional complication vs. 32.8% in the post-protocol group (p 50% in 81.3% in the pre-protocol group vs. 74.8% in the pos-protocol group) or the comorbidities. Bariatric surgery achieves excellent outcomes in weight loss, comorbidities, and quality of life, but presents nutritional, surgical, and psychiatric complications that require a protocol-based and multidisciplinary approach. Our protocol improves the outcomes regarding the withdrawal rates, feeding-behavior disorders, dietary habits, nutritional complications, and quality of life.

  10. Incompatible type A plasma transfusion in patients requiring massive transfusion protocol: Outcomes of an Eastern Association for the Surgery of Trauma multicenter study.

    Science.gov (United States)

    Stevens, W Tait; Morse, Bryan C; Bernard, Andrew; Davenport, Daniel L; Sams, Valerie G; Goodman, Michael D; Dumire, Russell; Carrick, Matthew M; McCarthy, Patrick; Stubbs, James R; Pritts, Timothy A; Dente, Christopher J; Luo-Owen, Xian; Gregory, Jason A; Turay, David; Gomaa, Dina; Quispe, Juan C; Fitzgerald, Caitlin A; Haddad, Nadeem N; Choudhry, Asad; Quesada, Jose F; Zielinski, Martin D

    2017-07-01

    With a relative shortage of type AB plasma, many centers have converted to type A plasma for resuscitation of patients whose blood type is unknown. The goal of this study is to determine outcomes for trauma patients who received incompatible plasma transfusions as part of a massive transfusion protocol (MTP). As part of an Eastern Association for the Surgery of Trauma multi-institutional trial, registry and blood bank data were collected from eight trauma centers for trauma patients (age, ≥ 15 years) receiving emergency release plasma transfusions as part of MTPs from January 2012 to August 2016. Incompatible type A plasma was defined as transfusion to patient blood type B or type AB. Of the 1,536 patients identified, 92% received compatible plasma transfusions and 8% received incompatible type A plasma. Patient characteristics were similar except for greater penetrating injuries (48% vs 36%; p = 0.01) in the incompatible group. In the incompatible group, patients were transfused more plasma units at 4 hours (median, 9 vs. 5; p plasma to patients with blood groups B and AB as part of a MTP does not appear to be associated with significant increases in morbidity or mortality. Therapeutic study, level IV.

  11. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Spieth, Peter M.; Güldner, Andreas; Uhlig, Christopher; Bluth, Thomas; Kiss, Thomas; Schultz, Marcus J.; Pelosi, Paolo; Koch, Thea; Gama de Abreu, Marcelo

    2014-01-01

    General anesthesia usually requires mechanical ventilation, which is traditionally accomplished with constant tidal volumes in volume- or pressure-controlled modes. Experimental studies suggest that the use of variable tidal volumes (variable ventilation) recruits lung tissue, improves pulmonary

  12. Are we ready for the ERAS protocol in colorectal surgery?

    Science.gov (United States)

    Kisielewski, Michał; Rubinkiewicz, Mateusz; Pędziwiatr, Michał; Pisarska, Magdalena; Migaczewski, Marcin; Dembiński, Marcin; Major, Piotr; Rembiasz, Kazimierz; Budzyński, Andrzej

    2017-01-01

    Modern perioperative care principles in elective colorectal surgery have already been established by international surgical authorities. Nevertheless, barriers to the introduction of routine evidence-based clinical care and changing dogmas still exist. One of the factors is the surgeon. To assess perioperative care trends in elective colorectal surgery among general surgery consultants in surgical departments in Malopolska Voivodeship, Poland. An anonymous standardized 20-question questionnaire was developed based on ERAS principles and sent out to Malopolska Voivodeship general surgery departments. Answers of general surgery consultants showed the level of acceptance of elements of perioperative care. The overall response rate was 66%. Several elements (antibiotic and antithrombotic prophylaxis, postoperative oxygen therapy, no nasogastric tubes) had quite a high acceptance rate. On the other hand, most crucial surgical perioperative elements (lack of mechanical bowel preparation, preoperative oral carbohydrate loading, use of laparoscopy and lack of drains, early fluid and oral diet intake, early mobilization) were not followed according to evidence-based ERAS protocol recommendations. Surgeons were not willing to change their practice, but were supportive of changes in anesthesiologist-dependent elements of perioperative care, such as restrictive fluid therapy, use of transversus abdominis plane blocks, etc. Many elements of perioperative care in elective colorectal surgery in Malopolska Voivodeship are still dictated by dogma and are not evidence-based. The level of acceptance of many important ERAS protocol elements is low. Surgeons are ready to accept only changes that do not interfere with their practice.

  13. RAPP, a systematic e-assessment of postoperative recovery in patients undergoing day surgery: study protocol for a mixed-methods study design including a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies.

    Science.gov (United States)

    Nilsson, U; Jaensson, M; Dahlberg, K; Odencrants, S; Grönlund, Å; Hagberg, L; Eriksson, M

    2016-01-13

    Day surgery is a well-established practice in many European countries, but only limited information is available regarding postoperative recovery at home though there is a current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is also a need for improvement of modern technology in assessing patient-related outcomes such as mobile applications. This article describes the Recovery Assessment by Phone Points (RAPP) study protocol, a mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing day surgery is cost-effective and improves postoperative recovery, health and quality of life. This study has a mixed-methods study design that includes a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies. 1000 patients >17 years of age who are undergoing day surgery will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR) or to standard care (ie, no follow-up). The primary aim is cost-effectiveness. Secondary aims are (A) to explore whether a systematic e-assessment follow-up after day surgery has a positive effect on postoperative recovery, health-related quality of life (QoL) and overall health; (B) to determine whether differences in postoperative recovery have an association with patient characteristic, type of surgery and anaesthesia; (C) to determine whether differences in health literacy have a substantial and distinct effect on postoperative recovery, health and QoL; and (D) to describe day surgery patient and staff experiences with a systematic e-assessment follow-up after day surgery.The primary aim will be measured at 2 weeks postoperatively and secondary outcomes (A-C) at 1 and 2 weeks and (D) at 1 and 4 months. NCT02492191; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use

  14. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    OpenAIRE

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Meth...

  15. The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

    2016-01-28

    Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

  16. A randomized controlled trial of skin care protocols for facial resurfacing: lessons learned from the Plastic Surgery Educational Foundation's Skin Products Assessment Research study.

    Science.gov (United States)

    Pannucci, Christopher J; Reavey, Patrick L; Kaweski, Susan; Hamill, Jennifer B; Hume, Keith M; Wilkins, Edwin G; Pusic, Andrea L

    2011-03-01

    The Skin Products Assessment Research Committee was created by the Plastic Surgery Educational Foundation in 2006. The Skin Products Assessment Research study aims were to (1) develop an infrastructure for Plastic Surgery Educational Foundation-conducted, industry-sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System versus conventional therapy as treatment adjuncts for facial resurfacing procedures. The Skin Products Assessment Research study was designed as a multicenter, double-blind, randomized, controlled trial. The study was conducted in women with Fitzpatrick type I to IV skin, moderate to severe facial photodamage, and periocular and/or perioral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to the Obagi Nu-Derm System or a standard care regimen. The study endpoints were time to reepithelialization, erythema, and pigmentation changes. Fifty-six women were enrolled and 82 percent were followed beyond reepithelialization. There were no significant differences in mean time to reepithelialization between Obagi Nu-Derm System and control groups. The Obagi Nu-Derm System group had a significantly higher median erythema score on the day of surgery (after 4 weeks of product use) that did not persist after surgery. Test-retest photographic evaluations demonstrated that both interrater and intrarater reliability were adequate for primary study outcomes. The authors demonstrated no significant difference in time to reepithelialization between patients who used the Obagi Nu-Derm System or a standard care regimen as an adjunct to facial resurfacing procedures. The Skin Products Assessment Research team has also provided a discussion of future challenges for Plastic Surgery Educational Foundation-sponsored clinical research for readers of this article.

  17. Robotic, laparoscopic and open surgery for gastric cancer compared on surgical, clinical and oncological outcomes: a multi-institutional chart review. A study protocol of the International study group on Minimally Invasive surgery for GASTRIc Cancer—IMIGASTRIC

    Science.gov (United States)

    Desiderio, Jacopo; Jiang, Zhi-Wei; Nguyen, Ninh T; Zhang, Shu; Reim, Daniel; Alimoglu, Orhan; Azagra, Juan-Santiago; Yu, Pei-Wu; Coburn, Natalie G; Qi, Feng; Jackson, Patrick G; Zang, Lu; Brower, Steven T; Kurokawa, Yukinori; Facy, Olivier; Tsujimoto, Hironori; Coratti, Andrea; Annecchiarico, Mario; Bazzocchi, Francesca; Avanzolini, Andrea; Gagniere, Johan; Pezet, Denis; Cianchi, Fabio; Badii, Benedetta; Novotny, Alexander; Eren, Tunc; Leblebici, Metin; Goergen, Martine; Zhang, Ben; Zhao, Yong-Liang; Liu, Tong; Al-Refaie, Waddah; Ma, Junjun; Takiguchi, Shuji; Lequeu, Jean-Baptiste; Trastulli, Stefano; Parisi, Amilcare

    2015-01-01

    Introduction Gastric cancer represents a great challenge for healthcare providers and requires a multidisciplinary treatment approach in which surgery plays a major role. Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and recently with the spread of robotic surgery, but a number of issues are currently being debated, including the limitations in performing an effective extended lymph node dissection, the real advantages of robotic systems, the role of laparoscopy for Advanced Gastric Cancer, the reproducibility of a total intracorporeal technique and the oncological results achievable during long-term follow-up. Methods and analysis A multi-institutional international database will be established to evaluate the role of robotic, laparoscopic and open approaches in gastric cancer, comprising of information regarding surgical, clinical and oncological features. A chart review will be conducted to enter data of participants with gastric cancer, previously treated at the participating institutions. The database is the first of its kind, through an international electronic submission system and a HIPPA protected real time data repository from high volume gastric cancer centres. Ethics and dissemination This study is conducted in compliance with ethical principles originating from the Helsinki Declaration, within the guidelines of Good Clinical Practice and relevant laws/regulations. A multicentre study with a large number of patients will permit further investigation of the safety and efficacy as well as the long-term outcomes of robotic, laparoscopic and open approaches for the management of gastric cancer. Trial registration number NCT02325453; Pre-results. PMID:26482769

  18. Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; Okamoto, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio

    2014-12-29

    Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of depression and insomnia after cataract surgery, randomized controlled trials are lacking. We will conduct a parallel-group, assessor-blinded, simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms, sleep quality, body mass regulation, and glucose and lipid metabolism. We will recruit patients who are aged 60 years and over, scheduled to receive their first cataract surgery, and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III. Exclusion criteria will be patients with major depression, severe corneal opacity, severe glaucoma, vitreous haemorrhage, proliferative diabetic retinopathy, macular oedema, age-related macular degeneration, and patients needing immediate or combined cataract surgery. After baseline participants will be randomized to two groups. Outcomes will be measured at three months after surgery among the intervention group, and three months after baseline among the control group. We will assess depressive symptoms as a primary outcome, using the short version geriatric depression scale (GDS-15). Secondary outcomes will be subjective and actigraph-measured sleep quality, sleepiness, glycated haemoglobin, fasting plasma glucose and triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, body mass index, abdominal circumference, circadian rhythms of physical

  19. Global incidence and case fatality rate of pulmonary embolism following major surgery: a protocol for a systematic review and meta-analysis of cohort studies.

    Science.gov (United States)

    Temgoua, Mazou N; Tochie, Joel Noutakdie; Noubiap, Jean Jacques; Agbor, Valirie Ndip; Danwang, Celestin; Endomba, Francky Teddy A; Nkemngu, Njinkeng J

    2017-12-04

    Pulmonary embolism (PE) is a life-threatening condition common after major surgery. Although the high incidence (0.3-30%) and mortality rate (16.9-31%) of PE in patients undergoing major surgical procedures is apparent from findings of contemporary observational studies, there is a lack of a summary and meta-analysis data on the epidemiology of postoperative PE in this same regard. Hence, we propose to conduct the first systematic review to summarise existing data on the global incidence, determinants and case fatality rate of PE following major surgery. Electronic databases including MEDLINE, EMBASE, SCOPUS, WHO global health library (including LILACS), Web of Science and Google scholar from inception to April 30, 2017, will be searched for cohort studies reporting on the incidence, determinants and case fatality rate of PE occurring after major surgery. Data from grey literature will also be assessed. Two investigators will independently perform study selection and data extraction. Included studies will be evaluated for risk of bias. Appropriate meta-analytic methods will be used to pool incidence and case fatality rate estimates from studies with identical features, globally and by subgroups of major surgical procedures. Random-effects and risk ratio with 95% confidence interval will be used to summarise determinants and predictors of mortality of PE in patients undergoing major surgery. This systematic review and meta-analysis will provide the most up-to-date epidemiology of PE in patients undergoing major surgery to inform health authorities and identify further research topics based on the remaining knowledge gaps. PROSPERO CRD42017065126.

  20. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    Science.gov (United States)

    Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Methods and analysis 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethics and dissemination Ethical approval has been obtained from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. Trial registration number ChiCTR-IOR-15006971. PMID:27334883

  1. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention.

    Science.gov (United States)

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-06-22

    Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. ChiCTR-IOR-15006971. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  2. Endoscopic surgery versus conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage (ECMOH: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zan Xin

    2012-06-01

    Full Text Available Abstract Background Spontaneous intracerebral hemorrhage is a disease with high morbidity, high disability rate, high mortality, and high economic burden. Whether patients can benefit from surgical evacuation of hematomas is still controversial, especially for those with moderate-volume hematomas in the basal ganglia. This study is designed to compare the efficacy of endoscopic surgery and conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage. Methods Patients meet the criteria will be randomized into the endoscopic surgery group (endoscopic surgery for hematoma evacuation and the best medical treatment or the conservative treatment group (the best medical treatment. Patients will be followed up at 1, 3, and 6 months after initial treatment. The primary outcomes include the Extended Glasgow Outcome Scale and the Modified Rankin Scale. The secondary outcomes consist of the National Institutes of Health Stroke Scale and the mortality. The Barthel Index(BI will also be evaluated. The sample size is 100 patients. Discussion The ECMOH trial is a randomized controlled trial designed to evaluate if endoscopic surgery is better than conservative treatment for patients with moderate-volume hematomas in the basal ganglia. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-11001614 (http://www.chictr.org/en/proj/show.aspx?proj=1618

  3. Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).

    Science.gov (United States)

    Risberg, May Arna; Ageberg, Eva; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; Løken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha; Kostogiannis, Ioannis; Crossley, Kay M; Glyn-Jones, Sion; Kemp, Joanne L

    2018-04-01

    Study Design Study protocol for a randomized controlled trial and a prospective cohort. Background The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. Objectives The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). Methods The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. Conclusion To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined. J Orthop Sports Phys Ther 2018;48(4):325-335. doi:10.2519/jospt.2018.7931.

  4. Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

    Science.gov (United States)

    Pastora-Bernal, Jose-Manuel; Martín-Valero, Rocío; Barón-López, Francisco Javier; García-Gómez, Oscar

    2017-02-23

    Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery. We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design. Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing. ClinicalTrials.gov, NCT02909920 . 14 September 2016.

  5. A Novel Inspection Protocol to Detect Volatile Compounds in Breast Surgery Electrocautery Smoke

    Directory of Open Access Journals (Sweden)

    Yu-Wen Lin

    2010-07-01

    Conclusion: The sampling protocol enabled acquisition of smoke samples near the source without interrupting surgery. The findings suggest that type of surgery, patient body mass index and duration of electrocautery are factors that can alter production of chemicals.

  6. Day case shoulder surgery: satisfactory pain control without regional anaesthesia. A prospective analysis of a perioperative protocol.

    LENUS (Irish Health Repository)

    Daruwalla, Z J

    2009-03-01

    Pain control is an issue which may limit patients\\' acceptance of day case shoulder surgery. This study prospectively examined the outcome of a protocol for day case shoulder surgery to determine if satisfactory pain relief could be achieved without regional anaesthesia.

  7. Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

    Science.gov (United States)

    Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

    2017-09-01

    Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

  8. Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial

    Directory of Open Access Journals (Sweden)

    Hengwei Jin

    2017-09-01

    Full Text Available Introduction: Brain arteriovenous malformations (BAVMs are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. Methods: This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety, and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy. Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula, volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS. Discussion: The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs. Keywords: Brain arteriovenous malformation, Clinical trial, Endovascular therapy, Gamma knife, Safety, Efficacy

  9. Role of preoperative intravenous iron therapy to correct anemia before major surgery: study protocol for systematic review and meta-analysis.

    Science.gov (United States)

    Elhenawy, Abdelsalam M; Meyer, Steven R; Bagshaw, Sean M; MacArthur, Roderick G; Carroll, Linda J

    2015-03-15

    Preoperative anemia is a common and potentially serious hematological problem in elective surgery and increases the risk for perioperative red blood cell (RBC) transfusion. Transfusion is associated with postoperative morbidity and mortality. Preoperative intravenous (IV) iron therapy has been proposed as an intervention to reduce perioperative transfusion; however, studies are generally small, limited, and inconclusive. We propose performing a systematic review and meta-analysis. We will search MEDLINE, EMBASE, EBM Reviews, Cochrane-controlled trial registry, Scopus, registries of health technology assessment and clinical trials, Web of Science, ProQuest Dissertations and Theses, and conference proceedings in transfusion, hematology, and surgery. We will contact our study drug manufacturer for unpublished trials. Titles and abstracts will be identified and assessed by two reviewers for potential relevance. Eligible studies are: randomized or quasi-randomized clinical trials comparing preoperative administration of IV iron with placebo or standard of care to reduce perioperative blood transfusion in anemic patients undergoing major surgery. Screening, data extraction, and quality appraisal will be conducted independently by two authors. Data will be presented in evidence tables and in meta-analytic forest plots. Primary efficacy outcomes are change in hemoglobin concentration and proportion of patients requiring RBC transfusion. Secondary outcomes include number of units of blood or blood products transfused perioperatively, transfusion-related acute lung injury, neurologic complications, adverse events, postoperative infections, cardiopulmonary complications, intensive care unit (ICU) admission/readmission, length of hospital stay, acute kidney injury, and mortality. Dichotomous outcomes will be reported as pooled relative risks and 95% confidence intervals. Continuous outcomes will be reported using calculated weighted mean differences. Meta-regression will be

  10. Changes in referral protocols for cardiac surgery: do financial considerations come at a cost?

    Science.gov (United States)

    Amado, José; Bento, Dina; Silva, Daniela; Chin, Joana; Marques, Nuno; Gago, Paula; Mimoso, Jorge; de Jesus, Ilídio

    2015-10-01

    The aim of this study was to determine whether changes to referral protocols for cardiac surgery have had an impact on waiting times, hospitalizations and mortality during the waiting period and during the first year of follow-up after surgery. In this retrospective study of patients referred for cardiac surgery between January 1, 2008 and September 30, 2014, the study population was divided into two groups: those referred before (group A, January 1, 2008 to August 31, 2011) and after (group B, September 1, 2011 to September 30, 2014) the change in referral protocols. A telephone follow-up was conducted. There were 864 patients referred for cardiac surgery, 557 in group A and 307 in group B. Patient characteristics were similar between groups. The mean waiting time for surgery was 10.6±18.5 days and 55.7±79.9 days in groups A and B, respectively (p=0.00). During the waiting period two patients (0.4%) were hospitalized in group A and 28 (9.1%) in group B (p=0:00); mortality was, respectively, 0% and 2.3% (p=0.00). During one-year follow-up 12.8% of group A patients and 16% of group B patients were hospitalized. Cardiovascular mortality in this period was around 5% in both groups (p>0.05). Changes to referral protocols for cardiac surgery had an impact on waiting times, on the number of hospitalizations and on mortality in this period. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

  11. Enhanced recovery after vascular surgery: protocol for a systematic review

    Directory of Open Access Journals (Sweden)

    Gotlib Conn Lesley

    2012-11-01

    Full Text Available Abstract Background The enhanced recovery after surgery (ERAS programme is a multimodal evidence-based approach to surgical care which begins in the preoperative setting and extends through to patient discharge in the postoperative period. The primary components of ERAS include the introduction of preoperative patient education; reduction in perioperative use of nasogastric tubes and drains; the use of multimodal analgesia; goal-directed fluid management; early removal of Foley catheter; early mobilization, and early oral nutrition. The ERAS approach has gradually evolved to become the standard of care in colorectal surgery and is presently being used in other specialty areas such as vascular surgery. Currently there is little evidence available for the implementation of ERAS in this field. We plan to conduct a systematic review of this literature with a view to incorporating ERAS principles into the management of major elective vascular surgery procedures. Methods We will search EMBASE (OVID, 1947 to June 2012, Medline (OVID, 1948 to June 2012, and Cochrane Central Register of Controlled Trials (Wiley, Issue 1, 2012. Searches will be performed with no year or language restrictions. For inclusion, studies must look at adult patients over 18 years. Major elective vascular surgery includes carotid, bypass, aneurysm and amputation procedures. Studies must have evaluated usual care against an ERAS intervention in the preoperative, perioperative or postoperative period of care. Primary outcome measures are length of stay, decreased complication rate, and patient satisfaction or expectations. Only randomized controlled trials will be included. Discussion Most ERAS approaches have been considered in the context of colorectal surgery. Given the increasing use of multiple yet different aspects of this pathway in vascular surgery, it is timely to systematically review the evidence for their independent or combined outcomes, with a view to implementing

  12. Patient participation in postoperative care activities in patients undergoing total knee replacement surgery: Multimedia Intervention for Managing patient Experience (MIME). Study protocol for a cluster randomised crossover trial.

    Science.gov (United States)

    McDonall, Jo; de Steiger, Richard; Reynolds, John; Redley, Bernice; Livingston, Patricia; Botti, Mari

    2016-07-18

    Patient participation is an important indicator of quality care. Currently, there is little evidence to support the belief that participation in care is possible for patients during the acute postoperative period. Previous work indicates that there is very little opportunity for patients to participate in care in the acute context. Patients require both capability, in terms of having the required knowledge and understanding of how they can be involved in their care, and the opportunity, facilitated by clinicians, to engage in their acute postoperative care. This cluster randomised crossover trial aims to test whether a multimedia intervention improves patient participation in the acute postoperative context, as determined by pain intensity and recovery outcomes. A total of 240 patients admitted for primary total knee replacement surgery will be invited to participate in a cluster randomised, crossover trial and concurrent process evaluation in at least two wards at a major non-profit private hospital in Melbourne, Australia. Patients admitted to the intervention ward will receive the multimedia intervention daily from Day 1 to Day 5 (or day of discharge, if prior). The intervention will be delivered by nurses via an iPad™, comprising information on the goals of care for each day following surgery. Patients admitted to the control ward will receive usual care as determined by care pathways currently in use across the organization. The primary endpoint is the "worst pain experienced in the past 24 h" on Day 3 following TKR surgery. Pain intensity will be measured using the numerical rating scale. Secondary outcomes are interference of pain on activities of daily living, length of stay in hospital, function and pain following TKR surgery, overall satisfaction with hospitalisation, postoperative complications and hospital readmission. The results of this study will contribute to our understanding of the effectiveness of interventions that provide knowledge and

  13. The Hip Fracture Surgery in Elderly Patients (HIPELD study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery

    Directory of Open Access Journals (Sweden)

    Coburn Mark

    2012-09-01

    Full Text Available Abstract Background Strategies to protect the brain from postoperative delirium (POD after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABAA receptor and (ii through beneficial anesthetic and organ-protective effects. Methods and design An international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM, in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane

  14. One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Strange, Simon; Whitehouse, Michael R; Beswick, Andrew D; Board, Tim; Burston, Amanda; Burston, Ben; Carroll, Fran E; Dieppe, Paul; Garfield, Kirsty; Gooberman-Hill, Rachael; Jones, Stephen; Kunutsor, Setor; Lane, Athene; Lenguerrand, Erik; MacGowan, Alasdair; Moore, Andrew; Noble, Sian; Simon, Joanne; Stockley, Ian; Taylor, Adrian H; Toms, Andrew; Webb, Jason; Whittaker, John-Paul; Wilson, Matthew; Wylde, Vikki; Blom, Ashley W

    2016-02-17

    Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months. The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients' and surgeons' experiences, including their views about trial participation and randomisation. INFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function

  15. Prevention of severe infectious complications after colorectal surgery using preoperative orally administered antibiotic prophylaxis (PreCaution) : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Mulder, Tessa; Kluytmans-van den Bergh, Marjolein F Q; de Smet, Anne Marie G A; van 't Veer, Nils E; Roos, Daphne; Nikolakopoulos, Stavros; Bonten, Marc J M; Kluytmans, Jan A J W

    2018-01-01

    BACKGROUND: Colorectal surgery is frequently complicated by surgical site infections (SSIs). The most important consequences of SSIs are prolonged hospitalization, an increased risk of surgical reintervention and an increase in mortality. Perioperative intravenously administered antibiotic

  16. Early-stage squamous cell carcinoma of the oropharynx: Radiotherapy vs. Trans-Oral Robotic Surgery (ORATOR) – study protocol for a randomized phase II trial

    International Nuclear Information System (INIS)

    Nichols, Anthony C; Kuruvilla, Sara; Chen, Jeff; Corsten, Martin; Odell, Michael; Eapen, Libni; Theurer, Julie; Doyle, Philip C; Wehrli, Bret; Kwan, Keith; Palma, David A; Yoo, John; Hammond, J Alex; Fung, Kevin; Winquist, Eric; Read, Nancy; Venkatesan, Varagur; MacNeil, S Danielle; Ernst, D Scott

    2013-01-01

    The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has markedly increased over the last three decades due to newly found associations with human papillomavirus (HPV) infection. Primary radiotherapy (RT) is the treatment of choice for OPSCC at most centers, and over the last decade, the addition of concurrent chemotherapy has led to a significant improvement in survival, but at the cost of increased acute and late toxicity. Transoral robotic surgery (TORS) has emerged as a promising alternative treatment, with preliminary case series demonstrating encouraging oncologic, functional, and quality of life (QOL) outcomes. However, comparisons of TORS and RT in a non-randomized fashion are susceptible to bias. The goal of this randomized phase II study is to compare QOL, functional outcomes, toxicity profiles, and survival following primary RT (± chemotherapy) vs. TORS (± adjuvant [chemo] RT) in patients with OPSCC. The target patient population comprises OPSCC patients who would be unlikely to require chemotherapy post-resection: Tumor stage T1-T2 with likely negative margins at surgery; Nodal stage N0-2, ≤3 cm in size, with no evidence of extranodal extension on imaging. Participants will be randomized in a 1:1 ratio between Arm 1 (RT ± chemotherapy) and Arm 2 (TORS ± adjuvant [chemo] RT). In Arm 1, patients with N0 disease will receive RT alone, whereas N1-2 patients will receive concurrent chemoradiation. In Arm 2, patients will undergo TORS along with selective neck dissections, which may be staged. Pathologic high-risk features will be used to determine the requirement for adjuvant radiotherapy +/- chemotherapy. The primary endpoint is QOL score using the M.D. Anderson Dysphagia Inventory (MDADI), with secondary endpoints including survival, toxicity, other QOL outcomes, and swallowing function. A sample of 68 patients is required. This study, if successful, will provide a much-needed randomized comparison of the conventional strategy of primary RT

  17. Preoperative magnetic resonance imaging protocol for endoscopic cranial base image-guided surgery.

    Science.gov (United States)

    Grindle, Christopher R; Curry, Joseph M; Kang, Melissa D; Evans, James J; Rosen, Marc R

    2011-01-01

    Despite the increasing utilization of image-guided surgery, no radiology protocols for obtaining magnetic resonance (MR) imaging of adequate quality are available in the current literature. At our institution, more than 300 endonasal cranial base procedures including pituitary, extended pituitary, and other anterior skullbase procedures have been performed in the past 3 years. To facilitate and optimize preoperative evaluation and assessment, there was a need to develop a magnetic resonance protocol. Retrospective Technical Assessment was performed. Through a collaborative effort between the otolaryngology, neurosurgery, and neuroradiology departments at our institution, a skull base MR image-guided (IGS) protocol was developed with several ends in mind. First, it was necessary to generate diagnostic images useful for the more frequently seen pathologies to improve work flow and limit the expense and inefficiency of case specific MR studies. Second, it was necessary to generate sequences useful for IGS, preferably using sequences that best highlight that lesion. Currently, at our institution, all MR images used for IGS are obtained using this protocol as part of preoperative planning. The protocol that has been developed allows for thin cut precontrast and postcontrast axial cuts that can be used to plan intraoperative image guidance. It also obtains a thin cut T2 axial series that can be compiled separately for intraoperative imaging, or may be fused with computed tomographic images for combined modality. The outlined protocol obtains image sequences effective for diagnostic and operative purposes for image-guided surgery using both T1 and T2 sequences. Copyright © 2011 Elsevier Inc. All rights reserved.

  18. Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Constable, Lynda; Cotterill, Nikki; Cooper, David; Glazener, Cathryn; Drake, Marcus J; Forrest, Mark; Harding, Chris; Kilonzo, Mary; MacLennan, Graeme; McCormack, Kirsty; McDonald, Alison; Mundy, Anthony; Norrie, John; Pickard, Robert; Ramsay, Craig; Smith, Rebecca; Wileman, Samantha; Abrams, Paul

    2018-02-21

    Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to

  19. Measuring skin necrosis in a randomised controlled feasibility trial of heat preconditioning on wound healing after reconstructive breast surgery: study protocol and statistical analysis plan for the PREHEAT trial.

    Science.gov (United States)

    Cro, Suzie; Mehta, Saahil; Farhadi, Jian; Coomber, Billie; Cornelius, Victoria

    2018-01-01

    Essential strategies are needed to help reduce the number of post-operative complications and associated costs for breast cancer patients undergoing reconstructive breast surgery. Evidence suggests that local heat preconditioning could help improve the provision of this procedure by reducing skin necrosis. Before testing the effectiveness of heat preconditioning in a definitive randomised controlled trial (RCT), we must first establish the best way to measure skin necrosis and estimate the event rate using this definition. PREHEAT is a single-blind randomised controlled feasibility trial comparing local heat preconditioning, using a hot water bottle, against standard care on skin necrosis among breast cancer patients undergoing reconstructive breast surgery. The primary objective of this study is to determine the best way to measure skin necrosis and to estimate the event rate using this definition in each trial arm. Secondary feasibility objectives include estimating recruitment and 30 day follow-up retention rates, levels of compliance with the heating protocol, length of stay in hospital and the rates of surgical versus conservative management of skin necrosis. The information from these objectives will inform the design of a larger definitive effectiveness and cost-effectiveness RCT. This article describes the PREHEAT trial protocol and detailed statistical analysis plan, which includes the pre-specified criteria and process for establishing the best way to measure necrosis. This study will provide the evidence needed to establish the best way to measure skin necrosis, to use as the primary outcome in a future RCT to definitively test the effectiveness of local heat preconditioning. The pre-specified statistical analysis plan, developed prior to unblinded data extraction, sets out the analysis strategy and a comparative framework to support a committee evaluation of skin necrosis measurements. It will increase the transparency of the data analysis for the

  20. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte

    2015-01-01

    , either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health...... and reduce hospitalization and healthcare costs after heart valve surgery. METHODS: This randomized clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210...... patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake...

  1. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

    Directory of Open Access Journals (Sweden)

    Vester-Andersen Morten

    2013-02-01

    Full Text Available Abstract Background Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. Methods and design The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. Discussion This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. Trial registration Clinicaltrials.gov identifier: NCT01209663

  2. Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Nguyen, Lee S; Merzoug, Messaouda; Estagnasie, Philippe; Brusset, Alain; Law Koune, Jean-Dominique; Aubert, Stephane; Waldmann, Thierry; Grinda, Jean-Michel; Gibert, Hadrien; Squara, Pierre

    2017-12-02

    Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) during surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain low tidal volume (LTV) ventilation. Indirect evidence points towards better pulmonary outcomes when LTV is performed but no large-scale prospective trial has yet been published in cardiac surgery. The MECANO trial is a single-center, double-blind, randomized, controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. In total, 1500 patients are expected to be included, without any restrictions. They will be randomized between noV and LTV on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 breaths/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. The primary endpoint will be a composite of all-cause mortality, early respiratory failure defined as a ratio of partial pressure of oxygen/fraction of inspired oxygen ventilation, mechanical ventilation or high-flow oxygen) at 2 days after arrival in the ICU or ventilator-acquired pneumonia defined by the Center of Disease Control. Lung recruitment maneuvers will be performed in the noV and LTV groups at the end of surgery and at arrival in ICU with an insufflation at +30 cmH20 for 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cell transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge. The MECANO trial is the first of its kind to compare in a double-blind design, a no-ventilation to a low-tidal volume strategy for mechanical ventilation during

  3. The DOMUS study protocol

    DEFF Research Database (Denmark)

    Nordly, Mie; Benthien, Kirstine Skov; Von Der Maase, Hans

    2014-01-01

    be a powerful tool to improve patients' quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient's preferred place of care and attempt to clarify challenges. TRIAL REGISTRATION: Clinicaltrials......BACKGROUND: The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate...... psychological intervention for patients and caregivers at home or b) standard care alone. Inclusion criteria are incurable cancer with no or limited antineoplastic treatment options. DISCUSSION: Programs that facilitate transition from hospital treatment to SPC at home for patients with incurable cancer can...

  4. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  5. End Stage Renal Disease: Not a Contraindication for Minor Oral Surgery-Protocol for the Management of Oral Surgery patients with ESRD on Hemodialysis.

    Science.gov (United States)

    Pendem, Sneha; Lakshmi Narayana, G; Ravi, Poornima

    2017-06-01

    To describe a safe and effective protocol for the management of patients with end stage renal disease (ESRD) undergoing minor oral surgery. A prospective cohort study was conducted on all patients with ESRD who were referred for dental consultation. A definite protocol was designed in consultation with the nephrologist to minimize the risk of bleeding and wound healing complications during and after the minor surgical procedures. 36 patients consented for the protocol to be followed while 4 patients did not comply with the protocol and in 2 cases the protocol could be followed. The intra operative, post operative bleeding, and the wound healing were assessed in these patients. 36 patients had uneventful extractions as the blood pressure was brought down to pre hypertensive stage following the protocol. 4 patients who did not comply with the protocol had episodes of bleeding in the post operative period. There were two special scenarios where additional precautions had to be taken have been discussed. The wound healing was satisfactory in all these patients. The protocol discussed in this article helps us provide safe minor oral surgical treatment in patients with ESRD.

  6. Efficacy of protocol-based pharmacotherapy management on anticoagulation with warfarin for patients with cardiovascular surgery.

    Science.gov (United States)

    Katada, Y; Nakagawa, S; Minakata, K; Odaka, M; Taue, H; Sato, Y; Yonezawa, A; Kayano, Y; Yano, I; Nakatsu, T; Sakamoto, K; Uehara, K; Sakaguchi, H; Yamazaki, K; Minatoya, K; Sakata, R; Matsubara, K

    2017-10-01

    Anticoagulation therapy with warfarin requires periodic monitoring of prothrombin time-international normalized ratio (PT-INR) and adequate dose adjustments based on the data to minimize the risk of bleeding and thromboembolic events. In our hospital, we have developed protocol-based pharmaceutical care, which we called protocol-based pharmacotherapy management (PBPM), for warfarin therapy. The protocol requires pharmacists to manage timing of blood sampling for measuring PT-INR and warfarin dosage determination based on an algorithm. This study evaluated the efficacy of PBPM in warfarin therapy by comparing to conventional pharmaceutical care. From October 2013 to June 2015, a total of 134 hospitalized patients who underwent cardiovascular surgeries received post-operative warfarin therapy. The early series of patients received warfarin therapy as the conventional care (control group, n=77), whereas the latter received warfarin therapy based on the PBPM (PBPM group, n=68). These patients formed the cohort of the present study and were retrospectively analysed. The indications for warfarin included aortic valve replacement (n=56), mitral valve replacement (n=4), mitral valve plasty (n=22) and atrial fibrillation (n=29). There were no differences in patients' characteristics between both groups. The percentage time in therapeutic range in the first 10 days was significantly higher in the PBPM group (47.1%) than that in the control group (34.4%, PWarfarin therapy based on our novel PBPM was clinically safe and resulted in significantly better anticoagulation control compared to conventional care. © 2017 John Wiley & Sons Ltd.

  7. Progressive preoperative pneumoperitoneum preparation (the Goni Moreno protocol) prior to large incisional hernia surgery: volumetric, respiratory and clinical impacts. A prospective study.

    Science.gov (United States)

    Sabbagh, C; Dumont, F; Fuks, D; Yzet, T; Verhaeghe, P; Regimbeau, J-M

    2012-02-01

    Progressive preoperative pneumoperitoneum (PPP) is used to prepare incisional hernias with loss of domain (IHLD) operations. The aim of the present study was to analyze the effect of PPP on peritoneal volume [measured using a new computed tomography (CT)-based method] and respiratory function. From July 2004 to July 2008, 19 patients were included in a prospective, observational study. The volumes of the incisional hernia (VIH), the abdominal cavity (VAC), the total peritoneal content (VP) and the VIH/VP ratio were measured before and after PPP using abdominal CT scan data. Spirometric parameters were measured before and after PPP, and postoperative clinical data were evaluated. Before and after PPP, the mean VIH was 1,420 cc and 2,110 cc (P  VIH before PPP. After PPP, the spirometric measurements revealed a restrictive syndrome. The overall postoperative morbidity rate was 37%. PPP increased the hernia and abdominal volumes. PPP induced a progressive, restrictive syndrome.

  8. Incidence, risk factors and the healthcare cost of falls postdischarge after elective total hip and total knee replacement surgery: protocol for a prospective observational cohort study

    Science.gov (United States)

    Hill, Anne-Marie; Ross-Adjie, Gail; McPhail, Steven M; Monterosso, Leanne; Bulsara, Max; Etherton-Beer, Christopher; Powell, Sarah-Jayne; Hardisty, Gerard

    2016-01-01

    Introduction The number of major joint replacement procedures continues to increase in Australia. The primary aim of this study is to determine the incidence of falls in the first 12 months after discharge from hospital in a cohort of older patients who undergo elective total hip or total knee replacement. Methods and analyses A prospective longitudinal observational cohort study starting in July 2015, enrolling patients aged ≥60 years who are admitted for elective major joint replacement (n=267 total hip replacement, n=267 total knee replacement) and are to be discharged to the community. Participants are followed up for 12 months after hospital discharge. The primary outcome measure is the rate of falls per thousand patient-days. Falls data will be collected by 2 methods: issuing a falls diary to each participant and telephoning participants monthly after discharge. Secondary outcomes include the rate of injurious falls and health-related quality of life. Patient-rated outcomes will be measured using the Oxford Hip or Oxford Knee score. Generalised linear mixed modelling will be used to examine the falls outcomes in the 12 months after discharge and to examine patient and clinical characteristics predictive of falls. An economic evaluation will be conducted to describe the nature of healthcare costs in the first 12 months after elective joint replacement and estimate costs directly attributable to fall events. Ethics and dissemination The results will be disseminated through local site networks and will inform future services to support older people undergoing hip or knee joint replacement and also through peer-reviewed publications and medical conferences. This study has been approved by The University of Notre Dame Australia and local hospital human research ethics committees. Trial registration number ACTRN12615000653561; Pre-results. PMID:27412102

  9. The impact of a multidisciplinary blood conservation protocol on patient outcomes and cost after cardiac surgery.

    Science.gov (United States)

    Ad, Niv; Holmes, Sari D; Patel, Jay; Shuman, Deborah J; Massimiano, Paul S; Choi, Elmer; Fitzgerald, David; Halpin, Linda; Fornaresio, Lisa M

    2017-03-01

    Although associations between transfusion and inferior outcomes have been documented, there is a lack of blood transfusion standardization in cardiac surgery. At the Inova Heart and Vascular Institute, a multidisciplinary, criterion-driven algorithm for transfusion management was implemented. We examined the effect of our blood conservation protocol on transfusion rates and outcomes after cardiac surgery and on stability of transfusion over time. Patients undergoing first-time cardiac surgery from 2006 (full year before protocol) were compared with those in 2009 (after protocol) and propensity score matched to improve balance. Data were prospectively collected. Stability of transfusion incidence also was compared (2005-2006 vs 2008-2014). After matching, 890 patients from each year were included. Use of blood products decreased from 54% in 2006 to 25% in 2009 (P platelets (P conservation program can significantly control blood transfusion rates, improve outcomes, and be sustained over time. Efforts are needed to implement evidence-based protocols to standardize and decrease blood use in cardiac surgery to improve outcomes and reduce cost. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  10. One or two trainees per workplace in a structured multimodality training curriculum for laparoscopic surgery? Study protocol for a randomized controlled trial – DRKS00004675

    Science.gov (United States)

    2014-01-01

    Background Laparoscopy training courses have been established in many centers worldwide to ensure adequate skill learning before performing operations on patients. Different training modalities and their combinations have been compared regarding training effects. Multimodality training combines different approaches for optimal training outcome. However, no standards currently exist for the number of trainees assigned per workplace. Methods This is a monocentric, open, three-arm randomized controlled trial. The participants are laparoscopically-naive medical students from Heidelberg University. After a standardized introduction to laparoscopic cholecystectomy (LC) with online learning modules, the participants perform a baseline test for basic skills and LC performance on a virtual reality (VR) trainer. A total of 100 students will be randomized into three study arms, in a 2:2:1 ratio. The intervention groups participate individually (Group 1) or in pairs (Group 2) in a standardized and structured multimodality training curriculum. Basic skills are trained on the box and VR trainers. Procedural skills and LC modules are trained on the VR trainer. The control group (Group C) does not receive training between tests. A post-test is performed to reassess basic skills and LC performance on the VR trainer. The performance of a cadaveric porcine LC is then measured as the primary outcome using standardized and validated ratings by blinded experts with the Objective Structured Assessment of Technical Skills. The Global Operative Assessment of Laparoscopic Surgical skills score and the time taken for completion are used as secondary outcome measures as well as the improvement of skills and VR LC performance between baseline and post-test. Cognitive tests and questionnaires are used to identify individual factors that might exert influence on training outcome. Discussion This study aims to assess whether workplaces in laparoscopy training courses for beginners should be used

  11. One or two trainees per workplace in a structured multimodality training curriculum for laparoscopic surgery? Study protocol for a randomized controlled trial - DRKS00004675.

    Science.gov (United States)

    Nickel, Felix; Jede, Felix; Minassian, Andreas; Gondan, Matthias; Hendrie, Jonathan D; Gehrig, Tobias; Linke, Georg R; Kadmon, Martina; Fischer, Lars; Müller-Stich, Beat P

    2014-04-23

    Laparoscopy training courses have been established in many centers worldwide to ensure adequate skill learning before performing operations on patients. Different training modalities and their combinations have been compared regarding training effects. Multimodality training combines different approaches for optimal training outcome. However, no standards currently exist for the number of trainees assigned per workplace. This is a monocentric, open, three-arm randomized controlled trial. The participants are laparoscopically-naive medical students from Heidelberg University. After a standardized introduction to laparoscopic cholecystectomy (LC) with online learning modules, the participants perform a baseline test for basic skills and LC performance on a virtual reality (VR) trainer. A total of 100 students will be randomized into three study arms, in a 2:2:1 ratio. The intervention groups participate individually (Group 1) or in pairs (Group 2) in a standardized and structured multimodality training curriculum. Basic skills are trained on the box and VR trainers. Procedural skills and LC modules are trained on the VR trainer. The control group (Group C) does not receive training between tests. A post-test is performed to reassess basic skills and LC performance on the VR trainer. The performance of a cadaveric porcine LC is then measured as the primary outcome using standardized and validated ratings by blinded experts with the Objective Structured Assessment of Technical Skills. The Global Operative Assessment of Laparoscopic Surgical skills score and the time taken for completion are used as secondary outcome measures as well as the improvement of skills and VR LC performance between baseline and post-test. Cognitive tests and questionnaires are used to identify individual factors that might exert influence on training outcome. This study aims to assess whether workplaces in laparoscopy training courses for beginners should be used by one trainee or two trainees

  12. Publication trends of study protocols in rehabilitation.

    Science.gov (United States)

    Jesus, Tiago S; Colquhoun, Heather L

    2017-09-04

    Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved

  13. [Perioperative transfusion of erythrocyte concentrates during elective surgery: introduction of a protocol for indications].

    Science.gov (United States)

    Ortega Andrés, M C; Abad Gosálbez, A; López Sánchez, P; Martínez Aparisi, A; Ortí Lucas, R; Aranda Arrufat, A; Madrid Rondón, V

    1999-10-01

    The aim of this paper is, first, to know the actual situation of the perioperatory red cell transfusion for elective surgery in our hospital. In a second phase and prospectively, we tested guidelines for red cell perioperatory transfusion in order to observe the change of transfusions. Then, we compared the results between the basal and postintervention periods. We performed an aleatory assay with two periods, basal and interventionist. Basal period: 151 patients undergoing elective surgery with perioperatory blood requested and general anesthesia. Intervention period: We applied a transfusion guidelines protocol for perioperatory red cell transfusion from the Hospital's Transfusion Committee, also a questionnaire to evaluate the medical indication; We studied 164 patients with clinical features like the basal period. Study/results variables: preoperative blood request, perioperatively transfusion, number of packed red-cell units transfused, crossmatch--to--transfusion ratio, haemoglobin level pre and posttransfusion. No significant drop of the cross match-transfusion ratio was observed after intervention. There is a slight reduction of the crossmatch--to--transfusion ratio, although these value is high (4.48), due to an increase of the transfusion keeping the percentage of appropriate transfusions. The most frequent reason (53%) of inadequate transfusion is the active bleeding. 1) The transfusional activity of the Marina Alta Hospital supposes approximately 17% of the request and 6% of the global transfusion. 2) The introduction of a protocol of perioperative transfusion instructions suppose a small decrease of the crossmatch--to--transfusion ratio, without statistical significance. This slight reduction is due to an increase of transfusion in the post-intervention period, since in this period there is a group of older age patients and with greater percentage of associated pathology. 3) The rate of appropriate transfusions in both periods is similar. 4) The

  14. Sustainability of protocolized handover of pediatric cardiac surgery patients to the intensive care unit.

    Science.gov (United States)

    Chenault, Kristin; Moga, Michael-Alice; Shin, Minah; Petersen, Emily; Backer, Carl; De Oliveira, Gildasio S; Suresh, Santhanam

    2016-05-01

    Transfer of patient care among clinicians (handovers) is a common source of medical errors. While the immediate efficacy of these initiatives is well documented, sustainability of practice changes that results in better processes of care is largely understudied. The objective of the current investigation was to evaluate the sustainability of a protocolized handover process in pediatric patients from the operating room after cardiac surgery to the intensive care unit. This was a prospective study with direct observation assessment of handover performance conducted in the cardiac ICU (CICU) of a free-standing, tertiary care children's hospital in the United States. Patient transitions from the operating room to the CICU, including the verbal handoff, were directly observed by a single independent observer in all phases of the study. A checklist of key elements identified errors classified as: (1) technical, (2) information omissions, and (3) realized errors. Total number of errors was compared across the different times of the study (preintervention, postintervention, and the current sustainability phase). A total of 119 handovers were studied: 41 preintervention, 38 postintervention, and 40 in the current sustainability phase. The median [Interquartile range (IQR)] number of technical errors was significantly reduced in the sustainability phase compared to the preintervention and postintervention phase, 2 (1-3), 6 (5-7), and 2.5 (2-4), respectively P = 0.0001. Similarly, the median (IQR) number of verbal information omissions was also significantly reduced in the sustainability phase compared to the preintervention and postintervention phases, 1 (1-1), 4 (3-5) and 2 (1-3), respectively. We demonstrate sustainability of an improved handover process using a checklist in children being transferred to the intensive care unit after cardiac surgery. Standardized handover processes can be a sustainable strategy to improve patient safety after pediatric cardiac surgery.

  15. [Sampling and measurement methods of the protocol design of the China Nine-Province Survey for blindness, visual impairment and cataract surgery].

    Science.gov (United States)

    Zhao, Jia-liang; Wang, Yu; Gao, Xue-cheng; Ellwein, Leon B; Liu, Hu

    2011-09-01

    To design the protocol of the China nine-province survey for blindness, visual impairment and cataract surgery to evaluate the prevalence and main causes of blindness and visual impairment, and the prevalence and outcomes of the cataract surgery. The protocol design was began after accepting the task for the national survey for blindness, visual impairment and cataract surgery from the Department of Medicine, Ministry of Health, China, in November, 2005. The protocol in Beijing Shunyi Eye Study in 1996 and Guangdong Doumen County Eye Study in 1997, both supported by World Health Organization, was taken as the basis for the protocol design. The relative experts were invited to discuss and prove the draft protocol. An international advisor committee was established to examine and approve the draft protocol. Finally, the survey protocol was checked and approved by the Department of Medicine, Ministry of Health, China and Prevention Program of Blindness and Deafness, WHO. The survey protocol was designed according to the characteristics and the scale of the survey. The contents of the protocol included determination of target population and survey sites, calculation of the sample size, design of the random sampling, composition and organization of the survey teams, determination of the examinee, the flowchart of the field work, survey items and methods, diagnostic criteria of blindness and moderate and sever visual impairment, the measures of the quality control, the methods of the data management. The designed protocol became the standard and practical protocol for the survey to evaluate the prevalence and main causes of blindness and visual impairment, and the prevalence and outcomes of the cataract surgery.

  16. A Survey of Enhanced Recovery After Surgery Protocols for Cesarean Delivery in Serbia

    Directory of Open Access Journals (Sweden)

    Borislava Pujic

    2018-04-01

    Full Text Available Enhanced recovery after surgery (ERAS protocols have been described for patients undergoing colon surgery. Similar protocols for cesarean delivery (CD have been developed recently. CD is one of the most commonly performed surgical procedures, and adoption of ERAS protocols following CD might benefit patients and the health-care system. We aimed to determine which Serbian hospitals reported ERAS protocols, which elements of ERAS protocols were used in CD patients, and whether ERAS and non-ERAS hospitals differed. The survey was sent to all hospitals with obstetric services and 46 of 49 responded. The questionnaire asked whether ERAS protocols had been formally adopted for surgical patients and about their use in CD patients. Specific questions on elements described in other obstetric ERAS protocols for CD included preoperative patient preparation, type of anesthesia and temperature monitoring used for CD, maternal/neonatal contact, and time to discharge. ERAS protocols are used in 24% of surveyed hospitals, 84% admit the patient the day before elective CDs, 87% use a maternal bowel preparation morning on the day of CD, and 80% administer maternal deep venous thrombosis prophylaxis. Only 33% remove IV in the first postoperative day, and 89% of women do not eat solid food until the day following their CD. Neuraxial anesthesia is used in 46% of elective CDs in ERAS hospitals compared to 9% in non-ERAS hospitals (P < 0.01, and neuraxial narcotics for post CD analgesia are given more often in ERAS hospitals. Thirty-six percentage of ERAS patients are discharged within 3 days vs. none in the non-ERAS group. Few elements of ERAS protocols reported from other centers outside Serbia are employed in Serbian hospitals performing CD. Despite significant changes that have been made recently in CD care, enhanced recovery after CD could be significantly improved in Serbian hospitals.

  17. Effect of a Standardized Protocol of Antibiotic Therapy on Surgical Site Infection after Laparoscopic Surgery for Complicated Appendicitis.

    Science.gov (United States)

    Park, Hyoung-Chul; Kim, Min Jeong; Lee, Bong Hwa

    Although it is accepted that complicated appendicitis requires antibiotic therapy to prevent post-operative surgical infections, consensus protocols on the duration and regimens of treatment are not well established. This study aimed to compare the outcome of post-operative infectious complications in patients receiving old non-standardized and new standard antibiotic protocols, involving either 5 or 10 days of treatment, respectively. We enrolled 1,343 patients who underwent laparoscopic surgery for complicated appendicitis between January 2009 and December 2014. At the beginning of the new protocol, the patients were divided into two groups; 10 days of various antibiotic regimens (between January 2009 and June 2012, called the non-standardized protocol; n = 730) and five days of cefuroxime and metronidazole regimen (between July 2012 and December 2014; standardized protocol; n = 613). We compared the clinical outcomes, including surgical site infection (SSI) (superficial and deep organ/space infections) in the two groups. The standardized protocol group had a slightly shorter operative time (67 vs. 69 min), a shorter hospital stay (5 vs. 5.4 d), and lower medical cost (US$1,564 vs. US$1,654). Otherwise, there was no difference between the groups. No differences were found in the non-standardized and standard protocol groups with regard to the rate of superficial infection (10.3% vs. 12.7%; p = 0.488) or deep organ/space infection (2.3% vs. 2.1%; p = 0.797). In patients undergoing laparoscopic surgery for complicated appendicitis, five days of cefuroxime and metronidazole did not lead to more SSIs, and it decreased the medical costs compared with non-standardized antibiotic regimens.

  18. Effectiveness of a patient blood management protocol on reduction of allogenic red blood cell transfusions in orthopedic surgery.

    Science.gov (United States)

    Polanco-García, Mauricio; Capielo, Ana María; Miret, Xavier; Chamero, Antonio; Sainz, Julio; Revilla, Elena; Guinjoan, Antoni; Arranz, Teresa

    2018-06-07

    Patient blood management in orthopaedic surgery reduces transfusion risk. The best protocol is unknown. The effectiveness of a protocol based on the Seville Consensus on the reduction of transfusion risk is evaluated and a predictive transfusion equation is proposed in knee surgery. Cohort study in patients undergoing knee and hip arthroplasty from January 2014 to December 2015 at a second level complexity hospital in Vilafranca del Penedès (Barcelona). Patients with Hb between 10 and 13g/dL were classified as anaemic with or without iron deficiency and received iron or combination of iron and erythropoietin. On the day of surgery, tranexamic acid was administered, the Hb drop was measured the next day and the requirements and the transfusion lintel were measured during the stay. A total of 334 patients were included in the study. The implementation of the programme decreased the transfusion risk from 41.5% to 14.8% at the end of the study. In hip surgery, transfused patients were significantly older, sicker and with lower preoperative Hb. Tranexamic acid did not decrease bleeding. In knee surgery, the administration of tranexamic acid was the variable that most decreased the transfusion risk followed by a high preoperative Hb. The equation predicts transfusion risk with a sensitivity of 55% and specificity of 95.7%. The implementation of the programme reduces transfusion risk. The effectiveness of tranexamic acid varies according to surgery site. The use of iron and recombinant human erythropoietin is necessary to improve Hb. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

  19. Quality improvement initiative: Preventative Surgical Site Infection Protocol in Vascular Surgery.

    Science.gov (United States)

    Parizh, David; Ascher, Enrico; Raza Rizvi, Syed Ali; Hingorani, Anil; Amaturo, Michael; Johnson, Eric

    2018-02-01

    Objective A quality improvement initiative was employed to decrease single institution surgical site infection rate in open lower extremity revascularization procedures. In an attempt to lower patient morbidity, we developed and implemented the Preventative Surgical Site Infection Protocol in Vascular Surgery. Surgical site infections lead to prolonged hospital stays, adjunctive procedure, and additive costs. We employed targeted interventions to address the common risk factors that predispose patients to post-operative complications. Methods Retrospective review was performed between 2012 and 2016 for all surgical site infections after revascularization procedures of the lower extremity. A quality improvement protocol was initiated in January 2015. Primary outcome was the assessment of surgical site infection rate reduction in the pre-protocol vs. post-protocol era. Secondary outcomes evaluated patient demographics, closure method, perioperative antibiotic coverage, and management outcomes. Results Implementation of the protocol decreased the surgical site infection rate from 6.4% to 1.6% p = 0.0137). Patient demographics and comorbidities were assessed and failed to demonstrate a statistically significant difference among the infection and no-infection groups. Wound closure with monocryl suture vs. staple proved to be associated with decreased surgical site infection rate ( p site infections in the vascular surgery population are effective and necessary. Our data suggest that there may be benefit in the incorporation of MRSA and Gram-negative coverage as part of the Surgical Care Improvement Project perioperative guidelines.

  20. Introduction of a standardized multimodality image protocol for navigation-guided surgery of suspected low-grade gliomas.

    Science.gov (United States)

    Mert, Aygül; Kiesel, Barbara; Wöhrer, Adelheid; Martínez-Moreno, Mauricio; Minchev, Georgi; Furtner, Julia; Knosp, Engelbert; Wolfsberger, Stefan; Widhalm, Georg

    2015-01-01

    OBJECT Surgery of suspected low-grade gliomas (LGGs) poses a special challenge for neurosurgeons due to their diffusely infiltrative growth and histopathological heterogeneity. Consequently, neuronavigation with multimodality imaging data, such as structural and metabolic data, fiber tracking, and 3D brain visualization, has been proposed to optimize surgery. However, currently no standardized protocol has been established for multimodality imaging data in modern glioma surgery. The aim of this study was therefore to define a specific protocol for multimodality imaging and navigation for suspected LGG. METHODS Fifty-one patients who underwent surgery for a diffusely infiltrating glioma with nonsignificant contrast enhancement on MRI and available multimodality imaging data were included. In the first 40 patients with glioma, the authors retrospectively reviewed the imaging data, including structural MRI (contrast-enhanced T1-weighted, T2-weighted, and FLAIR sequences), metabolic images derived from PET, or MR spectroscopy chemical shift imaging, fiber tracking, and 3D brain surface/vessel visualization, to define standardized image settings and specific indications for each imaging modality. The feasibility and surgical relevance of this new protocol was subsequently prospectively investigated during surgery with the assistance of an advanced electromagnetic navigation system in the remaining 11 patients. Furthermore, specific surgical outcome parameters, including the extent of resection, histological analysis of the metabolic hotspot, presence of a new postoperative neurological deficit, and intraoperative accuracy of 3D brain visualization models, were assessed in each of these patients. RESULTS After reviewing these first 40 cases of glioma, the authors defined a specific protocol with standardized image settings and specific indications that allows for optimal and simultaneous visualization of structural and metabolic data, fiber tracking, and 3D brain

  1. Modified enhanced recovery after surgery (ERAS) protocols for patients with obstructive colorectal cancer.

    Science.gov (United States)

    Shida, Dai; Tagawa, Kyoko; Inada, Kentaro; Nasu, Keiichi; Seyama, Yasuji; Maeshiro, Tsuyoshi; Miyamoto, Sachio; Inoue, Satoru; Umekita, Nobutaka

    2017-02-16

    Enhanced recovery after surgery (ERAS) protocols are now well-known to be useful for elective colorectal surgery, as they result in shorter hospital stays without adversely affecting morbidity. However, the efficacy and safety of ERAS protocols for patients with obstructive colorectal cancer have yet to be clarified. We evaluated 122 consecutive resections for obstructive colorectal cancer performed between July 2008 and November 2012 at Tokyo Metropolitan Bokutoh Hospital. Patients with rupture or impending rupture and those who received simple colostomy were excluded. The first set of 42 patients was treated based on traditional protocols, and the latter 80 according to modified ERAS protocols. The main endpoints were length of postoperative hospital stay, postoperative short-term morbidity, rate of readmission within 30 days, and mortality. Differences in modified ERAS protocols relative to traditional care include intensive preoperative counseling (by both surgeons and anesthesiologists), perioperative fluid management (avoidance of sodium/fluid overload), shortening of postoperative fasting period and early provision of oral nutrition, intraoperative warm air body heating, enforced postoperative mobilization, stimulation of gut motility, early removal of urinary catheter, and a multidisciplinary team approach to care. Median (interquartile range) postoperative hospital stay was 10 (10-14.25) days in the traditional group, and seven (7-8.75) days in the ERAS group, showing a 3-day reduction in hospital stay (p < 0.01). According to the Clavien-Dindo classification, overall incidences of grade 2 or higher postoperative complications for the traditional and ERAS groups were 15 and 10% (p = 0.48), and 30-day readmission rates were 0 and 1.3% (p = 1.00), respectively. As for mortality, one patient in the traditional group died and none in the ERAS group (p = 0.34). Modified ERAS protocols for obstructive colorectal cancer reduced hospital stay

  2. A Systematic Review to Uncover a Universal Protocol for Accuracy Assessment of 3-Dimensional Virtually Planned Orthognathic Surgery.

    Science.gov (United States)

    Gaber, Ramy M; Shaheen, Eman; Falter, Bart; Araya, Sebastian; Politis, Constantinus; Swennen, Gwen R J; Jacobs, Reinhilde

    2017-11-01

    The aim of this study was to systematically review methods used for assessing the accuracy of 3-dimensional virtually planned orthognathic surgery in an attempt to reach an objective assessment protocol that could be universally used. A systematic review of the currently available literature, published until September 12, 2016, was conducted using PubMed as the primary search engine. We performed secondary searches using the Cochrane Database, clinical trial registries, Google Scholar, and Embase, as well as a bibliography search. Included articles were required to have stated clearly that 3-dimensional virtual planning was used and accuracy assessment performed, along with validation of the planning and/or assessment method. Descriptive statistics and quality assessment of included articles were performed. The initial search yielded 1,461 studies. Only 7 studies were included in our review. An important variability was found regarding methods used for 1) accuracy assessment of virtually planned orthognathic surgery or 2) validation of the tools used. Included studies were of moderate quality; reviewers' agreement regarding quality was calculated to be 0.5 using the Cohen κ test. On the basis of the findings of this review, it is evident that the literature lacks consensus regarding accuracy assessment. Hence, a protocol is suggested for accuracy assessment of virtually planned orthognathic surgery with the lowest margin of error. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  3. Using a clinical protocol for orthognathic surgery and assessing a 3-dimensional virtual approach: current therapy.

    Science.gov (United States)

    Quevedo, Luis A; Ruiz, Jessica V; Quevedo, Cristobal A

    2011-03-01

    Oral and maxillofacial surgeons who perform orthognathic surgery face major changes in their practices, and these challenges will increase in the near future, because the extraordinary advances in technology applied to our profession are not only amazing but are becoming the standard of care as they promote improved outcomes for our patients. Orthognathic surgery is one of the favorite areas of practicing within the scope of practice of an oral and maxillofacial surgeon. Our own practice in orthognathic surgery has completed over 1,000 surgeries of this type. Success is directly related to the consistency and capability of the surgical-orthodontic team to achieve predictable, stable results, and our hypothesis is that a successful result is directly related to the way we take our records and perform diagnosis and treatment planning following basic general principles. Now that we have the opportunity to plan and treat 3-dimensional (3D) problems with 3D technology, we should enter into this new era with appropriate standards to ensure better results, instead of simply enjoying these new tools, which will clearly show not only us but everyone what we do when we perform orthognathic surgery. Appropriate principles need to be taken into account when implementing this new technology. In other words, new technology is welcome, but we do not have to reinvent the wheel. The purpose of this article is to review the current protocol that we use for orthognathic surgery and compare it with published protocols that incorporate new 3D and virtual technology. This report also describes our approach to this new technology. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  4. An investigation into the nutritional status of patients receiving an Enhanced Recovery After Surgery (ERAS) protocol versus standard care following Oesophagectomy.

    Science.gov (United States)

    Benton, Katie; Thomson, Iain; Isenring, Elisabeth; Mark Smithers, B; Agarwal, Ekta

    2018-06-01

    Enhanced Recovery After Surgery (ERAS) protocols have been effectively expanded to various surgical specialities including oesophagectomy. Despite nutrition being a key component, actual nutrition outcomes and specific guidelines are lacking. This cohort comparison study aims to compare nutritional status and adherence during implementation of a standardised post-operative nutritional support protocol, as part of ERAS, compared to those who received usual care. Two groups of patients undergoing resection of oesophageal cancer were studied. Group 1 (n = 17) underwent oesophagectomy between Oct 2014 and Nov 2016 during implementation of an ERAS protocol. Patients in group 2 (n = 16) underwent oesophagectomy between Jan 2011 and Dec 2012 prior to the implementation of ERAS. Demographic, nutritional status, dietary intake and adherence data were collected. Ordinal data was analysed using independent t tests, and categorical data using chi-square tests. There was no significant difference in nutrition status, dietary intake or length of stay following implementation of an ERAS protocol. Malnutrition remained prevalent in both groups at day 42 post surgery (n = 10, 83% usual care; and n = 9, 60% ERAS). A significant difference was demonstrated in adherence with earlier initiation of oral free fluids (p nutrition protocol, within an ERAS framework, results in earlier transition to oral intake; however, malnutrition remains prevalent post surgery. Further large-scale studies are warranted to examine individualised decision-making regarding nutrition support within an ERAS protocol.

  5. Effect of a preoperative decontamination protocol on surgical site infections in patients undergoing elective orthopedic surgery with hardware implantation.

    Science.gov (United States)

    Bebko, Serge P; Green, David M; Awad, Samir S

    2015-05-01

    365 patients developed an SSI) than the SSI rate in the control group (3.8%; 13 of 344 patients developed an SSI) (P = .02). Multivariate logistic regression identified MRSA decontamination as an independent predictor of not developing an SSI (adjusted odds ratio, 0.24 [95% CI, 0.08-0.77]; P = .02). Our study demonstrates that preoperative MRSA decontamination with chlorhexidine washcloths and oral rinse and intranasal povidone-iodine decreased the SSI rate by more than 50% among patients undergoing elective orthopedic surgery with hardware implantation. Universal decontamination using this low-cost protocol may be considered as an additional prevention strategy for SSIs in patients undergoing orthopedic surgery with hardware implantation and warrants further study.

  6. The Dutch Linguistic Intraoperative Protocol: a valid linguistic approach to awake brain surgery.

    Science.gov (United States)

    De Witte, E; Satoer, D; Robert, E; Colle, H; Verheyen, S; Visch-Brink, E; Mariën, P

    2015-01-01

    Intraoperative direct electrical stimulation (DES) is increasingly used in patients operated on for tumours in eloquent areas. Although a positive impact of DES on postoperative linguistic outcome is generally advocated, information about the neurolinguistic methods applied in awake surgery is scarce. We developed for the first time a standardised Dutch linguistic test battery (measuring phonology, semantics, syntax) to reliably identify the critical language zones in detail. A normative study was carried out in a control group of 250 native Dutch-speaking healthy adults. In addition, the clinical application of the Dutch Linguistic Intraoperative Protocol (DuLIP) was demonstrated by means of anatomo-functional models and five case studies. A set of DuLIP tests was selected for each patient depending on the tumour location and degree of linguistic impairment. DuLIP is a valid test battery for pre-, intraoperative and postoperative language testing and facilitates intraoperative mapping of eloquent language regions that are variably located. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. Protocol for the systematic review of the reporting of transoral robotic surgery.

    Science.gov (United States)

    Main, Barry G; Blencowe, Natalie S; Howes, Noah; Cousins, Sian; Avery, Kerry N L; Gormley, Alexander; Radford, Phil; Elliott, Daisy; Byrne, Benjamin; Wilson, Nicholas; Hinchliffe, Robert; Blazeby, Jane M

    2018-01-23

    Transoral robotic surgery (TORS) has been adopted in some parts of the world as an innovative approach to the resection of oropharyngeal tumours. The development, details and outcomes of early-to-later phase evaluation of this technique and the quality of evidence to support its adoption into practice have hitherto not been summarised. The aim of this review is to identify and summarise the early and later phase studies of, and evidence for, TORS and to understand how early phase studies report intervention development, governance procedures and selection and reporting of outcomes to optimise methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for surgical innovation that informs evidence-based practice. The protocol has been written in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist. Electronic searches in OVID SP versions of Medline and EMBASE, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews from the start of indexing to 30 April 2017 will identify studies reporting TORS. At least two independent researchers will identify studies for inclusion. Two researchers will extract data from each paper. Studies will be categorised into IDEAL stages of study design from 'pre-IDEAL' to randomised controlled trials (stage 3). Data will be collected about the (1) novel intervention and criteria for modification, (2) governance arrangements and patient information provision, (3) outcome domains selected and reported and (4) quality of study design, conduct and reporting. Descriptive statistics and a narrative synthesis will be presented. The results of this systematic review will be presented at relevant conferences. The methods will be used to inform future reviews exploring other novel surgical innovations. The findings will be published in a peer-reviewed journal. This study does not require ethical approval. © Article

  8. Exercise-based cardiac rehabilitation for adults after Heart valve surgery (protocol)

    DEFF Research Database (Denmark)

    Lærum Sibilitz, Kristine; Berg, Selina Kikkenborg; Tang, Lars Hermann

    2013-01-01

    This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the benefits and harms of exercise-based intervention programmes (exercise-based interventions alone or in combination with psycho-educational components), compared to no intervention, or treatment...... as usual, in adults who have had heart valve surgery. In this review we will focus on programmes that include an exercise-based intervention with, or without, another rehabilitation component (such as a psycho-educational component)....

  9. A comparison of high-dose and low-dose tranexamic acid antifibrinolytic protocols for primary coronary artery bypass surgery

    Directory of Open Access Journals (Sweden)

    Stephen M McHugh

    2016-01-01

    Full Text Available Background and Aims: Tranexamic acid (TA is used for prophylactic antifibrinolysis in coronary artery bypass surgeries to reduce bleeding. We evaluated the efficacy of two different doses of TA for prophylactic antifibrinolysis in patients undergoing primary coronary artery bypass grafting (CABG surgery in this retrospective cohort study at a tertiary care referral centre. Methods: One-hundred eighty-four patients who underwent primary CABG with cardiopulmonary bypass (CPB via sternotomy between January 2009 and June 2011 were evaluated. Pre-operative patient characteristics, intraoperative data, post-operative bleeding, transfusions, organ dysfunction and 30-day mortality were compared between high-dose TA (30 mg/kg loading dose followed by infusion of 15 mg/kg/h until the end of surgery along with 2 mg/kg priming dose in the bypass circuit and low-dose TA (15 mg/kg loading dose followed by infusion of 6 mg/kg/h until the end of surgery along with 1 mg/kg priming dose in the bypass circuit groups. Univariate comparative analysis of all categorical and continuous variables was performed between the two groups by appropriate statistical tests. Linear and logistic regression analyses were performed to control for the effect of confounding on the outcome variables. Results: Chest tube output, perioperative transfusion of blood products and incidence of re-exploration for bleeding did not differ significantly (P> 0.05 between groups. Post-operative complications and 30-day mortality were comparable between the groups. The presence of cardiogenic shock and increased pre-operative creatinine were found to be associated with increased chest tube output on the post-operative day 2 by multivariable linear regression model. Conclusions: Low-dose TA protocol is as effective as high-dose protocol for antifibrinolysis in patients undergoing primary CABG with CPB.

  10. A prospective randomised multi-centre study of the impact of Ga-68 PSMA-PET/CT imaging for staging high risk prostate cancer prior to curative-intent surgery or radiotherapy (proPSMA study): clinical trial protocol.

    Science.gov (United States)

    Hofman, Michael S; Murphy, Declan G; Williams, Scott G; Nzenza, Tatenda; Herschtal, Alan; De Abreu Lourenco, Richard; Bailey, Dale L; Budd, Ray; Hicks, Rodney J; Francis, Roslyn J; Lawrentschuk, Nathan

    2018-05-03

    Accurate staging of patients with prostate cancer is important for therapeutic decision making. Relapse following surgery or radiotherapy of curative intent is not uncommon and, in part, represents a failure of staging with current diagnostic imaging techniques to detect disease spread. Prostate-specific-membrane-antigen (PSMA) positron emission tomography / computed tomography (PET/CT) is a new whole body scanning technique that enables visualisation of prostate cancer with high contrast. The hypotheses of this study are that (a) PSMA-PET/CT has improved diagnostic performance compared to conventional imaging, (b) PSMA-PET/CT should be used as a first-line diagnostic test for staging, (c) the improved diagnostic performance of PSMA-PET/CT will result in significant management impact and (d) there are economic benefits if PSMA-PET/CT is incorporated into the management algorithm. This is a prospective, multi-centre study in which patients with untreated high-risk prostate cancer will be randomised to Gallium-68-PSMA11-PET/CT or conventional imaging, consisting of computer tomography of the abdomen/pelvis and bone scintigraphy with SPECT/CT. Inclusion criteria are newly diagnosed prostate cancer patients with select high-risk prostate cancer defined as International Society of Urological Pathology (ISUP) grade group ≥ 3 (primary Gleason grade 4, or any Gleason grade 5), PSA ≥ 20ng/mL or clinical stage ≥ T3. Patients with negative, equivocal or oligometastatic disease on first line-imaging will cross-over to receive the other imaging arm. The primary objective is to compare the accuracy of PSMA-PET/CT to conventional imaging for detecting nodal or distant metastatic disease. Histopathologic, imaging and clinical follow-up at six months will define the primary endpoint according to a pre-defined scoring system. Secondary objectives include comparing management impact, the number of equivocal studies, the incremental value of second-line imaging in patients who

  11. The use of LiDCO based fluid management in patients undergoing hip fracture surgery under spinal anaesthesia: Neck of femur optimisation therapy - targeted stroke volume (NOTTS: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Moran Chris G

    2011-09-01

    Full Text Available Abstract Background Approximately 70,000 patients/year undergo surgery for repair of a fractured hip in the United Kingdom. This is associated with 30-day mortality of 9% and survivors have a considerable length of acute hospital stay postoperatively (median 26 days. Use of oesophageal Doppler monitoring to guide intra-operative fluid administration in hip fracture repair has previously been associated with a reduction in hospital stay of 4-5 days. Most hip fracture surgery is now performed under spinal anaesthesia. Oesophageal Doppler monitoring may be unreliable in the presence of spinal anaesthesia and most patients would not tolerate the probes. An alternative method of guiding fluid administration (minimally-invasive arterial pulse contour analysis has been shown to reduce length of stay in high-risk surgical patients but has never been studied in hip fracture surgery. Methods Single-centre randomised controlled parallel group trial. Randomisation by website using computer generated concealed tables. Setting: University hospital in UK. Participants: 128 patients with acute primary hip fracture listed for operative repair under spinal anaesthesia and aged > 65 years. Intervention: Stroke volume guided intra-operative fluid management. Continuous measurement of SV recorded by a calibrated cardiac output monitor (LiDCOplus. Maintenance fluid and 250 ml colloid boluses given to achieve sustained 10% increases in stroke volume. Control group: fluid administration at the responsible (blinded anaesthetist's discretion. The intervention terminates at the end of the surgical procedure and post-operative fluid management is at the responsible anaesthetist's discretion. Primary outcome: length of acute hospital stay is determined by a blinded team of clinicians. Secondary outcomes include number of complications and total cost of care. Funding NIHR/RfPB: PB-PG-0407-13073. Trial registration number Trial registration: Current Controlled Trials ISRCTN

  12. Comparison of the Effects of Religious Cognitive Behavioral Therapy (RCBT), Cognitive Behavioral Therapy (CBT), and Sertraline on Depression and Anxiety in Patients after Coronary Artery Bypass Graft Surgery: Study Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Hosseini, Seyed Hamzeh; Rafiei, Alireza; Gaemian, Ali; Tirgari, Abdolhakim; Zakavi, Aliasghar; Yazdani, Jamshid; Bolhari, Jafar; Golzari, Mahmood; Esmaeili Douki, Zahra; Vaezzadeh, Nazanin

    2017-07-01

    Objective: The present study aimed at comparing the effects of Religious Cognitive Behavioral Therapy (RCBT), Cognitive Behavioral Therapy (CBT), and sertraline on depression, anxiety, biomarker levels, and quality of life in patients after coronary artery bypass graft (CABG) surgery. Method: This was a randomized controlled trial with parallel groups. A total of 160 patients after CABG surgery will be screened for anxiety and depression according to clinical interviews based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and Hospital Anxiety Depression Scale (HADS) scores (≥ 8). To assess religious attitude, Golriz and Baraheni's Religious Attitude questionnaire will be used. Participants will be randomly allocated to 4 groups of 40 including 3 intervention groups (RCBT, CBT, and sertraline) and 1 control group (usual care). RCBT and CBT programs will consist of 12 one-hour weekly sessions. The participants in the pharmacological intervention group will receive 25-200 mg/d of sertraline for 3 months. The Short Form-36 Health Survey (SF-36) will be administered to assess the patients' quality of life. Blood samples will be taken and biomarker levels will be determined using the enzyme-linked immunosorbent assay (ELISA). The primary outcome will be reduction in anxiety and depression scores after the interventions. The secondary outcomes will be increase in quality of life scores and normalized biomarker levels after the interventions. Discussion: If RCBT is found to be more effective than the other methods; it can be used to improve patients' health status after CABG surgery. Irct ID: IRCT201404122898N5.

  13. NEURAPRO-E study protocol

    DEFF Research Database (Denmark)

    Markulev, Connie; McGorry, Patrick D; Nelson, Barnaby

    2017-01-01

    polyunsaturated fatty acids (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study......AIM: Recent research has indicated that preventative intervention is likely to benefit patients 'at-risk' for psychosis, both in terms of symptom reduction and delay or prevention of onset of threshold psychotic disorder. The strong preliminary results for the effectiveness of omega-3...... omega-3 PUFAs plus cognitive-behavioural case management (CBCM) will be less likely to transition to psychosis over a 6-month period compared to treatment with placebo plus CBCM. Secondary outcomes will examine symptomatic and functional changes, as well as examine if candidate risk factors predict...

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

    Science.gov (United States)

    van der Kolk, Marion; van den Boogaard, Mark; Ter Brugge-Speelman, Corine; Hol, Jeroen; Noyez, Luc; van Laarhoven, Kees; van der Hoeven, Hans; Pickkers, Peter

    2017-12-01

    Cardiac surgery (CS) is facilitated by multiple perioperative guidelines and protocols. Use of a clinical pathway (CP) may facilitate the care of these patients. 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. 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 blueprint for the implementation and use of a CP in low-volume high complex surgery. © 2017 John Wiley & Sons, Ltd.

  15. PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Pasu, Saruban; Bunce, Catey; Hooper, Richard; Thomson, Ann; Bainbridge, James

    2015-11-17

    Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery. This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery. This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. UK CRN: 17966 (date of registration 26 November 2014).

  16. Protocol for concomitant temporomandibular joint custom-fitted total joint reconstruction and orthognathic surgery utilizing computer-assisted surgical simulation.

    Science.gov (United States)

    Movahed, Reza; Teschke, Marcus; Wolford, Larry M

    2013-12-01

    Clinicians who address temporomandibular joint (TMJ) pathology and dentofacial deformities surgically can perform the surgery in 1 stage or 2 separate stages. The 2-stage approach requires the patient to undergo 2 separate operations and anesthesia, significantly prolonging the overall treatment. However, performing concomitant TMJ and orthognathic surgery (CTOS) in these cases requires careful treatment planning and surgical proficiency in the 2 surgical areas. This article presents a new treatment protocol for the application of computer-assisted surgical simulation in CTOS cases requiring reconstruction with patient-fitted total joint prostheses. The traditional and new CTOS protocols are described and compared. The new CTOS protocol helps decrease the preoperative workup time and increase the accuracy of model surgery. Copyright © 2013 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  17. Antibiotic prophylaxis in orthopedic surgeries: the results of an implemented protocol

    Directory of Open Access Journals (Sweden)

    Raquel Queiroz

    Full Text Available Though the basic principles of antibiotic prophylaxis have been well established, there is still considerable incorrect usage, including how much is prescribed and especially in the duration of treatment, which is generally superior to what is indicated. The adequate use of these drugs contributes towards decreasing the time of internment of the patient, prevents surgical site infection (SSI, decreasing the development of resistant microorganisms, and towards reduced costs for the hospital pharmacy. A protocol for the use of antibiotic prophylaxis in the Orthopedics and Traumatology Service of the Hospital do Servidor Público Estadual de São Paulo was developed. The objectives of the study were to promote rational antibiotic surgical prophylaxis, through the implantation of a protocol for the use of these drugs in a surgical unit, with the direct contribution of a druggist in collaboration with the Infection Control Committee, to evaluate the adhesion of the health team to the protocol during three distinct periods (daily pre-protocol, early post-protocol and late post-protocol and to define the consumption of antimicrobials used, measured as daily defined dose.

  18. Clinical protocol levels are required in laboratory animal surgery when using medical devices: experiences with ureteral replacement surgery in goats.

    Science.gov (United States)

    de Jonge, Paul K J D; Sloff, Marije; Janke, Heinz P; Kortmann, Barbara B M; de Gier, Robert P E; Geutjes, Paul J; Oosterwijk, Egbert; Feitz, Wout F J

    2017-10-01

    It is common to test medical devices in large animal studies that are or could also be used in humans. In this short report we describe the use of a ureteral J-stent for the evaluation of biodegradable tubular constructs for tissue reconstruction, and the regeneration of ureters in Saanen goats. Similarly to a previous study in pigs, the ureteral J-stent was blindly inserted until some resistance was met. During evaluation of the goats after three months, perforation of the renal cortex by the stent was observed in four out of seven animals. These results indicated that blind stent placement was not possible in goats. In four new goats, clinical protocols were followed using X-ray and iodinated contrast fluids to visualize the kidney and stent during stent placement. With this adaptation the stents were successfully placed in the kidneys of these four new goats with minimal additional effort. It is likely that other groups in other fields ran into similar problems that could have been avoided by following clinical protocols. Therefore, we would like to stress the importance of following clinical protocols when using medical devices in animals to prevent unnecessary suffering and to reduce the number of animals needed.

  19. Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered

    Directory of Open Access Journals (Sweden)

    Kleinjan Jan H

    2009-07-01

    Full Text Available Abstract Background Stress urinary incontinence (SUI is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting. The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered. Methods/design A multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant SUI. Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration. Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation. Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information. Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires. Six hundred female patients will be recruited for registration from

  20. IMPLEMENTATION AND VALIDATION OF STATISTICAL TESTS IN RESEARCH'S SOFTWARE HELPING DATA COLLECTION AND PROTOCOLS ANALYSIS IN SURGERY.

    Science.gov (United States)

    Kuretzki, Carlos Henrique; Campos, Antônio Carlos Ligocki; Malafaia, Osvaldo; Soares, Sandramara Scandelari Kusano de Paula; Tenório, Sérgio Bernardo; Timi, Jorge Rufino Ribas

    2016-03-01

    The use of information technology is often applied in healthcare. With regard to scientific research, the SINPE(c) - Integrated Electronic Protocols was created as a tool to support researchers, offering clinical data standardization. By the time, SINPE(c) lacked statistical tests obtained by automatic analysis. Add to SINPE(c) features for automatic realization of the main statistical methods used in medicine . The study was divided into four topics: check the interest of users towards the implementation of the tests; search the frequency of their use in health care; carry out the implementation; and validate the results with researchers and their protocols. It was applied in a group of users of this software in their thesis in the strict sensu master and doctorate degrees in one postgraduate program in surgery. To assess the reliability of the statistics was compared the data obtained both automatically by SINPE(c) as manually held by a professional in statistics with experience with this type of study. There was concern for the use of automatic statistical tests, with good acceptance. The chi-square, Mann-Whitney, Fisher and t-Student were considered as tests frequently used by participants in medical studies. These methods have been implemented and thereafter approved as expected. The incorporation of the automatic SINPE (c) Statistical Analysis was shown to be reliable and equal to the manually done, validating its use as a research tool for medical research.

  1. Interdisciplinary preoperative patient education in cardiac surgery: effects of the implementation of an information protocol.

    NARCIS (Netherlands)

    Tromp, F.; Dulmen, S. van; Weert, J. van

    2004-01-01

    Background: In 1998, we carried out a study of interdisciplinary preoperative education in cardiac surgery given by nurses, physicians and health educators. Overlaps were found in gathering and providing information by physicians, nurses and health educators, and gaps were found in providing

  2. Continuing the Original Stanford Sleep Surgery Protocol From Upper Airway Reconstruction to Upper Airway Stimulation: Our First Successful Case.

    Science.gov (United States)

    Liu, Stanley Yung; Riley, Robert Wayne

    2017-07-01

    In 1993, a surgical protocol for dynamic upper airway reconstruction in patients with obstructive sleep apnea (OSA) was published, and it became commonly known as the Stanford phase 1 and 2 sleep surgery protocol. It served as a platform on which research and clinical studies have continued to perfect the surgical care of patients with OSA. However, relapse is inevitable in a chronic condition such as OSA, and a subset of previously cured surgical patients return with complaints of excessive daytime sleepiness. This report describes a patient who was successfully treated with phase 1 and 2 operations more than a decade previously. He returned at 65 years of age with relapse of moderate OSA, and after workup with polysomnography and drug-induced sleep endoscopy, he underwent upper airway stimulation of the hypoglossal nerve that resulted in a cure of OSA. This case shows why upper airway stimulation is an appropriate option for patients with OSA relapse, after previously successful maxillomandibular advancement. Copyright © 2017. Published by Elsevier Inc.

  3. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research...... to quantify relationships in data. Despite an increased focus on statistical content and complexity of biomedical research these topics remain difficult for most researchers. Statistical methods enable researchers to condense large spreadsheets with data into means, proportions, and difference between means...... the statistical principles for trial protocols in terms of design, analysis, and reporting of findings....

  4. Comparison of the Effects of Religious Cognitive Behavioral Therapy (RCBT, Cognitive Behavioral Therapy (CBT, and Sertraline on Depression and Anxiety in Patients after Coronary Artery Bypass Graft Surgery: A Study Protocol for a Randomized Controlled T

    Directory of Open Access Journals (Sweden)

    Nazanin Vaezzadeh

    2017-06-01

    Full Text Available Objectives: Our objective is to compare the effects of RCBT, CBT, and sertraline on depression, anxiety, biomarker levels, and the quality of life in patients after coronary artery bypass graft (CABG surgery.Method/Design: This is a randomized controlled trial with parallel groups. A total of 160 patients after CABG surgery will be screened for anxiety and depression according to clinical interviews based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV criteria and Hospital  Anxiety Depression Scale (HADS scores (≥ 8. To assess religious attitude, Golriz and Baraheni’s religious attitude questionnaire will be used. Participants will be randomly allocated to four groups of 40 including three intervention groups (RCBT, CBT, and sertraline and one control group (usual care. RCBT and CBT programs will consist of 12 one-hour weekly sessions. The participants in the pharmacological intervention group will receive 25-200 mg/d of sertraline for three months. The (SF-36 will be administered to assess the patients’ quality of life. Blood samples will be taken and biomarker levels will be determined using the enzyme-linked immunosorbent assay (ELISA. The primary outcome will be the reduction in anxiety and depression scores after the interventions. The secondary outcomes will be increases in quality of life scores and normalized biomarker levels after the interventions.Discussion: If RCBT is found to be more effective than the other methods, it can be used to improve patients’ health status after CABG surgery.Irct ID: IRCT201404122898N5

  5. Graft patency after off-pump coronary artery bypass surgery is inferior even with identical heparinization protocols

    DEFF Research Database (Denmark)

    Houlind, Kim; Fenger-Grøn, Morten; Holme, Susanne J

    2014-01-01

    OBJECTIVE: To determine whether graft patency after on-pump and off-pump coronary artery bypass surgery is similar when performed using the same heparinization protocol. METHODS: In a randomized, controlled, multicenter trial, 900 patients more than 70 years of age received either on-pump or off......-pump coronary artery bypass surgery. Heparin was given to achieve an activated clotting time of 400 seconds before arteriotomy in both groups. After the procedure, protamine sulfate was given to revert the activated clotting time to less than 120 seconds. Coronary angiography was performed 6 months after...

  6. Ultrasonic root-end preparation in apical surgery : a prospective randomized study

    NARCIS (Netherlands)

    de Lange, Jan; Putters, Thomas; Baas, Erik M.; van Ingen, Johan M.

    2007-01-01

    Objective. The purpose of this study was to evaluate the potential benefit of an ultrasonic device in apical surgery on the outcome of treatment. Study design. A randomized prospective design was used in a standardized treatment protocol. Patients were allocated to treatment with an ultrasonic

  7. Prayer Healing: A Case Study Research Protocol.

    Science.gov (United States)

    Kruijthoff, Dirk J; van der Kooi, Cornelis; Glas, Gerrit; Abma, Tineke A

    2017-01-01

    Context • Prayer healing is a common practice in many religious communities around the world. Even in the highly secularized Dutch society, cases of prayer healing are occasionally reported in the media, often generating public attention. There is an ongoing debate regarding whether such miraculous cures do actually occur and how to interpret them. Objective • The aim of the article was to present a research protocol for the investigation of reported cases of remarkable and/or unexplained healing after prayer. Design • The research team developed a method to perform a retrospective, case-based study of prayer healing. Reported prayer healings can be investigated systematically in accordance with a step-by-step methodology. The focus is on understanding the healing by studying it from multiple perspectives, using both medical judgment and patients' narratives collected by qualitative methods Setting • The study occurred at Vrije Universiteit (VU) and VU Medical Center (Amsterdam, Netherlands) as well as the general medical practice of the first author. Participants • Potential participants could be any individuals in the Netherlands or neighboring countries who claim to have been healed through prayer. The reports of healing came from multiple sources, including the research team's medical practices and their direct vicinities, newspaper articles, prayer healers, and medical colleagues. Outcome Measures • Medical data were obtained before and after prayer. Subsequently, a member of a research team and of a medical assessment committee made a standardized judgment that evaluated whether a cure was clinically remarkable or scientifically unexplained. The participants' experiences and insider perspectives were studied, using in-depth interviews in accordance with a qualitative research methodology, to gain insight into the perceptions and explanations of the cures that were offered by participants and by the members of the medical assessment committee. The

  8. Mac protocols for wireless sensor network (wsn): a comparative study

    International Nuclear Information System (INIS)

    Arshad, J.; Akram, Q.; Saleem, Y.

    2014-01-01

    Data communication between nodes is carried out under Medium Access Control (MAC) protocol which is defined at data link layer. The MAC protocols are responsible to communicate and coordinate between nodes according to the defined standards in WSN (Wireless Sensor Networks). The design of a MAC protocol should also address the issues of energy efficiency and transmission efficiency. There are number of MAC protocols that exist in the literature proposed for WSN. In this paper, nine MAC protocols which includes S-MAC, T-MAC, Wise-MAC, Mu-MAC, Z-MAC, A-MAC, D-MAC, B-MAC and B-MAC+ for WSN have been explored, studied and analyzed. These nine protocols are classified in contention based and hybrid (combination of contention and schedule based) MAC protocols. The goal of this comparative study is to provide a basis for MAC protocols and to highlight different mechanisms used with respect to parameters for the evaluation of energy and transmission efficiency in WSN. This study also aims to give reader a better understanding of the concepts, processes and flow of information used in these MAC protocols for WSN. A comparison with respect to energy reservation scheme, idle listening avoidance, latency, fairness, data synchronization, and throughput maximization has been presented. It was analyzed that contention based MAC protocols are less energy efficient as compared to hybrid MAC protocols. From the analysis of contention based MAC protocols in term of energy consumption, it was being observed that protocols based on preamble sampling consume lesser energy than protocols based on static or dynamic sleep schedule. (author)

  9. Update protocols for evaluating nuclear cardiology and management of coronary heart disease. Chilean Society of Cardiology and Cardiovascular Surgery

    International Nuclear Information System (INIS)

    Massardo, Teresa; Jaimovich, Rodrigo; Canessa, Jose; Castro, Gabriel; Soto, Juan Ramon

    2010-01-01

    Protocols are reviewed nuclear cardiology present, with emphasis on imaging studies Single photon ( S PECT ) myocardial perfusion mainly in assessment of coronary heart disease (EC). The indications and protocols used are detailed as well as the literature review relevant both to clinical use as a quality control and interpretation of studies

  10. Post-destructive eye surgery, associated depression at Sekuru Kaguvi Hospital Eye Unit, Zimbabwe: Pilot Study

    Directory of Open Access Journals (Sweden)

    M. M. Kawome

    2013-12-01

    Full Text Available Destructive eye surgery is associated with more complications than just loss of visual functions of the eye and aesthetics. Currently there is very little published literature on post-destructive eye surgery associated depression. Zimbabwe has been experiencing a surge in the rate of destructive eye surgery done at the National Tertiary Eye Unit. This situation could be churning out lots of unrecognized depressed clients into the community who require assistance in one form or another. Objectives: To determine the prevalence of post-destructive eye surgery associated depression among patients attending Sekuru Kaguvi Hospital Eye Unit and assess if the current management protocol of patients undergoing destructive eye surgery at the Eye Unit addresses the problem adequately. Methods: A cross-sectional study of 28 randomly selected patients who had destructive eye surgeries at Sekuru Kaguvi Hospital was conducted over five months from 1st March 2012 to end of July 2012. A structured questionnaire containing 15 questions on the following items: gender, age, diagnosis, surgical procedure done, expectations before and after surgery, adequacy of counseling given and involvement of family was used to collect data. Nine questions to assess depression were adapted from the Patient Health Questionnaire (PHQ-9. Setting:  The study was conducted at SekuruKaguvi Hospital Eye Unit, Parirenyatwa Group of Hospitals in Harare. Results:  Twenty-eight patients who underwent destructive eye surgery during the study period were selected using systematic random sampling. The gender ratio was 1:1 and the mean age was 38.7 years with a range from 24 to 65 years. Fifty percent of the patients in the study had orbital exenteration while the rest had enucleation (14% and evisceration (36%. Twenty-eight percent of the study population had depression. Conclusion: Destructive eye surgery is frequently associated with depression and our current management protocol of

  11. The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Boitor, Madalina; Martorella, Géraldine; Laizner, Andréa Maria; Maheu, Christine; Gélinas, Céline

    2016-11-07

    Postoperative pain is common in the intensive care unit despite the administration of analgesia. Some trials suggest that massage can be effective at reducing postoperative pain in acute care units; however, its effects on pain relief in the intensive care unit and when pain severity is highest remain unknown. The objective is to evaluate the effectiveness of hand massage on the pain intensity (primary outcome), unpleasantness and interference, muscle tension, anxiety, and vital signs of critically ill patients after cardiac surgery. A 3-arm randomized controlled trial will be conducted. A total of 79 patients who are 18 years or older, able to speak French or English and self-report symptoms, have undergone elective cardiac surgery, and do not have a high risk of postoperative complications and contraindications to hand massage will be recruited. They will be randomly allocated (1:1:1) to standard care plus either 3 20-minute hand massages (experimental), 3 20-minute hand holdings (active control), or 3 20-minute rest periods (passive control). Pain intensity, unpleasantness, anxiety, muscle tension, and vital signs will be evaluated before, immediately after, and 30 minutes later for each intervention administered within 24 hours postoperatively. Peer-reviewed competitive funding was received from the Quebec Nursing Intervention Research Network and McGill University in December 2015, and research ethics approval was obtained February 2016. Recruitment started in April 2016, and data collection is expected to be complete by January 2017. To date, 24 patients were randomized and had data collection done. This study will be one of the first randomized controlled trials to examine the effect of hand massage on the pain levels of critically ill patients after cardiac surgery and to provide empirical evidence for the use of massage among this population. ClinicalTrials.gov NCT02679534; https://clinicaltrials.gov/ct2/show/NCT02679534 (Archived by WebCite at http

  12. Interactive verification of Markov chains: Two distributed protocol case studies

    Directory of Open Access Journals (Sweden)

    Johannes Hölzl

    2012-12-01

    Full Text Available Probabilistic model checkers like PRISM only check probabilistic systems of a fixed size. To guarantee the desired properties for an arbitrary size, mathematical analysis is necessary. We show for two case studies how this can be done in the interactive proof assistant Isabelle/HOL. The first case study is a detailed description of how we verified properties of the ZeroConf protocol, a decentral address allocation protocol. The second case study shows the more involved verification of anonymity properties of the Crowds protocol, an anonymizing protocol.

  13. Adolescent girls' views on cosmetic surgery: A focus group study.

    Science.gov (United States)

    Ashikali, Eleni-Marina; Dittmar, Helga; Ayers, Susan

    2016-01-01

    This study examined adolescent girls' views of cosmetic surgery. Seven focus groups were run with girls aged 15-18 years (N = 27). Participants read case studies of women having cosmetic surgery, followed by discussion and exploration of their views. Thematic analysis identified four themes: (1) dissatisfaction with appearance, (2) acceptability of cosmetic surgery, (3) feelings about undergoing cosmetic surgery and (4) cosmetic surgery in the media. Results suggest the acceptability of cosmetic surgery varies according to the reasons for having it and that the media play an important role by normalising surgery and under-representing the risks associated with it. © The Author(s) 2014.

  14. Study Application of RADIUS Protocol on Ethernet

    Institute of Scientific and Technical Information of China (English)

    GUO Fang; YANG Huan-yu; LI Hong

    2004-01-01

    This paper presents how to apply the RADIUS (Remote Authentication Dial In User Service)protocol ,which is generally applied to dial-up network, to the authentication & charge of Broad Band accessing control system on Ethernet. It is provided that the Broad Band accessing control system included a self-designed communication protocol is used in communicating between an terminal user and Network Access Server .The interface module on the servers side and the Radius system is also given in this article.

  15. A protocol of rehabilitation after ACL reconstruction using a hamstring autograft in the first month after surgery--a preliminary report.

    Science.gov (United States)

    Biernat, Ryszard; Wołosewicz, Mariusz; Tomaszewski, Wiesław

    2007-01-01

    The purpose of this paper is to present a protocol of rehabilitation after ACL reconstruction using a hamstring autograft in the first month after surgery. The program enables the patient to return early to everyday activities (school, sedentary work) without crutches or a stabilizer. The program has been developed in accordance with rehabilitation protocols employed at Karolinska Institute in Sweden and Prof. Shelbourne's Clinic in the USA. The study group included 31 patients (18 men and 13 women). Patients rehabilitated in the Department according to our program achieved stable gait patterns and were able to step up and down within four to seven weeks. Early patient mobilization after ACL reconstruction is possible and does not cause any negative effects provided that the patient, doctor and physiotherapist cooperate very closely.

  16. A parathyroid adenoma case study: Protocol review

    International Nuclear Information System (INIS)

    Sorensen, B.J.; Chu, J.M.G.

    1998-01-01

    Full text: Technetium-99m ( 99m Tc) Sestamibi as opposed to Thallous-201 Chloride and 99m Tc Sodium Pertechnetate subtraction, has become the radiopharmaceutical of choice for detection of parathyroid adenomas. A 17-year-old female patient presented to the department for a parathyroid 99m Tc Sestamibi scan to evaluate possible parathyroid adenoma/s. She was initially admitted with increasing serum Calcium levels, polyuria, abdominal pain and general malaise. The patient was injected with 900MBq of 99m Tc Sestamibi, and a pinhole dynamic at a distance of 10 cm from the neck was acquired followed by a 5-minute static image at 7 cm. Single Photon Emission Computed Tomography (SPECT) was then performed on a dual-head gamma camera followed by an anterior and posterior 10-minute static image. At 3 and 5 hours post injection the 10-minute static image was repeated. This study was reported as normal with uniform uptake and washout of the tracer over the 5-hour period. An ultrasound study was performed, and it showed a lesion believed to be a parathyroid adenoma measuring 2.2 x 0.8 x 0.4 cm in size in the right upper lobe of the thyroid. A subsequent thyroid scan was performed to confirm that it was non-functioning thyroid tissue. The patient was injected with 250MBq of 99m Tc Sodium Pertechnetate and scanned with a pinhole collimator at a distance of 7 cm. When the 99m Tc Sestamibi and 99m Tc Sodium Pertechnetate scan were viewed together, it was clear that there was excess 99m Tc Sestamibi distribution on the right upper lobe of the thyroid, which washed out over time. This corresponded to the ultrasound findings and was confirmed at surgery to be a parathyroid adenoma. A 99m Tc Sodium Pertechnetate scan and an ultrasound are now also routinely performed on patients presenting for 99m Tc Sestamibi parathyroid scans

  17. A Time Study of Plastic Surgery Residents.

    Science.gov (United States)

    Lau, Frank H; Sinha, Indranil; Jiang, Wei; Lipsitz, Stuart R; Eriksson, Elof

    2016-05-01

    Resident work hours are under scrutiny and have been subject to multiple restrictions. The studies supporting these changes have not included data on surgical residents. We studied the workday of a team of plastic surgery residents to establish prospective time-study data of plastic surgery (PRS) residents at a single tertiary-care academic medical center. Five trained research assistants observed all residents (n = 8) on a PRS service for 10 weeks and produced minute-by-minute activity logs. Data collection began when the team first met in the morning and continued until the resident being followed completed all non-call activities. We analyzed our data from 3 perspectives: 1) time spent in direct patient care (DPC), indirect patient care, and didactic activities; 2) time spent in high education-value activities (HEAs) versus low education-value activities; and 3) resident efficiency. We defined HEAs as activities that surgeons must master; other activities were LEAs. We quantified resident efficiency in terms of time fragmentation and time spent waiting. A total of 642.4 hours of data across 50 workdays were collected. Excluding call, residents worked an average of 64.2 hours per week. Approximately 50.7% of surgical resident time was allotted to DPC, with surgery accounting for the largest segment of this time (34.8%). Time spent on HEAs demonstrated trended upward with higher resident level (P = 0.086). Time in spent in surgery was significantly associated with higher resident levels (P time study of PRS residents, we found that compared with medicine trainees, surgical residents spent 3.23 times more time on DPC. High education-value activities comprised most of our residents' workdays. Surgery was the leading component of both DPC and HEAs. Our residents were highly efficient and fragmented, with the majority of all activities requiring 4 minutes or less. Residents spent a large portion of their time waiting for other services. In light of these data, we

  18. Telemedicine and Plastic Surgery: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Denis Souto Valente

    2015-01-01

    Full Text Available Background. Telemedicine can be defined as the use of electronic media for transmission of information and medical data from one site to another. The objective of this study is to demonstrate an experience of telemedicine in plastic surgery. Methods. 32 plastic surgeons received a link with password for real-time streaming of a surgery. At the end of the procedure, the surgeons attending the procedure by the Internet answered five questions. The results were analyzed with descriptive statistics. Results. 27 plastic surgeons attended the online procedure in real-time. 96.3% considered the access to the website as good or excellent and 3.7% considered it bad. 14.8% reported that the transmission was bad and 85.2% considered the quality of transmission as good or excellent. 96.3% classified the live broadcasting as a good or excellent learning experience and 3.7% considered it a bad experience. 92.6% reported feeling able to perform this surgery after watching the demo and 7.4% did not feel able. 100% of participants said they would like to participate in other surgical demonstrations over the Internet. Conclusion. We conclude that the use of telemedicine can provide more access to education and medical research, for plastic surgeons looking for medical education from distant regions.

  19. A parathyroid adenoma case study: Protocol review

    Energy Technology Data Exchange (ETDEWEB)

    Sorensen, B.J.; Chu, J.M.G. [Liverpool Hospital, NSW (Australia). Department of Nuclear Medicine and Clinical Ultrasound

    1998-06-01

    Full text: Technetium-99m ({sup 99m}Tc) Sestamibi as opposed to Thallous-201 Chloride and {sup 99m}Tc Sodium Pertechnetate subtraction, has become the radiopharmaceutical of choice for detection of parathyroid adenomas. A 17-year-old female patient presented to the department for a parathyroid {sup 99m}Tc Sestamibi scan to evaluate possible parathyroid adenoma/s. She was initially admitted with increasing serum Calcium levels, polyuria, abdominal pain and general malaise. The patient was injected with 900MBq of {sup 99m}Tc Sestamibi, and a pinhole dynamic at a distance of 10 cm from the neck was acquired followed by a 5-minute static image at 7 cm. Single Photon Emission Computed Tomography (SPECT) was then performed on a dual-head gamma camera followed by an anterior and posterior 10-minute static image. At 3 and 5 hours post injection the 10-minute static image was repeated. This study was reported as normal with uniform uptake and washout of the tracer over the 5-hour period. An ultrasound study was performed, and it showed a lesion believed to be a parathyroid adenoma measuring 2.2 x 0.8 x 0.4 cm in size in the right upper lobe of the thyroid. A subsequent thyroid scan was performed to confirm that it was non-functioning thyroid tissue. The patient was injected with 250MBq of {sup 99m}Tc Sodium Pertechnetate and scanned with a pinhole collimator at a distance of 7 cm. When the {sup 99m}Tc Sestamibi and {sup 99m}Tc Sodium Pertechnetate scan were viewed together, it was clear that there was excess {sup 99m}Tc Sestamibi distribution on the right upper lobe of the thyroid, which washed out over time. This corresponded to the ultrasound findings and was confirmed at surgery to be a parathyroid adenoma. A {sup 99m}Tc Sodium Pertechnetate scan and an ultrasound are now also routinely performed on patients presenting for {sup 99m}Tc Sestamibi parathyroid scans

  20. Intrathecal hyperbaric versus isobaric bupivacaine for adult non-caesarean-section surgery: systematic review protocol.

    Science.gov (United States)

    Uppal, Vishal; Shanthanna, Harsha; Prabhakar, Christopher; McKeen, Dolores M

    2016-05-18

    Bupivacaine is the most commonly used local anaesthetic for spinal anaesthesia (SA). There are two forms of commercially available bupivacaine; isobaric bupivacaine (IB): a formulation with a specific gravity or density equal to cerebrospinal fluid, and hyperbaric bupivacaine (HB): a formulation with density heavier than cerebrospinal fluid. The difference in densities of the two available preparations is believed to affect the diffusion pattern that determines the effectiveness, spread and side-effect profile of bupivacaine. This systematic review will summarise the best available evidence regarding the effectiveness and safety on the use of HB compared with IB, when used to provide SA for surgery. Primarily, we will analyse the need for conversion to general anaesthesia. As secondary outcomes, we will compare the incidence of hypotension, incidence of nausea/vomiting, the onset time and duration of anaesthesia. We will search key electronic databases using search strategy (1) injections, spinal OR intrathecal OR subarachnoid; (2) bupivacaine OR levobupivacaine; (3) hypobaric OR isobaric OR plain; (4) baricity. We will search MEDLINE, EMBASE and Cochrane databases, from their inception for randomised controlled trials, with no restrictions on language. Caesarean section surgery will be excluded. 2 reviewers will independently extract the data using a standardised form. Extracted items will include study characteristics, risk of bias domains, as per modified Cochrane risk of bias, participant disposition and study outcomes. We will conduct a meta-analysis for variables that can be compared across the studies. We will evaluate clinical heterogeneity by qualitatively appraising differences in study characteristics in participants, interventions and the outcomes assessed. We will report our findings as relative risks (dichotomous), and weighted mean differences (continuous) for individual outcomes, along with their 95% CIs. We plan to submit, and will publish, our

  1. Optimizing the high-resolution manometry (HRM) study protocol.

    Science.gov (United States)

    Patel, A; Ding, A; Mirza, F; Gyawali, C P

    2015-02-01

    Intolerance of the esophageal manometry catheter may prolong high-resolution manometry (HRM) studies and increase patient distress. We assessed the impact of obtaining the landmark phase at the end of the study when the patient has acclimatized to the HRM catheter. 366 patients (mean age 55.4 ± 0.8 years, 62.0% female) undergoing esophageal HRM over a 1-year period were studied. The standard protocol consisted of the landmark phase, 10 5 mL water swallows 20-30 s apart, and multiple rapid swallows where 4-6 2 mL swallows were administered in rapid succession. The modified protocol consisted of the landmark phase at the end of the study after test swallows. Study duration, technical characteristics, indications, and motor findings were compared between standard and modified protocols. Of the 366 patients, 89.6% underwent the standard protocol (study duration 12.9 ± 0.3 min). In 10.4% with poor catheter tolerance undergoing the modified protocol, study duration was significantly longer (15.6 ± 1.0 min, p = 0.004) despite similar duration of study maneuvers. Only elevated upper esophageal sphincter basal pressures at the beginning of the study segregated modified protocol patients. The 95th percentile time to landmark phase in the standard protocol patients was 6.1 min; as many as 31.4% of modified protocol patients could not obtain their first study maneuver within this period (p = 0.0003). Interpretation was not impacted by shifting the landmark phase to the end of the study. Modification of the HRM study protocol with the landmark phase obtained at the end of the study optimizes study duration without compromising quality. © 2014 John Wiley & Sons Ltd.

  2. An Outcomes Study on the Effects of the Singapore General Hospital Burns Protocol.

    Science.gov (United States)

    Liang, Weihao; Kok, Yee Onn; Tan, Bien Keem; Chong, Si Jack

    2018-01-01

    The Singapore General Hospital Burns Protocol was implemented in May 2014 to standardize treatment for all burns patients, incorporate new techniques and materials, and streamline the processes and workflow of burns management. This study aims to analyze the effects of the Burns Protocol 2 years after its implementation. Using a REDCap electronic database, all burns patients admitted from May 2013 to April 2016 were included in the study. The historical preimplementation control group composed of patients admitted from May 2013 to April 2014 (n = 96). The postimplementation prospective study cohort consisted of patients admitted from May 2014 to April 2016 (n = 243). Details of the patients collected included age, sex, comorbidities, total body surface area (TBSA) burns, time until surgery, number of surgeries, number of positive tissue and blood cultures, and length of hospital stay. There was no statistically significant difference in the demographics of both groups. The study group had a statistically significant shorter time to surgery compared with the control group (20.8 vs 38.1, P burns, was statistically significant (number of surgeries/TBSA, 0.324 vs 0.506; P = 0.0499). The study group also had significantly shorter length of stay (12.5 vs 16.8, P = 0.0273), a shorter length of stay/TBSA burns (0.874 vs 1.342, P = 0.0101), and fewer positive tissue cultures (0.6 vs 1.3, P = 0.0003). The study group also trended toward fewer positive blood culture results (0.09 vs 0.35, P = 0.0593), although the difference was just shy of statistical significance. The new Singapore General Hospital Burns Protocol had revolutionized Singapore burns care by introducing a streamlined, multidisciplinary burns management, resulting in improved patient outcomes, lowered health care costs, and improved system resource use.

  3. Oral appliances and maxillomandibular advancement surgery : An alternative treatment protocol for the obstructive sleep apnea-hypopnea syndrome

    NARCIS (Netherlands)

    Hoekema, A; de Lange, J; Stegenga, B; de Bont, LGM

    Purpose: The present study comprises a retrospective evaluation of the potential application of mandibular repositioning appliance (MRA) therapy preceding maxillomandibular advancement (MMA) surgery in the treatment of the Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). Our initial experiences

  4. Extraction protocols for orthodontic treatment: A retrospective study

    Directory of Open Access Journals (Sweden)

    Vaishnevi N Thirunavukkarasu

    2016-01-01

    Full Text Available Background and Objectives: Various extraction protocols have been followed for successful orthodontic treatment. The purpose of this study was to evaluate the extraction protocols in patients who had previously undergone orthodontic treatment and also who had reported for continuing orthodontic treatment from other clinics. Materials and Methods: One hundred thirty eight patients who registered for orthodontic treatment at the Faculty of Dentistry were divided into 10 extraction protocols based on the Orthodontic treatment protocol given by Janson et al. and were evaluated for statistical significance. Results: The descriptive statistics of the study revealed a total of 40 (29% patients in protocol 1, 43 (31.2% in protocol 2, 18 (13% in protocol 3, 16 (11.6% in protocol 5, and 12 (8.7% in Type 3 category of protocol 9. The Type 3 category in protocol 9 was statistically significant compared to other studies. Midline shift and collapse of the arch form were noticed in these individuals. Conclusion: Extraction of permanent teeth such as canine and lateral incisors without rational reasons could have devastating consequences on the entire occlusion. The percentage of cases wherein extraction of permanent teeth in the crowded region was adopted as a treatment option instead of orthodontic treatment is still prevalent in dental practice. The shortage of orthodontists in Malaysia, the long waiting period, and lack of subjective need for orthodontic treatment at an earlier age group were the reasons for the patient's to choose extraction of the mal-aligned teeth such as the maxillary canine or maxillary lateral incisors.

  5. Imaging studies for failed back surgery syndrome

    International Nuclear Information System (INIS)

    Cosnard, G.; Cordoliani, Y.S.; Sarrazin, J.L.; Soulie, D.

    1995-01-01

    In patients with failed back surgery syndrome, magnetic resonance imaging (MRI) can be the best first-line imaging study because it simplifies the diagnosis. This update is based on over 600 cases. MRI shows the scar tissue at the surgical site, persistent evidence of disk herniation for several weeks after surgery, and evidence of local and regional edema in one-fourth of cases. The edema is most marked between two months and two years after the operation and can misleadingly suggest discitis. MRI is the best investigation for detecting recurrent herniation at the same vertebral level or another level. Herniated disk material is seen as a mass that does not enhance after gadolinium, in contrast to the vascularized scar tissue. Free fragments are often clearly visible within the scar tissue. Fragments that migrate to the epidural space can give rise to granulomatous reactions. Scar tissue can be seen in the epidural space and within the disk; it can show enhancement after gadolinium for several years. The scar can be atrophic or hypertrophic and can encase or impinge on the dural sac and nerve roots. Pathological fibrosis cannot be differentiated from ordinary scar tissue. Arachnoiditis causing adherence of the nerve roots to the dura mater or to each other occurs in 5 % to 10 % of cases. Nerve root enhancement after gadolinium is seen in three-fourths of cases. Bone lesions are common, especially some time after surgery; they are usually accompanied with other lesions. Hematomas are seen in less than 10 % of cases. Infections are similarly rare (0.25 % each for discitis and epiduritis). The diagnosis of discitis is difficult and requires percutaneous biopsy of the disk, especially when MRI shows fluid within the disk, with decreased signal intensity on T2 images, and non enhancement after intravenous gadolinium. (authors). 19 refs., 7 figs

  6. Quantitative methods for studying design protocols

    CERN Document Server

    Kan, Jeff WT

    2017-01-01

    This book is aimed at researchers and students who would like to engage in and deepen their understanding of design cognition research. The book presents new approaches for analyzing design thinking and proposes methods of measuring design processes. These methods seek to quantify design issues and design processes that are defined based on notions from the Function-Behavior-Structure (FBS) design ontology and from linkography. A linkograph is a network of linked design moves or segments. FBS ontology concepts have been used in both design theory and design thinking research and have yielded numerous results. Linkography is one of the most influential and elegant design cognition research methods. In this book Kan and Gero provide novel and state-of-the-art methods of analyzing design protocols that offer insights into design cognition by integrating segmentation with linkography by assigning FBS-based codes to design moves or segments and treating links as FBS transformation processes. They propose and test ...

  7. Integration of robotic surgery into routine practice and impacts on communication, collaboration, and decision making: a realist process evaluation protocol

    Science.gov (United States)

    2014-01-01

    Background Robotic surgery offers many potential benefits for patients. While an increasing number of healthcare providers are purchasing surgical robots, there are reports that the technology is failing to be introduced into routine practice. Additionally, in robotic surgery, the surgeon is physically separated from the patient and the rest of the team, with the potential to negatively impact teamwork in the operating theatre. The aim of this study is to ascertain: how and under what circumstances robotic surgery is effectively introduced into routine practice; and how and under what circumstances robotic surgery impacts teamwork, communication and decision making, and subsequent patient outcomes. Methods and design We will undertake a process evaluation alongside a randomised controlled trial comparing laparoscopic and robotic surgery for the curative treatment of rectal cancer. Realist evaluation provides an overall framework for the study. The study will be in three phases. In Phase I, grey literature will be reviewed to identify stakeholders’ theories concerning how robotic surgery becomes embedded into surgical practice and its impacts. These theories will be refined and added to through interviews conducted across English hospitals that are using robotic surgery for rectal cancer resection with staff at different levels of the organisation, along with a review of documentation associated with the introduction of robotic surgery. In Phase II, a multi-site case study will be conducted across four English hospitals to test and refine the candidate theories. Data will be collected using multiple methods: the structured observation tool OTAS (Observational Teamwork Assessment for Surgery); video recordings of operations; ethnographic observation; and interviews. In Phase III, interviews will be conducted at the four case sites with staff representing a range of surgical disciplines, to assess the extent to which the results of Phase II are generalisable and to

  8. Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Kelly Ickmans

    2016-07-01

    Discussion: This study will determine whether pain neuroscience education is worthwhile for patients undergoing surgery for lumbar radiculopathy. It is expected that participants who receive perioperative pain neuroscience education will report less pain and have improved endogenous pain modulation, lower postoperative healthcare costs and improved surgical experience. Lower pain and improved endogenous pain modulation after surgery may reduce the risk of developing postoperative chronic pain.

  9. Enhanced recovery pathways in thoracic surgery from Italian VATS Group: perioperative analgesia protocols.

    Science.gov (United States)

    Piccioni, Federico; Segat, Matteo; Falini, Stefano; Umari, Marzia; Putina, Olga; Cavaliere, Lucio; Ragazzi, Riccardo; Massullo, Domenico; Taurchini, Marco; Del Naja, Carlo; Droghetti, Andrea

    2018-03-01

    Video-assisted thoracoscopic surgery (VATS) is a minimally invasive technique that allows a faster recovery after thoracic surgery. Although enhanced recovery after surgery (ERAS) principles seem reasonably applicable to thoracic surgery, there is little literature on the application of such a strategy in this context. In regard to pain management, ERAS pathways promote the adoption of a multimodal strategy, tailored to the patients. This approach is based on combining systemic and loco-regional analgesia to favour opioid-sparing strategies. Thoracic paravertebral block is considered the first-line loco-regional technique for VATS. Other techniques include intercostal nerve block and serratus anterior plane block. Nonsteroidal anti-inflammatory drugs and paracetamol are essential part of the multimodal treatment of pain. Also, adjuvant drugs can be useful as opioid-sparing agents. Nevertheless, the treatment of postoperative pain must take into account opioid agents too, if necessary. All above is useful for careful planning and execution of a multimodal analgesic treatment to enhance the recovery of patients. This article summarizes the most recent evidences from literature and authors' experiences on perioperative multimodal analgesia principles for implementing an ERAS program after VATS lobectomy.

  10. Surgery of language-eloquent tumors in patients not eligible for awake surgery: the impact of a protocol based on navigated transcranial magnetic stimulation on presurgical planning and language outcome, with evidence of tumor-induced intra-hemispheric plasticity.

    Science.gov (United States)

    Raffa, Giovanni; Quattropani, Maria C; Scibilia, Antonino; Conti, Alfredo; Angileri, Filippo Flavio; Esposito, Felice; Sindorio, Carmela; Cardali, Salvatore Massimiliano; Germanò, Antonino; Tomasello, Francesco

    2018-05-01

    Awake surgery and intraoperative monitoring represent the gold standard for surgery of brain tumors located in the perisylvian region of the dominant hemisphere due to their ability to map and preserve the language network during surgery. Nevertheless, in some cases awake surgery is not feasible. This could increase the risk of postoperative language deficit. Navigated transcranial magnetic stimulation (nTMS) and nTMS-based DTI fiber tracking (DTI-FT) provide a preoperative mapping and reconstruction of the cortico-subcortical language network. This can be used to plan and guide the surgical strategy to preserve the language function. The objective if this study is to describe the impact of a non-invasive preoperative protocol for mapping the language network through the nTMS and nTMS-based DTI-FT in patients not eligible for awake surgery and thereby operated under general anesthesia for suspected language-eloquent brain tumors. We reviewed clinical data of patients not eligible for awake surgery and operated under general anaesthesia between 2015 and 2016. All patients underwent nTMS language cortical mapping and nTMS-based DTI-FT of subcortical language fascicles. The nTMS findings were used to plan and guide the maximal safe resection of the tumor. The impact on postoperative language outcome and the accuracy of the nTMS-based mapping in predicting language deficits were evaluated. Twenty patients were enrolled in the study. The nTMS-based reconstruction of the language network was successful in all patients. Interestingly, we observed a significant association between tumor localization and the cortical distribution of the nTMS errors (p = 0.004), thereby suggesting an intra-hemispheric plasticity of language cortical areas, probably induced by the tumor itself. The nTMS mapping disclosed the true-eloquence of lesions in 12 (60%) of all suspected cases. In the remaining 8 cases (40%) the suspected eloquence of the lesion was disproved. The n

  11. The use of throat packs in pediatric cleft lip/palate surgery: a retrospective study.

    Science.gov (United States)

    Smarius, B J A; Guillaume, C H A L; Jonker, G; van der Molen, A B Mink; Breugem, C C

    2018-02-22

    Throat packs are commonly used to prevent ingestion or aspiration of blood and other debris during cleft lip/palate surgery. However, dislodgement or (partial) retainment after extubation could have serious consequences. The aim of the present study was to investigate the effect of omitting pharyngeal packing during cleft lip/palate surgery on the incidence of early postoperative complications in children. A retrospective study was performed on all children who underwent cleft lip/palate surgery at the Wilhelmina Children's Hospital. This study compared the period January 2010 through December 2012 when pharyngeal packing was applied according to local protocol (group A) with the period January 2013 till December 2015 when pharyngeal packing was no longer applied after removal from the protocol (group B). Data were collected for sex, age at operation, cleft lip/palate type, type of repair, lateral incisions, length of hospital stay, and complications in the first 6 weeks after surgery. Early complications included wound dehiscence, postoperative bleeding, infection, fever, upper respiratory tract infection (URTI), and lower respiratory tract infection (LRTI). This study included 489 cleft lip/palate operations (group A n = 246, group B n = 243). A total of 39 (15.9%) early complications were recorded in group A and a total of 40 (16.5%) in group B. There were no significant differences (P = 0.902) in complications between the two groups; however, there was a significant difference (P cleft lip/palate surgery was not associated with an increased early postoperative complication rate. Therefore, the traditional, routine placement of a throat pack during cleft lip/palate surgery can be questioned. The traditional, routine placement of a throat pack during cleft lip/palate surgery can be questioned.

  12. Identification of a research protocol to study orthodontic tooth movement

    Directory of Open Access Journals (Sweden)

    Annalisa Dichicco

    2014-06-01

    Full Text Available Aim: The orthodontic movement is associated with a process of tissue remodeling together with the release of several chemical mediators in periodontal tissues. Each mediator is a potential marker of tooth movement and expresses biological processes as: tissue inflammation and bone remodeling. Different amounts of every mediator are present in several tissues and fluids of the oral cavity. Therefore, there are different methods that allow sampling with several degrees of invasiveness. Chemical mediators are also substances of different molecular nature, and multiple kind of analysis methods allow detection. The purpose of this study was to draft the best research protocol for an optimal study on orthodontic movement efficiency. Methods: An analysis of the international literature have been made, to identify the gold standard of each aspect of the protocol: type of mediator, source and method of sampling and analysis method. Results: From the analysis of the international literature was created an original research protocol for the study and the assessment of the orthodontic movement, by using the biomarkers of the tooth movement. Conclusions: The protocol created is based on the choice of the gold standard of every aspect already analyzed in the literature and in existing protocols for the monitoring of orthodontic tooth movement through the markers of tooth movement. Clinical trials re required for the evaluation and validation of the protocol created.

  13. Clinical protocol levels are required in laboratory animal surgery when using medical devices: experiences with ureteral replacement surgery in goats

    OpenAIRE

    de Jonge, Paul K. J. D.; Sloff, Marije; Janke, Heinz P.; Kortmann, Barbara B. M.; de Gier, Robert P. E.; Geutjes, Paul J.; Oosterwijk, Egbert; Feitz, Wout F. J.

    2017-01-01

    It is common to test medical devices in large animal studies that are or could also be used in humans. In this short report we describe the use of a ureteral J-stent for the evaluation of biodegradable tubular constructs for tissue reconstruction, and the regeneration of ureters in Saanen goats. Similarly to a previous study in pigs, the ureteral J-stent was blindly inserted until some resistance was met. During evaluation of the goats after three months, perforation of the renal cortex by th...

  14. Clinical protocol levels are required in laboratory animal surgery when using medical devices: experiences with ureteral replacement surgery in goats

    NARCIS (Netherlands)

    Jonge, P.K.J.D. de; Sloff, M.; Janke, H.P.; Kortmann, B.B.M.; Gier, R.P.E. de; Geutjes, P.J.; Oosterwijk, E.; Feitz, W.F.J.

    2017-01-01

    It is common to test medical devices in large animal studies that are or could also be used in humans. In this short report we describe the use of a ureteral J-stent for the evaluation of biodegradable tubular constructs for tissue reconstruction, and the regeneration of ureters in Saanen goats.

  15. The effect of two different glycemic management protocols on postoperative cognitive dysfunction in coronary artery bypass surgery

    Directory of Open Access Journals (Sweden)

    Pinar Kurnaz

    Full Text Available Abstract Introduction: Postoperative cognitive dysfunction (POCD is an adverse outcome of surgery that is more common after open heart procedures. The aim of this study is to investigate the role of tightly controlled blood glucose levels during coronary artery surgery on early and late cognitive decline. Methods: 40 patients older than 50 years undergoing elective coronary surgery were randomized into two groups. In the "Tight Control" group (GI, the glycemia was maintained between 80 and 120 mg dL-1 while in the "Liberal" group (GII, it ranged between 80-180 mg dL-1. A neuropsychological test battery was performed three times: baseline before surgery and follow-up first and 12th weeks, postoperatively. POCD was defined as a drop of one standard deviation from baseline on two or more tests. Results: At the postoperative first week, neurocognitive tests showed that 10 patients in the GI and 11 patients in GII had POCD. The incidence of early POCD was similar between groups. However the late assessment revealed that cognitive dysfunction persisted in five patients in the GII whereas none was rated as cognitively impaired in GI (p = 0.047. Conclusion: We suggest that tight perioperative glycemic control in coronary surgery may play a role in preventing persistent cognitive impairment.

  16. Study and development of a remote biometric authentication protocol

    OpenAIRE

    Bistarelli, Stefano; Claudio, Viti

    2003-01-01

    This paper reports the phases of study and implementation of a remote biometric authentication protocol developed during my internship at the I.i.t. of the C.n.r. in Pisa. Starting from the study of authentication history we had a look from the first system used since the 60ies to the latest technology; this helped us understand how we could realize a demonstration working protocol that could achieve a web remote authentication granting good reliability: to do this we choosed to modify the SS...

  17. Study protocol for the Cities Changing Diabetes programme

    DEFF Research Database (Denmark)

    Napier, A David; Nolan, John J; Bagger, Malene

    2017-01-01

    and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through...... the Cities Changing Diabetes (CCD) partnership programme. METHODS AND ANALYSIS: A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan...... Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. ETHICS AND DISSEMINATION: The protocol steers the collection of primary and secondary data across the study sites. Research ethics...

  18. Continuous sawmill studies: protocols, practices, and profits

    Science.gov (United States)

    Robert Mayer; Jan Wiedenbeck

    2005-01-01

    In today's global economy, the "opportunity cost" associated with suboptimal utilization of raw material and mill resources is significant. As a result, understanding the profit potential associated with different types of logs is critically important for sawmill survival. The conventional sawmill study typically has been conducted on a substantially...

  19. Study on Cloud Security Based on Trust Spanning Tree Protocol

    Science.gov (United States)

    Lai, Yingxu; Liu, Zenghui; Pan, Qiuyue; Liu, Jing

    2015-09-01

    Attacks executed on Spanning Tree Protocol (STP) expose the weakness of link layer protocols and put the higher layers in jeopardy. Although the problems have been studied for many years and various solutions have been proposed, many security issues remain. To enhance the security and credibility of layer-2 network, we propose a trust-based spanning tree protocol aiming at achieving a higher credibility of LAN switch with a simple and lightweight authentication mechanism. If correctly implemented in each trusted switch, the authentication of trust-based STP can guarantee the credibility of topology information that is announced to other switch in the LAN. To verify the enforcement of the trusted protocol, we present a new trust evaluation method of the STP using a specification-based state model. We implement a prototype of trust-based STP to investigate its practicality. Experiment shows that the trusted protocol can achieve security goals and effectively avoid STP attacks with a lower computation overhead and good convergence performance.

  20. Increasing volume and complexity of pediatric epilepsy surgery with stable seizure outcome between 2008 and 2014: A nationwide multicenter study.

    Science.gov (United States)

    Barba, Carmen; Specchio, Nicola; Guerrini, Renzo; Tassi, Laura; De Masi, Salvatore; Cardinale, Francesco; Pellacani, Simona; De Palma, Luca; Battaglia, Domenica; Tamburrini, Gianpiero; Didato, Giuseppe; Freri, Elena; Consales, Alessandro; Nozza, Paolo; Zamponi, Nelia; Cesaroni, Elisabetta; Di Gennaro, Giancarlo; Esposito, Vincenzo; Giulioni, Marco; Tinuper, Paolo; Colicchio, Gabriella; Rocchi, Raffaele; Rubboli, Guido; Giordano, Flavio; Lo Russo, Giorgio; Marras, Carlo Efisio; Cossu, Massimo

    2017-10-01

    The objective of the study was to assess common practice in pediatric epilepsy surgery in Italy between 2008 and 2014. A survey was conducted among nine Italian epilepsy surgery centers to collect information on presurgical and postsurgical evaluation protocols, volumes and types of surgical interventions, and etiologies and seizure outcomes in pediatric epilepsy surgery between 2008 and 2014. Retrospective data on 527 surgical procedures were collected. The most frequent surgical approaches were temporal lobe resections and disconnections (133, 25.2%) and extratemporal lesionectomies (128, 24.3%); the most frequent etiologies were FCD II (107, 20.3%) and glioneuronal tumors (105, 19.9%). Volumes of surgeries increased over time independently from the age at surgery and the epilepsy surgery center. Engel class I was achieved in 73.6% of patients (range: 54.8 to 91.7%), with no significant changes between 2008 and 2014. Univariate analyses showed a decrease in the proportion of temporal resections and tumors and an increase in the proportion of FCDII, while multivariate analyses revealed an increase in the proportion of extratemporal surgeries over time. A higher proportion of temporal surgeries and tumors and a lower proportion of extratemporal and multilobar surgeries and of FCD were observed in low (epilepsy surgery in Italy between 2008 and 2014, associated with a stable seizure outcome. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study.

    Science.gov (United States)

    Park-Hansen, Jesper; Holme, Susanne J V; Irmukhamedov, Akhmadjon; Carranza, Christian L; Greve, Anders M; Al-Farra, Gina; Riis, Robert G C; Nilsson, Brian; Clausen, Johan S R; Nørskov, Anne S; Kruuse, Christina R; Rostrup, Egill; Dominguez, Helena

    2018-05-23

    Open heart surgery is associated with high occurrence of atrial fibrillation (AF), subsequently increasing the risk of post-operative ischemic stroke. Concomitant with open heart surgery, a cardiac ablation procedure is commonly performed in patients with known AF, often followed by left atrial appendage closure with surgery (LAACS). However, the protective effect of LAACS on the risk of cerebral ischemia following cardiac surgery remains controversial. We have studied whether LAACS in addition to open heart surgery protects against post-operative ischemic brain injury regardless of a previous AF diagnosis. One hundred eighty-seven patients scheduled for open heart surgery were enrolled in a prospective, open-label clinical trial and randomized to concomitant LAACS vs. standard care. Randomization was stratified by usage of oral anticoagulation (OAC) planned to last at least 3 months after surgery. The primary endpoint was a composite of post-operative symptomatic ischemic stroke, transient ischemic attack or imaging findings of silent cerebral ischemic (SCI) lesions. During a mean follow-up of 3.7 years, 14 (16%) primary events occurred among patients receiving standard surgery vs. 5 (5%) in the group randomized to additional LAACS (hazard ratio 0.3; 95% CI: 0.1-0.8, p = 0.02). In per protocol analysis (n = 141), 14 (18%) primary events occurred in the control group vs. 4 (6%) in the LAACS group (hazard ratio 0.3; 95% CI: 0.1-1.0, p = 0.05). In a real-world setting, LAACS in addition to elective open-heart surgery was associated with lower risk of post-operative ischemic brain injury. The protective effect was not conditional on AF/OAC status at baseline. LAACS study, clinicaltrials.gov NCT02378116 , March 4th 2015, retrospectively registered.

  2. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research...... to quantify relationships in data. Despite an increased focus on statistical content and complexity of biomedical research these topics remain difficult for most researchers. Statistical methods enable researchers to condense large spreadsheets with data into means, proportions, and difference between means......, risk differences, and other quantities that convey information. One of the goals in biomedical research is to develop parsimonious models - meaning as simple as possible. This approach is valid if the subsequent research report (the article) is written independent of whether the results...

  3. Changing strategy and implementation of a new treatment protocol for cleft palate surgery in "Maria Sklodowska Curie" (MSC) Children's Hospital, Bucharest, Romania.

    Science.gov (United States)

    Spataru, Radu; Mark, Hans

    2014-12-01

    In "Maria Sklodowska Curie" (MSC) Children's Hospital, Bucharest, Romania, cleft palate repair has been performed according to von Langenbeck since 1984. The speech was good in most patients but wide clefts had a high percentage of fistulas, abnormal speech due to short length and limited mobility of the soft palate. In 2009, the protocol was changed to Gothenburg Delayed Hard Palate Closure, (DHPC) technique. The present evaluation was performed to study the implementation of this technique. One hundred and sixty-eight patients with cleft palate were admitted, 89 isolated cleft palate (ICP), 53 unilateral (UCLP) and 26 bilateral (BCLP). In these, 228 surgical interventions were performed. Soft Palate Repair (SPR) and Hard Palate Repair (HPR) were performed with the DHPC procedure. The transfer to this technique was successfully performed in three steps: one team visit to Gothenburg by a surgeon from MSC and two visits by surgeons from Gothenburg to the MSC. Patients with SPR and HPR were operated on without major complications and there were no differences in results between Gothenburg surgeons and MSC surgeons. The interventions with SPR and HPR technique were proven to be easy to teach and learn and successfully performed without major complications. For cleft patients at MSC hospital it has meant earlier surgery, less re-operations and complications. This report shows a successful change of strategy for palatal repair with improved outcome regarding surgery. In future, speech and growth will be followed on a regular basis and will be compared with results from the Gothenburg Cleft Team.

  4. Short- and long-term outcomes of laparoscopic surgery vs open surgery for transverse colon cancer: a retrospective multicenter study.

    Science.gov (United States)

    Kim, Jong Wan; Kim, Jeong Yeon; Kang, Byung Mo; Lee, Bong Hwa; Kim, Byung Chun; Park, Jun Ho

    2016-01-01

    The purpose of the present study was to compare the perioperative and oncologic outcomes between laparoscopic surgery and open surgery for transverse colon cancer. We conducted a retrospective review of patients who underwent surgery for transverse colon cancer at six Hallym University-affiliated hospitals between January 2005 and June 2015. The perioperative outcomes and oncologic outcomes were compared between laparoscopic and open surgery. Of 226 patients with transverse colon cancer, 103 underwent laparoscopic surgery and 123 underwent open surgery. There were no differences in the patient characteristics between the two groups. Regarding perioperative outcomes, the operation time was significantly longer in the laparoscopic group than in the open group (267.3 vs 172.7 minutes, Pstudy showed that laparoscopic surgery is associated with several perioperative benefits and similar oncologic outcomes to open surgery for the resection of transverse colon cancer. Therefore, laparoscopic surgery offers a safe alternative to open surgery in patients with transverse colon cancer.

  5. Epidemiological characterization of oral cancer. Study Protocol.

    Directory of Open Access Journals (Sweden)

    Alejandra Fernández

    2015-04-01

    Full Text Available Oral cancer is a disease of high impact globally. It ranks as the sixth more frequent one among all types of cancer. In spite of being a widely known pathology and easy access to the diagnosis, the lack of epidemiological data reported in the last 10 years in Chile called attention to. At the global level, the World Health Organization (WHO has developed a project called “GLOBOCAN” in order to collect epidemiological data of the global cancer, between its data, highlights the high incidence and high rate of mortality in the male sex, parameter that shows tendency to replicate in both America and Chile. In consequence to these data, a narrative review of the literature concerning the epidemiological profile of the different forms of oral cancer in the past 15 years was done. The diagnosis of oral cancer crosses transversely the Dental Science, forcing us to establish triads of work between oral and maxillofacial surgeons, pathologists and dentists of the various specialties, so as to allow a timely research, appropriate biopsies and histopathological studies finishes with the purpose of, on the one hand, obtain timely and accurate diagnostics, in addition, maintaining the epidemiological indicators.

  6. Fast-track surgery protocol in elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Liu G

    2016-06-01

    Full Text Available Guozheng Liu,1 Fengguo Jian,2 Xiuqin Wang,2 Lin Chen1 1Department of General Surgery, Chinese PLA General Hospital, Beijing, People’s Republic of China; 2Second Department of General Surgery, Changyi People’s Hospital, Shandong, People’s Republic of China Aim: To study the efficacy of the fast-track surgery (FTS program combined with laparoscopic radical gastrectomy for elderly gastric cancer (GC patients.Methods: Eighty-four elderly patients diagnosed with GC between September 2014 and August 2015 were recruited to participate in this study and were divided into four groups randomly based on the random number table as follows: FTS + laparoscopic group (Group A, n=21, FTS + laparotomy group (Group B, n=21, conventional perioperative care (CC + laparoscopic group (Group C, n=21, and CC + laparotomy group (Group D, n=21. Observation indicators include intrasurgery indicators, postoperative recovery indicators, nutritional status indicators, and systemic stress response indicators.Results: Preoperative and intraoperative baseline characteristics showed no significant differences between patients in each group (P>0.05. There were no significant differences between each group in nausea and vomiting, intestinal obstruction, urinary retention, incision infection, pulmonary infection, and urinary tract infection after operation (P>0.05. Time of first flatus and postoperative hospital stay time of FTS Group A were the shortest, and total medical cost of this group was the lowest. For all groups, serum albumin, prealbumin, and transferrin significantly decreased, while CRP and interleukin 6 were significantly increased postoperative day 1. From postoperative day 4–7, all indicators of the four groups gradually recovered, but compared with other three groups, those of Group A recovered fastest.Conclusion: FTS combined with laparoscopic surgery can promote faster postoperative recovery, improve early postoperative nutritional status, and more

  7. The Early vs. Late Infantile Strabismus Surgery Study: Monitoring Report

    NARCIS (Netherlands)

    H.J. Simonsz (Huib)

    1995-01-01

    textabstractAbstract: The Early vs. Late Infantile Strabismus Surgery Study Group is a group of strabismologists and orthoptists who investigate whether early or late surgery is preferable in infantile strabismus, in a non-randomized, prospective, multi-center trial. Infants between six and 18

  8. Simultaneous bilateral cataract surgery: economic analysis; Helsinki Simultaneous Bilateral Cataract Surgery Study Report 2.

    Science.gov (United States)

    Leivo, Tiina; Sarikkola, Anna-Ulrika; Uusitalo, Risto J; Hellstedt, Timo; Ess, Sirje-Linda; Kivelä, Tero

    2011-06-01

    To present an economic-analysis comparison of simultaneous and sequential bilateral cataract surgery. Helsinki University Eye Hospital, Helsinki, Finland. Economic analysis. Effects were estimated from data in a study in which patients were randomized to have bilateral cataract surgery on the same day (study group) or sequentially (control group). The main clinical outcomes were corrected distance visual acuity, refraction, complications, Visual Function Index-7 (VF-7) scores, and patient-rated satisfaction with vision. Health-care costs of surgeries and preoperative and postoperative visits were estimated, including the cost of staff, equipment, material, floor space, overhead, and complications. The data were obtained from staff measurements, questionnaires, internal hospital records, and accountancy. Non-health-care costs of travel, home care, and time were estimated based on questionnaires from a random subset of patients. The main economic outcome measures were cost per VF-7 score unit change and cost per patient in simultaneous versus sequential surgery. The study comprised 520 patients (241 patients included non-health-care and time cost analyses). Surgical outcomes and patient satisfaction were similar in both groups. Simultaneous cataract surgery saved 449 Euros (€) per patient in health-care costs and €739 when travel and paid home-care costs were included. The savings added up to €849 per patient when the cost of lost working time was included. Compared with sequential bilateral cataract surgery, simultaneous bilateral cataract surgery provided comparable clinical outcomes with substantial savings in health-care and non-health-care-related costs. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  9. Abdominal stab wound protocol: prospective study documents applicability for widespread use.

    Science.gov (United States)

    Rosemurgy, A S; Albrink, M H; Olson, S M; Sherman, H; Albertini, J; Kramer, R; Camps, M; Reiss, A

    1995-02-01

    Traditionally, stab wounds violating the abdominal wall fascia led to exploratory celiotomy that was often nontherapeutic. In an attempt to limit the number of nontherapeutic celiotomies (NTC), we devised a protocol to prospectively study stab wounds violating the anterior abdominal wall fascia. Through protocol, abdominal stab wounds were explored in stable adults. If the anterior fascia was violated, paracentesis and, if necessary, peritoneal lavage was undertaken in the absence of previous abdominal surgery. If evisceration was noted, it was reduced and the patient lavaged. Fascial penetration was noted in 72 patients. 46 patients underwent celiotomy: because of shock/peritonitis in 8 (2 NTC), fascial penetration with a history of previous celiotomy in 7 (5 NTC), positive paracentesis in 20 (5 NTC), or positive lavage in 10 (4 NTC). One patient underwent late celiotomy without ill-effect after a negative lavage because she subsequently developed fever and localized peritonitis (ice pick injury to cecum). Eleven patients had evisceration; nine underwent celiotomy. Patients with abdominal stab wounds can be selectively managed safely. More than one-third with fascial penetration, some with evisceration, avoided exploration. Only one patient underwent delayed celiotomy and did so without detriment. Nontherapeutic celiotomy rates were highest in patients with previous abdominal surgery who, thereby, could not undergo paracentesis/lavage; excluding these patients, the nontherapeutic celiotomy rate was 17% (11/65) for those with fascial penetration.

  10. Studying protocol-based pain management in the emergency department

    Directory of Open Access Journals (Sweden)

    Akkamahadevi Patil

    2017-01-01

    Full Text Available Background: Majority of the patients presenting to emergency department (ED have pain. ED oligoanalgesia remains a challenge. Aims: This study aims to study the effect of implementing a protocol-based pain management in the ED on (1 time to analgesia and (2 adequacy of analgesia obtained. Settings and Design: Cross-sectional study in the ED. Methods: Patients aged 18–65 years of age with pain of numeric rating scale (NRS ≥4 were included. A series of 100 patients presenting before introduction of the protocol-based pain management were grouped “pre-protocol,” and managed as per existing practice. Following this, a protocol for management of all patients presenting to ED with pain was implemented. Another series of 100 were grouped as “post-protocol” and managed as per the new pain management protocol. The data of patients from both the groups were collected and analyzed. Statistical Analysis Used: Descriptive statistical tests such as percentage, mean and standard deviation and inferential statistical tests such as Pearson coefficient, Student's t-test were applied. Differences were interpreted as significant when P < 0.05. Results: Mean time to administer analgesic was significantly lesser in the postprotocol group (preprotocol 20.30 min vs. postprotocol 13.05 min; P < 0.001. There was significant difference in the pain relief achieved (change in NRS between the two groups, with greater pain relief achieved in the postprotocol group (preprotocol group 4.6800 vs. postprotocol group 5.3600; P < 0.001. Patients' rating of pain relief (assessed on E5 scale was significantly higher in the postprotocol group (preprotocol 3.91 vs. postprotocol 4.27; P = 0.001. Patients' satisfaction (North American Spine Society scale with the overall treatment was also compared and found to be significantly higher in postprotocol group (mean: preprotocol 1.59 vs. postprotocol 1.39; P = 0.008. Conclusion: Protocol-based pain management provided timely and

  11. Conservative Treatment Protocol for Keratocystic Odontogenic Tumour: a Follow-up Study of 3 Cases

    Directory of Open Access Journals (Sweden)

    Gülsün Yildirim

    2010-07-01

    Full Text Available Background: The keratocystic odontogenic tumour is classified as a developmental cyst derived from the enamel organ or from the dental lamina. The treatment of keratocystic odontogenic tumour of the jaw remains controversial. The aim of this study was to report the outcome of our conservative treatment protocol for keratocystic odontogenic tumour.Methods: Three patients with different complaints referred to Oral and Maxillofacial Surgery Clinic, Faculty of Dentistry, Selçuk University. Initial biopsy was carried out in all patients and keratocystic odontogenic tumours was diagnosed subsequent to histopathological examination. The patients with keratocystic odontogenic tumours were treated by enucleation followed by open packing. This conservative treatment protocol was selected because of existing young aged patients. The average follow-up duration of the cases was 2 years.Results: Out of 3 cases, 2 lesions were present in mandible and 1 lesion in maxilla. There was no evidence of recurrence during follow-up. All the cases were monitored continuously with panoramic radiographs, computed tomography and clinical evaluations.Conclusions: This conservative treatment protocol for keratocystic odontogenic tumours, based on enucleation followed by open packing would be a possible choice with a view of offering low recurrence rate and low morbidity rate particularly in young patients.

  12. Is LMWH Sufficient for Anticoagulant Prophylaxis in Bariatric Surgery? Prospective Study.

    Science.gov (United States)

    Moaad, Farraj; Zakhar, Bramnik; Anton, Kvasha; Moner, Merie; Wisam, Sbeit; Safy, Farraj; Igor, Waksman

    2017-09-01

    The objective of this study was to evaluate the coagulation profile by thromboelastography in morbidly obese patients who undergo bariatric surgery. Morbid obesity entails increased risk for thromboembolic events. There is no clear protocol for thromboembolic prophylaxis, regarding timing and length of treatment, in bariatric surgery. Thromboelastography provides data on a coagulation process from creation of the clot until the fibrinolysis. Ninety-three morbidly obese patients were prospectively recruited within a 2-year period. Coagulation profile was measured by thromboelastography before surgery, in the immediate postoperative period, within 3 h from surgery, and in the late postoperative period, within 10-14 days after surgery. Venous thromboembolic prophylaxis was achieved by giving low molecular weight heparin (LMWH), once a day. Of the eligible patients, 67 underwent sleeve gastrectomy while 23 underwent Roux-en-Y gastric bypass. Normal values of coagulation factor function, clotting time, and fibrin function, as measured by R, K, and α (angle), were demonstrated in addition to higher maximal amplitude (MA) values, reflecting increased function of platelets. The average MA value before the surgery was above normal and continued rising consistently in the immediate postoperative as well as in the early postoperative period. Morbidly obese patients have a strong tendency toward thrombosis, as demonstrated by pathologically elevated MA values. Altered coagulation profiles were demonstrated 2 weeks postoperatively; thus, prophylaxis that continued at least for 2 weeks after bariatric surgery should be considered. Since LMW heparin is not sufficient alone as thromboembolic prophylaxis, we recommend adding antiplatelet therapy. Further evaluation of appropriate thromboprophylaxis is warranted.

  13. Plasma glutamine levels before cardiac surgery are related to post-surgery infections; an observational study

    Directory of Open Access Journals (Sweden)

    Hanneke Buter

    2016-11-01

    Full Text Available Abstract Background A low plasma glutamine level was found in 34% of patients after elective cardiothoracic surgery. This could be a result of the inflammation caused by surgical stress or the use of extracorporeal circulation (ECC. But it is also possible that plasma glutamine levels were already lowered before surgery and reflect an impaired metabolic state and a higher likelihood to develop complications. In the present study plasma glutamine levels were measured before and after cardiac surgery and we questioned whether there is a relation between plasma glutamine levels and duration of ECC and the occurrence of postoperative infections. Methods We performed a single-centre prospective, observational study in a closed-format, 20-bed, mixed ICU in a tertiary teaching hospital. We included consecutive patients after elective cardiac surgery with use of extracorporeal circulation. Blood samples were collected on the day prior to surgery and at admission on the ICU. The study was approved by the local Medical Ethics Committee (Regional Review Committee Patient-related Research, Medical Centre Leeuwarden, nWMO 115, April 28th 2015. Results Ninety patients were included. Pre-operative plasma glutamine level was 0.42 ± 0.10 mmol/l and post-operative 0.38 ± 0.09 mmol/l (p < 0.001. There was no relation between duration of extracorporeal circulation or aortic occlusion time and changes in plasma glutamine levels. A logistic regression analysis showed a significant correlation between the presence of a positive culture during the post-operative course and pre-operative plasma glutamine levels (p = 0.04. Conclusion Plasma glutamine levels are significantly lower just after cardiac surgery compared to pre-operative levels. We did not find a relation between the decrease in plasma glutamine levels and the duration of extracorporeal circulation or aortic clamp time. There was a correlation between pre-operative plasma glutamine levels

  14. A nationwide study on anastomotic leakage after colonic cancer surgery

    DEFF Research Database (Denmark)

    Krarup, Peter-Martin; Jorgensen, L N; Andreasen, A H

    2012-01-01

    Aim: Anastomotic leakage (AL) is a major challenge in colorectal cancer surgery due to increased morbidity and mortality. Possible risk factors should be investigated differentially, distinguishing between rectal and colonic surgery in large-scale studies to avoid selection bias and confounding....... Method: The incidence and risk factors associated with AL were analysed in an unselected nation-wide prospective cohort of patient subjected to curative colonic cancer surgery with primary anastomosis and entered into The Danish Colorectal Cancer Group database between May 2001 and December 2008. Results......: AL occurred in 593 (6.4%) of 9333 patients. Laparoscopic surgery (odds ratio [OR], 1.34; 95% confidence interval [CI], 1.05-1.70; P = 0.03); left hemicolectomy (OR, 2.02; 95% CI, 1.50-2.72) or sigmoid colectomy (OR, 1.69; 95% CI, 1.32-2.17; P = 0.01); intraoperative blood loss (OR, 1.04; 95% CI, 1...

  15. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial.

    Science.gov (United States)

    Garg, Amit X; Shehata, Nadine; McGuinness, Shay; Whitlock, Richard; Fergusson, Dean; Wald, Ron; Parikh, Chirag; Bagshaw, Sean M; Khanykin, Boris; Gregory, Alex; Syed, Summer; Hare, Gregory M T; Cuerden, Meaghan S; Thorpe, Kevin E; Hall, Judith; Verma, Subodh; Roshanov, Pavel S; Sontrop, Jessica M; Mazer, C David

    2018-01-01

    When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017). Patients (~4800) undergoing planned cardiac surgery with cardiopulmonary bypass. The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery), where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] blood cell transfusion in the presence of anemia during cardiac surgery done with cardiopulmonary bypass. www.clinicaltrials.gov; clinical trial registration number NCT 02042898.

  16. Quality and Variability of Online Available Physical Therapy Protocols From Academic Orthopaedic Surgery Programs for Anterior Cruciate Ligament Reconstruction.

    Science.gov (United States)

    Makhni, Eric C; Crump, Erica K; Steinhaus, Michael E; Verma, Nikhil N; Ahmad, Christopher S; Cole, Brian J; Bach, Bernard R

    2016-08-01

    To assess the quality and variability found across anterior cruciate ligament (ACL) rehabilitation protocols published online by academic orthopaedic programs. Web-based ACL physical therapy protocols from United States academic orthopaedic programs available online were included for review. Main exclusion criteria included concomitant meniscus repair, protocols aimed at pediatric patients, and failure to provide time points for the commencement or recommended completion of any protocol components. A comprehensive, custom scoring rubric was created that was used to assess each protocol for the presence or absence of various rehabilitation components, as well as when those activities were allowed to be initiated in each protocol. Forty-two protocols were included for review from 155 U.S. academic orthopaedic programs. Only 13 protocols (31%) recommended a prehabilitation program. Five protocols (12%) recommended continuous passive motion postoperatively. Eleven protocols (26%) recommended routine partial or non-weight bearing immediately postoperatively. Ten protocols (24%) mentioned utilization of a secondary/functional brace. There was considerable variation in range of desired full-weight-bearing initiation (9 weeks), as well as in the types of strength and proprioception exercises specifically recommended. Only 8 different protocols (19%) recommended return to sport after achieving certain strength and activity criteria. Many ACL rehabilitation protocols recommend treatment modalities not supported by current reports. Moreover, high variability in the composition and time ranges of rehabilitation components may lead to confusion among patients and therapists. Level II. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  17. Outpatient- and inpatient-based buckling surgery: a comparative study

    Directory of Open Access Journals (Sweden)

    Lee JC

    2014-04-01

    Full Text Available Jin Cheol Lee,* Yu Cheol Kim*Department of Ophthalmology, Keimyung University School of Medicine, Dongsan Medical Center, Daegu, Korea *Both authors contributed equally to this workPurpose: To evaluate the clinical outcomes of ambulatory buckling surgery, comparing outpatient- with inpatient-based surgery.Methods: The authors performed a retrospective study of 80 consecutive cases of rhegmato genous retinal detachment from January 2009 to December 2011 treated by scleral buckling surgery. Two groups of patients were defined according to inpatient (group 1 or outpatient (group 2 surgery, and a comparison of several parameters between these two groups was performed.Results: Of the 80 subjects in this study, the average age of group 1 (50 patients was 49.7 years, and that of group 2 (30 patients was 47.5 years. There were no statistically significant differences in the average logarithm of the minimum angle of resolution-visual acuity, the condition of the lens, or the presence of retinal lattice degeneration prior to the surgery between the groups. There were no statistically significant differences in the patterns of tear or retinal detachment or in surgical procedure between the groups. Comparing the best-corrected visual acuity after 6 months with that prior to the surgery, the changes in group 1 and group 2 were 0.26 and 0.31, respectively. The functional success rates of group 1 and group 2 after 6 months were 90% and 93%, respectively, and the anatomical success rates of group 1 and group 2 after 6 months were 94% and 96%, respectively, but these were also statistically insignificant.Conclusion: Hospitalization is not essential for buckling surgery in uncomplicated rhegmatogenous retinal detachment surgery.Keywords: ambulatory, scleral buckling, rhegmatogenous retinal detachment

  18. Application of Metabolomics to Study Effects of Bariatric Surgery

    Directory of Open Access Journals (Sweden)

    Paulina Samczuk

    2018-01-01

    Full Text Available Bariatric surgery was born in the 1950s at the University of Minnesota. From this time, it continues to evolve and, by the same token, gives new or better possibilities to treat not only obesity but also associated comorbidities. Metabolomics is also a relatively young science discipline, and similarly, it shows great potential for the comprehensive study of the dynamic alterations of the metabolome. It has been widely used in medicine, biology studies, biomarker discovery, and prognostic evaluations. Currently, several dozen metabolomics studies were performed to study the effects of bariatric surgery. LC-MS and NMR are the most frequently used techniques to study main effects of RYGB or SG. Research has yield many interesting results involving not only clinical parameters but also molecular modulations. Detected changes pertain to amino acid, lipids, carbohydrates, or gut microbiota alterations. It proves that including bariatric surgery to metabolic surgery is warranted. However, many molecular modulations after those procedures remain unexplained. Therefore, application of metabolomics to study this field seems to be a proper solution. New findings can suggest new directions of surgery technics modifications, contribute to broadening knowledge about obesity and diseases related to it, and perhaps develop nonsurgical methods of treatment in the future.

  19. Cognitive Investigation Study of Patients Admitted for Cosmetic Surgery: Information, Expectations, and Consent for Treatment

    Directory of Open Access Journals (Sweden)

    Mauro Barone

    2015-01-01

    Full Text Available BackgroundIn all branches of medicine, it is the surgeon's responsibility to provide the patient with accurate information before surgery. This is especially important in cosmetic surgery because the surgeon must focus on the aesthetic results desired by the patient.MethodsAn experimental protocol was developed based on an original questionnaire given to 72 patients. The nature of the responses, the patients' motivation and expectations, the degree of patient awareness regarding the planned operation, and the patients' perceptions of the purpose of the required consent for cosmetic surgery were all analyzed using Fisher's exact test.ResultsCandidates for abdominal wall surgery had significantly more preoperative psychological problems than their counterparts did (P=0.035. A significantly different percentage of patients under 40 years of age compared to those over 40 years of age searched for additional sources of information prior to the operation (P=0.046. Only 30% of patients with a lower educational background stated that the preoperative information had been adequate, whereas 92% of subjects with secondary schooling or a postsecondary degree felt that the information was sufficient (P=0.001. A statistically significant difference was also present between patients according to their educational background regarding expected improvements in their quality of life postoperatively (P=0.008.ConclusionsThis study suggests that patients require more attention in presurgical consultations and that clear communication should be prioritized to ensure that the surgeon understands the patient's expectations.

  20. Protocols to Study Growth and Metabolism in Drosophila.

    Science.gov (United States)

    Strassburger, Katrin; Teleman, Aurelio A

    2016-01-01

    Signaling pathways such as the insulin/insulin-like growth factor pathway concurrently regulate organismal growth and metabolism. Drosophila has become a popular model system for studying both organismal growth and metabolic regulation. Care must be taken, however, when assessing such phenotypes because they are quantitative in nature, and influenced by environment. This chapter first describes how to control animal age and nutrient availability, since growth and metabolism are sensitive to these parameters. It then provides protocols for measuring tissue growth, cell size, and metabolic parameters such as stored lipids and glycogen, and circulating sugars.

  1. Sexual satisfaction following bariatric surgery: A prospective exploratory study.

    Science.gov (United States)

    Ferrer-Márquez, Manuel; Pomares-Callejón, María Ángeles; Fernández-Agis, Inmaculada; Belda-Lozano, Ricardo; Vidaña-Márquez, Elisabet; Soriano-Maldonado, Alberto

    2017-11-01

    Bariatric surgery improves sexual function in obese individuals, although the extent to which sexual satisfaction is improved following surgery is unknown. The aims of this study were 1) to describe sexual satisfaction in severely/morbidly obese men and women candidates for bariatric surgery; 2) to assess the effects of bariatric surgery on sexual satisfaction at 12-months follow-up; and 3) to assess whether weight changes at follow-up following bariatric surgery are associated with changes in sexual satisfaction. We conducted a prospective observational study from February 2011 to June 2014. A total of 44 patients with severe/morbid obesity participated in the study. Sexual satisfaction was assessed (at baseline and 12-months follow-up) through the Index of Sexual Satisfaction (ISS) questionnaire. Of 44 patients who completed the ISS at baseline (mean age 40.3 [SD=9.4] years and BMI 46.9 [SD=6.2] kg/m 2 ), 17 were lost to follow-up. The baseline ISS total scores were 32.0 (SD=20.1) in women and 24.4 (SD=16.0) in men (P>0.05). The proportion of sexually satisfied men and women at baseline was 62.5% and 46.4%, respectively (P=0.360). At follow-up, sexual satisfaction improved significantly in women (average difference 13.7 units; P=0.032) but not in men (average difference 3.6 units; P=0.717). The percentage of women with sexual satisfaction problems was reduced by 33% at follow-up (P=0.038). A relatively large percentage of severely/morbidly obese women and men present clinically significant sexual satisfaction problems before undergoing bariatric surgery. Sexual satisfaction improves significantly 12 months following bariatric surgery, particularly in women. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. Intraoperative Death During Cervical Spinal Surgery: A Retrospective Multicenter Study.

    Science.gov (United States)

    Wang, Jeffrey C; Buser, Zorica; Fish, David E; Lord, Elizabeth L; Roe, Allison K; Chatterjee, Dhananjay; Gee, Erica L; Mayer, Erik N; Yanez, Marisa Y; McBride, Owen J; Cha, Peter I; Arnold, Paul M; Fehlings, Michael G; Mroz, Thomas E; Riew, K Daniel

    2017-04-01

    A retrospective multicenter study. Routine cervical spine surgeries are typically associated with low complication rates, but serious complications can occur. Intraoperative death is a very rare complication and there is no literature on its incidence. The purpose of this study was to determine the intraoperative mortality rates and associated risk factors in patients undergoing cervical spine surgery. Twenty-one surgical centers from the AOSpine North America Clinical Research Network participated in the study. Medical records of patients who received cervical spine surgery from January 1, 2005, to December 31, 2011, were reviewed to identify occurrence of intraoperative death. A total of 258 patients across 21 centers met the inclusion criteria. Most of the surgeries were done using the anterior approach (53.9%), followed by posterior (39.1%) and circumferential (7%). Average patient age was 57.1 ± 13.2 years, and there were more male patients (54.7% male and 45.3% female). There was no case of intraoperative death. Death during cervical spine surgery is a very rare complication. In our multicenter study, there was a 0% mortality rate. Using an adequate surgical approach for patient diagnosis and comorbidities may be the reason how the occurrence of this catastrophic adverse event was prevented in our patient population.

  3. Effects of chronic inflammatory bowel diseases on left ventricular structure and function: a study protocol

    Directory of Open Access Journals (Sweden)

    Botti Fiorenzo

    2002-09-01

    Full Text Available Abstract Background Experimental evidences suggest an increased collagen deposition in inflammatory bowel diseases (IBD. In particular, large amounts of collagen type I, III and V have been described and correlated to the development of intestinal fibrotic lesions. No information has been available until now about the possible increased collagen deposition far from the main target organ. In the hypothesis that chronic inflammation and increased collagen metabolism are reflected also in the systemic circulation, we aimed this study to evaluate the effects on left ventricular wall structure by assessing splancnic and systemic collagen metabolism (procollagen III assay, deposition (ultrasonic tissue characterization, and cardiac function (echocardiography in patients with different long standing history of IBD, before and after surgery. Methods Thirty patients affected by active IBD, 15 with Crohn and 15 with Ulcerative Colitis, submitted to surgery will be enrolled in the study in a double blind fashion. They will be studied before the surgical operation and 6, 12 months after surgery. A control group of 15 healthy age and gender-matched subjects will also be studied. At each interval blood samples will be collected in order to assess the collagen metabolism; a transthoracic echocardiogram will be recorded for the subsequent determination of cardiac function and collagen deposition. Discussion From this study protocol we expect additional information about the association between IBD and cardiovascular disorders; in particular to address the question if chronic inflammation, through the altered collagen metabolism, could affect left ventricular structure and function in a manner directly related to the estimated duration of the disease.

  4. A cohort study of the recovery of health and wellbeing following colorectal cancer (CREW study: protocol paper

    Directory of Open Access Journals (Sweden)

    Fenlon Deborah

    2012-04-01

    Full Text Available Abstract Background The number of people surviving colorectal cancer has doubled in recent years. While much of the literature suggests that most people return to near pre-diagnosis status following surgery for colorectal cancer, this literature has largely focused on physical side effects. Longitudinal studies in colorectal cancer have either been small scale or taken a narrow focus on recovery after surgery. There is a need for a comprehensive, long-term study exploring all aspects of health and wellbeing in colorectal cancer patients. The aim of this study is to establish the natural history of health and wellbeing in people who have been treated for colorectal cancer. People have different dispositions, supports and resources, likely resulting in individual differences in restoration of health and wellbeing. The protocol described in this paper is of a study which will identify who is most at risk of problems, assess how quickly people return to a state of subjective health and wellbeing, and will measure factors which influence the course of recovery. Methods/design This is a prospective, longitudinal cohort study following 1000 people with colorectal cancer over a period of two years, recruiting from 30 NHS cancer treatment centres across the UK. Questionnaires will be administered prior to surgery, and 3, 9, 15 and 24 months after surgery, with the potential to return to this cohort to explore on-going issues related to recovery after cancer. Discussion Outcomes will help inform health care providers about what helps or hinders rapid and effective recovery from cancer, and identify areas for intervention development to aid this process. Once established the cohort can be followed up for longer periods and be approached to participate in related projects as appropriate and subject to funding.

  5. Case-Cohort Studies: Design and Applicability to Hand Surgery.

    Science.gov (United States)

    Vojvodic, Miliana; Shafarenko, Mark; McCabe, Steven J

    2018-04-24

    Observational studies are common research strategies in hand surgery. The case-cohort design offers an efficient and resource-friendly method for risk assessment and outcomes analysis. Case-cohorts remain underrepresented in upper extremity research despite several practical and economic advantages over case-control studies. This report outlines the purpose, utility, and structure of the case-cohort design and offers a sample research question to demonstrate its value to risk estimation for adverse surgical outcomes. The application of well-designed case-cohort studies is advocated in an effort to improve the quality and quantity of observational research evidence in hand and upper extremity surgery. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  6. Patients' perceptions of waiting for bariatric surgery: a qualitative study.

    Science.gov (United States)

    Gregory, Deborah M; Temple Newhook, Julia; Twells, Laurie K

    2013-10-18

    In Canada waiting lists for bariatric surgery are common, with wait times on average > 5 years. The meaning of waiting for bariatric surgery from the patients' perspective must be understood if health care providers are to act as facilitators in promoting satisfaction with care and quality care outcomes. The aims of this study were to explore patients' perceptions of waiting for bariatric surgery, the meaning and experience of waiting, the psychosocial and behavioral impact of waiting for treatment and identify health care provider and health system supportive measures that could potentially improve the waiting experience. Twenty-one women and six men engaged in in-depth interviews that were digitally recorded, transcribed verbatim and analysed using a grounded theory approach to data collection and analysis between June 2011 and April 2012. The data were subjected to re-analysis to identify perceived health care provider and health system barriers to accessing bariatric surgery. Thematic analysis identified inequity as a barrier to accessing bariatric surgery. Three areas of perceived inequity were identified from participants' accounts: socioeconomic inequity, regional inequity, and inequity related to waitlist prioritization. Although excited about their acceptance as candidates for surgery, the waiting period was described as stressful, anxiety provoking, and frustrating. Anger was expressed towards the health care system for the long waiting times. Participants identified the importance of health care provider and health system supports during the waiting period. Recommendations on how to improve the waiting experience included periodic updates from the surgeon's office about their position on the wait list; a counselor who specializes in helping people going through this surgery, dietitian support and further information on what to expect after surgery, among others. Patients' perceptions of accessing and waiting for bariatric surgery are shaped by perceived

  7. Ambulatory laparoscopic minor hepatic surgery: Retrospective observational study.

    Science.gov (United States)

    Gaillard, M; Tranchart, H; Lainas, P; Tzanis, D; Franco, D; Dagher, I

    2015-11-01

    Over the last decade, laparoscopic hepatic surgery (LHS) has been increasingly performed throughout the world. Meanwhile, ambulatory surgery has been developed and implemented with the aims of improving patient satisfaction and reducing health care costs. The objective of this study was to report our preliminary experience with ambulatory minimally invasive LHS. Between 1999 and 2014, 172 patients underwent LHS at our institution, including 151 liver resections and 21 fenestrations of hepatic cysts. The consecutive series of highly selected patients who underwent ambulatory LHS were included in this study. Twenty patients underwent ambulatory LHS. Indications were liver cysts in 10 cases, liver angioma in 3 cases, focal nodular hyperplasia in 3 cases, and colorectal hepatic metastasis in 4 cases. The median operative time was 92 minutes (range: 50-240 minutes). The median blood loss was 35 mL (range: 20-150 mL). There were no postoperative complications or re-hospitalizations. All patients were hospitalized after surgery in our ambulatory surgery unit, and were discharged 5-7 hours after surgery. The median postoperative pain score at the time of discharge was 3 (visual analogue scale: 0-10; range: 0-4). The median quality-of-life score at the first postoperative visit was 8 (range: 6-10) and the median cosmetic satisfaction score was 8 (range: 7-10). This series shows that, in selected patients, ambulatory LHS is feasible and safe for minor hepatic procedures. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  8. An analysis of moderate sedation protocols used in dental specialty programs: a retrospective observational study.

    Science.gov (United States)

    Setty, Madhavi; Montagnese, Thomas A; Baur, Dale; Aminoshariae, Anita; Mickel, Andre

    2014-09-01

    Pain and anxiety control is critical in dental practice. Moderate sedation is a useful adjunct in managing a variety of conditions that make it difficult or impossible for some people to undergo certain dental procedures. The purpose of this study was to analyze the sedation protocols used in 3 dental specialty programs at the Case Western Reserve University School of Dental Medicine, Cleveland, OH. A retrospective analysis was performed using dental school records of patients receiving moderate sedation in the graduate endodontic, periodontic, and oral surgery programs from January 1, 2010, to December 31, 2012. Information was gathered and the data compiled regarding the reasons for sedation, age, sex, pertinent medical conditions, American Society of Anesthesiologists physical status classifications, routes of administration, drugs, dosages, failures, complications, and other information that was recorded. The reasons for the use of moderate sedation were anxiety (54%), local anesthesia failures (15%), fear of needles (15%), severe gag reflex (8%), and claustrophobia with the rubber dam (8%). The most common medical conditions were hypertension (17%), asthma (15%), and bipolar disorder (8%). Most patients were classified as American Society of Anesthesiologists class II. More women (63.1%) were treated than men (36.9%). The mean age was 45 years. Monitoring and drugs varied among the programs. The most common tooth treated in the endodontic program was the mandibular molar. There are differences in the moderate sedation protocols used in the endodontic, periodontic, and oral surgery programs regarding monitoring, drugs used, and record keeping. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  9. Biomass to energy : GHG reduction quantification protocols and case study

    International Nuclear Information System (INIS)

    Reusing, G.; Taylor, C.; Nolan, W.; Kerr, G.

    2009-01-01

    With the growing concerns over greenhouses gases and their contribution to climate change, it is necessary to find ways of reducing environmental impacts by diversifying energy sources to include non-fossil fuel energy sources. Among the fastest growing green energy sources is energy from waste facilities that use biomass that would otherwise be landfilled or stockpiled. The quantification of greenhouse gas reductions through the use of biomass to energy systems can be calculated using various protocols and methodologies. This paper described each of these methodologies and presented a case study comparing some of these quantification methodologies. A summary and comparison of biomass to energy greenhouse gas reduction protocols in use or under development by the United Nations, the European Union, the Province of Alberta and Environment Canada was presented. It was concluded that regulatory, environmental pressures, and public policy will continue to impact the practices associated with biomass processing or landfill operations, such as composting, or in the case of landfills, gas collection systems, thus reducing the amount of potential credit available for biomass to energy facility offset projects. 10 refs., 2 tabs., 6 figs

  10. Biomass to energy : GHG reduction quantification protocols and case study

    Energy Technology Data Exchange (ETDEWEB)

    Reusing, G.; Taylor, C. [Conestoga - Rovers and Associates, Waterloo, ON (Canada); Nolan, W. [Liberty Energy, Hamilton, ON (Canada); Kerr, G. [Index Energy, Ajax, ON (Canada)

    2009-07-01

    With the growing concerns over greenhouses gases and their contribution to climate change, it is necessary to find ways of reducing environmental impacts by diversifying energy sources to include non-fossil fuel energy sources. Among the fastest growing green energy sources is energy from waste facilities that use biomass that would otherwise be landfilled or stockpiled. The quantification of greenhouse gas reductions through the use of biomass to energy systems can be calculated using various protocols and methodologies. This paper described each of these methodologies and presented a case study comparing some of these quantification methodologies. A summary and comparison of biomass to energy greenhouse gas reduction protocols in use or under development by the United Nations, the European Union, the Province of Alberta and Environment Canada was presented. It was concluded that regulatory, environmental pressures, and public policy will continue to impact the practices associated with biomass processing or landfill operations, such as composting, or in the case of landfills, gas collection systems, thus reducing the amount of potential credit available for biomass to energy facility offset projects. 10 refs., 2 tabs., 6 figs.

  11. [Colombia 2015 National Mental Health Survey. Study Protocol].

    Science.gov (United States)

    Gómez-Restrepo, Carlos; de Santacruz, Cecilia; Rodriguez, María Nelcy; Rodriguez, Viviana; Tamayo Martínez, Nathalie; Matallana, Diana; Gonzalez, Lina M

    2016-12-01

    The 2015 National Mental Health Survey (NMHS) is the fourth mental survey conducted in Colombia, and is part of the National System of Surveys and Population Studies for health. A narrative description is used to explain the background, references, the preparation, and characteristics of the 2015 NMHS. The 2015 NMHS and its protocol emerge from the requirements that support the national and international policies related to mental health. Together with the Ministry of Health and Social Protection, the objectives, the collection tools, the sample, and the operational plan are defined. The main objective was to obtain updated information about the mental health, mental problems and disorders, accessibility to health services, and an evaluation of health conditions. Participants were inhabitants from both urban and rural areas, over 7 years old, and in whom the comprehension of social determinants and equity were privileged. An observational cross-sectional design with national, regional and age group representativity, was used. The age groups selected were 7-11, 12-17, and over 18 years old. The regions considered were Central, Orient, Atlantic, Pacific, and Bogota. The calculated sample had a minimum of 12,080 and a maximum of 14,496 participants. A brief summary of the protocol of the 2015 NMHS is presented. The full document with all the collection tools can be consulted on the Health Ministry webpage. Copyright © 2016. Publicado por Elsevier España.

  12. [Thymus surgery in a general surgery department].

    Science.gov (United States)

    Mega, Raquel; Coelho, Fátima; Pimentel, Teresa; Ribero, Rui; Matos, Novo de; Araújo, António

    2005-01-01

    Evaluation of thymectomy cases between 1990-2003, in a General Surgery Department. Evaluation of the therapeutic efficacy in Miastenia Gravis patients. Retrospective study based on evaluation of data from Serviço de Cirurgia, Neurologia and Consult de Neurology processes, between 1990-2003, of 15 patients submitted to total thymectomy. 15 patients, aged 17 to 72, 11 female and 4 male. Miastenia Gravis was the main indication for surgery, for uncontrollable symptoms or suspicion of thymoma. In patients with myasthenia, surgery was accomplish after compensation of symptoms. There weren't post-surgery complications. Pathology were divided in thymic hyperplasia and thymoma. Miastenia patients have there symptoms diminished or stable with reduction or cessation of medical therapy. Miastenia was the most frequent indication for thymectomy. Surgery was good results, with low morbimortality, as long as the protocols are respected.

  13. A STUDY ON INCISIONAL HERNIA FOLLOWING OBSTETRICS AND GYNAECOLOGICAL SURGERIES

    Directory of Open Access Journals (Sweden)

    Sumathi Ravikumar

    2016-12-01

    Full Text Available BACKGROUND The term ventral hernia encompasses incisional, epigastric, paraumbilical, spigelian and traumatic hernias. This is a hernia that protrudes through defect in an abdominal wound. With evolution of modern surgery and rapid increase in the number of abdominal operations performed, incisional hernias have risen in frequency and this hernia seems to be more common in females following obstetric and gynaecological surgeries. This study undertaken to stress the problem of incisional hernias in females occurring after obstetric and gynaecological surgeries. The aim of the study is to- 1. Study the incidence and prevalence of incisional hernias following obstetrics and gynaecological surgeries in KAPV Government Medical College, Tiruchirappalli. 2. Study aetiological factors for incisional hernia following obstetric and gynaecological surgeries. 3. Analyse preventive measures. 4. Analyse the problems in females, which led to incisional hernia. MATERIALS AND METHODS 178 cases of incisional hernia admitted in KAPV Government Medical College, Tiruchirappalli, during the period of 2 years from June 2014 to May 2016. The cases analysed according to age, previous history, type of incision, suture material used and associated comorbidities. RESULTS Maximum age affected is between 50 to 59 years and with 10 years of surgery. Incidence more following LSCS with midline incision. Incidence more with the usage of absorbable suture material. Postoperative wound infection and anaemia were leading associated factors for incisional hernia. CONCLUSION The incidence of incisional hernia is more common in females especially in obese and multiparous woman. The incidence is more after LSCS and puerperal sterilisation. Onlay reinforced mesh repair using Prolene mesh have given good results. Prolene mesh appears to be best tolerated by body tissues. The use of closed suction drain have significantly reduced the postoperative wound infection.

  14. Algorithm for planning a double-jaw orthognathic surgery using a computer-aided surgical simulation (CASS) protocol. Part 1: planning sequence

    Science.gov (United States)

    Xia, J. J.; Gateno, J.; Teichgraeber, J. F.; Yuan, P.; Chen, K.-C.; Li, J.; Zhang, X.; Tang, Z.; Alfi, D. M.

    2015-01-01

    The success of craniomaxillofacial (CMF) surgery depends not only on the surgical techniques, but also on an accurate surgical plan. The adoption of computer-aided surgical simulation (CASS) has created a paradigm shift in surgical planning. However, planning an orthognathic operation using CASS differs fundamentally from planning using traditional methods. With this in mind, the Surgical Planning Laboratory of Houston Methodist Research Institute has developed a CASS protocol designed specifically for orthognathic surgery. The purpose of this article is to present an algorithm using virtual tools for planning a double-jaw orthognathic operation. This paper will serve as an operation manual for surgeons wanting to incorporate CASS into their clinical practice. PMID:26573562

  15. Efficacy of anchoring the four-arm transvaginal mesh to the mid-urethra vs original surgery as a surgical correction for stress urine incontinence in coexisting anterior vaginal prolapse grades II and III: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Fekete, Zoltán; Surányi, Andrea; Rénes, Lórand; Németh, Gábor; Kozinszky, Zoltan

    2017-12-28

    The prevalence of obesity with aging is escalating alarmingly; and pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are now becoming a growing epidemic among the elderly. Synthetic transvaginal mesh has been employed with increasing popularity in the treatment of POP and is usually highly effective in controlling the principal symptoms of prolapse. However, studies have reported that mesh operations provide fairly unfavorable SUI cure rates. Therefore, additional anti-incontinence surgical strategies are increasingly being scrutinized to achieve better postoperative continence without any significant side-effects for patients with both POP and SUI. We hypothesize that the modification with the fixing of the mesh to the mid-urethra is superior to the original transvaginal mesh operation (TVM) with regard to anti-incontinence. One hundred and thirty patients diagnosed with POP-Q II-III and concomitant SUI requiring surgical treatment will be included in this prospective, randomized, double-blind, controlled clinical trial. Patients will be randomly allocated to receive either original TVM (TVM group, n = 65) or modified TVM surgery (mTVM group, n = 65). As the primary outcome parameter, we will evaluate the objective SUI and POP cure rates. Secondary endpoints include postoperative morbidity as assessed with the International Urogynaecological Association classification and subjective prolapse and incontinence cure rates reported by questionnaires. Recognizing the importance of an additional surgical procedure for anti-incontinence management, we aim to investigate whether a stabilizing suturing of the mesh to the mid-urethra delivers superior SUI correction compared to the original prosthesis surgery. ClinicalTrials.gov, NCT02935803. Registered on 20 May 2016.

  16. Protocol of study and pursuit of the radioinduced burns

    International Nuclear Information System (INIS)

    Portas, Mercedes; Glustein, Daniel; Pomerane, Armando; Peragallo, Mabel; Guzman, Alejandra; Ciordia, Irma; Genovese, Jorge; Cymberknoh, Manuel; Dubner, Diana; Michelin, Severino; Perez, Maria del Rosario; Trano, Jose Luis Di; Gisone, Pablo

    2001-01-01

    A study of localized overexposures based on local experience and international criteria is being carried out within the framework of a cooperation agreement between the Buenos Aires Burned Hospital and the Nuclear Regulatory Authority. This protocol was designed considering separately acute and chronic reactions, including the following aspects: patient reception: clinical findings, laboratory tests, photographic recording, and multidisciplinary evaluation; dose reconstruction: evaluation of the dose distribution by biophysical and biological procedures; extension and depth estimation: telethermography, computed tomography, magnetic resonance, radioisotopic procedures, capillaroscopy and percutaneous oxymetry; therapeutic strategies: pain treatment, prevention of infections, systemic administration of pentoxiphyllin and alpha-tocopherol, local application of trolamine and antioxidants, prevention and treatment of radioinduced fibrosis. When it is indicated, surgical treatment includes partial or total excision followed by covering by graft or flap. The application of tissue-engineering techniques will be considered. Study of individual radiosensitivity: evaluation of apoptosis in peripheral lymphocytes and clonogenic assays in dermal fibroblasts 'in vitro' irradiated. (author)

  17. Fundamental principles of conducting a surgery economic analysis study.

    Science.gov (United States)

    Kotsis, Sandra V; Chung, Kevin C

    2010-02-01

    The use of economic evaluation in surgery is scarce. Economic evaluation is used even less so in plastic surgery, in which health-related quality of life is of particular importance. This article, part of a tutorial series on evidence-based medicine, focuses on the fundamental principles of conducting a surgery economic analysis. The authors include the essential aspects of conducting a surgical cost-utility analysis by considering perspectives, costs, outcomes, and utilities. The authors also describe and give examples of how to conduct the analyses (including calculating quality-adjusted life-years and discounting), how to interpret the results, and how to report the results. Although economic analyses are not simple to conduct, a well-conducted one provides many rewards, such as recommending the adoption of a more effective treatment. For comparing and interpreting economic analysis publications, it is important that all studies use consistent methodology and report the results in a similar manner.

  18. Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. Methods/design This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). Discussion This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. Trial registration The trial

  19. Developing a comprehensive presurgical functional MRI protocol for patients with intractable temporal lobe epilepsy: a pilot study

    International Nuclear Information System (INIS)

    Deblaere, K.; Vandemaele, P.; Achten, E.; Backes, W.H.; Hofman, P.; Wilmink, J.; Boon, P.A.; Vonck, K.; Boon, P.; Troost, J.; Vermeulen, J.; Aldenkamp, A.

    2002-01-01

    Our aim was to put together and test a comprehensive functional MRI (fMRI) protocol which could compete with the intracarotid amytal (IAT) or Wada test for the localisation of language and memory function in patients with intractable temporal lobe epilepsy. The protocol was designed to be performed in under 1 h on a standard 1.5 tesla imager. We used five paradigms to test nine healthy right-handed subjects: complex scene-encoding, picture-naming, reading, word-generation and semantic-decision tasks. The combination of these tasks generated two activation maps related to memory in the mesial temporal lobes, and three language-related maps of activation in a major part of the known language network. The functional maps from the encoding and naming tasks showed typical and symmetrical posterior mesial temporal lobe activation related to memory in all subjects. Only four of nine subjects also showed symmetrical anterior hippocampal activation. Language lateralisation was best with the word generation and reading paradigms and proved possible in all subjects. The reading paradigm enables localisation of language function in the left anterior temporal pole and middle temporal gyrus, areas typically resected during epilepsy surgery. The combined results of this comprehensive f MRI protocol are adequate for a comparative study with the IAT in patients with epilepsy being assessed for surgery. (orig.)

  20. Developing a comprehensive presurgical functional MRI protocol for patients with intractable temporal lobe epilepsy: a pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Deblaere, K.; Vandemaele, P.; Achten, E. [MRI Department -1 K12, Department of Radiology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent (Belgium); Backes, W.H.; Hofman, P.; Wilmink, J. [Department of Neuroradiology, University Hospital Maastricht, Postbus 5800, 6202 AZ Maastricht (Netherlands); Boon, P.A.; Vonck, K. [Department of Neurology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent (Belgium); Boon, P. [Department of Medical Psychology, University Hospital Maastricht (Netherlands); Troost, J. [Department of Neurology, University Hospital Maastricht (Netherlands); Vermeulen, J. [S.E.I.N Heemstede, Psychological Laboratory, Achterweg 5, 2103 SW Heemstede (Netherlands); Aldenkamp, A. [Epilepsy Center ' Kempenhaeghe' , Postbus 61, 5900 AB Heeze (Netherlands)

    2002-08-01

    Our aim was to put together and test a comprehensive functional MRI (fMRI) protocol which could compete with the intracarotid amytal (IAT) or Wada test for the localisation of language and memory function in patients with intractable temporal lobe epilepsy. The protocol was designed to be performed in under 1 h on a standard 1.5 tesla imager. We used five paradigms to test nine healthy right-handed subjects: complex scene-encoding, picture-naming, reading, word-generation and semantic-decision tasks. The combination of these tasks generated two activation maps related to memory in the mesial temporal lobes, and three language-related maps of activation in a major part of the known language network. The functional maps from the encoding and naming tasks showed typical and symmetrical posterior mesial temporal lobe activation related to memory in all subjects. Only four of nine subjects also showed symmetrical anterior hippocampal activation. Language lateralisation was best with the word generation and reading paradigms and proved possible in all subjects. The reading paradigm enables localisation of language function in the left anterior temporal pole and middle temporal gyrus, areas typically resected during epilepsy surgery. The combined results of this comprehensive f MRI protocol are adequate for a comparative study with the IAT in patients with epilepsy being assessed for surgery. (orig.)

  1. Mortality after surgery in Europe: a 7 day cohort study

    NARCIS (Netherlands)

    Pearse, Rupert M.; Moreno, Rui P.; Bauer, Peter; Pelosi, Paolo; Metnitz, Philipp; Spies, Claudia; Vallet, Benoit; Vincent, Jean-Louis; Hoeft, Andreas; Rhodes, Andrew; Moreno, Rui; Pearse, Rupert; Damster, Sandrine; Golder, Kim; Hewson, Russell; Januszewska, Marta; Leva, Brigitte; Ramos, Vasco; Hoste, Eric; Huyghens, Luc; Jacobs, Rita; van Mossevelde, Veerle; Opdenacker, Godelieve; Poelaert, Jan; Spapen, Herbert; Leleu, Kris; Rijckaert, Dirk; de Decker, Koen; Foubert, Luc; de Neve, Nikolaas; Biston, Patrick; Piagnerelli, Michael; Collin, Vincent; Blauwen, Nadia den; Clauwaert, Charlotte; de Crop, Luc; Verbeke, An; Roeselare, Heilige Hartziekenhuis; Derumeaux, Pieter; Gardin, Christophe; Kindt, Sebastiaan; Louage, Sofie; Verhamme, Bruno; Druwé, Patrick; Lahaye, Ingrid; Rosseel, Francis; Rutsaert, Robert; Vanlinthout, Luc; de Kock, Marc; Forget, Patrice; Georges, Pascal; Grosu, Irina; Kahn, David; Lois, Fernande; Momeni, Mona; Pospiech, Audrey; Yemnga, Bernadette; Jadoul, Jean-Luc; Malbrain, Manu; Bosinceanu, Dana; Collard, Edith; Jorens, Philippe; Reyntiens, Dirk; Smitz, Carine; Vercauteren, Marcel; Fagnoul, David; van Obbergh, Luc; Goranović, Tatjana; Mazul-Sunko, Branka; Toplice, Krapinske; Oremuš, Krešimir; Bešlić, Gabrijela; Duzel, Viktor; Hauptman, Ada; Peremin, Sanja; Šribar, Andrej; Župčić, Miroslav; Brod, Slavonski; Mirković, Ivan; Bauer, Zlata Šarić; Belavić, Matija; Blažanin, Božidar; Katušin, Mirjana Lončarić; Krijan, Antonija Brozović; Mišković, Petar; Šimić-Korać, Nataša; Topić, Jasna; Žilić, Antonio; Žuni, Josip; Acan, Ivana; Adanić, Mirta; Ivanov, Nikola; Šarić, Jadranka Pavičić; Tomulić, Katarina; Visković, Nataša; Bošnjak, Silvana; Drenjančevic, Ivana Haršanji; Kristek, Gordana; Kvolik, Slavica; Markić, Stela; Rakipovic, Andreja Stojanovic; Tot, Ozana Katarina; Venzera- Azenic, Darija; Fabris, Lada Kalagac; Bačak-Kocman, Iva; Balenović, Igor; Bandić, Daniela; Deutsch, Patricia Adrianne Judith; Divjak, Loredana; Filipović, Ina Grčić; Gužvinec, Zvonka; Krznarić, Zrinka; Lončarić, Yvonne; Magaš, Jelena Vadlja; Mitrović, Marek; Okić, Marija; Pavlek, Mario; Ramov, Elza; Rezek, Karolina; Sekulić, Ante; Tomasevic, Boris; Mirić, Mirjana; Tomašević, Anita; Mahečić, Tina Tomić; Vrbanović, Vilena; Bobinac, Mirna; Božić, Alfred; Debelic, Danijela; Frkovic, Vedran; Batinica, Inga Mladić; Baranović, Senka; Gavranović, Željka; Kikec, Mirna; Maldini, Branka; Marić, Stela; Agnić, Ivan; Delić, Nikola; Dropulić, Nataša; Gašpić, Toni Kljaković; Ilić, Darko; Ivančev, Božena; Karanović, Nenad; Kuščević, Dorjan; Marović, Zlatko; Milić, Matija; Nevešćanin, Ana; Petković, Tatjana; Smoje, Mario; Brozović, Gordana; Jelisavac, Milana; Matolić, Martina; Oberhofer, Dagmar; Pavičić, Ana Marija; Šakić, Kata; Bozovic, Margarita Delija; Krecek, Zvjezdana Kotorac; Krobot, Renata; Andabaka, Tatjana; Bratanić, Mislav; Dzepina, Orjana; Kraljev, Martina; Šeric, Julija; Šimurina, Tatjana; Grujić, Rosa; Nacevski-Bulaja, Biljana; Barižon, Mirna; Danira, Vrančić; Dražen, Bulaja; Dušanka, Kimer; Halužan, Marijana Bašić; Joško, Žaja; Katica, Roca; Labor, Magda; Marinković, Tea Grgurević; Mihovilčević, Danči; Marija, Bego; Srečko, Marinković; Vranković, Srđan; Kyprianou, Theodoros; Neophytou, Kyriakos; Cerny, Vladimir; Cvachovec, Karel; Belikova, Barbora; Drab, Michal; Hudacek, Kamil; Krikava, Ivo; Stourac, Petr; Zadrazilova, Katarina; Bicek, Vladimír; Brabcová, Milena; Klozová, Radka; Vajter, Jaromír; Vymazal, Tomáš; Toft, Palle; Blichfeldt, Louise; Hansen, Bo Dilling; Moller, Kirsten; Nielsen, Jeppe Sylvest; Frederiksen, Joachim; Andersen, Johnny Dohn; Kühne, Jan Peter; Leivdal, Siv; Stendell, Line; Simonsen, Martin; Zoltowski, Marcin Konrad; Ali, Zahida Salman; Freundlich, Morten; Pilypaite, Jurgita; Clausen, Nicola Groes; Thorup, Line; Hansen, Frank; Bestle, Morten; Hansen, Christian Steen; Afshari, Arash; Bille, Anders Bastholm; Lefort, Michele; Secher, Erik L.; Liboriussen, Lisbeth; Herodes, Veiko; Härma, Eve; Marvet, Kadri; Pool, Kristiina; Kallas, Pille; Mägi, Triinu-Kreete; Sütt, Jaan; Vijar, Kerli; Visk, Evelin; Vinnal, Mare; Ellermaa, Jaanus; Liibusk, Liia; Tikkerberi, Artur; Falk, Ilme; Mällo, Esta; Talving, Jaak; Pettilä, Ville; Hovilehto, Seppo; Kirsi, Anne; Mustola, Seppo; Tiainen, Pekka; Toivonen, Juhani; Dabnell, Sandra; Kaminski, Tadeusz; Sysimetsa, Anu; Kaukonen, Maija; Silvasti, Päivi; Vainio, Kaisa; Lund, Vesa; Sjövall, Sari; Saarinen, Kari; Viitanen, Matti; Ahonen, Tommi; Alaspää, Ari; Zittling, Ritva; Saarinen, Aarne; Moisander, Annette; Wagner, Bodo; Laru-Sompa, Raili; Elomaa, Esa; Lavonen, Leena; Nevantaus, Juha; Geier, Klaus; Kavasmaa, Tomi; Koorits, Ursula; Kubjas, Mare; Lauritsalo, Seppo; Ottelin, Lauri; Palve, Markki; Pynnönen, Jari; Rääbis, Inga; Saarelainen, Minna; Heikkilä, Tapani; Kontula, Timo; Lehtimäki, Markku; Liimatainen, Jari; Moilanen-Oikarinen, Mari; Pakarinen, Marika; Palanne, Riku; Seppänen, Hanna; Pulkkinen, Anni; Vääräniemi, Heikki; Paananen, Sami; Koskenkari, Juha; Sälkiö, Sinikka; Vakkala, Merja; Koskue, Talvikki; Loisa, Pekka; Laitio, Ruut; Hautamäki, Raku; Koivisto, Simo-Pekka; Futier, Emmanuel; Lefrant, Jean-Yves; Leon, Alain; Bonnet, Francis; Marret, Emmanuel; Spielvogel, Catherine; Papageorgiou, Chryssa; Szymkiewicz, Olga; Tounou-Akue, Felix; Aubrun, Frederic; Bonnet, Aurélie; Gazon, Mathieu; Guiraud, Michel; Laurent, Virginie; Béclère, Antoine; Tachon, Guillaume; Demars, Nadège; Dumenil, Anne-Sylvie; Mercier, Frederic; Landais, Alain; Mentec, Herve; Bazin, Marie; Gonnu, Sophie; Petit, Antoine; Albaladejo, Pierre; Almeras, Luc; Bataillard, Amélie; Rossi-Blancher, Marine; Lefrant, Jean Yves; Barthel, Florian; Hallel, Dan; Sbai, Hicham; Khalifeh, Pamela; Lidzborski, Lionel; Jully, Marion; Platon, Ecaterina; Pottecher, Julien; Baumgarten, Romain; Schultz, Christel; ElMiloudi, Fayçal; Lefebvre, Julie; Waton, Karen; Sprunck, Adrien; Steib, Annick; Thibaud, Adrien; Thuet, Vincent; Kieffer, Vianney; Dubois-Vallaud, Delphine; Jacob, Laurent; Becanne, Xavier; Cherfaoui, Salim; Gauzit, Remy; Godier, Anne; Lakhdari, Mourad; Samma, Charles; Bigeon, Jean-Yves; Burtin, Philippe; Halchini, Constantin; Lacroix, Magali; Pinna, Frederic; Barbes, Aurélie; Just, Bernard; Mateu, Philippe; Benayoun, Laurent; Berger, Philippe; Granier, Nathalie; Perrigault, Pierre Francois; Libert, Nicolas; de Rudnicki, Stephan; Merat, Stéphane; Bourdet, Benoit; Ferré, Fabrice; Minville, Vincent; Piriou, Vincent; Rague, Philippe; Wallet, Florent; Lebuffe, Gilles; Desbordes, Jacques; Robin, Emmanuel; Ichai, Carole; Orban, Jean-Christophe; Marx, Gernot; Sander, Michael; Gottschalk, André; Piontek, André; Unterberg, Matthias; Hilpert, Justus; Kees, Martin; Triltsch, Andreas; Wiegand-Löhnert, Carola; Glöckner, Christiane; Hohn, Andreas; Rose, Elmar; Schröder, Stefan; Wiese, Oliver; Awlakpui, Eli; Scheidemann, Mona; Wittmann, Maria; Ramminger, Axel; Dresden, Carus; Gama de Abreu, Marcelo; Heller, Axel; Marx, Christine; Neidel, Julia; Goldmann, Anton; von Heymann, Christian; Laetsch, Beatrix; Maahs, Esther; Scholz, Lars; Frenzel, Dirk; Massarat, Kyros; Lenhart, Franz-Peter; Reichle, Florian; Rudlof, Kristina; Borchers, Friedrich; Buettner, Christoph; Schmutzler, Martin; Burgard, Gerald; Lucht, Alexander; Wagner, Jan; Pilge, Stefanie; Schneider, Gerhard; Untergehrer, Gisela; Bis, Beata; Krassler, Jens; Dittmann, Jan; Haberkorn, Jörg; Eberitsch, Jürgen; Eberitsch, Karola; Nippraschk, Thomas; Wepler, Ulrich; Engelen, Wolf-Christian; Nau, Carla; Scholler, Axel; Schüttler, Jürgen; Wintzheimer, Simone; Bloos, Frank; Braune, Anke; Fergen, Daniela; Ludewig, Katrin; Paxian, Markus; Reinhart, Konrad; Graf, Nikolaus; Schwarzkopf, Konrad; Berger, Katharina; Habicher, Marit; Kasperiunaite, Ruta; Savelsberg, Sabine; Krep, Henning; Reindl, Michael; Weber, Matthias; Bauer, Wolfgang; Bingold, Florian; Christ, Saskia; Friederich, Patrick; Kaviani, Reza; Auer, Patrick; Bonnländer, Georg; Drescher, Jürgen; Braun, Roland; Eichenauer, Tim; Kerner, John; Bierbaum, Kathrin; Brünner, Horst; Grond, Stefan; Perez-Platz, Ursula; Andresen, Bent; Linstedt, Ulf; Stegmann, Nils; Erkens, Uwe; Kopcke, Jens; Meyer, Andreas; Brestrich, Hartmut; Ernst, Sandra; Merkel, Stella; Krieger, Lena; Luers, Frank; Weyland, Andreas; Noeldge-Schomburg, Gabriele; Menckie, Thomas; Wasmund, Christina; Bredtmann, Ralph-Dieter; Erler, Ines; Raufhake, Carsten; Haumann, Christine; Möllemann, Angela; Oehmichen, Uwe; Sergejewa, Olga; Lehning, Brigitte; Czeslick, Elke; Geyer, Michaela; Malcharek, Michael; Sablotzki, Armin; Stier, Marina; Feld, Florian; Rossaint, Rolf; Simon, Verena; Armaganidis, Apostolos; Koulenti, Despoina; Kotanidou, Anastasia; Nanas, Serafim; Papastylianou, Androula; Psevdi, Aikaterini; Stathopoulos, Anastasios; Voulas, Asklepieion; Kanna, Efthymia; Koutsikou, Anastasia; Moustaka, Alexandra; Chovas, Achilleas; Komnos, Apostolos; Zafiridis, Tilemachos; Franses, Josef; Lavrentieva, Athena; Koraki, Eleni; Katsenos, Chrysostomos; Kasianidou, Maria Flora; Nasopoulou, Pantelia; Spyropoulou, Eleni; Gousia, Chrysoula; Katsanoulas, Constantine; Lathyris, Dimitrios; Kyriazopoulos, George; Sfyras, Dimitrios; Tsirogianni, Athanasia; Kostopanagiotou, Georgia; Lignos, Mihail; Matsota, Paraskevi; Christopoulos, Christos; Mouratidou, Alexandra; Vrettou, Efstratia; Boufidis, Spyros; Moka, Eleni; Arnaoutoglou, Eleni; Koulouras, Vasileios; Nakos, George; Papathanakos, Georgios; Anthopoulos, Georgios; Choutas, Georgios; Karapanos, Dimitrios; Tzani, Vaso; Gkiokas, Georgios; Nastos, Konstantinos; Nikolakopoulos, Fotios; Dragoumanis, Christos; Nikitidis, Nikos; Pneumatikos, Ioannis; Theodorou, Vassiliki; Zacharouli, Danai; Kandi, Stella; Tasopoulos, Konstantinos; Arvaniti, Kostoula; Matamis, Dimitrios; Mplougoura, Eva; Petropoulou, Polixeni; Soumpasis, Ioannis; Amaniti, Ekaterini; Giannakou-Peftoulidou, Maria; Gkeka, Eleni; Soultati, Ioanna; Kokinou, Maria; Papatheodorou, Lambrini; Stafylaraki, Maria; Giasnetsova, Tatiana; Gritsi-Gerogianni, Nikoleta; Kydona, Christina; Kiskira, Olga; Koulentis, Ioannis; Apsokardos, Alexandros; Dimitropoulos, Konstantinos; Soldatou, Ourania; Nathanail, Christodoulos; Papazotos, Alexios; Tsakas, Pirros; Clouva-Molyvdas, Phyllis-Maria; Kolotoura, Athina; Sartzi, Monika; Papanikolaou, Spiros; Polakis, Pavlos; Karatzas, Stylianos; Kyparissi, Aikaterini; Papavasilopoulou, Theonymfi; Koukoubani, Triantafillia; Mastora, Evangelia; Spyropoulou-Pagdatoglou, Kyriaki; Nyktari, Vasileia; Malliotakis, Polychronis; Papaioannou, Alexandra; Bekos, Vasileios; Maragkou, Elisavet; Spring, Anna; Evagelatos, Stavros; Ioakeimidou, Aikaterini; Noulas, Nikos; Molnár, Zsolt; Csüllög, Emese; Elekes, Enikő; Molnár, Tamás; Katona, Zsuzsana; Kremer, Ildiko; Miko, Angela; Csomos, Akos; Galambos, Zsuzsanna; Szucs, Akos; Nyikos, Gyorgy; Szekeres, Gabor; Szabo, Ervin; Kranitz, Katalin; Simon, Melinda; Szigeti, Janos; Gaál, Emánuel; Havas, Attila; Ille, Alexandru; Bráz, Krisztina; Nagy, Geza; Sigurdsson, Gisli; Sigurbjörnsson, Fridrik T.; Sigurdsson, Gisli H.; Kárason, Sigurbergur; Sigurdardottir, Elin Edda; Blöndal, Ásbjörn; Gunnarsson, Björn; Westbrook, Andrew; Broderick, Alan; Hafeez, Parvaiz; Hanumanthaiah, Deepak; Brohan, Janette; O'Chroinin, Donal; Bailey, Kevin; Ramamoorthy, Karthik; Doyle, Yvonne; Freir, Noelle; O'Rourke, James; Jonson, Philip; Saeed, Sabir; Hayes, Ivan; Loughrey, John; Frohlich, Stephen; McCauley, Nuala; Ryan, Donal; Fitzpatrick, Gerry; Kevin, Leo; Thomas, Jubil; Warde, Barry; Woolhead, Alan; Duggan, Michelle; Egan, Cara; Crowley, Seamus; Lebese, Soloman; Bergin, Anne; Page, Rory; Collins, Daniel; McKenny, Michael; Della Rocca, Giorgio; Grasso, Salvatore; Bresciani, Anna; Carmino, Livio; Ghelfi, Silvia; Lorenzelli, Laura; Novelli, Maria Teresa; Pescarmona, Chiara; Roasio, Agostino; Gatta, Alessandro; Nastasi, Mauro; Sanseverino, Manlio; Tinti, Carla; Bianchin, Andrea; Tormena, Maria; Franco, Antonio; Marini, Federica; Di Mauro, Piero; Rapido, Francesca; Tommasino, Concezione; Bellotti, Ferdinando; Boninsegna, Daniele; Castellani, Gianluca; Sances, Daniele; Spano, Gianluca; Tredici, Stefano; Vezzoli, Dario; Fucecchio, Igneo; Bacci, Alessandro; Coppini, Roberta; Dell'unto, Sandro; Mori, Emanuele; Stanzani, Maria Rosa; Tosi, Monica; Collareta, Michele; Forfori, Francesco; Franchi, Matteo; Mancino, Giuseppe; Battistella, Massimo; Baricocchi, Elisa; Bona, Francesco; Debernardi, Felicino; Giacoletto, Gianmarco; Iacobellis, Antonio; Massucco, Paolo; Moselli, Nora; Muratore, Andrea; Palomba, Graziella; Sardo, Elena; de Simone, Michele; Suita, Luisa; Zocca, Edoardo; Bucci, Barbara; Della Corte, Francesco; Piciucco, Tiziana; Viarengo, Valeria; Bettelli, Gabriella; Cantarini, Eugenia; Giampieri, Marina; Tanfani, Alessandra; Recchia, Eugenio; Milano, S. Raffaele; Bignami, Elena; Bruno, Giovanna; Costagliola, Roberto; Gandolfi, Azzurra; Greco, Massimiliano; Lembo, Rosalba; Monti, Giacomo; Nicelli, Elisa; Pasculli, Nicola; Turi, Stefano; Baroselli, Antonio; Brazzoni, Marcella; Buttazzoni, Mattia; Buttera, Stefania; Centonze, Carlo; Serena, Giovanni; Spagnesi, Lorenzo; Toretti, Ilaria; Vilardi, Anna; Zearo, Ester; Arpino, Ines; Baraldi, Sara; Guarnerio, Chiara; Molene, Vincenzo; Monea, Maria Concetta; Vaccarisi, Enrico; Vicari, Luigi; Albante, Alida; Aversano, Marco; Loiacono, Cinzia; Marandola, Maurizio; Fusari, Maurizio; Petrucci, Nicola; Galla, Amerigo; Mascia, Antonio; Primieri, Paolo; Di Noto, Anna; Gratarola, Angelo; Molin, Alessandro; Spagnolo, Luigi; Spena, Claudio; Calligaro, Plinio; Marchiotto, Simonetta; Merlini, Alberto; Pedrazzoli, Eleonora; Perina, Giulia; Visentin, Renea; Fumagalli, Roberto; Garbagnati, Andrea; Manetti, Bruna; Snaier, Chiara; Somaini, Marta; Farnia, Antonio; Nani, Roberto; Pierantonio, Novello; de Michele, Michele; Gazzanelli, Sergio; Pugliese, Francesco; Ruberto, Franco; Anna, Universitaria S.; Bergamini, Elena; Tassinati, Tania; Capuzzo, Maurizia; Cirillo, Vera; Tufano, Rosalba; Oggioni, Roberto; Parrini, Vieri; Brunori, Emanuela; Capone, Micaela; Carbone, Luigi; Corradetti, Francesco; Elisei, Daniele; Fiorentino, Stefano; Francesconi, Maurizio; Gattari, Diego; Gorgoglione, Maria; Lacobone, Emanuele; Minnucci, Francesco; Montironi, Claudio; Riccioni, Gianrenato; Tappata, Giuseppe; Zompanti, Valeria; Verdenelli, Paola; Cerutti, Elisabetta; Ranieri, Vito Marco; Golubovska, Iveta; Grigorjevs, Sergejs; Rikmane, Maija; Rozkalne, Daina; Stepanovs, Jevgenijs; Suba, Olegs; Kazune, Sigita; Miscuk, Aleksej; Nemme, Janis; Oss, Peteris; Sipylaite, Jurate; Macas, Andrius; Ragaisis, Vytautas; Kontrimaviciute, Egle; Tomkute, Gabija; Boerma, Christiaan; Kramer, Irene Fleur; Poeze, Martijn; Ziekenhuis, Antonius; Maria, John; Pelzer, Gerardus; Winsser, Lex; Nijsten, Maarten; Schoorl, Michiel; Spanjersberg, Rob; Buhre, Wolfgang; Dieleman, Stefan; van Klei, Wilton; Bouw, Martijn; Pickkers, Peter; van der A, Marieke; Schreiner, Frodo; Zandvliet, Ria; van den Berg, Roy; de Wit, Esther; Keijzer, Christaan; Hollmann, Markus; Preckel, Benedikt; van Acker, Gijs; Dennesen, Paul; Veld, Bas; Kuijpers-Visser, Agnes; Inan, T.; Koopman-van Gemert, A.; Ponssen, Huibert; Brouwer, Tammo; Koopmans, Matty; van Bommel, Jasper; van Duijn, Ditty; van der Hoven, Ben; Ormskerk, Patricia; Beck, Oliver; Schiere, Sjouke; Reidinga, Auke; Venema, Allart; Hoogendoorn, Marga; Olthof, Kees; Flaatten, Hans; Jammer, Ib; Dokka, Vegard; Monsen, Svein Arne; Ytrebo, Lars Marius; Noursadeghi, Mostafa; Shahzad, Ahmed; Boksasp, Ola Dagfinn; Roiss, Christoph; Strietzel, Hans Frank; Gina, Anne; Berntsen, Schie; Haugland, Helge; Vingsnes, Svein Ove; Axelsson, Patric; Olsen, Thomas; Katre, Sanjay; Aakeroey, Kristin; Mikstacki, Adam; Tamowicz, Barbara; Bożiłow, Dominika; Goch, Robert; Grabowski, Piotr; Kupisiak, Jacek; Małłek, Małgorzata; Szyca, Robert; Kostyrka, Włodzimierz; Choma, Robert; Jankowski, Grzegorz; Kościelniak, Władysław; Pietraszek, Paweł; Szarowar, Bartosz; Matos, Ricardo; França, Carlos; Lacerda, António Pais; Ormonde, Lucindo; Rosa, Rosário; Pereira, Inês; Vitor, Paula; Bento, Henrique Completo; Lopes, Maria Raquel; Carvalho, Marques; Faria, Manuela; de Sousa, Ana Cláudia; de Freitas, Pereira; Almeida, Eduardo; Mealha, Rui; Vicente, Rachel; Monte, Raquel; Rua, Fernando; Barros, Nelson; Esteves, Francisco; Gouveia Pinheiro, Célia Maria; Real, Vila; Oliveira, Vítor Miguel; Oliveira, Maria Fátima; Martins, Isabel; Saraiva, José Pedro; Assunção, José Pedro; Bártolo, Anabela; Carvalho, Anabela; Correia, Carlos; Martins, Salomé; Milheiro, Ruth; Diaz, Alejandro; Gonçalves, Maria Imelda; Ribeiro, Rosa; Estilita, Joana; Glória, Carlos; de Almeida, José; Barros, Filipa; Ramos, Armindo; Camara, Margarida; Maul, Edward Richard; Nobrega, Julio; Langner, Anuscka; Maia, Dionísio; Afonso, Ofélia; Faria, Filomena; Serra, Sofia; Botelho, Maria Manuela; Ferreira, Pedro; Mourão, Luís; Oliveira, Ana Vintém; Resende, Margarida; Aleman, Miguel; Fonseca, Jorge; Isidoro, Marta; de Meneses, Helena; Pêgas, António; Pereira, José; Pereira, Luis; Ramos, Bárbara; Matos, Francisco; Castro, Maria de Lurdes Gonçalves; Martins, Ana; Ramos, Cristina; de Sousa, Manuel; Bento, Luís; Botas, Conceição; Lopes, Vitor; Mendes, Rosa; Grigoras, Ioana; Blaj, Mihaela; Damian, Mihaela; Lupusoru, Andreea; Ristescu, Irina; Codreanu, Monica; Diaconescu, Ciresica; Nistor, Alina; Stelian, Dorin Stanescu; Streanga, Livia; Berneanu, Maria; Bordeianu, Cristina; Florenta, Calarasu; Iacob, Alina; Lupu, Mary Nicoleta; Mocanu, Iulian; Moraru, Coca; Meran, Carleta; Nicolae, Bacalbasa; Sandu, Madalina; Turcanu, Roxana; Epure, Florina; Grigore, Monica; Hotaranu, Cristina; Popescu, Nicoleta; Baban, Oleg; Baciu, Manuela; Ciobanu, Aurica; Denciu, Catalin Ioan; Gurau, Vitalie; Maftei, Ion; Moldovan, Ion; Ungureanu, Liviu; Bogdan, Prodan; Corneci, Dan; Dinu, Melania; Madalina, Dutu; Rely, Manolescu; Silvius, Negoita; Tomescu, Dana; Gabriela, Droc; Dinescu, Stelian Adrian; Calin, Mitre; Ionescu, Daniela; Margarit, Simona; Vasian, Horatiu; Albu, Corina; Balasa, Carmen; Cadrigati, Alina; Dragulescu, Dorian; Gavra, Loredana; Hentia, Ciprian; Macarie, Claudiu; Manescu, Mihaela; Nediglea, Ioan; Ocica, Dana; Ovidiu, Bedreag; Papurica, Marius; Plavat, Cosmin; Popa, Claudia; Ramneantu, Mihaela; Sandesc, Dorel; Sandici, Zoran; Sarandan, Mihaela; Belciu, Ioana; Tincu, Eugen; Ursu, Irina; Aignatoaie, Mariana; Huzuneanu, Mariana; Cocu, Simona; Hagau, Natalia; Ciubotaru, Roxana; Copotoiu, Sanda-Maria; Copotoiu, Ruxandra; Ioana, Ghitescu; Kovacs, Judit; Leonard, Azamfirei; Szederjesi, Ianos; Genoveva, Vanvu; Mosnegutu, Simona; Surbatovic, Maja; Djordjevic, Dragan; Djordjevic, Biljana; Grujic, Krasimirka; Jovanovic, Dusko; Krstic-Lecic, Ivana; Obradovic, Jovana; Zeba, Snjezana; Jevdjic, Jasna; Miletic, Milos; Zunic, Filip; Bulasevic, Aleksandra; Brko, Radoslava; Gazibegovic, Narcisa; Kendrisic, Mirjana; Vojinovic, Radisa; Firment, Jozef; Zahorec, Roman; Capková, Judita; Grochova, Monika; Trenkler, Stefan; Griger, Martin; Bakosova, Erika; Kvasnica, Martin; Saniova, Beata; Sulaj, Miroslav; Zacharovska, Andrea; Simkova, Alexandra; Číková, Andrea; Gebhardtova, Andrea; Hanuljaková, Slávka; Koutun, Juraj; Martonová, Andrea; Žilinčárová, Veronika; Galkova, Katarína; Krbila, Stefan; Sobona, Viliam; Ocenasova, Marieta; Novak-Jankovic, Vesna; Stecher, Adela; Stivan, Feri; Grynyuk, Andriy; Damjanovska, Marija; Kostadinov, Ivan; Knezevic, Mile; Malivojevic, Marko; Borovsak, Zvonko; Kamenik, Mirt; Mekiš, Dušan; Osojnik, Irena; Kosec, Lučka; Kapš, Silva Ostojič; Aleksic, Dragoslav; Gerjevič, Božena; Kalan, Katja; Ursic, Tomaz; Aldecoa, Cesar; González, Juan Montejo; Artigas, Anna; Garcia, Andres; Lisi, Alberto; Perez, Isabel; Perez, Gisela; Poch, Nuria; Vaquer, Sergi; Balciscueta, Goiatz; Barrasa, Helena; Cabanes, Sara; Maynar, Javier; Poveda, Yolanda; Rodero, Amaia Quintano; Vallejo, Ana; Duque, Patricia; Garcia-Bunger, Beatriz; Elvira, Maria Adoracion; Lajara, Ana María; Palencia, María; Ramos, Rafael; Fernandez, Ana Saez; León, Juan Tirapu; López, Jaione Iza; Murillo, Francisco Yoldi; Ramirez, Eva Turumbay; Rico, Patricia Unzué; Patricia, Marta; Vizcaíno, Martín; Bernat Álvarez, Maria José; Real, Kenneth Planas; Serra, Arantxa Mas; Aracil, Norma; Bodega, Begoña Menendez; García, Raquel Fernández; García, Marivi Álvarez; Gordon, Borja de la Quintana; Jodrá, Alicia Gutiérrez; López, Angela De Santos; Ros, Juan José Llavador; Soto, Rocío Ayala; Sepúlveda, Isabel; Díez, Esperanza Pascual; Fernández, Luisa Fernández; Gulina, Carlos Soria; Arviza, Laura Pérez; Fernandez, Lorena Mouriz; Gómez, Antía Río; Martínez, Concepción Alonso; Rodríguez, Ana Belén Rodríguez; Soto, Carmen Lopez; Garcia, Clara; Lorenzo, Mario; Pinilla, Elena; Rico, Jesus; Ruperez, Irene; Alonso, Eduardo; Leira, Fernando; Maseda, David Pestaña Emilio; Royo, Concepcion; Villagran, Jose; Candi, Giralt Murillo; Esteva, Garcia Eduardo; Folgado, Raquel Mansilla; Fornaguera, Nadal Joan; Montse, Pijoan Calonge; Prat, Anna Sape; Sintes, Dolores; Arteta, Donaldo Arteta; Delgado, Horacio García; López-Cuervo, Juan Fajardo; López, Mikel Celaya; Ramírez, Alejandro; Saldaña, Francisco José; Aliste, Pilar; Anchuelo, Ana Hermira; Campos, Ascensión García; Catalán, Mercedes; Gómez, Mónica García; Gonzalaez, Olga Gonzalez; López, Eloísa López; Navacerrada, Isabel Real; de Quevedo, Sara Arlanzón; Serrano, Matilde Gonzalez; Silvestre, Francisco Perez-Cerdá; Torrente, Francisco Martinez; Arocas, Blanca; Martinez, Ernesto Pastor; Soro, Marina; Maroto, Fernando; Algarra, Ruth Robledo; Aleixandre, Inés Silla; Argente, Gemma Rodriguez; Lleó, Ana Broseta; Rubio, Antonio Vela; Sánchez, José Luis Vicente; Valcárcel, Irene Enríquez; Balust, Clara; Balust, Jaume; Borrat, Xavier; Carretero, Maria Jose; Gracia, Isabel; Matute, Purificacion; Mercadal, Jordi; Pujol, Roger; Tena, Beatriz; Ubre, Marta; Albalad, Dolores Dorda; Alcaide, Concepción Muñoz; Caballero, Jesus; Cervantes, Angels Camps; Clanchet, Miriam de Nadal; Estruch, Nuria Montferrer; Ferrer, Mercè Ballvé; Fornells, Albert Lacasta; Galera, Eduard Terrer; Martinez, Irene Garcia; Muñoz, Susana Manrique; Pelavski, Andres; Perez, Pilar Tormos; Posada, Miguel Angel Gonzalez; de Prat, Ivette Chocron; Rello, Jordi; Serrano, Llum García; Sieiro, José Manuel Naya; Silva, Lorena; Sole, Maria Jose Colomina; Suñé, Alfons Biarnes; Villach, Isabel Rochera; Herreras, José Ignacio Gómez; Poves, Rodrigo; Rafael, Beatriz Martinez; Almeida, Icier Martinez; Collates, Angel Fernandez; Bartolomé, Maria Jose; Cimadevilla, Bonifacio; González, Antonio Manuel González; Llevot, Jose Manuel Rabanal; Mira, Juan Carlos Diaz de Terán; Molina, Begoña González; Pardo, Sara; Sánchez, Carlos López; Williams, Monica; Zaldibar, Estibaliz; Corsini, Lourdes Muñoz; Fraile, José Ramón Rodríguez; de la Lastra, Maria; Sacramento, Monir Kabiri; Saña, Francisco Javier López; Ålvarez, Josep Trenado; Bulnes, Maria Luisa Cantón; Carrasco, Violeta Gándara; Crespo, María del Rocío Míguez; Cubillos, Diana Narváez; Laza, Enrique Laza; Pérez, María del Pino Heredia; Seisdedos, Ángel Arenzana; Torres, Bartolomé Fernández; Ampuero, Marian Santos; Llano, Marta Chicot; Mata, Esperanza; Munoz, Manuel; Orts, Mar; Planas, Antonio; Ramasco, Fernando; Roman, Carlos; Durán, Marina Varela; Fernandez, Sabela del Río; Otero, Yolanda Sanduende; Pineiro, Susana Lopez; Pardal, Cristina Barreiro; Alcantud, Jesús Fernández; Antolinos, Mercedes Ayuso; Barrios, Francisco; Casanova, Ana Collantes; Castro, Manuel Ruiz; Crespo, Beatriz Infantes; Felipe, Uzuri Lancha; Fuster, Marta Liceras; García, Máximo Sanz; Garrote, Begoña Herrero; Gonzalez, Ricardo Moreno; Granero, Maria José Montes; de la Guía, Carlos Lloreda; López, Raquel Chaves; López, Santiago de Frutos; Martinez, Jose Javier Marco; Mostaza, Angel Garcia; Moreno, Antonio Jiménez; Osado, Irene Riquelme; Pastor, Ana Bardina; Peña, Rosa; Pérez, Mónica Rustarazo; Piña, María Aliaño; Romero, Carlos Aranda; Rodríguez, Elena Rodríguez; Sáez, Vicente Pedroviejo; Safatle, Fernando; Salvan, Javier Hernández; Sampedro, Mar Galán; de la Torre, Patricia Alfaro; Toro, Jonatan Pérez; Unzúe, Crsitina Lasa; Vargas, Maria José; Bernal, David Garcia; Echevarria, Mercedes; Iglesias, Alejandro Ubeda; Loza, Ana; Morillo, Araceli Rodriguez; Serrano, Pedro Diaz; Sevilla, Fernando Caba Barrientos; Cacho, Elena; Calderón, Ricardo; Dufur, Mercedes; Marginet, Carolina; Monedero, Pablo; Yepes, Maria José; Alvarez, Luzdivina Rellán; Carballal, Francisca Fernández; Castiñeiras, Alberto Pensado; García, Paula Dieguez; López, Lorena Ramos; Maceiras, Pablo Rama; Puente, María Socorro Martínez; Rilo, Maria Teresa Rey; Alonso, Ana Esther Trujillo; Fernández, Sonia Rodríguez; García, Rafael Omaña; García, Aníbal Pérez; Puentes, Rafael Bello; Aguado, Domingo Nunez; Carballo, Carlos Lopez; Fernandez, Ricardo Fernandez; Presedo, Amadeo Toledo; de Rabago, Ricardo Bermejo Diaz; Velasco, Ana Rodriguez; Capel, Yolanda Jiménez; Cortés, Ana Fernández; García, Esther Martínez; Gimeno, Laura Martinez; Klamburg, Jordi; Omedas, Rosa Castillo; Núñez, Miriam González; Maristany, Clara Llubià; Ruiz, Enrique Moret; Artigas, Xavier; Castrillón, Sebastian; Espinosa, Nieves; Gomez-Caro, Ana María; Illa, Susana; India, Inmaculada; Martín-Huerta, Beatriz; Moral, Victoria; Moreno, Marisa; Fernández, Cristina Iglesias; García, Violeta Fernández; Hernández, Pedro Picatto; Checa, Angel Alberto Honrubia; Diaz, David Salvatierra; Noguera, Manuel Linero; Varela, Ignacio Pujol; Gallego, Miguel González; García, Oscar Martínez; Irujo, José Javier Ariño; Perrino, Carlos González; Picazo, Julio Rey; Timoneda, Francisco López; Arroyo, María Manzanero; Blanco, Isabel Albalá; Borja, Marcos Martínez; Burcio, Sara Martín; Castro, Nilda Martinez; Cerdeiriña, Aránzazu Puente; Concostrina, Marta de la Torre; Cristina, Medrano Viñas; Díaz, Trinidad Dorado; Esteruelas, Juan Avellanosa; Ingelmo, Ildefonso Ingelmo; Insuga, Paco Duran; Llamas, Elisabeth Claros; Lopez, Jose Juan Martín; Martín, María Beltran; Martín, Elena Elías; Mesa, Eva Ureta; Monterde, Manuela Loren; Montoiro, Paloma Alonso; Móstoles, Maria Luisa Gonzalez; Olarte, Eva Velasco; Pérez, Adolfo Martínez; Perez, Fernando Domínguez; Romero, Ana Serrano; Rous, Diego Parise; Ruiz, Nuria Mané; Ruiz, Jose Angel Palomo; Saiz, Alvaro Ruigomez; Terol, Alvaro de la Vega; Toha, Angel Candela; Utrera, Fernando Alvarez; Alberdi, Fermín; Elósegui, Itxaso; García, Javier; Garde, Pilar Marco; Mintegui, Escudero Itziar; Sáez, Iker García; Salas, Estibaliz; Zabarte, Mercedes; Diaz-Boladeras, Rosa-Maria; Mora-Guevara, Emilio; Zamora, Julia Ferreras; Bonet, Alfons; Salo, Lidia; Salinas, Unai; Zaballos, Juan; Alvarez, Ana Abella; Garrido, Carlos Jimenez; Roa, Juan Ramón Hita; Vidal, Federico Gordo; Garcia-Egea, Jorge; Elson, Monica Zamora; Seron-Arbeloa, Carlos; Asensio, Miguel Angel Mendiola; Simeón, Rosa Gastaldo; Alameda, Luis Enrique Muñoz; Angulo, Guillermo Oeding; Aranzubia, Monserrat; Arcas, Jose Juan; Arevalo, Julian; Belvert, Belén Quesada; Calvo, César Pérez; Cremades, Marta; Crespo, Pascual; Cuarental, Ana; del Olmo, Mercedes; Fernández, Pablo Turrión; Vega, José Luis Franqueza García Isabel Garcia; Herrera, Elena II; Llorente, Miguel Angel Alcala; Rabes, Cecilia Martin; de Maeyer, Ana Gamo; Marquez, Manuel Pérez; Mendoza, Diego López; Muñoz, José María Milicua; Martínez, Natividad Arias; Oviedo, Arnoldo Santos; Garrigues, Pau Benavent; Íñigo, José Alonso; Ferrandiz, Sergi Tormo; Sanchez-Morcillo, Silvia; Sánchez, Matilde Lafuente; Parra, Asunción Marqués; Vidal, Sonia Gomar; Allué, Raquel Montoiro; Etayo, Begoña Zalba; Rodriguez, Raquel Bustamante; Villen, Luis Martin; Jimenez, Cristina Molla; de Zayas, Ricardo Salas; Moreno, Cristina Dolera; Pacheco, Fernando SanJose; Pascual, Jose Luis Anton; Gude, Fernando Tejera; Riestra, Eva Manteiga; Delgado, Francisco Cota; Prados, Maria Victoria de la Torre; Barrios, Javier; Cervera-Montes, Manuel; García-Sanz, Mercedes; García, Vicente; Sanmiguel, Guillermo; Álvaro, Julian López; Barrachima, Beatriz Bornay; Bermejo, Francisco Jose Romero; Pilar, Alberto Garcia Fernandez; Garcia, Martinez; Ramírez, Carolina Navarro; Ramos, Jorge Gómez; Samaniego, Luis Angel; Belenguer-Muncharaz, Alberto; Ferrándiz-Selles, Amparo; Mateu-Campos, Maria-Lidon; Domínguez, David; Espinosa, Elena; León, Teresa; Betancor, Nazario Ojeda; Cortes, Javier Garcia; Díaz, Juan José Díaz; Canalechevarria, Ana Manzano; Novales, Beatriz Fores; Peña, Jose Manuel Garcia; Delgado, Tomas Rodriguez; Roquerio, Beatriz Santamaria; Sainz, Juan Jose Gomez; Soto, Teresa Tebar; Chew, Michelle; Seeman-Lodding, Heléne; Dahm, Peter; Hergès, Helena Odenstedt; Lundborg, Christoffer; Söndergaard, Sören; Rylander, Christian; Sari, Ferenc; Tibblin, Anna Oscarsson; Adolfsson, Anne; Klarin, Bengt; Schrey, Susann; Merisson, Edyta; Rydén, Jörgen; Divander, Mona Britt; Hedin, Annika; Hedlund, Daniel; Lindkvist, Mikael Axelsson; Jawad, Monir; Layous, Lona; Wernerman, Jan; Björne, Håkan; Brattström, Olof; Olheden, Staffan; Oldner, Anders; Sellden, Eva; Walder, Bernhard; Wickboldt, Nadine; Rossi, Ariane; Steiner, Luzius; Djurdjevic, Mirjana; Lussmann, Roger; Geisen, Martin; Hofer, Christoph; Turina, Matthias; Grocott, Mike; Goldhill, David; Everett, Lynn; Harris, Katy; Wright, Maggie; Adams, David; Alderson, Lorraine; Baker, Julie; Christie, Iain; Ferguson, Colin; Hill, Matthew; Holmes, Kate; Hutton, Andrew; Minto, Gary; Moor, Paul; Porter, Andrew; Struthers, Richard; Akotia, Niven; Belhaj, Alaa; Chang, Serene; Collantes, Enrique; Eigener, Katrin; Husband, Michael; Khan, Ahsun; Kong, Ming-Li; McAlees, Eleanor Jane; MacDonald, Neil; Niebrzegowska, Edyta; Parnell, Wendy; Smith, Amanda; Chhatwal, Ally; Jhingan, Smriti; Muswell, Richard; Poon, Yoyo; Singh, Nidhita; Stephens, Robert; Vasan, Robin; Waife, Nicola; Weda, Tahmina; Clarke, Adrian; Szakmany, Tamas; Fletcher, Simon; Rosbergen, Melissa; Blunt, Mark; Prince, Liz; Wong, Kate; Kumar, Ram; Stilwell, Sarah; Couper, Keith; Crooks, Neil; Gao-Smith, Fang; Melody, Teresa; Snaith, Catherine; Patel, Jaimin; Parekh, Dhruv; Yeung, Joyce; Loughnan, Bernadette; Moosajee, Vas; Rope, Tamsin; Edger, Lliam; Dawson, Julie; Hadfield, Daniel; Hopkins, Phil; McDonald, Lisa; Willars, Chris; Campbell, Gillian; Craig, Jayne; Smith, Andrew; Ladipo, Karleen; Lockwood, Geoff; Moreno, Juan; Ballington, Ruth; Hamandishe, Sibongilele; Rogerson, David; Cowman, Sarah; Hayden, Paul; Pinto, Nuno; Sandhar, Taj; Arawwawala, Dilshan; Brotherston, Lauren; Mitchell-Inwang, Christine; Walsh, Helena; Alagarsamy, Famila; Goon, Serena; Karcheva, Sylvia; Krepska, Amy; McKinney, Brian; Patil, Vishal; Batchelor, Nicholas; Day, Christopher; Finch, Louise; Gibson, Charlie; Grayling, Matthew; Hubble, Sheena; Key, William; Knight, Thomas; Loosley, Alexander; Margetts, Paul; Stewart, Hannah; Bewley, Jeremy; Hurley, Katrina; Murphy, Ruth; Philpott, Catherine; Pollock, Kathryn; Sweet, Katie; Thomas, Matthew; Tucker, Katy; Windsor, David; Conway, Daniel; Gold, Steve; Quraishi, Tanviha; Cupitt, Jason; Baddeley, Sally; Brown, John David; Foo, Irwin; Mantle, Damien; Carvalho, Peter; Huddart, Sam; Kirk-Bayley, Justin; Smith, Rebecca; Milligan, Lisa; Poulose, Sonia; Sarkar, Som; Nolan, Jerry; Pedley, Emma; Padkin, Andrew; Pesian, Siamak; Rajamanickam, Satish; Ramkumar, Konnur; Thomas, Jerry; Crayford, Alison; Turner, Angus; Bottrill, Fiona; Webb, Stephen; Jhanji, Shaman; MacCallum, Niall; Wessels, Kate; Wigmore, Tim; Meikle, Alistair; Wilson, Stephen; White, Stuart; Bonnett, Andrew; Rushton, Andrew; Williams, Colin; Zuzan, Oliver; Hall, Andrew; Montgomery, Jane; Piggot, Ailie; Read, Richard; Stocker, Mary; Tamm, Tiina; Agarwal, Banwari; Ward, Stephen; Brown, Lucy; Joy, Manju; Venkatesh, Suresh; Hughes, Thomas; Zsisku, Lajos; Roy, Alistair; Hooper, Victoria; Mouland, Johanna; Nightingale, Jeremy; Rose, Steve; Chiam, Patrick; Chohan, Harnita; Dickson, Chris; Gibb, Sarah; Higham, Charley; Harvey, Caroline; Janarthanan, Chandra; Jones, Laura; Kapoor, Avinash; Moll, Mark; Roberts, Louise; Saunders, David; Arnold, Glenn; Gibbs, Claire; Jhurgursing, Mhairi; Pierro, Dena; Pritchard, Frances; Doyle, Patrick; Templeton, Maie; Wilson, Robert; Zantua, Kim; Collyer, Thomas; Featherstone, James; Worton, Rachael; Bruce, Jane; McGuigan, Kate; Price, Grant; Moreton, Sarah; Pulletz, Mark; Anderson, Helen; Baxter, Ian; Beckingsale, Alex; Callaghan, Mark; Datta, Ansu; Dawson, Jo; Gollogly, Jackit; Izod, Chris; Lobaz, Steve; MacFie, Caroline; Patel, Manju; Payne, Heather; Singh, Raj; Timms, Gemma; McLeod, Shaun; O'Brian, Peter; Horner, Elspeth; Joshi, Vivekananda; Stuart-Smith, Karen; Seale, Tania; Bolger, Clare; Collins, Hannah; Ekins, Emma; Hawkins, Lesley; Jonas, Max; Linford, Karen; Wadams, Beverley; Beach, Madeleine; Vizcaychipi, Marcela; Jewsbury, William; Davies, Simon; Balaji, Packianathaswamy; Kangaraj, Muthuraj; Pissay, Nagesh; Smith, Neil; Gopalakrishnan, Senthilkumar; MacKinnon, John; Strandvik, Gustav; Francis, Ruth; Jennings, Adrian; Keating, Matthew; Kumar, Sajith; Leese, Sarah; Magee, Cliona; Pilsbury, Jane; Ralph, James; Riddington, David; Sachdeva, Rajneesh; Snelson, Catherine; Vasanth, Suresh; Wilde, Judith; Lavender, Beth; Lyons, Rachel; Watters, Malcolm; Adams, Tim; Dyer, Simon; Tindall, Lucy; Claxton, Andrew; Netke, Meenu; Akouds, Esam; Bates, Debrah; Gallagher, Heather; Hatton, Jonathan; Holroyd, William; Mitra, Atideb; Nurse, Trudy; Reed, Deborah; Desikan, Somi; Barber, Russell; Childs, Sophie; O'Carroll-Kuehn, Britta; Wyldbore, Mark; Al-Abdaly, Ayad; Amatya, Suman; Bhaskaran, Sherly; Chandan, Garud; Chaudhry, Suman; Chikungwa, Moses; Earnshaw, Greg; Grewal, Moni; Haque, Shamimul; Hawkins, John; Javaid, Ahmed; Jackson, Clare; Kamel, Miriam; Marla, Ruchira; Mculloch, Dori-Ann; Parker, Tom; Salib, Yussof; Saravanmuthu, Ramesh; Secker, Chris; Sockalingam, Siva; Taylor, Anne; Austine, Pauline; Kanade, Vrushali; Paal, Dora; Mok, May Un Sam; Burtenshaw, Andrew; Davis, Laura; Ellahee, Parvez; Freeman, David; Pierson, Richard; Wollaston, Julie; Karmarkar, Amara; Ball, Clare; Calton, Emily; Maxwell, Louise; Walker, Rachel; Bland, Martin; Bullock, Lynne; Harrison-Briggs, Donna; Hodge, Paul; Krige, Anton; Dempsey, Ged; Hammell, Claire; Loveridge, Robert; Parker, Robert; Snell, Jane; Wright, Carl; Baker, Andy; Barr, Katharine; Belcher, Alex; Bonnington, Sam; Bougeard, Anne-Marie; Fitzgerald, Emma; Ford, Rachael; Gillard, Chantal; Griffiths, Liz; Greenberg, Lizzie; Huber, Jonathan; Mathieu, Steve; Richardson, Neil; Tompsett, Laura; White, Nigel; Patel, Santosh; Corner, Victoria; Thomas, Richard; Trodd, Dawn; Wilson, Jennifer; Copley, Ed; Flutter, Laura; Hulme, Jonathan; Susarla, Jay; Thwaites, Alison; Jayasundera, Suraj; McAfee, Sean; Chantler, Jonathan; McKechnie, Stuart; Neely, Julia; Mouton, Ronelle; Scarth, Edward; Soar, Jasmeet; Buss, Joanne; Currie, Vicki; Sange, Mansoor; Kuttler, Anja; Power, Fiona; Alexander, David; Dunne, Kevin; Shinner, Guy; Black, Euan; Haldane, Grant; Kerr, Jennie; Saran, Taj; Ward, Geraldine; Jefferies, Fiona; Alexander, Peter; Royle, Alison; Nahla, Farid; Bowles, Tim; Gregory, Maggie; Ahern, Rebecca; Cartlidge, David; Craker, Lloyd; Thompson, Christopher; Bidd, Heena; Giles, Julian; Manser, Amanda; Parry, Gareth; Chan, Peter; Das, Dinesh; Fahmy, Nisreen; Higgins, David; Khader, Ahmed; Stone, Alex; Leonardi, Silvia; Rose, Oliver; Bright, Elizabeth; Ercole, Ari; Rafi, Muhammed Amir; Ramasamy, Radhika; Sheshgiri, Bengeri; Merrill, Colin; Page, Valerie; Walker, Elaine; Harris, Stephen; Hughes, Sarah; Morrison, Alan; Razouk, Khaled; Ayman, Mustafa; al-Subaie, Nawaf; Arif, Fuhazia; Cashman, Jeremy; Cecconi, Maurizio; Edsell, Mark; Fossati, Nicoletta; Hammond, Sarah Jane; Hamilton, Mark; Lonsdale, Dagan; Moran, Carl; Siegmueller, Claas; Velzeboer, Freya; Wong, Patrick; Jakeman, Alicia; Mowatt, Chris

    2012-01-01

    Clinical outcomes after major surgery are poorly described at the national level. Evidence of heterogeneity between hospitals and health-care systems suggests potential to improve care for patients but this potential remains unconfirmed. The European Surgical Outcomes Study was an international

  2. Recommended Protocol for Round Robin Studies in Additive Manufacturing

    Science.gov (United States)

    Moylan, Shawn; Brown, Christopher U.; Slotwinski, John

    2016-01-01

    One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST’s experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed. PMID:27274602

  3. Weight loss in orthognathic surgery: a clinical study.

    Science.gov (United States)

    Hammond, Douglas; Williams, Rhodri W; Juj, Kiranjit; O'Connell, Susan; Isherwood, Grant; Hammond, Nichola

    2015-09-01

    To analyse weight change, body composition change and Body Mass Index change in patients undergoing orthognathic surgery. A service evaluation was undertaken in orthognathic patients pre-operatively and at 4 weeks post-surgery. Queen Elizabeth Hospital Birmingham outpatient department. Thirty-one patients scheduled for single- or two-jaw orthognathic surgery and rigid internal fixation. Immediately pre-operatively and at 4 weeks post-surgery the following information was gathered: (1) patient height; (2) patient weight (kg); (3) Patient Body Mass Index; and (4) patient body fat percentage. In the 4-week post-operative period, the average weight loss was -4·96 kg (range: -9·6 to +3·0 kg), with a body fat reduction of -3·07% (range: -5·80% to +2·30%) and an average reduction in Body Mass Index of -1·63 (range: -3·4 to +0·8). There was no statistically significant difference in weight loss (P = 0·1562) or body fat composition change (P = 0·2391) between single- or two-jaw surgery. There was no statistically significant difference in weight loss (P = 0·4858) or body fat composition change (P = 0·5321) between male and female patients. Weight loss observed was similar to that reported in studies using inter-maxillary fixation. Closer psychological and dietetic support is needed for patients who have a low normal or underweight Body Mass Index. Better and more bespoke tailored Oral Nutritional Supplementation must be provided for all orthognathic surgery patients to potentially reduce this significant weight loss.

  4. Constant round group key agreement protocols: A comparative study

    NARCIS (Netherlands)

    Makri, E.; Konstantinou, Elisavet

    2011-01-01

    The scope of this paper is to review and evaluate all constant round Group Key Agreement (GKA) protocols proposed so far in the literature. We have gathered all GKA protocols that require 1,2,3,4 and 5 rounds and examined their efficiency. In particular, we calculated each protocol’s computation and

  5. Short- and long-term outcomes of laparoscopic surgery vs open surgery for transverse colon cancer: a retrospective multicenter study

    Directory of Open Access Journals (Sweden)

    Kim JW

    2016-04-01

    Full Text Available Jong Wan Kim,1 Jeong Yeon Kim,1 Byung Mo Kang,2 Bong Hwa Lee,3 Byung Chun Kim,4 Jun Ho Park5 1Department of Surgery, Dongtan Sacred Heart Hospital, College of Medicine, Hallym University, Hwaseong Si, 2Department of Surgery, Chuncheon Sacred Heart Hospital, College of Medicine, Hallym University, Chuncheon Si, 3Department of Surgery, Hallym Sacred Heart Hospital, College of Medicine, Hallym University, Anyang Si, 4Department of Surgery, Kangnam Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, 5Department of Surgery, Kangdong Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea Purpose: The purpose of the present study was to compare the perioperative and oncologic outcomes between laparoscopic surgery and open surgery for transverse colon cancer.Patients and methods: We conducted a retrospective review of patients who underwent surgery for transverse colon cancer at six Hallym University-affiliated hospitals between January 2005 and June 2015. The perioperative outcomes and oncologic outcomes were compared between laparoscopic and open surgery.Results: Of 226 patients with transverse colon cancer, 103 underwent laparoscopic surgery and 123 underwent open surgery. There were no differences in the patient characteristics between the two groups. Regarding perioperative outcomes, the operation time was significantly longer in the laparoscopic group than in the open group (267.3 vs 172.7 minutes, P<0.001, but the time to soft food intake (6.0 vs 6.6 days, P=0.036 and the postoperative hospital stay (13.7 vs 15.7 days, P=0.018 were shorter in the laparoscopic group. The number of harvested lymph nodes was lower in the laparoscopic group than in the open group (20.3 vs 24.3, P<0.001. The 5-year overall survival (90.8% vs 88.6%, P=0.540 and disease-free survival (86.1% vs 78.9%, P=0.201 rates were similar in both groups.Conclusion: The present study showed that laparoscopic surgery is associated

  6. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial

    Directory of Open Access Journals (Sweden)

    Amit X. Garg

    2018-01-01

    Full Text Available Background: When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. Objective: The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Design and Setting: Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017. Patients: Patients (~4800 undergoing planned cardiac surgery with cardiopulmonary bypass. Measurements: The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery, where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. Methods: We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m 2 . Limitations: It is not possible to blind patients or providers to the intervention; however, objective measures will be used to assess

  7. Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial.

    Science.gov (United States)

    Kjeken, Ingvild; Eide, Ruth Else Mehl; Klokkeide, Åse; Matre, Karin Hoegh; Olsen, Monika; Mowinckel, Petter; Andreassen, Øyvor; Darre, Siri; Nossum, Randi

    2016-11-15

    In the absence of disease-modifying interventions for hand osteoarthritis (OA), occupational therapy (OT) comprising patient education, hand exercises, assistive devices and orthoses are considered as core treatments, whereas surgery are recommended for those with severe carpometacarpal (CMC1) OA. However, even though CMC1 surgery may reduce pain and improve function, the risk of adverse effects is high, and randomized controlled trials comparing surgery with non-surgical interventions are warranted. This multicentre randomized controlled trial aims to address the following questions: Does OT in the period before surgical consultation reduce the need for surgery in CMC1-OA? What are patients' motivation and reasons for wanting CMC1-surgery? Are there differences between departments of rheumatology concerning the degree of CMC1-OA, pain and functional limitations in patients who are referred for surgical consultation for CMC1 surgery? Is the Measure of Activity Performance of the Hand a reliable measure in patients with CMC1-OA? Do patients with CMC1-OA with and without affection of the distal and proximal interphalangeal finger joints differ with regard to symptoms and function? Do the degree of CMC1-OA, symptoms and functional limitations significantly predict improvement after 2 years following OT or CMC1-surgery? Is OT more cost-effective than surgery in the management of CMC1-OA? All persons referred for surgical consultation due to their CMC1-OA at one of three Norwegian departments of rheumatology are invited to participate. Those who agree attend a clinical assessment and report their symptoms, function and motivation for surgery in validated outcome measures, before they are randomly selected to receive OT in the period before surgical consultation (estimated n = 180). The primary outcome will be the number of participants in each group who have received surgical treatment after 2 years. Secondary and tertiary outcomes are pain, function and

  8. Successful implementation of a perioperative glycemic control protocol in cardiac surgery: barrier analysis and intervention using lean six sigma.

    Science.gov (United States)

    Martinez, Elizabeth A; Chavez-Valdez, Raul; Holt, Natalie F; Grogan, Kelly L; Khalifeh, Katherine W; Slater, Tammy; Winner, Laura E; Moyer, Jennifer; Lehmann, Christoph U

    2011-01-01

    Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU) in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period.

  9. Successful Implementation of a Perioperative Glycemic Control Protocol in Cardiac Surgery: Barrier Analysis and Intervention Using Lean Six Sigma

    Science.gov (United States)

    Martinez, Elizabeth A.; Chavez-Valdez, Raul; Holt, Natalie F.; Grogan, Kelly L.; Khalifeh, Katherine W.; Slater, Tammy; Winner, Laura E.; Moyer, Jennifer; Lehmann, Christoph U.

    2011-01-01

    Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU) in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period. PMID:22091218

  10. Successful Implementation of a Perioperative Glycemic Control Protocol in Cardiac Surgery: Barrier Analysis and Intervention Using Lean Six Sigma

    Directory of Open Access Journals (Sweden)

    Elizabeth A. Martinez

    2011-01-01

    Full Text Available Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period.

  11. Study protocol: The Intensive Care Outcome Network ('ICON' study

    Directory of Open Access Journals (Sweden)

    Barber Vicki S

    2008-06-01

    Full Text Available Abstract Background Extended follow-up of survivors of ICU treatment has shown many patients suffer long-term physical and psychological consequences that affect their health-related quality of life. The current lack of rigorous longitudinal studies means that the true prevalence of these physical and psychological problems remains undetermined. Methods/Design The ICON (Intensive Care Outcome Network study is a multi-centre, longitudinal study of survivors of critical illness. Patients will be recruited prior to hospital discharge from 20–30 ICUs in the UK and will be assessed at 3, 6, and 12 months following ICU discharge for health-related quality of life as measured by the Short Form-36 (SF-36 and the EuroQoL (EQ-5D; anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS; and post traumatic stress disorder (PTSD symptoms as measured by the PTSD Civilian Checklist (PCL-C. Postal questionnaires will be used. Discussion The ICON study will create a valuable UK database detailing the prevalence of physical and psychological morbidity experienced by patients as they recover from critical illness. Knowledge of the prevalence of physical and psychological morbidity in ICU survivors is important because research to generate models of causality, prognosis and treatment effects is dependent on accurate determination of prevalence. The results will also inform economic modelling of the long-term burden of critical illness. Trial Registration ISRCTN69112866

  12. [Factors involved in the development of vasoplegia after cardiac surgery with extracorporeal circulation. A prospective observational study].

    Science.gov (United States)

    Durán Bruce, M; Gomar Sancho, C; Holguera, J C; Muliterno Español, E

    2014-05-01

    The incidence and risk factors for vasoplegia in the early postoperative period and at 24h are investigated in patients subjected to cardiopulmonary bypass surgery. Vasoplegia following cardiac surgery with cardiopulmonary bypass is associated with a high morbimortality. The risk factors described emerged from retrospective, non-controlled studies. Observational prospective study of 188 consecutive patients subjected to cardiac surgery with cardiopulmonary bypass in a single hospital between November 2011 and May 2012. Emergency surgery or complex procedures were excluded. Vasoplegia was assessed during the immediate postoperative period, and at 24h after surgery, and was defined as a mean arterial pressure below 50mmHg, and the need for a noradrenaline perfusion of more than 0.08μg/kg/min, monitored by cardiac output and systemic vascular resistances. The anaesthetic and cardiopulmonary bypass protocols, as well as haemodynamic management, were the same in all patients. Almost half (48%) of patients had vasoplegia in the immediate postoperative period, and 34% at 24h. Risk factors for immediate vasoplegia development were preoperative use of angiotensin converting enzyme inhibitor drugs, a mean arterial pressure<50mmHg immediately after beginning cardiopulmonary bypass, duration of aortic clamping as well as the cardiopulmonary bypass, and minimum temperature in cardiopulmonary bypass. Vasoplegia at 24h after surgery was correlated to preoperative angiotensin converting enzyme inhibitor drug treatment and cardiopulmonary bypass duration. The incidence of vasoplegia after cardiac surgery with cardiopulmonary bypass is high during the first 24 postoperative hours. Preoperative treatment with angiotensin converting enzyme inhibitor and the mean arterial pressure at the beginning of cardiopulmonary bypass are the more easily controllable risk factors. In patients arriving to surgery with those drugs, treatment or prevention of vasoplejia should be planned. Copyright

  13. Case-mix study of single incision laparoscopic surgery (SILS) vs. Conventional laparoscopic surgery in colonic cancer resections

    DEFF Research Database (Denmark)

    Mynster, Tommie; Wille-Jørgensen, Peer

    2013-01-01

    of administrations or amount of opioids were seen. Conclusion. With reservation of a small study group we find SILS is like worthy to CLS in colorectal cancer surgery and a benefit in postoperative recovery and pain is possible, but has to be investigated in larger randomised studies.......Single incision laparoscopic surgery (SILS) may be even less invasive to a patient than conventional laparoscopic surgery (CLS). Aim of the study of the applicability of the procedure, the first 1½ year of experiences and comparison with CLS for colonic cancer resections Material and methods. Since...

  14. Comparative study of postoperative stability between conventional orthognathic surgery and a surgery-first orthognathic approach after bilateral sagittal split ramus osteotomy for skeletal class III correction.

    Science.gov (United States)

    Mah, Deuk-Hyun; Kim, Su-Gwan; Oh, Ji-Su; You, Jae-Seek; Jung, Seo-Yun; Kim, Won-Gi; Yu, Kyung-Hwan

    2017-02-01

    The purpose of this study is to compare the postoperative stability of conventional orthognathic surgery to a surgery-first orthognathic approach after bilateral sagittal split ramus osteotomy (BSSRO). The study included 20 patients who underwent BSSRO for skeletal class III conventional orthognathic surgery and 20 patients who underwent a surgery-first orthognathic approach. Serial lateral cephalograms were analyzed to identify skeletal changes before surgery (T0), immediately after surgery (T1), and after surgery (T2, after 1 year or at debonding). The amount of relapse of the mandible in the conventional orthognathic surgery group from T1 to T2 was 2.23±0.92 mm ( P surgery-first orthognathic approach group from T1 to T2 was 3.49±1.71 mm ( P surgery-first orthognathic approach. Therefore, careful planning and skeletal stability should be considered in orthognathic surgery.

  15. A Study of Shared-Memory Mutual Exclusion Protocols Using CADP

    Science.gov (United States)

    Mateescu, Radu; Serwe, Wendelin

    Mutual exclusion protocols are an essential building block of concurrent systems: indeed, such a protocol is required whenever a shared resource has to be protected against concurrent non-atomic accesses. Hence, many variants of mutual exclusion protocols exist in the shared-memory setting, such as Peterson's or Dekker's well-known protocols. Although the functional correctness of these protocols has been studied extensively, relatively little attention has been paid to their non-functional aspects, such as their performance in the long run. In this paper, we report on experiments with the performance evaluation of mutual exclusion protocols using Interactive Markov Chains. Steady-state analysis provides an additional criterion for comparing protocols, which complements the verification of their functional properties. We also carefully re-examined the functional properties, whose accurate formulation as temporal logic formulas in the action-based setting turns out to be quite involved.

  16. Tissue engineering and surgery: from translational studies to human trials

    Directory of Open Access Journals (Sweden)

    Vranckx Jan Jeroen

    2017-06-01

    Full Text Available Tissue engineering was introduced as an innovative and promising field in the mid-1980s. The capacity of cells to migrate and proliferate in growth-inducing medium induced great expectancies on generating custom-shaped bioconstructs for tissue regeneration. Tissue engineering represents a unique multidisciplinary translational forum where the principles of biomaterial engineering, the molecular biology of cells and genes, and the clinical sciences of reconstruction would interact intensively through the combined efforts of scientists, engineers, and clinicians. The anticipated possibilities of cell engineering, matrix development, and growth factor therapies are extensive and would largely expand our clinical reconstructive armamentarium. Application of proangiogenic proteins may stimulate wound repair, restore avascular wound beds, or reverse hypoxia in flaps. Autologous cells procured from biopsies may generate an ‘autologous’ dermal and epidermal laminated cover on extensive burn wounds. Three-dimensional printing may generate ‘custom-made’ preshaped scaffolds – shaped as a nose, an ear, or a mandible – in which these cells can be seeded. The paucity of optimal donor tissues may be solved with off-the-shelf tissues using tissue engineering strategies. However, despite the expectations, the speed of translation of in vitro tissue engineering sciences into clinical reality is very slow due to the intrinsic complexity of human tissues. This review focuses on the transition from translational protocols towards current clinical applications of tissue engineering strategies in surgery.

  17. [Laparoscopic versus open surgery for colorectal cancer. A comparative study].

    Science.gov (United States)

    Arribas-Martin, Antonio; Díaz-Pizarro-Graf, José Ignacio; Muñoz-Hinojosa, Jorge Demetrio; Valdés-Castañeda, Alberto; Cruz-Ramírez, Omar; Bertrand, Martin Marie

    2014-01-01

    Laparoscopic surgery for colorectal cancer is currently accepted and widespread worldwide. However, according tol the surgical experience on this approach, surgical and short-term oncologic results may vary. Studies comparing laparoscopic vs. open surgery in our population are scarce. To determine the superiority of the laparoscopic vs. open technique for colorectal cancer surgery. This retrospective and comparative study collected data from patients operated on for colorectal cancer between 1999 and 2011 at the Angeles Lomas Hospital, Mexico. A total of 82 patients were included in this study; 47 were operated through an open approach and 35 laparoscopically. Mean operative time was significantly lower in the open approach group (p= 0.008). There were no significant difference between both techniques for intraoperative bleeding (p= 0.3980), number of lymph nodes (p= 0.27), time to initiate oral feeding (p= 0.31), hospital stay (p= 0.12), and postoperative pain (p= 0.19). Procedure-related complications rate and type were not significantly different in both groups (p= 0.44). Patients operated laparoscopically required significantly less analgesic drugs (p= 0.04) and less need for epidural postoperative analgesia (p= 0.01). Laparoscopic approach is as safe as the traditional open approach for colorectal cancer. Early oncological and surgical results confirm its suitability according to this indication.

  18. [Plastic surgery application in artistic studies of breast cosmetic].

    Science.gov (United States)

    Fabié, A; Delay, E; Chavoin, J-P; Soulhiard, F; Seguin, P

    2006-04-01

    As, quest for beauty has always been an aim. There is a need to define the "ideal" beautifull breast with objective caracteristics, usable in plastic, reconstructive and aesthetic surgery. After, we have defined the necessary parameters usable in breast surgery. We realized an anthropomorphic study including 70 volunteer women and one molded model. Multiple pictures have been taken for each volunteer, that were evaluated and noted by five plastic surgeon, five doctors from other speciality, five women, five men. A twenty notation was used for this study. The main values for the ten women that obtained best notation (>or=14/20) were used in order to defined the ideal measures for surgery. Breast arrow and breast arrow over the trunck height were the most significant factors. According statistical studies, this fraction is about 0,387 (P=0,000969). The nice breast has a round shape and look like juvenile breast. Bra size, cup size, base, segments II and III, fraction II/III are not significant in our series of (non operated) natural breast. The ideal breast is in harmony and proportional to the trunck height, with the main fraction of breast arrow on the trunck height about 0,387 in our serie.

  19. Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury.

    Science.gov (United States)

    Patel, Darshan P; Lenherr, Sara M; Stoffel, John T; Elliott, Sean P; Welk, Blayne; Presson, Angela P; Jha, Amitabh; Rosenbluth, Jeffrey; Myers, Jeremy B

    2017-10-10

    The majority of spinal cord injury (SCI) patients have urinary issues, such as incontinence, retention, and frequency. These problems place a significant burden on patients' physical health and quality of life (QoL). There are a wide variety of bladder management strategies available to patients with no clear guidelines on appropriate selection. Inappropriate bladder management can cause hospitalizations and serious complications, such as urosepsis and renal failure. Patients believe that both independence and ability to carry out daily activities are just as important as physical health in selecting the right bladder-management strategy but little is known about patient's QoL with different bladder managements. Our study's aim is to assess patient reported QoL measures with various bladder managements after SCI. This manuscript describes the approach, study design and common data elements for our central study. This is a multi-institutional prospective cohort study comparing three different bladder-management strategies (clean intermittent catheterization, indwelling catheters, and surgery). Information collected from participants includes demographics, past medical and surgical history, injury characteristics, current and past bladder management, and SCI /bladder-related complications. Patient reported outcomes and QoL questionnaires were administered at enrollment and every 3 months for 1 year. Aims of this study protocol are: (1) to assess baseline QoL differences between the three different bladder-management strategies; (2) determine QoL impact when those using either form of catheter management undergo a surgery over the 1 year of follow-up among patients eligible for surgery; (3) assess the effects of changes in bladder management and complications on QoL over a 1-year longitudinal follow-up. By providing information about patient-reported outcomes associated with different bladder management strategies after SCI, and the impact of bladder management

  20. Changes in taste preference after colorectal surgery: A longitudinal study.

    Science.gov (United States)

    Welchman, Sophie; Hiotis, Perryhan; Pengelly, Steven; Hughes, Georgina; Halford, Jason; Christiansen, Paul; Lewis, Stephen

    2015-10-01

    Nutrition is a key component of surgical enhanced recovery programmes. However, alterations in food preferences are often reported as reasons for patients not eating in the early postoperative period. We hypothesised that taste preferences are altered in the early postoperative period and this dysgeusia affects patients' food choices during this critical time. This is a longitudinal study looking at taste preferences of patients recovering from surgery. Patients undergoing colonic resections were recruited. Using visual analogue scales participants completed a questionnaire, taste tests and preference scoring of food images for the 6 groups of taste (bitter, salty, savoury, sour, spicy and sweet) preoperatively and on postoperative days 1-3. Patients were also offered snacks postoperatively, which represented foods from the six groups and consumption was measured. Differences from baseline were assessed using the Friedman's and Wilcoxon tests. 31 patients were studied. In the immediate postoperative period participants reported deterioration in their sense of taste (p ≤ 0.001), increased nausea (p palatability for salty taste increased (p = 0.001) following surgery. The highest rated images were for savoury food with only the ratings for salty food increasing after surgery (p foods in the postoperative period. Bitter, sour and spicy foods were the least frequently consumed. This is the first study to investigate postsurgical patients' food preferences. A consistent change in all the individual tastes with the exception of salty in the postoperative period was observed. The most desirable tastes were for savoury and sweet, reflecting patients' preoperative preferences. An improved understanding of taste may improve the resumption of eating after colonic surgery. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  1. A protocol for conducting rainfall simulation to study soil runoff.

    Science.gov (United States)

    Kibet, Leonard C; Saporito, Louis S; Allen, Arthur L; May, Eric B; Kleinman, Peter J A; Hashem, Fawzy M; Bryant, Ray B

    2014-04-03

    Rainfall is a driving force for the transport of environmental contaminants from agricultural soils to surficial water bodies via surface runoff. The objective of this study was to characterize the effects of antecedent soil moisture content on the fate and transport of surface applied commercial urea, a common form of nitrogen (N) fertilizer, following a rainfall event that occurs within 24 hr after fertilizer application. Although urea is assumed to be readily hydrolyzed to ammonium and therefore not often available for transport, recent studies suggest that urea can be transported from agricultural soils to coastal waters where it is implicated in harmful algal blooms. A rainfall simulator was used to apply a consistent rate of uniform rainfall across packed soil boxes that had been prewetted to different soil moisture contents. By controlling rainfall and soil physical characteristics, the effects of antecedent soil moisture on urea loss were isolated. Wetter soils exhibited shorter time from rainfall initiation to runoff initiation, greater total volume of runoff, higher urea concentrations in runoff, and greater mass loadings of urea in runoff. These results also demonstrate the importance of controlling for antecedent soil moisture content in studies designed to isolate other variables, such as soil physical or chemical characteristics, slope, soil cover, management, or rainfall characteristics. Because rainfall simulators are designed to deliver raindrops of similar size and velocity as natural rainfall, studies conducted under a standardized protocol can yield valuable data that, in turn, can be used to develop models for predicting the fate and transport of pollutants in runoff.

  2. Immediate postoperative complications in transsphenoidal pituitary surgery: A prospective study

    Directory of Open Access Journals (Sweden)

    Tumul Chowdhury

    2014-01-01

    Full Text Available Background: Considering the important role of pituitary gland in regulating various endocrine axes and its unique anatomical location, various postoperative complications can be anticipated resulting from surgery on pituitary tumors. We examined and categorized the immediate postoperative complications according to various tumor pathologies. Materials and Methods: We carried out a prospective study in 152 consecutive patients and noted various postoperative complications during neurosurgical intensive care unit stay (within 48 hrs of hospital stay in patients undergoing transsphenoidal removal of pituitary tumors. Results: In our series, various groups showed different postoperative complications out of which, cerebrospinal fluid leak was the commonest followed by diabetes insipidus, postoperative nausea and vomiting, and hematoma at operation site. Conclusion: Various immediate postoperative complications can be anticipated in transsphenoidal pituitary surgery even though, it is considered to be relatively safe.

  3. Comparative Study on Various Authentication Protocols in Wireless Sensor Networks.

    Science.gov (United States)

    Rajeswari, S Raja; Seenivasagam, V

    2016-01-01

    Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated.

  4. Comparative Study on Various Authentication Protocols in Wireless Sensor Networks

    Science.gov (United States)

    Rajeswari, S. Raja; Seenivasagam, V.

    2016-01-01

    Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated. PMID:26881272

  5. Glove failure in elective thyroid surgery: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Dariusz Timler

    2015-06-01

    Full Text Available Objectives: To analyze perforation rate in sterile gloves used by surgeons in the operating theatre of the Department of Endocrinological and General Surgery of Medical University of Lodz. Material and Methods: Randomized and controlled trial. This study analyses the incidents of tears in sterile surgical gloves used by surgeons during operations on 3 types of thyroid diseases according to the 10th revision of International Statistical Classification of Diseases and Related Health Problems (ICD-10 codes. Nine hundred seventy-two pairs (sets of gloves were collected from 321 surgical procedures. All gloves were tested immediately following surgery using the water leak test (EN455-1 to detect leakage. Results: Glove perforation was detected in 89 of 972 glove sets (9.2%. Statistically relevant more often glove tears occurred in operator than the 1st assistant (p < 0.001. The sites of perforation were localized mostly on the middle finger of the non-dominant hand (22.5%, and the non-dominant ring finger (17.9%. Conclusions: This study has proved that the role performed by the surgeon during the procedure (operator, 1st assistant has significant influence on the risk of glove perforations. Nearly 90% of glove perforations are unnoticed during surgery.

  6. Surgery resident selection and evaluation. A critical incident study.

    Science.gov (United States)

    Edwards, J C; Currie, M L; Wade, T P; Kaminski, D L

    1993-03-01

    This article reports a study of the process of selecting and evaluating general surgery residents. In personnel psychology terms, a job analysis of general surgery was conducted using the Critical Incident Technique (CIT). The researchers collected 235 critical incidents through structured interviews with 10 general surgery faculty members and four senior residents. The researchers then directed the surgeons in a two-step process of sorting the incidents into categories and naming the categories. The final essential categories of behavior to define surgical competence were derived through discussion among the surgeons until a consensus was formed. Those categories are knowledge/self-education, clinical performance, diagnostic skills, surgical skills, communication skills, reliability, integrity, compassion, organization skills, motivation, emotional control, and personal appearance. These categories were then used to develop an interview evaluation form for selection purposes and a performance evaluation form to be used throughout residency training. Thus a continuum of evaluation was established. The categories and critical incidents were also used to structure the interview process, which has demonstrated increased interview validity and reliability in many other studies. A handbook for structuring the interviews faculty members conduct with applicants was written, and an interview training session was held with the faculty. The process of implementation of the structured selection interviews is being documented currently through qualitative research.

  7. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Pascal H Colson

    Full Text Available To estimate the incidence of active bleeding after cardiac surgery (AB based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications.AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications.Among 4,904 patients, 129 experienced AB (2.6%, among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16% but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication.A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  8. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Science.gov (United States)

    Colson, Pascal H; Gaudard, Philippe; Fellahi, Jean-Luc; Bertet, Héléna; Faucanie, Marie; Amour, Julien; Blanloeil, Yvonnick; Lanquetot, Hervé; Ouattara, Alexandre; Picot, Marie Christine

    2016-01-01

    To estimate the incidence of active bleeding after cardiac surgery (AB) based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications. AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration) were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications. Among 4,904 patients, 129 experienced AB (2.6%), among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16%) but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication. A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  9. Group schema therapy for eating disorders: study protocol.

    Science.gov (United States)

    Calvert, Fiona; Smith, Evelyn; Brockman, Rob; Simpson, Susan

    2018-01-01

    The treatment of eating disorders is a difficult endeavor, with only a relatively small proportion of clients responding to and completing standard cognitive behavioural therapy (CBT). Given the prevalence of co-morbidity and complex personality traits in this population, Schema Therapy has been identified as a potentially viable treatment option. A case series of Group Schema Therapy for Eating Disorders (ST-E-g) yielded positive findings and the study protocol outlined in this article aims to extend upon these preliminary findings to evaluate group Schema Therapy for eating disorders in a larger sample ( n  = 40). Participants undergo a two-hour assessment where they complete a number of standard questionnaires and their diagnostic status is ascertained using the Eating Disorder Examination. Participants then commence treatment, which consists of 25 weekly group sessions lasting for 1.5 h and four individual sessions. Each group consists of five to eight participants and is facilitated by two therapists, at least one of who is a registered psychologist trained on schema therapy. The primary outcome in this study is eating disorder symptom severity. Secondary outcomes include: cognitive schemas, self-objectification, general quality of life, self-compassion, schema mode presentations, and Personality Disorder features. Participants complete psychological measures and questionnaires at pre, post, six-month and 1-year follow-up. This study will expand upon preliminary research into the efficacy of group Schema Therapy for individuals with eating disorders. If group Schema Therapy is shown to reduce eating disorder symptoms, it will hold considerable promise as an intervention option for a group of disorders that is typically difficult to treat. ACTRN12615001323516. Registered: 2/12/2015 (retrospectively registered, still recruiting).

  10. [Thymomectomy by minimally invasive surgery. Comparative study videosurgery versus robot-assisted surgery].

    Science.gov (United States)

    Witte Pfister, A; Baste, J-M; Piton, N; Bubenheim, M; Melki, J; Wurtz, A; Peillon, C

    2017-05-01

    To report the results of minimally invasive surgery in patients with stage I or II thymoma in the Masaoka classification. The reference technique is partial or complete thymectomy by sternotonomy. A retrospective single-center study of a prospective database including all cases of thymoma operated from April 2009 to February 2015 by minimally invasive techniques: either videosurgery (VATS) or robot-assisted surgery (RATS). The surgical technique, type of resection, length of hospital stay, postoperative complications and recurrences were analysed. Our series consisted of 22 patients (15 women and 7 men). The average age was 53 years. Myasthenia gravis was present in 12 patients. Eight patients were operated on by VATS and 14 patiens by RATS. There were no conversions to sternotomy and no perioperative deaths. The mean operating time was 92min for VATS and 137min for RATS (P<0.001). The average hospital stay was 5 days. The mean weight of the specimen for the VATS group was 13.2 and 45.7mg for the RATS group. Twelve patients were classified Masaoka stage I and 10 were stage II. According to the WHO classification there were 7 patients type A, 5 type AB, 4 type B1, 4 type B2 4 and 2 type B3. As proposed by the Group ITMIG-IASLC in 2015 all patients corresponded to group I. The mean follow-up period was 36 months. We noted 3 major perioperative complications according to the Clavien-Dindo classification: one pneumonia, one phrenic nerve paralysis and one recurrent laryngeal nerve palsy. We observed one case of local recurrence at 22 months. Following surgery 4 patients were treated with radiotherapy and 2 patients with chemotherapy. The minimally invasive route is safe, relatively atraumatic and may be incorporated in the therapeutic arsenal for the treatment of Masaoka stage I and II thymoma as an alternative to conventional sternotomy. RATS and VATS are two minimally invasive techniques and the results in the short and medium term are

  11. A Study on IP Network Recovery through Routing Protocols

    Directory of Open Access Journals (Sweden)

    K. Karthik

    2016-09-01

    Full Text Available Internet has taken major role in our communication infrastructure. Such that requirement of internet availability and reliability has increasing accordingly. The major network failure reasons are failure of node and failure of link among the nodes. This can reduce the performance of major applications in an IP networks. The network recovery should be fast enough so that service interruption of link or node failure. The new path taken by the diverted traffic can be computed either at the time of failures or before failures. These mechanisms are known as Reactive and Proactive protocols respectively. In this paper, we surveyed reactive and proactive protocols mechanisms for IP network recovery.

  12. Protocols for Migration and Invasion Studies in Prostate Cancer.

    Science.gov (United States)

    van de Merbel, Arjanneke F; van der Horst, Geertje; Buijs, Jeroen T; van der Pluijm, Gabri

    2018-01-01

    Prostate cancer is the most common malignancy diagnosed in men in the western world. The development of distant metastases and therapy resistance are major clinical problems in the management of prostate cancer patients. In order for prostate cancer to metastasize to distant sites in the human body, prostate cancer cells have to migrate and invade neighboring tissue. Cancer cells can acquire a migratory and invasive phenotype in several ways, including single cell and collective migration. As a requisite for migration, epithelial prostate cancer cells often need to acquire a motile, mesenchymal-like phenotype. This way prostate cancer cells often lose polarity and epithelial characteristics (e.g., expression of E-cadherin homotypic adhesion receptor), and acquire mesenchymal phenotype (for example, cytoskeletal rearrangements, enhanced expression of proteolytic enzymes and other repertory of integrins). This process is referred to as epithelial-to-mesenchymal transition (EMT). Cellular invasion, one of the hallmarks of cancer, is characterized by the movement of cells through a three-dimensional matrix, resulting in remodeling of the cellular environment. Cellular invasion requires adhesion, proteolysis of the extracellular matrix, and migration of cells. Studying the migratory and invasive ability of cells in vitro represents a useful tool to assess the aggressiveness of solid cancers, including those of the prostate.This chapter provides a comprehensive description of the Transwell migration assay, a commonly used technique to investigate the migratory behavior of prostate cancer cells in vitro. Furthermore, we will provide an overview of the adaptations to the Transwell migration protocol to study the invasive capacity of prostate cancer cells, i.e., the Transwell invasion assay. Finally, we will present a detailed description of the procedures required to stain the Transwell filter inserts and quantify the migration and/or invasion.

  13. Study of problems with appendicitis in children undergoing laparoscopic surgery

    International Nuclear Information System (INIS)

    Kosumi, Takuya; Yonekura, Takeo; Yamauchi, Katsuji; Kuroda, Seika; Kimura, Takuya; Ihara, Yoshiyuki

    2011-01-01

    Seventy-one children who underwent laparoscopic appendectomy over the 8 years previous to the study were investigated. The patients were divided into 2 groups: those who had undergome surgery within 24 hours (EA group) and after conservative treatment (IA group). The condition of appendicitis on CT was classified into appendiceal mass (Group A), perforation (Group B), and non-perforation (Group C). Perioperative complications were mainly investigated in these groups. The EA group included 45 patients, and postoperative complications occurred in 2 of 12 patients in Group A (wound infection and intraperitoneal abscess in 1 each) and 2 of 14 patients in Group B (postoperative ileus and intraperitoneal abscess in 1 each). The IA group included 26 patients, and complications occurred only during conservative treatment in 2 of 7 patients in Group A (recurrence of inflammation and ileus in 1 each) and 2 of 2 patients in Group B (recurrence of inflammation and emergency surgery for the aggravation of symptoms in 1 each). No complication occurred in Group C of either the EA or IA group. Treatment was not switched to laparotomy in any patient in the EA or IA group, and no complication occurred during surgery. The total duration of hospitalization was shorter in the EA than in the IA group in all Groups A, B, and C. The risk of postoperative complications was high in the EA group, whereas complications during conservative treatment were problematic in the IA group. (author)

  14. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies.Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care

  15. Protocol: using virus-induced gene silencing to study the arbuscular mycorrhizal symbiosis in Pisum sativum

    DEFF Research Database (Denmark)

    Grønlund, Mette; Olsen, Anne; Johansen, Elisabeth

    2010-01-01

    , the available PEBV-VIGS protocols are inadequate for studying genes involved in the symbiosis with arbuscular mycorrhizal fungi (AMF). Here we describe a PEBV-VIGS protocol suitable for reverse genetics studies in pea of genes involved in the symbiosis with AMF and show its effectiveness in silencing genes...... involved in the early and late stages of AMF symbiosis....

  16. Prospective randomized study of arthroscopic rotator cuff repair using an early versus delayed postoperative physical therapy protocol.

    Science.gov (United States)

    Cuff, Derek J; Pupello, Derek R

    2012-11-01

    This study evaluated patient outcomes and rotator cuff healing after arthroscopic rotator cuff repair using a postoperative physical therapy protocol with early passive motion compared with a delayed protocol that limited early passive motion. The study enrolled 68 patients (average age, 63.2 years) who met inclusion criteria. All patients had a full-thickness crescent-shaped tear of the supraspinatus that was repaired using a transosseous equivalent suture-bridge technique along with subacromial decompression. In the early group, 33 patients were randomized to passive elevation and rotation that began at postoperative day 2. In the delayed group, 35 patients began the same protocol at 6 weeks. Patients were monitored clinically for a minimum of 12 months, and rotator cuff healing was assessed using ultrasound imaging. Both groups had similar improvements in preoperative to postoperative American Shoulder and Elbow Surgeons scores (early group: 43.9 to 91.9, P rotator cuff healing, or range of motion between the early and delayed groups. Patients in the early group and delayed group both demonstrated very similar outcomes and range of motion at 1 year. There was a slightly higher rotator cuff healing rate in the delayed passive range of motion group compared with the early passive range of motion group (91% vs 85%). Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  17. Metabolic Syndrome Prevalence and Associations in a Bariatric Surgery Cohort from the Longitudinal Assessment of Bariatric Surgery-2 Study

    Science.gov (United States)

    Selzer, Faith; Smith, Mark D.; Berk, Paul D.; Courcoulas, Anita P.; Inabnet, William B.; King, Wendy C.; Pender, John; Pomp, Alfons; Raum, William J.; Schrope, Beth; Steffen, Kristine J.; Wolfe, Bruce M.; Patterson, Emma J.

    2014-01-01

    Abstract Background: Metabolic syndrome is associated with higher risk for cardiovascular disease, sleep apnea, and nonalcoholic steatohepatitis, all common conditions in patients referred for bariatric surgery, and it may predict early postoperative complications. The objective of this study was to determine the prevalence of metabolic syndrome, defined using updated National Cholesterol Education Program criteria, in adults undergoing bariatric surgery and compare the prevalence of baseline co-morbid conditions and select operative and 30-day postoperative outcomes by metabolic syndrome status. Methods: Complete metabolic syndrome data were available for 2275 of 2458 participants enrolled in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2), an observational cohort study designed to evaluate long-term safety and efficacy of bariatric surgery in obese adults. Results: The prevalence of metabolic syndrome was 79.9%. Compared to those without metabolic syndrome, those with metabolic syndrome were significantly more likely to be men, to have a higher prevalence of diabetes and prior cardiac events, to have enlarged livers and higher median levels of liver enzymes, a history of sleep apnea, and a longer length of stay after surgery following laparoscopic Roux-en-Y gastric bypass (RYGB) and gastric sleeves but not open RYGB or laparoscopic adjustable gastric banding. Metabolic syndrome status was not significantly related to duration of surgery or rates of composite end points of intraoperative events and 30-day major adverse surgical outcomes. Conclusions: Nearly four in five participants undergoing bariatric surgery presented with metabolic syndrome. Establishing a diagnosis of metabolic syndrome in bariatric surgery patients may identify a high-risk patient profile, but does not in itself confer a higher risk for short-term adverse postsurgery outcomes. PMID:24380645

  18. MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

    Science.gov (United States)

    Benyamin, Ramsin M; Staats, Peter S

    2015-01-01

    efficacy outcome measures include the proportion of Zurich Claudication Questionnaire (ZCQ) and Numeric Pain Rating Scale (NPRS) responders from baseline to follow-up using validated MIC thresholds. Improvement in ZCQ domains of ≥ 0.5 is considered significant, and a Patient Satisfaction score of at least 2.5 represents a satisfied patient. A reduction of ≥ 2 points in NPRS is considered significant pain relief. The primary safety outcome measure is the incidence of device- and/or procedure-related adverse events. Descriptive summaries will be presented by randomized group for all outcome measures at baseline and follow-up time points. Inferential statistical analysis will be conducted to determine significant differences related to functional improvement, pain relief, and safety outcomes. Primary study results will be presented based on one-year follow-up data, with an interim analysis report when 6-month follow-up data become available. Patients are not blinded due to significant differences in treatment protocols between study groups. Also, since neither study arm is focused on treatment of radicular pain, there may be a higher non-responder rate for both groups versus standard of care due to study restrictions on adjunctive pain therapies. This prospective, multi-center, randomized controlled study will provide Level I evidence of the safety and effectiveness of mild versus ESIs in managing neurogenic claudication symptoms in LSS patients.

  19. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

    Directory of Open Access Journals (Sweden)

    Norrie John

    2010-04-01

    Full Text Available Abstract Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676

  20. Temporomandibular joint dysfunction and orthognathic surgery: a retrospective study

    Directory of Open Access Journals (Sweden)

    Raoul Gwénael

    2010-11-01

    Full Text Available Abstract Background Relations between maxillo-mandibular deformities and TMJ disorders have been the object of different studies in medical literature and there are various opinions concerning the alteration of TMJ dysfunction after orthognathic surgery. The purpose of the present study was to evaluate TMJ disorders changes before and after orthognathic surgery, and to assess the risk of creating new TMJ symptoms on asymptomatic patients. Methods A questionnaire was sent to 176 patients operated at the Maxillo-Facial Service of the Lille's 2 Universitary Hospital Center (Chairman Pr Joël Ferri from 01.01.2006 to 01.01.2008. 57 patients (35 females and 22 males, age range from 16 to 65 years old, filled the questionnaire. The prevalence and the results on pain, sounds, clicking, joint locking, limited mouth opening, and tenseness were evaluated comparing different subgroups of patients. Results TMJ symptoms were significantly reduced after treatment for patients with pre-operative symptoms. The overall subjective treatment outcome was: improvement for 80.0% of patients, no change for 16.4% of patients, and an increase of symptoms for 3.6% of them. Thus, most patients were very satisfied with the results. However the appearance of new onset of TMJ symptoms is common. There was no statistical difference in the prevalence of preoperative TMJ symptoms and on postoperative results in class II compared to class III patients. Conclusions These observations demonstrate that: there is a high prevalence of TMJ disorders in dysgnathic patients; most of patients with preoperative TMJ signs and symptoms can improve TMJ dysfunction and pain levels can be reduced by orthognathic treatment; a percentage of dysgnathic patients who were preoperatively asymptomatic can develop TMJ disorders after surgery but this risk is low.

  1. Development of a systematic observation protocol of physical exposure of the back: a preliminary study.

    Science.gov (United States)

    Tousignant, M; Tougas, G; Rossignol, M; Goulet, L

    2002-04-01

    At present there is no systematic observation protocol for the assessment of the multi-factorial aspects of physical exposure related to the back used within the constraints of occupational epidemiological research. In this context, a new preliminary systematic observation protocol is proposed to assess exposure to physical loading of the back using nine categories of physical risk factors: the SOPE back protocol. The objective of this study was to investigate whether the new protocol can correctly identify the level of exposure related to measured physical loading of the back. The subjects of this closed cohort study were 451 manual workers at a natural gas distribution company. The assessment of exposure was made with the protocol using groups with different job titles. The workers were followed for a 2 yr period to establish the risk of a new occurrence of complete disability related to the back (NOCD back injury) in each job grouping. Based on the median of the total scores derived from the protocol, two levels of exposure were identified (high and low). Taking into account the limitations of this study, the protocol in development may be a good tool to establish two levels of exposure to physical loading of the back in large epidemiological studies of occupational low back pain. Further research is needed to replicate these results with larger samples and to test the reliability and predictive validity of the protocol.

  2. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  3. Hemodynamic challenge to early mobilization after cardiac surgery: A pilot study

    Directory of Open Access Journals (Sweden)

    Tiziano Cassina

    2016-01-01

    Full Text Available Background: Active mobilization is a key component in fast-track surgical strategies. Following major surgery, clinicians are often reluctant to mobilize patients arguing that circulatory homeostasis would be impaired as a result of myocardial stunning, fluid shift, and autonomic dysfunction. Aims: We examined the feasibility and safety of a mobilization protocol 12-24 h after elective cardiac surgery. Setting and Design: This observational study was performed in a tertiary nonacademic cardiovascular Intensive Care Unit. Materials and Methods: Over a 6-month period, we prospectively evaluated the hemodynamic response to a two-staged mobilization procedure in 53 consecutive patients. Before, during, and after the mobilization, hemodynamics parameters were recorded, including the central venous oxygen saturation (ScvO 2 , lactate concentrations, mean arterial pressure (MAP, heart rate (HR, right atrial pressure (RAP, and arterial oxygen saturation (SpO 2 . Any adverse events were documented. Results: All patients successfully completed the mobilization procedure. Compared with the supine position, mobilization induced significant increases in arterial lactate (34.6% [31.6%, 47.6%], P = 0.0022 along with reduction in RAP (−33% [−21%, −45%], P 10% and nine of them (17% required treatment. Hypotensive patients experienced a greater decrease in ScvO 2 (−18 ± 5% vs. −9 ± 4%, P = 0.004 with similar changes in RAP and HR. All hemodynamic parameters, but arterial lactate, recovered baseline values after resuming the horizontal position. Conclusions: Early mobilization after cardiac surgery appears to be a safe procedure as far as it is performed under close hemodynamic and clinical monitoring in an intensive care setting.

  4. [A study on English loan words in French plastic surgery].

    Science.gov (United States)

    Hansson, E; Tegelberg, E

    2014-10-01

    The French language is less and less used as an international scientific language and many French researchers publish their work in English. Nowadays, Annales de Chirurgie Plastique Esthétique is the only international plastic surgical journal published completely in French. The use of English loan words in French plastic surgery has never been studied. The aim of this study was to describe the frequency and types of English loan words in French plastic surgery. A corpus consisting of all the articles in a number of Annales de Chirurgie Plastique Esthethique, chosen by default, was created. The frequency of English loan words was calculated and the types of words were analysed. The corpus contains 367 (0.8%) English loan words. Most of them are non-integrated loan words and calques. The majority of the plastic surgical loan words describe surgical techniques. The French plastic surgical language seems to be influenced by English. The usage of loan words does not always follow the recommendations and the usage is sometimes ambiguous. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  5. A Performance Study of LEACH and Direct Diffusion Routing Protocols in Wireless Sensor Network

    International Nuclear Information System (INIS)

    Fakher, S.; Sharshar, K.; Moawad, M.I.; Shokair, M.

    2016-01-01

    The Wireless Sensor Network (WSN) is composed of a large number of sensor nodes with limited computation communication, and battery facilities. One of the common applications of this network is environment monitoring through sensing motion, measuring temperature, humidity and radiation. One of the basic activities in WSN is data gathering which represents a great challenge. Many routing protocols are proposed for that network to collect and aggregate the data. The most popular ones are hierarchy and data centric routing protocols. The main goal of this study is to identify the most preferable routing protocol, to be used in each mobility model. This paper studies the performance of LEACH (Low Energy Adaptive Clustering Hierarchy) from hierarchy routing protocol and direct diffusion from data centric routing protocol which is not clarified until now. Moreover, a comparison between LEACH and direct diffusion protocol using NS2 simulator will be made, and an analysis of these protocols will be conducted. The comparison includes packet delivery ratio, throughput, average energy ratio, average delay, network lifetime, and routing overhead. The performance is evaluated by varying the number of sensor nodes under three mobility models Reference Point Group Mobility Model (RPGM), Manhattan and random waypoint mobility model. Simulation results show that LEACH routing protocol has a good performance in RPGM and Manhattan than random waypoint mobility model. Direct diffusion has a good performance in random waypoint mobility model than in RPGM and Manhattan mobility model

  6. Prognosis of oesophageal adenocarcinoma and squamous cell carcinoma following surgery and no surgery in a nationwide Swedish cohort study

    Science.gov (United States)

    Mattsson, Fredrik

    2018-01-01

    Objectives To assess the recent prognostic trends in oesophageal adenocarcinoma and oesophageal squamous cell carcinoma undergoing resectional surgery and no such surgery. Additionally, risk factors for death were assessed in each of these patient groups. Design Cohort study. Setting A population-based, nationwide study in Sweden. Participants All patients diagnosed with oesophageal adenocarcinoma and oesophageal squamous cell carcinoma in Sweden from 1 January 1990 to 31 December 2013, with follow-up until 14 May 2017. Outcome measures Observed and relative (to the background population) 1-year, 3-year and 5-year survivals were analysed using life table method. Multivariable Cox regression provided HR with 95% CI for risk factors of death. Results Among 3794 patients with oesophageal adenocarcinoma and 4631 with oesophageal squamous cell carcinoma, 82% and 63% were men, respectively. From 1990–1994 to 2010–2013, the relative 5-year survival increased from 12% to 15% for oesophageal adenocarcinoma and from 9% to 12% for oesophageal squamous cell carcinoma. The corresponding survival following surgery increased from 27% to 45% in oesophageal adenocarcinoma and from 24% to 43% in oesophageal squamous cell carcinoma. In patients not undergoing surgery, the survival increased from 3% to 4% for oesophageal adenocarcinoma and from 3% to 6% for oesophageal squamous cell carcinoma. Women with oesophageal squamous cell carcinoma had better prognosis than men both following surgery (HR 0.71, 95% CI 0.61 to 0.83) and no surgery (HR 0.86, 95% CI 0.81 to 0.93). Conclusions The prognosis has improved over calendar time both in oesophageal adenocarcinoma and oesophageal squamous cell carcinoma in Sweden that did and did not undergo surgery. Women appear to have better prognosis in oesophageal squamous cell carcinoma than men, independent of treatment. PMID:29748347

  7. A Comparative Study of Wireless Sensor Networks and Their Routing Protocols

    Directory of Open Access Journals (Sweden)

    Subhajit Pal

    2010-11-01

    Full Text Available Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs. Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols.

  8. CROSS and beyond: a clinical perspective on the results of the randomized ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study.

    Science.gov (United States)

    van der Woude, Stephanie O; Hulshof, Maarten C C M; van Laarhoven, Hanneke W M

    2016-02-01

    Despite extensive research efforts oesophageal cancer remains a malignancy with a poor prognosis. Improvement of treatment is urgently needed. Although multimodality treatment for resectable oesophageal cancer has established it place in standard practice, there are still many differences worldwide in the preferred treatment. The Dutch ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) trial has contributed significantly to the current use of neoadjuvant chemoradiation. This study compared neoadjuvant chemoradiotherapy (CRT) using a moderate radiation dose weekly combined with carboplatin and paclitaxel followed by surgery versus surgery alone. Median overall survival in the CRT group is 49.4 months compared to 24.0 months in the surgery alone group, resulting in an overall survival benefit of 13% in favor of the CRT group (HR, 0.81; 95% CI: 0.70-0.93; P=0.002). Recently the results after long-term follow-up (median 60 months) have been published and confirm the benefit of neoadjuvant CRT to surgery alone. Perioperative mortality rates are low and did not increase by adding CRT (4%) and the CROSS scheme has a favorable toxicity profile. Recurrence patterns in patients treated according to the CROSS protocol report significantly reduced loco regional recurrence in the CRT group (34% to 14%; P<0.001) and less peritoneal carcinomatosis (14% to 4%; P<0.001). With the contemporary focus of research on tumor tailored therapy, the effective and safe CROSS protocol serves as a backbone in many ongoing trials.

  9. Clinical study of salvage surgery after concurrent chemoradiotherapy

    International Nuclear Information System (INIS)

    Shimane, Toshikazu; Nakamura, Taisuke; Shimotatara, Yuko

    2013-01-01

    As the use of concurrent chemoradiotherapy (CCRT) is becoming more widespread, with numerous facilities performing it to maintain function and form, the number of cases requiring salvage surgery is also increasing. We investigated the postoperative prognosis of patients who experienced complications during salvage surgery after CCRT. Subjects were 27 patients who underwent salvage surgery following CCRT at our department during the 7-year period between January 2005 and December 2011. We selected all cases of salvage surgery, comprising neck dissections, total laryngectomies, partial laryngectomies, esophageal resections, and reconstructive surgeries, for analysis. The results were favorable, with a complication rate during salvage surgery after CCRT of 14.8% and a survival rate of 77.8%. Although it is difficult to compare these complications and outcome findings with available reports on salvage surgery without CCRT, it is believed complications can arise in approximately half of the cases. Thus, surgeons should be cognizant of the potential for serious complications, which are sometimes unexpected. Different from our findings, the prognosis following salvage surgery is generally not thought to be favorable and therefore care should be taken to detect recurrence and provide treatment early in salvage surgery cases. (author)

  10. Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.

    Directory of Open Access Journals (Sweden)

    Angus G K McNair

    2016-08-01

    Full Text Available Colorectal cancer (CRC is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs; however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard "core" set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery.The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods. Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78% centers, including 90 professionals, and 97 out of 267 (35% patients. Second round response rates were high for all stakeholders (>80%. Analysis of responses lead to 45 and 23 outcome domains being retained after the first and

  11. Physical Therapy Protocols for Arthroscopic Bankart Repair.

    Science.gov (United States)

    DeFroda, Steven F; Mehta, Nabil; Owens, Brett D

    Outcomes after arthroscopic Bankart repair can be highly dependent on compliance and participation in physical therapy. Additionally, there are many variations in physician-recommended physical therapy protocols. The rehabilitation protocols of academic orthopaedic surgery departments vary widely despite the presence of consensus protocols. Descriptive epidemiology study. Level 3. Web-based arthroscopic Bankart rehabilitation protocols available online from Accreditation Council for Graduate Medical Education (ACGME)-accredited orthopaedic surgery programs were included for review. Individual protocols were reviewed to evaluate for the presence or absence of recommended therapies, goals for completion of ranges of motion, functional milestones, exercise start times, and recommended time to return to sport. Thirty protocols from 27 (16.4%) total institutions were identified out of 164 eligible for review. Overall, 9 (30%) protocols recommended an initial period of strict immobilization. Variability existed between the recommended time periods for sling immobilization (mean, 4.8 ± 1.8 weeks). The types of exercises and their start dates were also inconsistent. Goals to full passive range of motion (mean, 9.2 ± 2.8 weeks) and full active range of motion (mean, 12.2 ± 2.8 weeks) were consistent with other published protocols; however, wide ranges existed within the reviewed protocols as a whole. Only 10 protocols (33.3%) included a timeline for return to sport, and only 3 (10%) gave an estimate for return to game competition. Variation also existed when compared with the American Society of Shoulder and Elbow Therapists' (ASSET) consensus protocol. Rehabilitation protocols after arthroscopic Bankart repair were found to be highly variable. They also varied with regard to published consensus protocols. This discrepancy may lead to confusion among therapists and patients. This study highlights the importance of attending surgeons being very clear and specific with

  12. Postoperative laryngeal symptoms in a general surgery setting. Clinical study.

    Science.gov (United States)

    Geraci, Girolamo; Cupido, Francesco; Lo Nigro, Chiara; Sciuto, Antonio; Sciumè, Carmelo; Modica, Giuseppe

    2013-01-01

    Vocal cord injuries (VI), postoperative hoarseness (PH), dysphonia (DN), dysphagia (DG) and sore throat (ST) are common complications after general anesthesia; there is actually a lack of consensus to support the proper timing for post-operative laryngoscopy that is reliable to support the diagnosis of laryngeal or vocal fold lesions after surgery and there are no valid studies about the entity of laryngeal trauma in oro-tracheal intubation. Aim of our study is to evaluate the statistical relation between anatomic, anesthesiological and surgical variables in the case of PH, DG or impaired voice register. 50 patients (30 thyroidectomies, 8 videolaparoscopic cholecistectomies, 2 right emicolectomies, 2 left emicolectomies, 1 gastrectomy, 1 hemorrhoidectomy, 1 nefrectomy, 1 diagnostic videothoracoscopy, 1 superior right lung lobectomy, 1 appendicectomy, 1 incisional hernia repair, 1 low anterior rectal resection, 1 radical hysterectomy) underwent clinical evaluation and direct laryngoscopy before surgery, within 6 hours, after 72 hours and after 30 days, to evaluate motility and breathing space, phonatory motility, true and false vocal folds and arytenoids oedema. We evaluated also mean age (56.6 ± 3.6 years), male:female ratio (1:1.5), cigarette smoke (20%), atopic comorbidity (17/50 = 34%), Mallampati class (32% 1, 38% 2, 26% 3, 2% 4), mean duration of intubation (159 minutes, range 50 - 405 minutes), Cormack-Lehane score (34% 1, 22% 2, 22% 3, 2% 4), difficult intubation in 9 cases (18%). No complication during the laryngoscopy were registered. We investigated the statistic relationship between pre and intraoperative variables and laryngeal symptoms and lesions. In our experience, statistically significant relations were found in prevalence of vocal folds oedema in smokers (p < 0.005), self limiting DG and DN in younger patients (p < 0.005) and in thyroidectomy (p < 0.01), DG after thyroidectomy (p < 0.01). The short preoperative use of steroids and antihistaminic

  13. A clinical study of navigation accuracy during surgery

    International Nuclear Information System (INIS)

    Hirabayashi, Hidehiro; Uchiyama, Yoshitomo; Hoshida, Toru; Nakase, Hiroyuki; Morimoto, Tetsuya; Sakaki, Toshisuke

    2000-01-01

    It is essential to implement image-guided surgery or neuronavigation technologies that can be applied during functional surgery to localize targets accurately in the surgical field. Various navigation systems have been developed, such as the optical system and mechanical-arm-based system, to localize targets in the operative field. However, either the reference system, in optical systems, or the arm joint, in mechanical-arm-based systems, can sometimes interfere with surgical maneuvers. Therefore, we used the magnetic-force-based Computed Assisted Neurosurgery system (CANS system, Shimadzu, Co. Ltd., Kyoto, Japan) for neuronavigation. The purpose of this study was to evaluate the accuracy of the CANS navigation system. Ten patients with medically refractory epilepsy underwent implantation of subdural electrode grids to detect the epilepsy focus, and then lobectomy or multiple subpial transection was performed after informed consent was obtained. The male/female ratio was 6:4 and the mean age was 30.7 years. The CANS navigator system consists mainly of a magnetic source, a localizer probe with magnetic sensor, a three-dimensional locating measuring instrument (digitizer), an image scanner, and a personal computer. To determine the localization accuracy, the probe was moved on the subdural electrode grid which typically consists of 64 or 16 platinum-iridium electrode contacts (3 mm in the diameter) embedded in a Silastic sheet. The array of electrodes was 8 x 8 cm or 2 x 8 cm and the center-to-center inter-electrode distance was 10 mm. We evaluated the inter-electrode distances and spatial relationships among the electrodes to quantitate the precision of the probe tip localization and assumed the nasion origin reference system to assess the distribution of target coordinates. The measurement errors of each component derived from different planes for the same targets were evaluated in ten patients. The error in X-dimension ranged from 0.38 mm to 7.8 mm, the error in Y

  14. Nutritional risk in major abdominal surgery: NURIMAS Liver (DRKS00010923 – protocol of a prospective observational trial to evaluate the prognostic value of different nutritional scores in hepatic surgery

    Directory of Open Access Journals (Sweden)

    Pascal Probst

    Full Text Available Background: Malnutrition is commonly known as a risk factor in surgical procedures. The nutritional status seems particularly relevant to the clinical outcome of patients undergoing hepatic resection. Thus, identifying affected individuals and taking preventive therapeutic actions before surgery is an important task. However, there are only very few studies, that investigate which existing nutritional assessment score (NAS is suited best to predict the postoperative outcome in liver surgery. Objective: Nutritional Risk in Major Abdominal Surgery (NURIMAS Liver is a prospective observational trial that analyses the predictive value of 12 different NAS for postoperative morbidity and mortality after liver resection. Methods: After admission to the surgical department of the University Hospital in Heidelberg or the municipal hospital of Karlsruhe, all patients scheduled for elective liver resection will be screened for eligibility. Participants will fill in a questionnaire and undergo a physical examination in order to evaluate nutritional status according to Nutritional Risk Index, Nutritional Risk Screening Score, Subjective Global Assessment, Malnutrition Universal Screening Tool, Mini Nutritional Assessment, Short Nutritional Assessment Questionnaire, Imperial Nutritional Screening System, Imperial Nutritional Screening System II, Nutritional Risk Classification and the ESPEN malnutrition criteria. Postoperative morbidity and mortality will be tracked prospectively throughout the postoperative course. The association of malnutrition according to each score and occurrence of at least one major complication will be analysed using both chi-squared tests and a multivariable logistic regression analysis. Already established risk factors in liver surgery will be added as covariates. Discussion: NURIMAS Liver is a bicentric, prospective observational trial. The aim of this study is to investigate the predictive value of clinical nutritional assessment

  15. [Effect of compliance with an antibiotic prophylaxis protocol in surgical site infections in appendectomies. Prospective cohort study].

    Science.gov (United States)

    Sánchez-Santana, Tomás; Del-Moral-Luque, Juan Antonio; Gil-Yonte, Pablo; Bañuelos-Andrío, Luis; Durán-Poveda, Manuel; Rodríguez-Caravaca, Gil

    Antibiotic prophylaxis is the most suitable tool for preventing surgical site infection. This study assessed compliance with antibiotic prophylaxis in surgery for acute appendicitis, and the effect of this compliance on surgical site infection. Prospective cohort study to evaluate compliance with antibiotic prophylaxis protocol in appendectomies. An assessment was made of the level of compliance with prophylaxis, as well as the causes of non-compliance. The incidence of surgical site infection was studied after a maximum incubation period of 30 days. The relative risk adjusted with a logistic regression model was used to assess the effect of non-compliance of prophylaxis on surgical site infection. The study included a total of 930 patients. Antibiotic prophylaxis was indicated in all patients, and administered in 71.3% of cases, with an overall protocol compliance of 86.1%. The principal cause of non-compliance was time of initiation. Cumulative incidence of surgical site infection was 4.6%. No relationship was found between inadequate prophylaxis compliance and infection (relative risk=0.5; 95% CI: 0.1-1.9) (P>.05). Compliance of antibiotic prophylaxis was high, but could be improved. No relationship was found between prophylaxis compliance and surgical site infection rate. Copyright © 2016 Academia Mexicana de Cirugía A.C. Publicado por Masson Doyma México S.A. All rights reserved.

  16. Enhanced Recovery After Surgery: The Plastic Surgery Paradigm Shift.

    Science.gov (United States)

    Bartlett, Erica L; Zavlin, Dmitry; Friedman, Jeffrey D; Abdollahi, Aariane; Rappaport, Norman H

    2017-12-14

    With a focus on providing high quality care and reducing facility based expenses there has been an evolution in perioperative care by way of enhanced recovery after surgery (ERAS). ERAS allows for a multidisciplinary and multimodal approach to perioperative care which not only expedites recovery but maximizes patient outcomes. This paradigm shift has been generally accepted by most surgical specialties, including plastic surgery. The goal of this study was to evaluate the impact of ERAS on outcomes in cosmetic plastic surgery. A prospective study consisting of phone call questionnaires was designed where patients from two senior plastic surgeons (N.H.R. and J.D.F.) were followed. The treatment group (n = 10) followed an ERAS protocol while the control group (n = 12) followed the traditional recovery after surgery which included narcotic usage. Patients were contacted on postoperative days (POD) 0 through 7+ and surveyed about a number of outcomes measures. The ERAS group demonstrated a significant reduction in postoperative pain on POD 0, 1, 2, and 3 (all P plastic surgery. The utility lies in the ability to expedite patient's recovery while still providing quality care. This study showed a reduction in postoperative complaints by avoiding narcotics without an increase in complications. Our findings signify the importance of ERAS protocols within cosmetic plastic surgery. 4. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

  17. Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya

    DEFF Research Database (Denmark)

    Bailey, Jeanette; Lelijveld, Natasha; Marron, Bethany

    2018-01-01

    Background: Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify...... the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6-59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings.  Methods/design: This study...... is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6-59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM...

  18. Predicting implementation from organizational readiness for change: a study protocol

    Directory of Open Access Journals (Sweden)

    Kelly P Adam

    2011-07-01

    Full Text Available Abstract Background There is widespread interest in measuring organizational readiness to implement evidence-based practices in clinical care. However, there are a number of challenges to validating organizational measures, including inferential bias arising from the halo effect and method bias - two threats to validity that, while well-documented by organizational scholars, are often ignored in health services research. We describe a protocol to comprehensively assess the psychometric properties of a previously developed survey, the Organizational Readiness to Change Assessment. Objectives Our objective is to conduct a comprehensive assessment of the psychometric properties of the Organizational Readiness to Change Assessment incorporating methods specifically to address threats from halo effect and method bias. Methods and Design We will conduct three sets of analyses using longitudinal, secondary data from four partner projects, each testing interventions to improve the implementation of an evidence-based clinical practice. Partner projects field the Organizational Readiness to Change Assessment at baseline (n = 208 respondents; 53 facilities, and prospectively assesses the degree to which the evidence-based practice is implemented. We will conduct predictive and concurrent validities using hierarchical linear modeling and multivariate regression, respectively. For predictive validity, the outcome is the change from baseline to follow-up in the use of the evidence-based practice. We will use intra-class correlations derived from hierarchical linear models to assess inter-rater reliability. Two partner projects will also field measures of job satisfaction for convergent and discriminant validity analyses, and will field Organizational Readiness to Change Assessment measures at follow-up for concurrent validity (n = 158 respondents; 33 facilities. Convergent and discriminant validities will test associations between organizational readiness and

  19. Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR).

    Science.gov (United States)

    Baldi, Enrico; Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

    2018-04-19

    Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). ETHICS AND DISSEMINATION: . Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. NCT02632500. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Short-term supervised inpatient physiotherapy exercise protocol improves cardiac autonomic function after coronary artery bypass graft surgery--a randomised controlled trial.

    Science.gov (United States)

    Mendes, Renata Gonçalves; Simões, Rodrigo Polaquini; De Souza Melo Costa, Fernando; Pantoni, Camila Bianca Falasco; Di Thommazo, Luciana; Luzzi, Sérgio; Catai, Aparecida Maria; Arena, Ross; Borghi-Silva, Audrey

    2010-01-01

    Coronary artery bypass grafting (CABG) is accompanied by severe impairment of cardiac autonomous regulation (CAR). This study aimed to determine whether a short-term physiotherapy exercise protocol post-CABG, during inpatient cardiac rehabilitation (CR), might improve CAR. Seventy-four patients eligible for CABG were recruited and randomised into physiotherapy exercise group (EG) or physiotherapy usual care group (UCG). EG patients underwent a short-term supervised inpatient physiotherapy exercise protocol consisting of an early mobilisation with progressive exercises plus usual care (respiratory exercises). UCG only received respiratory exercises. Forty-seven patients (24 EG and 23 UGC) completed the study. Outcome measures of CAR included linear and non-linear measures of heart rate variability (HRV) assessed before discharge. By hospital discharge, EG presented significantly higher parasympathetic HRV values [rMSSD, high frequency (HF), SD1)], global power (STD RR, SD2), non-linear HRV indexes [detrended fluctuation analysis (DFA)alpha1, DFAalpha2, approximate entropy (ApEn)] and mean RR compared to UCG (pexercise protocol during inpatient CR improves CAR at the time of discharge. Thus, exercise-based inpatient CR might be an effective non-pharmacological tool to improve autonomic cardiac tone in patient's post-CABG.

  1. Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction.

    Science.gov (United States)

    Hofmeijer, Jeannette; Amelink, G Johan; Algra, Ale; van Gijn, Jan; Macleod, Malcolm R; Kappelle, L Jaap; van der Worp, H Bart

    2006-09-11

    Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year.

  2. Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol.

    Science.gov (United States)

    Röösli, Martin; Frei, Patrizia; Bolte, John; Neubauer, Georg; Cardis, Elisabeth; Feychting, Maria; Gajsek, Peter; Heinrich, Sabine; Joseph, Wout; Mann, Simon; Martens, Luc; Mohler, Evelyn; Parslow, Roger C; Poulsen, Aslak Harbo; Radon, Katja; Schüz, Joachim; Thuroczy, György; Viel, Jean-François; Vrijheid, Martine

    2010-05-20

    The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF) is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas.

  3. Preclinical experimental stress studies: protocols, assessment and comparison.

    Science.gov (United States)

    Bali, Anjana; Jaggi, Amteshwar Singh

    2015-01-05

    Stress is a state of threatened homeostasis during which a variety of adaptive processes are activated to produce physiological and behavioral changes. Preclinical models are pivotal for understanding these physiological or pathophysiological changes in the body in response to stress. Furthermore, these models are also important for the development of novel pharmacological agents for stress management. The well described preclinical stress models include immobilization, restraint, electric foot shock and social isolation stress. Stress assessment in animals is done at the behavioral level using open field, social interaction, hole board test; at the biochemical level by measuring plasma corticosterone and ACTH; at the physiological level by measuring food intake, body weight, adrenal gland weight and gastric ulceration. Furthermore the comparison between different stressors including electric foot shock, immobilization and cold stressor is described in terms of intensity, hormonal release, protein changes in brain, adaptation and sleep pattern. This present review describes these preclinical stress protocols, and stress assessment at different levels. Copyright © 2014 Elsevier B.V. All rights reserved.

  4. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  5. Pilot studies for the North American Soil Geochemical Landscapes Project - Site selection, sampling protocols, analytical methods, and quality control protocols

    Science.gov (United States)

    Smith, D.B.; Woodruff, L.G.; O'Leary, R. M.; Cannon, W.F.; Garrett, R.G.; Kilburn, J.E.; Goldhaber, M.B.

    2009-01-01

    In 2004, the US Geological Survey (USGS) and the Geological Survey of Canada sampled and chemically analyzed soils along two transects across Canada and the USA in preparation for a planned soil geochemical survey of North America. This effort was a pilot study to test and refine sampling protocols, analytical methods, quality control protocols, and field logistics for the continental survey. A total of 220 sample sites were selected at approximately 40-km intervals along the two transects. The ideal sampling protocol at each site called for a sample from a depth of 0-5 cm and a composite of each of the O, A, and C horizons. The Ca, Fe, K, Mg, Na, S, Ti, Ag, As, Ba, Be, Bi, Cd, Ce, Co, Cr, Cs, Cu, Ga, In, La, Li, Mn, Mo, Nb, Ni, P, Pb, Rb, Sb, Sc, Sn, Sr, Te, Th, Tl, U, V, W, Y, and Zn by inductively coupled plasma-mass spectrometry and inductively coupled plasma-atomic emission spectrometry following a near-total digestion in a mixture of HCl, HNO3, HClO4, and HF. Separate methods were used for Hg, Se, total C, and carbonate-C on this same size fraction. Only Ag, In, and Te had a large percentage of concentrations below the detection limit. Quality control (QC) of the analyses was monitored at three levels: the laboratory performing the analysis, the USGS QC officer, and the principal investigator for the study. This level of review resulted in an average of one QC sample for every 20 field samples, which proved to be minimally adequate for such a large-scale survey. Additional QC samples should be added to monitor within-batch quality to the extent that no more than 10 samples are analyzed between a QC sample. Only Cr (77%), Y (82%), and Sb (80%) fell outside the acceptable limits of accuracy (% recovery between 85 and 115%) because of likely residence in mineral phases resistant to the acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset of 73 of these samples was analyzed for a suite of

  6. Adolescent Perspectives Following Ostomy Surgery: A Grounded Theory Study.

    Science.gov (United States)

    Mohr, Lynn D; Hamilton, Rebekah J

    2016-01-01

    This purpose of this study was to provide a theoretical account of how adolescents aged 13 to 18 years process the experience of having an ostomy. Qualitative study using grounded theory design. The sample comprised of 12 English-speaking adolescents aged 13-18 years: 10 with an ostomy and 2 with medical management of their disease. Respondents completed audio-recorded interviews that were transcribed verbatim. Data were analyzed using the constant comparative method until data saturation occurred. Dedoose, a Web-based qualitative methods management tool, was used to capture major themes arising from the data. Study results indicate that for adolescents between 13 and 18 years of age, processing the experience of having an ostomy includes concepts of the "physical self" and "social self" with the goal of "normalizing." Subcategories of physical self include (a) changing reality, (b) learning, and (c) adapting. Subcategories of social self include (a) reentering and (b) disclosing. This study sheds light on how adolescents process the experience of having an ostomy and how health care providers can assist adolescents to move through the process to get back to their desired "normal" state. Health care providers can facilitate the adolescent through the ostomy experience by being proactive in conversations not only about care issues but also about school and family concerns and spirituality. Further research is needed in understanding how parents process their adolescents' ostomy surgery experience and how spirituality assists adolescents in coping and adjustment with body-altering events.

  7. Socioeconomic outcome of epilepsy surgery: A controlled national study

    DEFF Research Database (Denmark)

    Jennum, Poul; Sabers, Anne; Christensen, Jakob

    2016-01-01

    severely affected by their disease as indicated by health care use and social impact before the surgical procedure. Patients who underwent epilepsy surgery had a significantly lower costs associated with the use of medication, outpatient services, inpatient admissions, and accident and emergency visits...... after surgery. The surgical intervention had no significant effects on social status in terms of occupation and educational level. CONCLUSION: Although epilepsy surgery was followed by a reduction in inpatient and outpatient health care use, medication and use of accident and emergency facilities...

  8. Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: the LaCeS feasibility trial protocol.

    Science.gov (United States)

    Harji, Deena; Marshall, Helen; Gordon, Katie; Crow, Hannah; Hiley, Victoria; Burke, Dermot; Griffiths, Ben; Moriarty, Catherine; Twiddy, Maureen; O'Dwyer, John L; Verjee, Azmina; Brown, Julia; Sagar, Peter

    2018-02-22

    Acute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection. The LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes. The LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The

  9. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).

    Science.gov (United States)

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-08-31

    Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology

  10. Electroacupuncture to alleviate postoperative pain after a laparoscopic appendectomy: study protocol for a three-arm, randomised, controlled trial.

    Science.gov (United States)

    Lee, Seunghoon; Nam, Dongwoo; Kwon, Minsoo; Park, Won Seo; Park, Sun Jin

    2017-08-04

    The purpose of this study is to evaluate the efficacy and safety of electroacupuncture (EA) for postoperative pain after laparoscopic appendectomy compared with sham electroacupuncture (SEA) and no acupuncture treatment. This study is a protocol for a three-arm, randomised, patient-assessor-blinded (to the type of acupuncture treatment), controlled, parallel trial. 138 participants diagnosed with appendicitis and scheduled for laparoscopic appendectomy will be randomly assigned to the EA group (n=46), SEA group (n=46) or control group (n=46). The EA group will receive acupuncture treatment at both regional and distal acupuncture points with electrostimulation. The SEA group will receive sham acupuncture treatment with mock electrostimulation. Both EA and SEA groups will receive a total of four treatments 1 hour preoperative, 1 hour postoperative and during the morning and afternoon the day after surgery with the same routine postoperative pain control. The control group will receive only routine postoperative pain control. The primary outcome is the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at 24 hours after surgery. The secondary outcomes are the PI-NRS, analgesic consumption, opioid-related side effects, time to first passing flatus, quality of life and adverse events evaluated 6, 12, 24 and 36 hours and 7 days after surgery. The study was planned in accordance with the Helsinki Declaration and the Korean Good Clinical Practice Guidelines to protect the participants and was approved by the institutional review board (IRB) of Kyung Hee University Medical Center (KMC IRB-1427-02). The results will be disseminated in peer-reviewed journals and presented at international conferences. Clinical Research Information Service (KCT0001328). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. A Randomized Controlled Trial Study in Abdominal Surgery

    African Journals Online (AJOL)

    ADMIN

    , and finally, greatly improved postoperative recovery 5-7. In recent years, FTS has been applied to several surgical diseases including radical prostatectomy 8, cardiac surgery 9, total knee replacement 10, cesarean section11, coronary artery ...

  12. Epilepsy Surgery Series: A Study of 502 Consecutive Patients from a Developing Country

    Science.gov (United States)

    Al-Otaibi, Faisal; Baz, Salah; Althubaiti, Ibrahim; Aldhalaan, Hisham; MacDonald, David; Abalkhail, Tareq; Fiol, Miguel E.; Alyamani, Suad; Chedrawi, Aziza; Leblanc, Frank; Parrent, Andrew; Maclean, Donald; Girvin, John

    2014-01-01

    Purpose. To review the postoperative seizure outcomes of patients that underwent surgery for epilepsy at King Faisal Specialist Hospital & Research Centre (KFSHRC). Methods. A descriptive retrospective study for 502 patients operated on for medically intractable epilepsy between 1998 and 2012. The surgical outcome was measured using the ILAE criteria. Results. The epilepsy surgery outcome for temporal lobe epilepsy surgery (ILAE classes 1, 2, and 3) at 12, 36, and 60 months is 79.6%, 74.2%, and 67%, respectively. The favorable 12- and 36-month outcomes for frontal lobe epilepsy surgery are 62% and 52%, respectively. For both parietal and occipital epilepsy lobe surgeries the 12- and 36-month outcomes are 67%. For multilobar epilepsy surgery, the 12- and 36-month outcomes are 65% and 50%, respectively. The 12- and 36-month outcomes for functional hemispherectomy epilepsy surgery are 64.2% and 63%, respectively. According to histopathology diagnosis, mesiotemporal sclerosis (MTS) and benign CNS tumors had the best favorable outcome after surgery at 1 year (77.27% and 84.3%, resp.,) and 3 years (76% and 75%, resp.,). The least favorable seizure-free outcome after 3 years occurred in cases with dual pathology (66.6%). Thirty-four epilepsy patients with normal magnetic resonance imaging (MRI) brain scans were surgically treated. The first- and third-year epilepsy surgery outcome of 17 temporal lobe surgeries were (53%) and (47%) seizure-free, respectively. The first- and third-year epilepsy surgery outcomes of 15 extratemporal epilepsy surgeries were (47%) and (33%) seizure-free. Conclusion. The best outcomes are achieved with temporal epilepsy surgery, mesial temporal sclerosis, and benign CNS tumor. The worst outcomes are from multilobar surgery, dual pathology, and normal MRI. PMID:24627805

  13. The Oxford Participation and Activities Questionnaire: study protocol

    Directory of Open Access Journals (Sweden)

    Morley D

    2013-12-01

    Full Text Available David Morley, Sarah Dummett, Laura Kelly, Jill Dawson, Ray Fitzpatrick, Crispin JenkinsonNuffield Department of Population Health, University of Oxford, Oxford, UKBackground: With an ageing population and increasing demands on health and social care services, there is growing importance attached to the management of long-term conditions, including maximizing the cost-effectiveness of treatments. In line with this, there is increasing emphasis on the need to keep people both active and participating in daily life. Consequently, it is essential that well developed and validated instruments that can meaningfully assess levels of participation and activity are widely available. Current measures, however, are largely focused on disability and rehabilitation, and there is no measure of activity or participation for generic use that fully meets the standards set by regulatory bodies such as the US Food and Drug Administration. Here we detail a protocol for the development and validation of a new patient-reported outcome measure (PROM for assessment of participation and activity in people experiencing a variety of health conditions, ie, the Oxford Participation and Activities Questionnaire (Ox-PAQ. The stages incorporated in its development are entirely in line with current regulations and represent best practice in the development of PROMs.Methods: Development of the Ox-PAQ is theoretically grounded in the World Health Organization International Classification of Functioning, Disability, and Health. The project incorporates a new strategy of engaging with stakeholders from the outset in an attempt to identify those characteristics of PROMs considered most important to a range of potential users. Items will be generated through interviews with patients from a range of conditions. Pretesting of the instrument will be via cognitive interviews and focus groups. A postal survey will be conducted, with data subject to factor and Rasch analysis in order to

  14. The Oxford Participation and Activities Questionnaire: study protocol.

    Science.gov (United States)

    Morley, David; Dummett, Sarah; Kelly, Laura; Dawson, Jill; Fitzpatrick, Ray; Jenkinson, Crispin

    2013-01-01

    With an ageing population and increasing demands on health and social care services, there is growing importance attached to the management of long-term conditions, including maximizing the cost-effectiveness of treatments. In line with this, there is increasing emphasis on the need to keep people both active and participating in daily life. Consequently, it is essential that well developed and validated instruments that can meaningfully assess levels of participation and activity are widely available. Current measures, however, are largely focused on disability and rehabilitation, and there is no measure of activity or participation for generic use that fully meets the standards set by regulatory bodies such as the US Food and Drug Administration. Here we detail a protocol for the development and validation of a new patient-reported outcome measure (PROM) for assessment of participation and activity in people experiencing a variety of health conditions, ie, the Oxford Participation and Activities Questionnaire (Ox-PAQ). The stages incorporated in its development are entirely in line with current regulations and represent best practice in the development of PROMs. Development of the Ox-PAQ is theoretically grounded in the World Health Organization International Classification of Functioning, Disability, and Health. The project incorporates a new strategy of engaging with stakeholders from the outset in an attempt to identify those characteristics of PROMs considered most important to a range of potential users. Items will be generated through interviews with patients from a range of conditions. Pretesting of the instrument will be via cognitive interviews and focus groups. A postal survey will be conducted, with data subject to factor and Rasch analysis in order to identify appropriate dimensions and redundant items. Reliability will be assessed by Cronbach's alpha and item-total correlations. A second, large-scale postal survey will follow, with the Ox-PAQ being

  15. What should be the antibiotic prescription protocol for burn patients admitted in the department of burns, plastic and reconstructive surgery.

    Science.gov (United States)

    Mir, Mohd Altaf; Khurram, Mohammad Fahud; Khan, Arshad Hafiz

    2017-02-01

    This is a prospective study with the aim to determine specific patterns of burn wound bacterial colonisation and antimicrobial resistance profiles. There is a high incidence of infections and septicaemia in post-burn patients, which, in turn, are associated with high morbidity and mortality, a fact that compelled us to undertake this study. The study was conducted over a period 11 months, from 1 August 2014 to 30 June 2015, in 50 burn patients admitted in our burn unit. Wound cultures were taken after 72 hours of admission from all the patients, and then, empirical systemic antibiotics were administered. For wound cultures; 1 cubic cm tissue was taken and placed in aerobic and anaerobic culture vials and transported to the microbiology lab under all aseptic precautions as soon as possible. At the time of fever any time after 72 hours of admission, 16 ml of blood was drawn under all aseptic precautions. Both aerobic and anaerobic blood culture vials were filled with 8 ml of blood each and transported to the microbiology lab. The results of culture and sensitivity reports of 50 patients were recorded. The data obtained was analysed using appropriate statistical analytical tests. The most common organism responsible for bacteraemia is Pseudomonas (43%). Most of the strains of organisms isolated were resistant to commonly used antibiotics in the hospital; Pseudomonas was found 100% resistant to a combination of ampicillin + sulbactum, ceftriaxone and was most often sensitive to imipenem, amikacin and vancomycin. Methicillin-resistant Staphylococcus aureus (MRSA) was also found resistant to commonly used antibiotics like ceftriaxone, ampicillin + sulbactum and ceftazidime + calvulanic acid. Linzolid and vancomycin were effective in 83% and 100% cases, respectively. We conclude that similar institution-specific studies should be conducted, and such studies will be helpful in providing useful guidelines for choosing effective empirical therapy that will have a great

  16. Management of minor head injury in patients receiving oral anticoagulant therapy: a prospective study of a 24-hour observation protocol.

    Science.gov (United States)

    Menditto, Vincenzo G; Lucci, Moira; Polonara, Stefano; Pomponio, Giovanni; Gabrielli, Armando

    2012-06-01

    Patients receiving warfarin who experience minor head injury are at risk of intracranial hemorrhage, and optimal management after a single head computed tomography (CT) scan is unclear. We evaluate a protocol of 24-hour observation followed by a second head CT scan. In this prospective case series, we enrolled consecutive patients receiving warfarin and showing no intracranial lesions on a first CT scan after minor head injury treated at a Level II trauma center. We implemented a structured clinical pathway, including 24-hour observation and a CT scan performed before discharge. We then evaluated the frequency of death, admission, neurosurgery, and delayed intracranial hemorrhage. We enrolled and observed 97 consecutive patients. Ten refused the second CT scan and were well during 30-day follow-up. Repeated CT scanning in the remaining 87 patients revealed a new hemorrhage lesion in 5 (6%), with 3 subsequently hospitalized and 1 receiving craniotomy. Two patients discharged after completing the study protocol with 2 negative CT scan results were admitted 2 and 8 days later with symptomatic subdural hematomas; neither received surgery. Two of the 5 patients with delayed bleeding at 24 hours had an initial international normalized ratio greater than 3.0, as did both patients with delayed bleeding beyond 24 hours. The relative risk of delayed hemorrhage with an initial international normalized ratio greater than 3.0 was 14 (95% confidence interval 4 to 49). For patients receiving warfarin who experience minor head injury and have a negative initial head CT scan result, a protocol of 24-hour observation followed by a second CT scan will identify most occurrences of delayed bleeding. An initial international normalized ratio greater than 3 suggests higher risk. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

  17. The Utility of Outcome Studies in Plastic Surgery

    Directory of Open Access Journals (Sweden)

    Hani Sinno, MD, MEng

    2014-07-01

    Full Text Available Summary: Outcome studies help provide the evidence-based science rationalizing treatment end results that factor the experience of patients and the impact on society. They improve the recognition of the shortcoming in clinical practice and provide the foundation for the development of gold standard care. With such evidence, health care practitioners can develop evidence-based justification for treatments and offer patients with superior informed consent for their treatment options. Furthermore, health care and insurance agencies can recognize improved cost-benefit options in the purpose of disease prevention and alleviation of its impact on the patient and society. Health care outcomes are ultimately measured by the treatment of disease, the reduction of symptoms, the normalization of laboratory results and physical measures, saving a life, and patient satisfaction. In this review, we outline the tools available to measure outcomes in plastic surgery and subsequently allow the objective measurements of plastic surgical conditions. Six major outcome categories are discussed: (1 functional measures; (2 preference-based measures and utility outcome scores; (3 patient satisfaction; (4 health outcomes and time; (5 other tools: patient-reported outcome measurement information system, BREAST-Q, and Tracking Operations and Outcomes for Plastic Surgeons; and (6 cost-effectiveness analysis. We use breast hypertrophy requiring breast reduction as an example throughout this review as a representative plastic surgical condition with multiple treatments available.

  18. Comparative Evaluation of Pain, Stress, Neuropeptide Y, ACTH, and Cortisol Levels Between a Conventional Postoperative Care Protocol and a Fast-Track Recovery Program in Patients Undergoing Major Abdominal Surgery.

    Science.gov (United States)

    Kapritsou, Maria; Papathanassoglou, Elizabeth D; Bozas, Evangelos; Korkolis, Dimitrios P; Konstantinou, Evangelos A; Kaklamanos, Ioannis; Giannakopoulou, Margarita

    2017-03-01

    Fast-track (FT) postoperative protocol in oncological patients after major abdominal surgery reduces complications and length of postoperative stay compared to the conventional (CON) protocol. However, stress and pain responses have not been compared between the two protocols. To compare stress, pain, and related neuropeptidic responses (adrenocorticotropic hormone [ACTH], cortisol, and neuropeptide Y [NPY]) between FT and CON protocols. A clinical trial with repeated measurements was conducted (May 2012 to May 2014) with a sample of 63 hepatectomized or pancreatectomized patients randomized into two groups: FT ( n = 29) or CON ( n = 34). Demographic and clinical data were collected, and pain (Visual Analog Scale [VAS] and Behavioral Pain Scale [BPS]) and stress responses (3 self-report questions) assessed. NPY, ACTH, and cortisol plasma levels were measured at T1 = day of admission, T2 = day of surgery, and T3 = prior to discharge. ACTH T1 and ACTH T2 levels were positively correlated with self-reported stress levels (ρ = .43 and ρ = .45, respectively, p .05). Neuropeptidic levels were higher in the FT group. Future research should evaluate this association further, as these biomarkers might serve as objective indicators of postoperative pain and stress.

  19. A prospective qualitative study on patients' perceptions of endoscopic endonasal transsphenoidal surgery.

    Science.gov (United States)

    Edem, Idara J; Banton, Beverly; Bernstein, Mark; Lwu, Shelly; Vescan, Allan; Gentilli, Fred; Zadeh, Gelareh

    2013-02-01

    Endoscopic transsphenoidal surgery has been shown to be a safe and effective treatment option for patients with pituitary tumours, but no study has explored patients' perceptions before and after this surgery. The authors in this study aim to explore patients' perceptions on endoscopic transsphenoidal surgery. Using qualitative research methodology, two semi-structured interviews were conducted with 30 participants who were adults aged > 18 undergoing endoscopic transsphenoidal surgery for the resection of a pituitary tumour between December 2008 and June 2011. The interviews were audiotaped and transcribed. The resulting data was analyzed using a modified thematic analysis. Seven overarching themes were identified: (1) Patients had a positive surgical experience; (2) patients were satisfied with the results of the procedure; (3) patients were initially surprised that neurosurgery could be performed endonasally; (4) patients expected a cure and to feel better after the surgery; (5) many patients feared that something might go wrong during the surgery; (6) patients were psychologically prepared for the surgery; (7) most patients reported receiving adequate pre-op and post-op information. This is the first qualitative study reporting on patients' perceptions before and after an endoscopic endonasal transsphenoidal pituitary surgery, which is increasingly used as a standard surgical approach for patients with pituitary tumours. Patients report a positive perception and general satisfaction with the endoscopic transsphenoidal surgical experience. However, there is still room for improvement in post-surgical care. Overall, patients' perceptions can help improve the delivery of comprehensive care to future patients undergoing pituitary tumour surgery.

  20. Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol

    Directory of Open Access Journals (Sweden)

    Radon Katja

    2010-05-01

    Full Text Available Abstract Background The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. Methods The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. Results We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Conclusion Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas.

  1. PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial.

    Science.gov (United States)

    Cooke, Marie; Rickard, Claire; Rapchuk, Ivan; Shekar, Kiran; Marshall, Andrea P; Comans, Tracy; Doi, Suhail; McDonald, John; Spooner, Amy

    2014-11-13

    Postoperative nausea and vomiting (PONV) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery, affecting at least a third of patients, despite pharmacological treatment. The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients. In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support, or impede, the use of PC6 acupoint stimulation, a knowledge translation approach. 712 postcardiac surgery participants will be recruited to take part in a two-group, parallel, superiority, randomised controlled trial. Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo. Randomisation will be computer generated, use randomly varied block sizes, and be concealed prior to the enrolment of each patient. The wristbands will remain in place for 36 h. PONV will be evaluated by the assessment of both nausea and vomiting, use of rescue antiemetics, quality of recovery and cost. Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use, feasibility, acceptability and challenges of using acupressure wristbands for PONV. Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study. A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only. Study progress will be reviewed by a Data Safety Monitoring Committee (DSMC) for nausea and vomiting outcomes at n=350. Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals. Study participants will receive a one-page lay-summary of results. Australian New Zealand Clinical Trials Registry--ACTRN12614000589684. Published by the BMJ

  2. The erasure of gender in academic surgery: a qualitative study.

    Science.gov (United States)

    Webster, Fiona; Rice, Kathleen; Christian, Jennifer; Seemann, Natashia; Baxter, Nancy; Moulton, Carol-Anne; Cil, Tulin

    2016-10-01

    The number of women in surgery has steadily increased, yet their numbers in academic surgery positions and in high-ranking leadership roles remain low. To create strategies to address and improve this problem, it is essential to examine how gender plays into the advancement of a woman's career in academic surgery. Focus group (1) and one-on-one qualitative interviews (8) were conducted with women academic surgeons from various subspecialties in a large university setting. Interviews examined women surgeons' accounts of their experiences as women in surgery. Audio-recorded data were transcribed verbatim and coded thematically. NVivo10 software was used for cross-referencing of data and categorization of data into themes. Focus group data suggested that gender discrimination was pervasive in academic surgery. However, in interviews, most interviewees strongly disavowed the possibility that their gender had any bearing on their professional lives. These surgeons attempted to distance themselves from the possibility of discrimination by suggesting that differences in men and women surgeons' experiences are due to personality issues and personal choices. However, their narratives highlighted deep contradiction; they both affirmed and denied the relevance of gender for their experience as surgeons. As overt acts of discrimination become less acceptable in society, it does not necessarily disappear but rather manifests itself in covert forms. By disavowing and distancing themselves from discrimination, these women exposed the degree to which these issues continue to be pervasive in surgery. Women surgeons' ability to both identify and resist discrimination was hobbled by narratives of individualism, gender equality, and normative ideas of gender difference. Copyright © 2016. Published by Elsevier Inc.

  3. Value of preoperative esophageal function studies before laparoscopic antireflux surgery.

    Science.gov (United States)

    Chan, Walter W; Haroian, Laura R; Gyawali, C Prakash

    2011-09-01

    The value of esophageal manometry and ambulatory pH monitoring before laparoscopic antireflux surgery (LARS) has been questioned because tailoring the operation to the degree of hypomotility often is not required. This study evaluated a consecutive cohort of patients referred for esophageal function studies in preparation for LARS to determine the rates of findings that would alter surgical decisions. High-resolution manometry (HRM) was performed for each subject using a 21-lumen water-perfused system, and motor function was characterized. Gastroesophageal reflux disease (GERD) was evident from ambulatory pH monitoring if thresholds for acid exposure time and/or positive symptom association probability were passed. Of 1,081 subjects (age, 48.4 ± 0.4 years; 56.7% female) undergoing preoperative HRM, 723 (66.9%) also had ambulatory pH testing performed. Lower esophageal sphincter (LES) hypotension (38.9%) and nonspecific spastic disorder (NSSD) of the esophageal body (36.1%) were common. Obstructive LES pathophysiology was noted in 2.5% (achalasia in 1%; incomplete LES relaxation in 1.5%), and significant esophageal body hypomotility in 4.5% (aperistalsis in 3.2%; severe hypomotility in 1.3%) of the subjects. Evidence of GERD was absent in 23.9% of the subjects. Spastic disorders were more frequent in the absence of GERD (43.9% vs. 23.1% with GERD; p esophageal function testing that could be used in preoperative counseling and candidate selection. Physiologic testing remains important in the preoperative evaluation of patients being considered for LARS.

  4. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mujagic, Edin; Zwimpfer, Tibor; Marti, Walter R; Zwahlen, Marcel; Hoffmann, Henry; Kindler, Christoph; Fux, Christoph; Misteli, Heidi; Iselin, Lukas; Lugli, Andrea Kopp; Nebiker, Christian A; von Holzen, Urs; Vinzens, Fabrizio; von Strauss, Marco; Reck, Stefan; Kraljević, Marko; Widmer, Andreas F; Oertli, Daniel; Rosenthal, Rachel; Weber, Walter P

    2014-05-24

    Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis. In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years. The results of this

  5. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery.

    Science.gov (United States)

    Ganry, L; Hersant, B; Sidahmed-Mezi, M; Dhonneur, G; Meningaud, J P

    2018-01-06

    Preoperative anxiety may lead to medical and surgical complications, behavioral problems and emotional distress. The most common means of prevention are based on using medication and, more recently, hypnosis. The aim of our study was to determine whether a virtual reality (VR) program presenting natural scenes could be part of a new therapy to reduce patients' preoperative anxiety. Our prospective pilot study consisted of a single-blind trial in skin cancer surgery at the Henri-Mondor teaching hospital in France. In the outpatient surgery department, 20 patients with a score of >11 on the Amsterdam preoperative anxiety and information scale (APAIS) were virtually immersed into a natural universe for 5minutes. Their stress levels were assessed before and after this experience by making use of a visual analog scale (VAS), by measuring salivary cortisol levels, and by determining physiological stress based on heart coherence scores. The VAS score was significantly reduced after the simulation (P<0.009) as was the level of salivary cortisol (P<0.04). Heart coherence scores remained unchanged (P=0.056). VR allows patients to be immersed in a relaxing, peaceful environment. It represents a non-invasive way to reduce preoperative stress levels with no side effects and no need for additional medical or paramedical staff. Our results indicate that VR may provide an effective complementary technique to manage stress in surgery patients. Randomized trials are necessary to determine precise methods and benefits. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

  6. Cancer incidence in kidney transplant recipients: a study protocol

    OpenAIRE

    Pita-Fernandez, Salvador; Valdes-Ca?edo, Francisco; Pertega-Diaz, Sonia; Seoane-Pillado, Maria Teresa; Seijo-Bestilleiro, Rocio

    2009-01-01

    Abstract Background Different publications show an increased incidence of neoplasms in renal transplant patients. The objective of this study is to determine the incidence of cancer in the recipients of renal transplants performed in the A Coruña Hospital (Spain) during the period 1981–2007. Methods/Design During the study period 1967 kidney transplants were performed, corresponding to 1710 patients. Patients with neoplasms prior to the transplant will be excluded (n = 38). A follow-up study ...

  7. Pregnancy outcome of “delayed start” GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study

    Directory of Open Access Journals (Sweden)

    Abbas Aflatoonian

    2017-08-01

    Full Text Available Background: Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART. Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards. Objective: The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF outcomes. Materials and Methods: This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30, delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30 treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups. Results: Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups. Conclusion: There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.

  8. Health effects of smoke from planned burns: a study protocol

    Directory of Open Access Journals (Sweden)

    David O’Keeffe

    2016-02-01

    Full Text Available Abstract Background Large populations are exposed to smoke from bushfires and planned burns. Studies investigating the association between bushfire smoke and health have typically used hospital or ambulance data and been done retrospectively on large populations. The present study is designed to prospectively assess the association between individual level health outcomes and exposure to smoke from planned burns. Methods/design A prospective cohort study will be conducted during a planned burn season in three locations in Victoria (Australia involving 50 adult participants who undergo three rounds of cardiorespiratory medical tests, including measurements for lung inflammation, endothelial function, heart rate variability and markers of inflammation. In addition daily symptoms and twice daily lung function are recorded. Outdoor particulate air pollution is continuously measured during the study period in these locations. The data will be analysed using mixed effect models adjusting for confounders. Discussion Planned burns depend on weather conditions and dryness of ‘fuels’ (i.e. forest. It is potentially possible that no favourable conditions occur during the study period. To reduce the risk of this occurring, three separate locations have been identified as having a high likelihood of planned burn smoke exposure during the study period, with the full study being rolled out in two of these three locations. A limitation of this study is exposure misclassification as outdoor measurements will be conducted as a measure for personal exposures. However this misclassification will be reduced as participants are only eligible if they live in close proximity to the monitors.

  9. NSAID Use after Bariatric Surgery : a Randomized Controlled Intervention Study

    NARCIS (Netherlands)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N.

    2016-01-01

    Background Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. Aim To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID

  10. Bariatric surgery and incidental gastrointestinal stromal tumors - a single-center study: VSJ Competition, 1st place.

    Science.gov (United States)

    Walędziak, Maciej; Różańska-Walędziak, Anna; Kowalewski, Piotr K; Janik, Michał R; Brągoszewski, Jakub; Paśnik, Krzysztof

    2017-09-01

    Gastrointestinal stromal tumors (GISTs), originating from Cajal cells, are most commonly located in the stomach; therefore they can be found in the specimens excised during bariatric operations. The global prevalence of GISTs is about 130 cases per million population. Morbidity differs depending on geographical latitude. Although surgery is the treatment of choice for GISTs, 40-50% of patients after radical surgical treatment will have a relapse or metastases. To analyze the incidence of GISTs in patients undergoing bariatric surgery and to verify whether an operation performed according to the bariatric protocol is oncologically radical in case of GIST. A single-center retrospective study. The study group comprised 1252 obese patients qualified for bariatric procedures, with no upper gastrointestinal tract neoplasms found during preoperative diagnostic examinations. In case of suspicious macroscopic pathologies (n = 81) present during the operation, tissue specimens underwent histopathological examination with further investigation performed if GISTs were found, including tumor size and localization, mitotic index and immunohistochemical analysis. Gastrointestinal stromal tumors were found in 16 cases, and benign tumors of various histological origin in 33 cases. All cases of GIST found came from stomach specimens, 7 from the gastric corpus vs. 9 from the fundus. Fourteen GISTs were found during laparoscopic sleeve gastrectomies (LSGs) vs. 2 during laparoscopic Roux-en-Y gastric bypasses (LRYGBs). In case of incidental findings of GISTs during bariatric surgery, tumor resection with negative margins of incision may be considered as complete oncological treatment if there was very low/low risk stratification of GIST's recurrence after surgery.

  11. Beyond repair - family and community reintegration after obstetric fistula surgery: study protocol

    OpenAIRE

    Byamugisha, Josaphat; El Ayadi, Alison; Obore, Susan; Mwanje, Haruna; Kakaire, Othman; Barageine, Justus; Lester, Felicia; Butrick, Elizabeth; Korn, Abner; Nalubwama, Hadija; Knight, Sharon; Miller, Suellen

    2015-01-01

    Background Obstetric fistula is a debilitating birth injury that affects an estimated 2?3 million women globally, most in sub-Saharan Africa and Asia. The urinary and/or fecal incontinence associated with fistula affects women physically, psychologically and socioeconomically. Surgical management of fistula is available with clinical success rates ranging from 65?95 %. Previous research on fistula repair outcomes has focused primarily on clinical outcomes without considering the broader goal ...

  12. Parameters for determining inoculated pack/challenge study protocols.

    Science.gov (United States)

    2010-01-01

    The National Advisory Committee on Microbiological Criteria for Foods developed guidelines for conducting challenge studies on pathogen inhibition and inactivation studies in a variety of foods. The document is intended for use by the food industry, including food processors, food service operators, and food retailers; federal, state, and local food safety regulators; public health officials; food testing laboratories; and process authorities. The document is focused on and limited to bacterial inactivation and growth inhibition and does not make specific recommendations with respect to public health. The Committee concluded that challenge studies should be designed considering the most current advances in methodologies, current thinking on pathogens of concern, and an understanding of the product preparation, variability, and storage conditions. Studies should be completed and evaluated under the guidance of an expert microbiologist in a qualified laboratory and should include appropriate statistical design and data analyses. This document provides guidelines for choice of microorganisms for studies, inoculum preparation, inoculum level, methods of inoculation, incubation temperatures and times, sampling considerations, and interpreting test results. Examples of appropriately designed growth inhibition and inactivation studies are provided.

  13. Assessment of competence in video-assisted thoracoscopic surgery lobectomy: A Danish nationwide study.

    Science.gov (United States)

    Petersen, René Horsleben; Gjeraa, Kirsten; Jensen, Katrine; Møller, Lars Borgbjerg; Hansen, Henrik Jessen; Konge, Lars

    2018-04-18

    Competence in video-assisted thoracoscopic surgery lobectomy has previously been established on the basis of numbers of procedures performed, but this approach does not ensure competence. Specific assessment tools, such as the newly developed video-assisted thoracoscopic surgery lobectomy assessment tool, allow for structured and objective assessment of competence. Our aim was to provide validity evidence for the video-assisted thoracoscopic surgery lobectomy assessment tool. Video recordings of 60 video-assisted thoracoscopic surgery lobectomies performed by 18 thoracic surgeons were rated using the video-assisted thoracoscopic surgery lobectomy assessment tool. All 4 centers of thoracic surgery in Denmark participated in the study. Two video-assisted thoracoscopic surgery experts rated the videos. They were blinded to surgeon and center. The total internal consistency reliability Cronbach's alpha was 0.93. Inter-rater reliability between the 2 raters was Pearson's r = 0.71 (P video-assisted thoracoscopic surgery lobectomy assessment tool scores for the 10 procedures performed by beginners were 22.1 (standard deviation [SD], 8.6) for the 28 procedures performed by the intermediate surgeons, 31.2 (SD, 4.4), and for the 20 procedures performed by experts 35.9 (SD, 2.9) (P better than intermediates (P better than beginners (P video-assisted thoracoscopic surgery lobectomy (video-assisted thoracoscopic surgery lobectomy assessment tool) in a clinical setting. The discriminatory ability among expert surgeons, intermediate surgeons, and beginners proved highly significant. The video-assisted thoracoscopic surgery lobectomy assessment tool could be an important aid in the future training and certification of thoracic surgeons. Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  14. Sarcopenia and its determinants among Iranian elderly (SARIR: study protocol

    Directory of Open Access Journals (Sweden)

    Hashemi Rezvan

    2012-11-01

    Full Text Available Abstract Background The elderly populations increase in world because of improved health status in communities, so health and independency of seniors has become and will be one of the main priorities of public health systems. Ageing have been associated with changes in body composition, including loss of muscle mass, loss of bone mass and increase fat mass. Involuntary age related loss of muscle mass, sarcopenia,has been linked to functional impairment and physical disability. Several definitions for sarcopenia have been presented based on the method of measuring body composition, but an internationally accepted definition doesn’t presently exist yet. In 2010, the European working group on sarcopenia developed a new definition for sarcopenia according to measure muscle mass and muscle function. Several studies have been done about sarcopenia in world, but to our knowledge this study is the first in Iran which is one of the largest countries of the Middle East that faces a fast growing elderly population. The aim of this study is to evaluate sarcopenia and related risk factors in Iran according new definition of sarcopenia. Methods This study will be conducted in two phase among elderly men and women over 55 years in the 6th district of TehranThe first phase will be a population-based cross-sectional study to determine the frequency of sarcopenia in the study population, and to conduct case finding for the second phase. The second phase will be a case–control study to comparison the metabolic and inflammatory factors in sarcopenic and non sarcopenic groups. The association between sarcopenia and major dietary pattern will be evaluated using factor analysis. Conclusion This study is the first study that evaluates sarcopenia and its risk factor in Iranian elderlies. We discuss details of how we collect the data and appropriate instruments to measure muscle mass, muscle power and muscle strength, and suitable cut- off to define sarcopenia in

  15. Older Persons’ Transitions in Care (OPTIC: a study protocol

    Directory of Open Access Journals (Sweden)

    Cummings Greta G

    2012-12-01

    Full Text Available Abstract Background Changes in health status, triggered by events such as infections, falls, and geriatric syndromes, are common among nursing home (NH residents and necessitate transitions between NHs and Emergency Departments (EDs. During transitions, residents frequently experience care that is delayed, unnecessary, not evidence-based, potentially unsafe, and fragmented. Furthermore, a high proportion of residents and their family caregivers report substantial unmet needs during transitions. This study is part of a program of research whose overall aim is to improve quality of care for frail older adults who reside in NHs. The purpose of this study is to identify successful transitions from multiple perspectives and to identify organizational and individual factors related to transition success, in order to inform improvements in care for frail elderly NH residents during transitions to and from acute care. Specific objectives are to: 1. define successful and unsuccessful elements of transitions from multiple perspectives; 2. develop and test a practical tool to assess transition success; 3. assess transition processes in a discrete set of transfers in two study sites over a one year period; 4. assess the influence of organizational factors in key practice locations, e.g., NHs, emergency medical services (EMS, and EDs, on transition success; and 5. identify opportunities for evidence-informed management and quality improvement decisions related to the management of NH – ED transitions. Methods/Design This is a mixed-methods observational study incorporating an integrated knowledge translation (IKT approach. It uses data from multiple levels (facility, care unit, individual and sources (healthcare providers, residents, health records, and administrative databases. Discussion Key to study success is operationalizing the IKT approach by using a partnership model in which the OPTIC governance structure provides for team decision-makers and

  16. Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions.

    Science.gov (United States)

    Taylor, Lauren J; Rathouz, Paul J; Berlin, Ana; Brasel, Karen J; Mosenthal, Anne C; Finlayson, Emily; Cooper, Zara; Steffens, Nicole M; Jacobson, Nora; Buffington, Anne; Tucholka, Jennifer L; Zhao, Qianqian; Schwarze, Margaret L

    2017-05-29

    Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations. This Patient-Centered Outcomes Research Institute-funded trial will be conducted at five academic medical centres in the USA. Study participants include surgeons who routinely perform vascular or oncological surgery, their patients and families. We aim to enrol 40 surgeons and 480 patients over 24 months. Patients age 65 or older who see a study-enrolled surgeon to discuss a vascular or oncological problem that could be treated with high-risk surgery will be enrolled at their clinic visit. Together with stakeholders, we developed a QPL intervention addressing preoperative communication needs of patients considering major surgery. Guided by the theories of self-determination and relational autonomy, this intervention is designed to increase patient activation. Patients will receive the QPL brochure and a letter from their surgeon encouraging its use. Using audio recordings of the outpatient surgical consultation, patient and family member questionnaires administered at three time points and retrospective chart review, we will compare the effectiveness of the QPL intervention to usual care with respect to the following primary outcomes: patient engagement in decision making, psychological well-being and post-treatment regret for patients and families, and interpersonal and intrapersonal conflict relating to treatment decisions and treatments received. Approvals have been granted by the

  17. EVA Human Health and Performance Benchmarking Study Overview and Development of a Microgravity Protocol

    Science.gov (United States)

    Norcross, Jason; Jarvis, Sarah; Bekdash, Omar; Cupples, Scott; Abercromby, Andrew

    2017-01-01

    The primary objective of this study is to develop a protocol to reliably characterize human health and performance metrics for individuals working inside various EVA suits under realistic spaceflight conditions. Expected results and methodologies developed during this study will provide the baseline benchmarking data and protocols with which future EVA suits and suit configurations (e.g., varied pressure, mass, center of gravity [CG]) and different test subject populations (e.g., deconditioned crewmembers) may be reliably assessed and compared. Results may also be used, in conjunction with subsequent testing, to inform fitness-for-duty standards, as well as design requirements and operations concepts for future EVA suits and other exploration systems.

  18. Impact of age on the selection of nuclear cardiology stress protocols: The INCAPS (IAEA nuclear cardiology protocols) study.

    Science.gov (United States)

    Al-Mallah, Mouaz H; Pascual, Thomas N B; Mercuri, Mathew; Vitola, João V; Karthikeyan, Ganesan; Better, Nathan; Dondi, Maurizio; Paez, Diana; Einstein, Andrew J

    2018-05-15

    There is growing concern about radiation exposure from nuclear myocardial perfusion imaging (MPI), particularly among younger patients who are more prone to develop untoward effects of ionizing radiation, and hence US and European professional society guidelines recommend age as a consideration in weighing radiation risk from MPI. We aimed to determine how patient radiation doses from MPI vary across age groups in a large contemporary international cohort. Data were collected as part of a global cross-sectional study of centers performing MPI coordinated by the International Atomic Energy Agency (IAEA). Sites provided information on each MPI study completed during a single week in March-April 2013. We compared across age groups laboratory adherence to pre-specified radiation-related best practices, radiation effective dose (ED; a whole-body measure reflecting the amount of radiation to each organ and its relative sensitivity to radiation's deleterious effects), and the proportion of patients with ED ≤ 9 mSv, a target level specified in guidelines. Among 7911 patients undergoing MPI in 308 laboratories in 65 countries, mean ED was 10.0 ± 4.5 mSv with slightly higher exposure among younger age groups (trend p value < 0.001). There was no difference in the proportion of patients with ED ≤ 9 mSv across age groups, or in adherence to best practices based on the median age of patients in a laboratory. In contemporary nuclear cardiology practice, the age of the patient appears not to impact protocol selection and radiation dose, contrary to professional society guidelines. Copyright © 2018. Published by Elsevier B.V.

  19. Minimally invasive strabismus surgery versus paralimbal approach: A randomized, parallel design study is minimally invasive strabismus surgery worth the effort?

    Directory of Open Access Journals (Sweden)

    Richa Sharma

    2014-01-01

    Full Text Available Introduction : Minimal access surgery is common in all fields of medicine. We compared a new minimally invasive strabismus surgery (MISS approach with a standard paralimbal strabismus surgery (SPSS approach in terms of post-operative course. Materials and Methods: This parallel design study was done on 28 eyes of 14 patients, in which one eye was randomized to MISS and the other to SPSS. MISS was performed by giving two conjunctival incisions parallel to the horizontal rectus muscles; performing recession or resection below the conjunctival strip so obtained. We compared post-operative redness, congestion, chemosis, foreign body sensation (FBS, and drop intolerance (DI on a graded scale of 0 to 3 on post-operative day 1, at 2-3 weeks, and 6 weeks. In addition, all scores were added to obtain a total inflammatory score (TIS. Statistical Analysis: Inflammatory scores were analyzed using Wilcoxon′s signed rank test. Results: On the first post-operative day, only FBS (P = 0.01 and TIS (P = 0.04 showed significant difference favoring MISS. At 2-3 weeks, redness (P = 0.04, congestion (P = 0.04, FBS (P = 0.02, and TIS (P = 0.04 were significantly less in MISS eye. At 6 weeks, only redness (P = 0.04 and TIS (P = 0.05 were significantly less. Conclusion: MISS is more comfortable in the immediate post-operative period and provides better cosmesis in the intermediate period.

  20. Outcomes From an Enhanced Recovery Program for Laparoscopic Gastric Surgery

    DEFF Research Database (Denmark)

    Wong-Chong, Nathalie; Kehlet, Henrik; Grantcharov, Teodor P

    2016-01-01

    PURPOSE: To examine the outcomes from an enhanced recovery after surgery (ERAS) program for laparoscopic gastric surgery. MATERIALS AND METHODS: This was a prospective study of patients undergoing elective laparoscopic gastric resection in an ERAS protocol at a single institution between 2008 and...

  1. The Siblings With Ischemic Stroke Study (SWISS Protocol

    Directory of Open Access Journals (Sweden)

    Hardy John

    2002-02-01

    Full Text Available Abstract Background Family history and twins studies suggest an inherited component to ischemic stroke risk. Candidate gene association studies have been performed but have limited capacity to identify novel risk factor genes. The Siblings With Ischemic Stroke Study (SWISS aims to conduct a genome-wide scan in sibling pairs concordant or discordant for ischemic stroke to identify novel genetic risk factors through linkage analysis. Methods Screening at multiple clinical centers identifies patients (probands with radiographically confirmed ischemic stroke and a family history of at least 1 living full sibling with stroke. After giving informed consent, without violating privacy among other family members, the proband invites siblings concordant and discordant for stroke to participate. Siblings then contact the study coordinating center. The diagnosis of ischemic stroke in potentially concordant siblings is confirmed by systematic centralized review of medical records. The stroke-free status of potentially discordant siblings is confirmed by validated structured telephone interview. Blood samples for DNA analysis are taken from concordant sibling pairs and, if applicable, from 1 discordant sibling. Epstein-Barr virus-transformed lymphoblastoid cell lines are created, and a scan of the human genome is planned. Discussion Conducting adequately powered genomics studies of stroke in humans is challenging because of the heterogeneity of the stroke phenotype and the difficulty of obtaining DNA samples from clinically well-characterized members of a cohort of stroke pedigrees. The multicentered design of this study is intended to efficiently assemble a cohort of ischemic stroke pedigrees without invoking community consent or using cold-calling of pedigree members.

  2. The Spectrum of Histopathological Changes in the Renal Allograft - a 12 Months Protocol Biopsy Study

    Directory of Open Access Journals (Sweden)

    Galina Severova-Andreevska

    2018-03-01

    CONCLUSION: Our 12-month protocol biopsy study revealed the presence of different forms of mixed subclinical rejection. Use of recent BANFF classification and scoring system enables more precise diagnosis and subsequently different approach to the further treatment of the KTR. More correlative long-term studies including Anti HLA antibodies and Endothelial Cell Activation- Associated Transcripts (ENDAT are needed.

  3. Carotid body paragangliomas : a systematic study on management with surgery and radiotherapy

    NARCIS (Netherlands)

    Suarez, Carlos; Rodrigo, Juan P.; Mendenhall, William M.; Hamoir, Marc; Silver, Carl E.; Gregoire, Vincent; Strojan, Primoz; Neumann, Hartmut P. H.; Obholzer, Rupert; Offergeld, Christian; Langendijk, Johannes A.; Rinaldo, Alessandra; Ferlito, Alfio

    The definitive universally accepted treatment for carotid body tumors (CBT) is surgery. The impact of surgery on cranial nerves and the carotid artery has often been underestimated. Alternatively, a few CBTs have been followed without treatment or irradiation. The goal of this study is to summarize

  4. Children Coping with Surgery through Drawings: A Case Study from a Parenting Class

    Science.gov (United States)

    Broecher, Joachim

    2012-01-01

    This case study illustrates how parents can help their children cope with the fear and pain of surgery by engaging them in expressive drawing. As part of a parenting class that utilized art therapy techniques, a father shared his 6-year-old son's spontaneous drawings that had been created directly before and after surgery. Through guidance by the…

  5. Incidence and prognostic factors for postoperative frozen shoulder after shoulder surgery: a prospective cohort study.

    Science.gov (United States)

    Koorevaar, Rinco C T; Van't Riet, Esther; Ipskamp, Marcel; Bulstra, Sjoerd K

    2017-03-01

    Frozen shoulder is a potential complication after shoulder surgery. It is a clinical condition that is often associated with marked disability and can have a profound effect on the patient's quality of life. The incidence, etiology, pathology and prognostic factors of postoperative frozen shoulder after shoulder surgery are not known. The purpose of this explorative study was to determine the incidence of postoperative frozen shoulder after various operative shoulder procedures. A second aim was to identify prognostic factors for postoperative frozen shoulder after shoulder surgery. 505 consecutive patients undergoing elective shoulder surgery were included in this prospective cohort study. Follow-up was 6 months after surgery. A prediction model was developed to identify prognostic factors for postoperative frozen shoulder after shoulder surgery using the TRIPOD guidelines. We nominated five potential predictors: gender, diabetes mellitus, type of physiotherapy, arthroscopic surgery and DASH score. Frozen shoulder was identified in 11% of the patients after shoulder surgery and was more common in females (15%) than in males (8%). Frozen shoulder was encountered after all types of operative procedures. A prediction model based on four variables (diabetes mellitus, specialized shoulder physiotherapy, arthroscopic surgery and DASH score) discriminated reasonably well with an AUC of 0.712. Postoperative frozen shoulder is a serious complication after shoulder surgery, with an incidence of 11%. Four prognostic factors were identified for postoperative frozen shoulder: diabetes mellitus, arthroscopic surgery, specialized shoulder physiotherapy and DASH score. The combination of these four variables provided a prediction rule for postoperative frozen shoulder with reasonable fit. Level II, prospective cohort study.

  6. Michigan dioxin exposure study: planning phase and protocol development

    Energy Technology Data Exchange (ETDEWEB)

    Adriaens, P. [Univ. of Michigan, Coll. of Engineering, Ann Arbor (United States); Garabrant, D.; Franzblau, A. [Univ. of Michigan, School for Public Health, Ann Arbor (United States); Gillespie, B. [Univ. of Michigan, Center for Statistics, Ann Arbor (United States); Lepowski, J. [Univ. of Michigan, Inst. for Social Research, Ann Arbor (United States)

    2004-09-15

    The University of Michigan has been commissioned to conduct one of the largest environmental epidemiology studies (700 residents) of dioxin exposure among the population of Michigan to describe the pattern of serum dioxin levels among adults and to understand the factors that explain variation in serum dioxin levels. The study is being undertaken (2004-2006) in response to concerns among the population of Midland and Saginaw Counties that dioxins from the Dow Chemical Company facilities in Midland have resulted in contamination of areas of the City of Midland and have contaminated the sediments in the Tittabawassee River flood plain. There is concern that body burdens of dioxins are elevated because of environmental contamination. The appropriate way to respond to these concerns is to measure the serum dioxin levels in a probability sample of the population in the region and to estimate each individual's past exposure to various factors that are believed to contribute to the body burden of dioxins. By measuring factors that reflect potential exposure to dioxins through air, water, soil, food intake, occupations, and various recreational activities, we can identify the factors that correlate with (and explain variation in) serum dioxin levels. The central goal of the study is to determine which factors explain variation in serum dioxin levels, and to quantify how much variation each factor explains. This paper provides information on the planning phase, study scope and objectives.

  7. An open-label pilot study of pulsed electromagnetic field therapy in the treatment of failed back surgery syndrome pain

    Directory of Open Access Journals (Sweden)

    Harper WL

    2014-12-01

    Full Text Available Wayne L Harper,1 William K Schmidt,2 Nicole J Kubat,3 Richard A Isenberg41Tarheel Clinical Research, LLC, Raleigh, NC, USA; 2NorthStar Consulting, LLC, Davis, CA, USA; 3Nicole Kubat Consulting, Pasadena, CA, USA; 4Regenesis Biomedical, Inc., Scottsdale, AZ, USAAbstract: Persistent pain following back surgery remains a major treatment challenge. The primary objective of this open-label exploratory study was to investigate the analgesic effectiveness of pulsed electromagnetic field therapy administered twice daily over a 45-day period in 34 subjects (68% female with persistent or recurrent pain following back surgery. A secondary goal was to guide the design of future randomized controlled trials that could target responsive subpopulations. All predefined primary and secondary outcomes, including change in pain intensity (PI, physical function (Oswestry Disability Index, analgesic consumption, and overall well-being (Patient Global Impression of Change, are reported. A responder analysis (≥30% reduction in PI versus baseline was added as a post hoc evaluation. Safety outcomes, as well as results of a cost-avoidance survey, are also summarized. Of the 30 per-protocol subjects who completed the study, 33% reported a clinically meaningful (≥30% reduction in PI. A higher response rate (60% was reported for subjects who had undergone discectomy prior to the trial compared to subjects who had undergone other types of surgical interventions (decompression or fusion without discectomy. Improvements in PI were paralleled by improvements in secondary outcomes. Relative to baseline, responders reported an average 44% and 55% reduction in back PI and leg PI (respectively, and an average 13% improvement in Oswestry Disability Index scores. In the per-protocol population, 50% of responders and 12% of nonresponders reported less analgesia consumption at the end of treatment versus baseline. Sixty-seven percent of per-protocol responders and 0% of

  8. Cognitive and Neurophysiological Recovery Following Electroconvulsive Therapy: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Ben J. A. Palanca

    2018-05-01

    Full Text Available Electroconvulsive therapy (ECT employs the elective induction of generalizes seizures as a potent treatment for severe psychiatric illness. As such, ECT provides an opportunity to rigorously study the recovery of consciousness, reconstitution of cognition, and electroencephalographic (EEG activity following seizures. Fifteen patients with major depressive disorder refractory to pharmacologic therapy will be enrolled (Clinicaltrials.gov, NCT02761330. Adequate seizure duration will be confirmed following right unilateral ECT under etomidate anesthesia. Patients will then undergo randomization for the order in which they will receive three sequential treatments: etomidate + ECT, ketamine + ECT, and ketamine + sham ECT. Sessions will be repeated in the same sequence for a total of six treatments. Before each session, sensorimotor speed, working memory, and executive function will be assessed through a standardized cognitive test battery. After each treatment, the return of purposeful responsiveness to verbal command will be determined. At this point, serial cognitive assessments will begin using the same standardized test battery. The presence of delirium and changes in depression severity will also be ascertained. Sixty-four channel EEG will be acquired throughout baseline, ictal, and postictal epochs. Mixed-effects models will correlate the trajectories of cognitive recovery, clinical outcomes, and EEG metrics over time. This innovative research design will answer whether: (1 time to return of responsiveness will be prolonged with ketamine + ECT compared with ketamine + sham ECT; (2 time of restoration to baseline function in each cognitive domain will take longer after ketamine + ECT than after ketamine + sham ECT; (3 postictal delirium is associated with delayed restoration of baseline function in all cognitive domains; and (4 the sequence of reconstitution of cognitive domains following the three treatments in this study is similar to that

  9. The Comparative Study Some of Reactive and Proactive Routing Protocols in The Wireless Sensor Network

    Directory of Open Access Journals (Sweden)

    Anas Ali Hussien

    2018-02-01

    Full Text Available The wireless sensor network (WSN consists mostly of a large number of nodes in a large area where not all nodes are directly connected. The applications of comprise a wide variety of scenarios.The mobile nodes are free to move because this network has selfــstructured topology. Routing protocols are responsible for detecting and maintaining paths in the network, and it classified into reactive (OnـــDemand, proactive (Table driven, and hybrid. In this paper represents a performance study of some WSN routing protocols: the Dynamic Source Routing (DSR, Ad hoc On-Demand Distance Vector (AODV, and Destination-Sequenced Distance-Vector (DSDV. The comparison made according to important metrics like packet delivery ratio (PDR, total packets dropped, Average end-to-end delay (Avg EED, and normalized routing load under the Transmission Control Protocol (TCP and User Datagram Protocol (UDP traffic connection and with varying number of nodes, pause time; and  varying speed. In this work used (NSــ2.35 that installed on (Ubuntu 14.04 operating system to implementing the scenario. Conclude that the DSR has better performance in TCP connection; while the DSDV has better performance in UDP protocol.

  10. Shortened protocol in practical [11C]SA4503-PET studies for sigma1 receptor quantification

    International Nuclear Information System (INIS)

    Sakata, Muneyuki; Kimura, Yuichi; Ishikawa, Masatomo; Oda, Keiichi; Ishii, Kenji; Ishiwata, Kiichi; Naganawa, Mika; Hashimoto, Kenji; Chihara, Kunihiro

    2008-01-01

    In practical positron emission tomography (PET) diagnosis, a shortened protocol is preferred for patients with brain disorders. In this study, the applicability of a shortened protocol as an alternative to the 90-min PET scan with [ 11 C]SA4503 for quantitative sigma 1 receptor measurement was investigated. Tissue time-activity curves of 288 regions of interest in the brain from 32 [ 11 C]SA4503-PET scans of 16 healthy subjects prior to and following administration of a selective serotonin reuptake inhibitor (fluvoxamine or paroxetine) were applied to two algorithms of quantitative analysis; binding potential (BP) was derived from compartmental analysis based on nonlinear estimation, and total distribution volume (tDV) was derived from Logan plot analysis. As a result, although both BP and tDV tended to be underestimated by the shortened method, the estimates from the shortened protocol had good linear relationships with those of the full-length protocol. In conclusion, if approximately 10% differences in the estimated results are acceptable for a specific purpose, then a 60-min measurement protocol is capable of providing reliable results. (author)

  11. Protocol Development and Preliminary Toxicity Study of CBRN Nanomaterials

    Science.gov (United States)

    2013-12-05

    FBS) were purchased from ATCC and used for growing cells. 5.2.3 Positive Control The positive control, sodium lauryl sulfate (SLS), (Cat. # 71736 for 10...Inc.; New Castle, DE). Toxicology Study No. 87-XE-0EJ5-11 (FY12 Continuation) 5 5.1.2 Positive Control Zinc sulfate is recommended as a standard or...Inc.(Austin, TX). • Nano Sodium Bicarbonate is a component in the formulation being investigated as a replacement fire extinguishing agent for the Halon

  12. The effect of expedited rotator cuff surgery in injured workers: a case-control study.

    Science.gov (United States)

    Razmjou, Helen; Lincoln, Sandra; Boljanovic, Dragana; Gallay, Stephen; Henry, Patrick; Richards, Robin R; Holtby, Richard

    2017-07-01

    Expediting rotator cuff surgery is expected to facilitate recovery and return to work in injured workers. This case-control study examined the effect of expedited rotator cuff surgery on recovery and work status in injured workers. Injured workers who had undergone an expedited rotator cuff surgery funded by parallel-pay insurance (study group) were compared with workers who had used the public health insurance (control group) while adjusting for sex, age, severity of pathology, and follow-up period. Disability was measured by the American Shoulder and Elbow Surgeons (ASES) Standardized Assessment Form score. The percentage of patients who exceeded the minimal clinically important difference of 17 points in the ASES was calculated. The study group waited less time to have surgery than the control group (P workers who underwent expedited rotator cuff surgery reported less disability and had a more successful return to work after surgery than injured workers who waited longer for specialist assessment and surgery within the public health system. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  13. Standardization of a Videofluoroscopic Swallow Study Protocol to Investigate Dysphagia in Dogs.

    Science.gov (United States)

    Harris, R A; Grobman, M E; Allen, M J; Schachtel, J; Rawson, N E; Bennett, B; Ledyayev, J; Hopewell, B; Coates, J R; Reinero, C R; Lever, T E

    2017-03-01

    Videofluoroscopic swallow study (VFSS) is the gold standard for diagnosis of dysphagia in veterinary medicine but lacks standardized protocols that emulate physiologic feeding practices. Age impacts swallow function in humans but has not been evaluated by VFSS in dogs. To develop a protocol with custom kennels designed to allow free-feeding of 3 optimized formulations of contrast media and diets that address limitations of current VFSS protocols. We hypothesized that dogs evaluated by a free-feeding VFSS protocol would show differences in objective swallow metrics based on age. Healthy juvenile, adult, and geriatric dogs (n = 24). Prospective, experimental study. Custom kennels were developed to maintain natural feeding behaviors during VFSS. Three food consistencies (thin liquid, pureed food, and dry kibble) were formulated with either iohexol or barium to maximize palatability and voluntary prehension. Dogs were evaluated by 16 swallow metrics and compared across age groups. Development of a standardized VFSS protocol resulted in successful collection of swallow data in healthy dogs. No significant differences in swallow metrics were observed among age groups. Substantial variability was observed in healthy dogs when evaluated under these physiologic conditions. Features typically attributed to pathologic states, such as gastric reflux, were seen in healthy dogs. Development of a VFSS protocol that reflects natural feeding practices may allow emulation of physiology resulting in clinical signs of dysphagia. Age did not result in significant changes in swallow metrics, but additional studies are needed, particularly in light of substantial normal variation. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  14. Understanding context in knowledge translation: a concept analysis study protocol.

    Science.gov (United States)

    Squires, Janet E; Graham, Ian D; Hutchinson, Alison M; Linklater, Stefanie; Brehaut, Jamie C; Curran, Janet; Ivers, Noah; Lavis, John N; Michie, Susan; Sales, Anne E; Fiander, Michelle; Fenton, Shannon; Noseworthy, Thomas; Vine, Jocelyn; Grimshaw, Jeremy M

    2015-05-01

    To conduct a concept analysis of clinical practice contexts (work environments) that facilitate or militate against the uptake of research evidence by healthcare professionals in clinical practice. This will involve developing a clear definition of context by describing its features, domains and defining characteristics. The context where clinical care is delivered influences that care. While research shows that context is important to knowledge translation (implementation), we lack conceptual clarity on what is context, which contextual factors probably modify the effect of knowledge translation interventions (and hence should be considered when designing interventions) and which contextual factors themselves could be targeted as part of a knowledge translation intervention (context modification). Concept analysis. The Walker and Avant concept analysis method, comprised of eight systematic steps, will be used: (1) concept selection; (2) determination of aims; (3) identification of uses of context; (4) determination of defining attributes of context; (5) identification/construction of a model case of context; (6) identification/construction of additional cases of context; (7) identification/construction of antecedents and consequences of context; and (8) definition of empirical referents of context. This study is funded by the Canadian Institutes of Health Research (January 2014). This study will result in a much needed framework of context for knowledge translation, which identifies specific elements that, if assessed and used to tailor knowledge translation activities, will result in increased research use by nurses and other healthcare professionals in clinical practice, ultimately leading to better patient care. © 2014 John Wiley & Sons Ltd.

  15. Regional South Australia Health (RESONATE) survey: study protocol

    Science.gov (United States)

    Jones, Martin; Gillam, Marianne; May, Esther

    2018-01-01

    Introduction Access to quality healthcare services is considered a moral right. However, for people living in regional locations, timely access to the services that they need may not always be possible because of structural and attitudinal barriers. This suggests that people living in regional areas may have unmet healthcare needs. The aim of this research will be to examine the healthcare needs, expectations and experiences of regional South Australians. Methods and analysis The Regional South Australia Health (RESONATE) survey is a cross-sectional study of adult health consumers living in any private or non-private dwelling, in any regional, rural, remote or very remote area of South Australia and with an understanding of written English. Data will be collected using a 45-item, multidimensional, self-administered instrument, designed to measure healthcare need, barriers to healthcare access and health service utilisation, attitudes, experiences and satisfaction. The instrument has demonstrated acceptable psychometric properties, including good content validity and internal reliability, good test–retest reliability and a high level of acceptability. The survey will be administered online and in hard-copy, with at least 1832 survey participants to be recruited over a 12-month period, using a comprehensive, multimodal recruitment campaign. Ethics and dissemination The study has been reviewed and approved by the Human Research Ethics Committee of the University of South Australia. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media, the internet and various community/stakeholder engagement activities. PMID:29654014

  16. The Living Donor Lost Wages Trial: Study Rationale and Protocol.

    Science.gov (United States)

    Rodrigue, James R; Fleishman, Aaron; Carroll, Michaela; Evenson, Amy R; Pavlakis, Martha; Mandelbrot, Didier A; Baliga, Prabhakar; Howard, David H; Schold, Jesse D

    2018-03-01

    This paper describes the background, rationale, and design of an NIH-funded, single-center study to test the impact of offering reimbursement for donor lost wages incurred during the post-nephrectomy recovery period on the live donor kidney transplant (LDKT) rate in newly evaluated kidney transplant candidates, to examine whether offering reimbursement for donor lost wages reduces racial disparity in LDKT rates, and to determine whether higher reimbursement amounts lead to higher LDKT rates. LDKT is the optimal treatment for renal failure. However, living kidney donation has declined in the past decade, particularly among men, younger adults, blacks, and low-income adults. There is evidence that donation-related costs may deter both transplant candidates and potential donors from considering LDKT. Lost wages is a major source of financial loss for some living donors and, unlike travel and lodging expenses, is not reimbursed by financial assistance programs. The study addresses the transplant community's call to reduce the financial burden of living donation and examine its impact on LDKT rates. Findings have the potential to influence policy, clinical practice, LDKT access, and income-related and racial disparities in LDKT and living donation.

  17. Cancer incidence in kidney transplant recipients: a study protocol

    International Nuclear Information System (INIS)

    Pita-Fernandez, Salvador; Valdes-Cañedo, Francisco; Pertega-Diaz, Sonia; Seoane-Pillado, Maria Teresa; Seijo-Bestilleiro, Rocio

    2009-01-01

    Different publications show an increased incidence of neoplasms in renal transplant patients. The objective of this study is to determine the incidence of cancer in the recipients of renal transplants performed in the A Coruña Hospital (Spain) during the period 1981–2007. During the study period 1967 kidney transplants were performed, corresponding to 1710 patients. Patients with neoplasms prior to the transplant will be excluded (n = 38). A follow-up study was carried out in order to estimate cancer incidence after transplantation. For each patient, information included donor and recipient characteristics, patients and graft survival and cancer incidence after transplantation. Incident cancer is considered as new cases of cancer after the transplant with anatomopathological confirmation. Their location will be classified according to the ICD-9. The analysis will be calculated using the indirect standardisation method. Age-adjusted cancer incidence rates in the Spanish general population will be obtained from the Carlos III Health Institute, the National Epidemiology Centre of the Ministry of Science and Technology. Crude first, second and third-year post-transplantation cancer incidence rates will be calculated for male and female recipients. The number of cases of cancer at each site will be calculated from data in the clinical records. The expected number of cancers will be calculated from data supplied by the Carlos III Health Institute. For each tumour location we will estimate the standardized incidence ratios (SIRs), using sex-specific cancer incidence rates, by dividing the incidence rate for the transplant patients by the rate of the general population. The 95% confidence intervals of the SIRs and their associated p-values will be calculated by assuming that the observed cancers follow a Poisson distribution. Stratified analysis will be performed to examine the variation in the SIRs with sex and length of follow-up. Competing risk survival analysis

  18. Utility of melatonin to treat surgical stress after major vascular surgery--a safety study

    DEFF Research Database (Denmark)

    Kücükakin, Bülent; Lykkesfeldt, Jens; Nielsen, Hans Jørgen

    2008-01-01

    of reducing oxidative damage. The aim of this pilot study was to evaluate the safety of various doses of melatonin administered during or after surgery and to monitor the changes in biomarkers of oxidative stress and inflammation during the pre-, intra-, and postoperative period. Six patients undergoing......Surgery for abdominal aortic aneurysm is associated with elevated oxidative stress. As an antioxidant in animal and human studies, melatonin has the potential of ameliorating some of this oxidative stress, but melatonin has never been administered to adults during surgery for the purpose......-reactive protein (CRP) were also measured for 4 days after surgery. Melatonin administration did not change hemodynamic parameters (mean arterial pressure or pulse rate) during surgery (P = 0.499 and 0.149, respectively), but oxidative stress parameters (MDA and AA) decreased significantly (P = 0.014 and 0...

  19. Utility of melatonin to treat surgical stress after major vascular surgery - a safety study

    DEFF Research Database (Denmark)

    Kücükakin, Bülent; Lykkesfeldt, Jens; Nielsen, Hans Jørgen

    2008-01-01

    of reducing oxidative damage. The aim of this pilot study was to evaluate the safety of various doses of melatonin administered during or after surgery and to monitor the changes in biomarkers of oxidative stress and inflammation during the pre-, intra- and postoperative period. Six patients undergoing aortic......Surgery for abdominal aortic aneurysm is associated with elevated oxidative stress. As an antioxidant in animal and human studies, melatonin has the potential of ameliorating some of this oxidative stress, but melatonin has never been administered to adults during surgery for the purpose......) were also measured for four days after surgery. Melatonin administration did not change hemodynamic parameters (mean arterial pressure or pulse rate) during surgery (P=0.499 and 0.149, respectively), but oxidative stress parameters (MDA and AA) decreased significantly (P=0.014 and 0.001, respectively...

  20. Application and study of conjunctival sac disinfectants in ophthalmic surgeries

    Directory of Open Access Journals (Sweden)

    Yan-Fei Luo

    2016-01-01

    Full Text Available Postoperative endophthalmitis is the most serious complications of ophthalmic surgeries. Conjunctival sac disinfection is currently recognized as an effectively important way to reduce the risk of endophthalmitis. At present, there are some disinfectants has been used in clinic or in the researches:mercury agent, gentamicin, povidone iodine and acid electrolytic water. All kinds of disinfectants play the role of disinfection by different ways. Povidone iodine is the most widely used conjunctival sac disinfectant. Mercurial and gentamicin have been rarely used because they pollute the environment, are easy to cause drug resistant bacteria, localized side reactions and so on. The acid electrolyte water is not used in clinic at present. With the popularization and development of the ophthalmic surgeries, the ophthalmologists have become more and more concerned about the postoperative eye comfort, the research and application of conjunctival sac disinfectant in the future will continue to be updated and developed.

  1. Children's vomiting following posterior fossa surgery: A retrospective study

    Directory of Open Access Journals (Sweden)

    Dundon Belinda

    2009-07-01

    Full Text Available Abstract Background Nausea and vomiting is a problem for children after neurosurgery and those requiring posterior fossa procedures appear to have a high incidence. This clinical observation has not been quantified nor have risk factors unique to this group of children been elucidated. Methods A six year retrospective chart audit at two Canadian children's hospitals was conducted. The incidence of nausea and vomiting was extracted. Hierarchical multivariable logistic regression was used to quantify risk and protective factors at 120 hours after surgery and early vs. late vomiting. Results The incidence of vomiting over a ten day postoperative period was 76.7%. Documented vomiting ranged from single events to greater than 20 over the same period. In the final multivariable model: adolescents (age 12 to Conclusion The incidence of vomiting in children after posterior fossa surgery is sufficient to consider all children requiring these procedures to be at high risk for POV. Nausea requires better assessment and documentation.

  2. Replication protocol analysis: a method for the study of real-world design thinking

    DEFF Research Database (Denmark)

    Galle, Per; Kovacs, L. B.

    1996-01-01

    Given the brief of an architectural competition on site planning, and the design awarded the first prize, the first author (trained as an architect but not a participant in the competition) produced a line of reasoning that might have led from brief to design. In the paper, such ‘design replication......’ is refined into a method called ‘replication protocol analysis’ (RPA), and discussed from a methodological perspective of design research. It is argued that for the study of real-world design thinking this method offers distinct advantages over traditional ‘design protocol analysis’, which seeks to capture...

  3. FIRE (facilitating implementation of research evidence: a study protocol

    Directory of Open Access Journals (Sweden)

    Seers Kate

    2012-03-01

    Full Text Available Abstract Background Research evidence underpins best practice, but is not always used in healthcare. The Promoting Action on Research Implementation in Health Services (PARIHS framework suggests that the nature of evidence, the context in which it is used, and whether those trying to use evidence are helped (or facilitated affect the use of evidence. Urinary incontinence has a major effect on quality of life of older people, has a high prevalence, and is a key priority within European health and social care policy. Improving continence care has the potential to improve the quality of life for older people and reduce the costs associated with providing incontinence aids. Objectives This study aims to advance understanding about the contribution facilitation can make to implementing research findings into practice via: extending current knowledge of facilitation as a process for translating research evidence into practice; evaluating the feasibility, effectiveness, and cost-effectiveness of two different models of facilitation in promoting the uptake of research evidence on continence management; assessing the impact of contextual factors on the processes and outcomes of implementation; and implementing a pro-active knowledge transfer and dissemination strategy to diffuse study findings to a wide policy and practice community. Setting and sample Four European countries, each with six long-term nursing care sites (total 24 sites for people aged 60 years and over with documented urinary incontinence Methods and design Pragmatic randomised controlled trial with three arms (standard dissemination and two different programmes of facilitation, with embedded process and economic evaluation. The primary outcome is compliance with the continence recommendations. Secondary outcomes include proportion of residents with incontinence, incidence of incontinence-related dermatitis, urinary tract infections, and quality of life. Outcomes are assessed at baseline

  4. Study protocol for the Fukushima health management survey

    International Nuclear Information System (INIS)

    Yasumura, Seiji; Hosoya, Mitsuaki; Yamashita, Shunichi; Kamiya, Kenji; Abe, Masafumi; Akashi, Makoto; Kodama, Kazunori; Ozasa, Kotaro

    2012-01-01

    The accidents that occurred at the Fukushima Daiichi Nuclear Power Plant after the Great East Japan Earthquake on 11 March 2011 have resulted in long-term, ongoing anxiety among the residents of Fukushima, Japan. Soon after the disaster, Fukushima Prefecture launched the Fukushima Health Management Survey to investigate long-term low-dose radiation exposure caused by the accident. Fukushima Medical University took the lead in planning and implementing this survey. The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects. This report describes the rationale and implementation of the Fukushima Health Management Survey. This cohort study enrolled all people living in Fukushima Prefecture after the earthquake and comprises a basic survey and 4 detailed surveys. The basic survey is to estimate levels of external radiation exposure among all 2.05 million residents. It should be noted that internal radiation levels were estimated by Fukushima Prefecture using whole-body counters. The detailed surveys comprise a thyroid ultrasound examination for all Fukushima children aged 18 years or younger, a comprehensive health check for all residents from the evacuation zones, an assessment of mental health and lifestyles of all residents from the evacuation zones, and recording of all pregnancies and births among all women in the prefecture who were pregnant on 11 March. All data have been entered into a database and will be used to support the residents and analyze the health effects of radiation. The low response rate (<30%) to the basic survey complicates the estimation of health effects. There have been no cases of malignancy to date among 38 114 children who received thyroid ultrasound examinations. The importance of mental health care was revealed by the mental health and lifestyle survey and the pregnancy and birth survey. This long

  5. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  6. Study protocol for a multicenter investigation of reablement in Norway.

    Science.gov (United States)

    Langeland, Eva; Langland, Eva; Tuntland, Hanne; Førland, Oddvar; Aas, Eline; Folkestad, Bjarte; Jacobsen, Frode F; Kjeken, Ingvild

    2015-09-15

    Reablement is a promising new rehabilitation model, which is being implemented in some Western countries to meet current and future needs for home-based services. There is a need for further investigation of the effects of reablement among community-dwelling adults in terms of clinical and economic outcomes. This study will investigate the effectiveness of reablement in home-dwelling adults compared with standard treatment in terms of daily activities, physical functioning, health-related quality of life, coping, mental health, use of health care services, and costs. The study is a multicenter controlled trial. In total, 44 Norwegian municipalities will participate, including eight municipalities as a control group. For three municipalities with two zones, one will be assigned to the control group and the other to the intervention group. The experimental group will be offered reablement and the control group standard treatment. The sample will comprise approximately 750 participants. People will be eligible if they are home-dwelling adults, understand Norwegian, and have functional decline. Participants will be assessed at baseline, and after 10 weeks, 6 months, and 12 months. The primary outcome will be activity and participation measured by the Canadian Occupational Performance Measure. Physical functioning will be measured by the Short Physical Performance Battery and health-related quality of life by the European Quality of Life Scale. Coping will be measured by the Sense of Coherence questionnaire and mental health by the Mental Health Continuum Short Form. Costs will be generated based on registered working hours in different professions. Data analyses will be performed according to intention to treat. Univariate analysis of covariance will be used to investigate differences between the groups at baseline and the end of intervention. The data will be organized into two levels using a multilevel structure, i.e., individuals and municipalities, which will be

  7. Study protocol: can a school gardening intervention improve children's diets?

    Science.gov (United States)

    Christian, Meaghan S; El Evans, Charlotte; Conner, Mark; Ransley, Joan K; Cade, Janet E

    2012-04-26

    The current academic literature suggests there is a potential for using gardening as a tool to improve children's fruit and vegetable intake. This study is two parallel randomised controlled trials (RCT) devised to evaluate the school gardening programme of the Royal Horticultural Society (RHS) Campaign for School Gardening, to determine if it has an effect on children's fruit and vegetable intake. Trial One will consist of 26 schools; these schools will be randomised into two groups, one to receive the intensive intervention as "Partner Schools" and the other to receive the less intensive intervention as "Associate Schools". Trial Two will consist of 32 schools; these schools will be randomised into either the less intensive intervention "Associate Schools" or a comparison group with delayed intervention. Baseline data collection will be collected using a 24-hour food diary (CADET) to collect data on dietary intake and a questionnaire exploring children's knowledge and attitudes towards fruit and vegetables. A process measures questionnaire will be used to assess each school's gardening activities. The results from these trials will provide information on the impact of the RHS Campaign for School Gardening on children's fruit and vegetable intake. The evaluation will provide valuable information for designing future research in primary school children's diets and school based interventions. ISRCTN11396528.

  8. Epilepsy surgery in a pediatric population: a retrospective study of 129 children from a tertiary care hospital in a developing country along with assessment of quality of life.

    Science.gov (United States)

    Dagar, Amit; Chandra, P Sarat; Chaudhary, Kapil; Avnish, Chauhan; Bal, C S; Gaikwad, Shailesh; Garg, Ajay; Sarkar, Chitra; Srivastava, A; Padma, M V; Rekha, Diwedi; Gulati, Sheffali; Paul, Vinod; Prasad, K; Singh, M B; Tripathi, Manjari

    2011-01-01

    To assess the outcome of a pediatric population operated for drug-resistant epilepsy from a large tertiary care center in India. Retrospectively: quality of life (QOL); prospectively: preoperative assessment included interictal EEG, MRI (as per epilepsy protocol), video-EEG. Ictal SPECT (with subtraction) and PET were performed when required. QOL scores were assessed using the HASS or SSQ for seizure severity, Quality of Life in Childhood Epilepsy (QOLCE) for QOL, and Child Behavior Check List (CBCL) for behavior. 142 were operated from January 2000 to June 2011 by the senior author. 118 patients with at least 1 year of follow-up were included in the study. Mean age at surgery was 9.8 ± 4.3 years. In addition, 40 patients underwent QOL assessment prospectively both before and after surgery. Mean duration of epilepsy was 5.3 ± 3.3 years. A class I outcome (Engel's) was seen in 79.5% patients, class II in 8.6%, class III in 10.7%, and class IV in 1 patient. As per surgical procedures, class I outcome in patients who underwent temporal resection, hemispherotomy and extratemporal resection was 76, 87 and 72%, respectively. QOL scores correlated with duration of seizures, epileptic encephalopathy and outcome of surgery, but not with side of surgery, age and sex. This study, the largest reported from India, has demonstrated satisfactory results for epilepsy surgery in children. Copyright © 2011 S. Karger AG, Basel.

  9. The Bipolar Interactive Psychoeducation (BIPED study: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Jones Ian

    2009-08-01

    Full Text Available Abstract Background Bipolar disorders affect between 3–5% of the population and are associated with considerable lifelong impairment. Since much of the morbidity associated with bipolar disorder is caused by recurrent depressive symptoms, which are often only poorly responsive to antidepressants, there is a need to develop alternative, non-pharmacological interventions. Psychoeducational interventions have emerged as promising long-term therapeutic options for bipolar disorder. Methods/design The study is an exploratory, individually randomised controlled trial. The intervention known as 'Beating Bipolar' is a psychoeducational programme which is delivered via a novel web-based system. We will recruit 100 patients with a diagnosis of DSM-IV bipolar disorder (including type I and type II currently in clinical remission. The primary outcome is quality of life. This will be compared for those patients who have participated in the psychoeducational programme with those who received treatment as usual. Quality of life will be assessed immediately following the intervention as well as 10 months after randomisation. Secondary outcomes include current depressive and manic symptoms, number of episodes of depression and mania/hypomania experienced during the follow-up period, global functioning, functional impairment and insight. An assessment of costs and a process evaluation will also be conducted which will explore the feasibility and acceptability of the intervention as well as potential barriers to effectiveness. Discussion Bipolar disorder is common, under-recognised and often poorly managed. It is a chronic, life-long, relapsing condition which has an enormous impact on the individual and the economy. This trial will be the first to explore the effectiveness of a novel web-based psychoeducational intervention for patients with bipolar disorder which has potential to be easily rolled out to patients. Trial registration Current Controlled Trials

  10. Journey to vaccination: a protocol for a multinational qualitative study.

    Science.gov (United States)

    Wheelock, Ana; Miraldo, Marisa; Parand, Anam; Vincent, Charles; Sevdalis, Nick

    2014-01-31

    In the past two decades, childhood vaccination coverage has increased dramatically, averting an estimated 2-3 million deaths per year. Adult vaccination coverage, however, remains inconsistently recorded and substandard. Although structural barriers are known to limit coverage, social and psychological factors can also affect vaccine uptake. Previous qualitative studies have explored beliefs, attitudes and preferences associated with seasonal influenza (flu) vaccination uptake, yet little research has investigated how participants' context and experiences influence their vaccination decision-making process over time. This paper aims to provide a detailed account of a mixed methods approach designed to understand the wider constellation of social and psychological factors likely to influence adult vaccination decisions, as well as the context in which these decisions take place, in the USA, the UK, France, India, China and Brazil. We employ a combination of qualitative interviewing approaches to reach a comprehensive understanding of the factors influencing vaccination decisions, specifically seasonal flu and tetanus. To elicit these factors, we developed the journey to vaccination, a new qualitative approach anchored on the heuristics and biases tradition and the customer journey mapping approach. A purposive sampling strategy is used to select participants who represent a range of key sociodemographic characteristics. Thematic analysis will be used to analyse the data. Typical journeys to vaccination will be proposed. Vaccination uptake is significantly influenced by social and psychological factors, some of which are under-reported and poorly understood. This research will provide a deeper understanding of the barriers and drivers to adult vaccination. Our findings will be published in relevant peer-reviewed journals and presented at academic conferences. They will also be presented as practical recommendations at policy and industry meetings and healthcare

  11. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  12. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

    Science.gov (United States)

    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  13. Resolution of neurosensory deficit after mandibular orthognathic surgery: A prospective longitudinal study.

    Science.gov (United States)

    Alolayan, Albraa Badr; Leung, Yiu Yan

    2017-05-01

    To investigate the longitudinal resolution of neurosensory deficit (NSD) and the possible risk factors that might contribute to NSD following mandibular orthognathic procedures. A prospective longitudinal observational study on patients who had mandibular orthognathic procedures was performed. Standardized neurosensory assessments were performed. The 2 years longitudinal resolution and risk factors of NSD including patients' age and gender, specific mandibular procedures and surgeons' experience were analyzed. 66 patients (44 females) with 132 sides of mandibular procedures were enrolled in the study. Surgical procedures included mandibular ramus surgery, anterior mandibular surgery, or the combination of the two. The overall occurrences of subjective NSD improved from 78.8% at postoperative 2 weeks to 13.8% at post-operative 2 years. Combinations of ramus surgery and anterior mandibular surgery increased the risk of NSD at the first three post-operative months (p orthognathic surgery. The occurrence of NSD after mandibular orthognathic procedures reduced progressively within the post-operative 2 years. Combination of mandibular ramus surgery and anterior mandibular surgery increased the risk of NSD in the early post-operative period. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  14. Evaluation of aesthetic and functional outcomes in rhinoplasty surgery: a prospective study.

    Science.gov (United States)

    Sena Esteves, Sara; Gonçalves Ferreira, Miguel; Carvalho Almeida, João; Abrunhosa, José; Almeida E Sousa, Cecília

    Evaluation of surgery outcome measured by patient satisfaction or quality of life is very important, especially in plastic surgery. There is increasing interest in self-reporting outcomes evaluation in plastic surgery. The aim of our study was to determine patient satisfaction in regard to nose appearance and function with the use of a validated questionnaire, before and after rhinoplasty surgery. A prospective study was realized at a tertiary centre. All rhinoplasty surgeries performed in adults between February 2013 and August 2014 were included. Many patients underwent additional nasal surgery such as septoplasty or turbinoplasty. The surgical procedures and patients' characteristics were also recorded. Among 113 patients, 107 completed the questionnaires and the follow-up period. Analysis of pre-operative and post-operative Rhinoplasty Evaluation Outcome showed a significant improvement after 3 and 6 months in functional and aesthetic questions (pprocedures, primary or revision surgery and open versus closed approach. We found that patients with lower literacy degree were more satisfied with the procedure. Rhinoplasty surgery significantly improved patient quality of life regarding nose function and appearance. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  15. Psychological and health comorbidities before and after bariatric surgery: a longitudinal study

    Directory of Open Access Journals (Sweden)

    Susana Sofia Pereira da Silva

    2013-12-01

    Full Text Available INTRODUCTION: Morbid obesity has multiple implications for psychological and physical health. Bariatric surgery has been selected as the treatment of choice for this chronic disease, despite the controversial impact of the surgery on psychosocial health. The objective of this study was to describe candidates for bariatric surgery and analyze changes in weight, psychopathology, personality, and health problems and complaints at 6- and 12- month follow-up assessments. METHODS: Thirty obese patients (20 women and 10 men with a mean age of 39.17±8.81 years were evaluated in different dimensions before surgery and 6 and 12 months after the procedure. RESULTS: Six and 12 months after bariatric surgery, patients reported significant weight loss and a significant reduction in the number of health problems and complaints. The rates of self-reported psychopathology were low before surgery, and there were no statistically significant changes over time. The conscientiousness, extraversion, and agreeableness dimensions increased, but neuroticism and openness remained unchanged. All changes had a medium effect size. CONCLUSIONS: Our results suggest that patients experience significant health improvements and some positive personality changes after bariatric surgery. Even though these findings underscore the role of bariatric surgery as a relevant treatment for morbid obesity, more in-depth longitudinal studies are needed to elucidate the evolution of patients after the procedure.

  16. A Field-Based Testing Protocol for Assessing Gross Motor Skills in Preschool Children: The Children's Activity and Movement in Preschool Study Motor Skills Protocol

    Science.gov (United States)

    Williams, Harriet G.; Pfeiffer, Karin A.; Dowda, Marsha; Jeter, Chevy; Jones, Shaverra; Pate, Russell R.

    2009-01-01

    The purpose of this study was to develop a valid and reliable tool for use in assessing motor skills in preschool children in field-based settings. The development of the Children's Activity and Movement in Preschool Study Motor Skills Protocol included evidence of its reliability and validity for use in field-based environments as part of large…

  17. Metacognitive Protocols: A Qualitative Study of Perceptions of "Smartness" of Adults and Children.

    Science.gov (United States)

    Morse, Linda W.; Smith-Mallette, Geraldine; Talento-Miller, Eileen

    Metacognition is a theoretical construct used to describe individuals' perceptions of their thinking processes and their own control over their thinking processes. This study examined the protocols of 78 undergraduates who responded to 3 questions from the Swanson Metacognitive Questionnaire: (1) What makes someone really smart? (2) How do…

  18. Risk factors for acute surgical site infections after lumbar surgery: a retrospective study.

    Science.gov (United States)

    Lai, Qi; Song, Quanwei; Guo, Runsheng; Bi, Haidi; Liu, Xuqiang; Yu, Xiaolong; Zhu, Jianghao; Dai, Min; Zhang, Bin

    2017-07-19

    Currently, many scholars are concerned about the treatment of postoperative infection; however, few have completed multivariate analyses to determine factors that contribute to the risk of infection. Therefore, we conducted a multivariate analysis of a retrospectively collected database to analyze the risk factors for acute surgical site infection following lumbar surgery, including fracture fixation, lumbar fusion, and minimally invasive lumbar surgery. We retrospectively reviewed data from patients who underwent lumbar surgery between 2014 and 2016, including lumbar fusion, internal fracture fixation, and minimally invasive surgery in our hospital's spinal surgery unit. Patient demographics, procedures, and wound infection rates were analyzed using descriptive statistics, and risk factors were analyzed using logistic regression analyses. Twenty-six patients (2.81%) experienced acute surgical site infection following lumbar surgery in our study. The patients' mean body mass index, smoking history, operative time, blood loss, draining time, and drainage volume in the acute surgical site infection group were significantly different from those in the non-acute surgical site infection group (p operative type in the acute surgical site infection group were significantly different than those in the non-acute surgical site infection group (p operative type, operative time, blood loss, and drainage time were independent predictors of acute surgical site infection following lumbar surgery. In order to reduce the risk of infection following lumbar surgery, patients should be evaluated for the risk factors noted above.

  19. Tissue oxygenation as a target for goal-directed therapy in high-risk surgery : a pilot study

    NARCIS (Netherlands)

    van Beest, Paul A.; Vos, Jaap Jan; Poterman, Marieke; Kalmar, Alain F.; Scheeren, Thomas W. L.

    2014-01-01

    Background:  Tissue hypoperfusion occurs frequently during surgery and may contribute to postoperative organ dysfunction. There is a need for perioperative treatment protocols aiming at improving tissue oxygenation (StO(2)). We hypothesised that intra-operative optimisation of StO(2) improves tissue

  20. Study protocol

    DEFF Research Database (Denmark)

    Madsen, Helle Østergaard; Dam, Ole Henrik; Hageman, Ida

    2012-01-01

    ranging from total blindness to Snellen visual acuity 6/60 receive information letter and questionnaire by post. Completed questionnaires can be returned by post, email or telephone. For each respondent, all eye-related diagnoses will be obtained from national registries. Normally sighted...... and demographically matched control respondents will be contacted in a similar manner the subsequent winter season. The Seasonal Pattern Assessment Questionnaire rates seasonal variation within the six items: sleep, appetite, social activity, mood, energy and body weight. The Seasonal Pattern Assessment Questionnaire...

  1. A comparative study of short- and medium-term outcomes comparing emergent surgery and stenting as a bridge to surgery in patients with acute malignant colonic obstruction.

    LENUS (Irish Health Repository)

    Kavanagh, Dara O

    2013-04-01

    The use of self-expanding metal stents as a bridge to surgery in the setting of malignant colorectal obstruction has been advocated as an acceptable alternative to emergency surgery. However, concerns about the safety of stenting have been raised following recent randomized studies.

  2. Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

    Science.gov (United States)

    Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

    2014-12-01

    Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

  3. Therapeutic outcomes of transsphenoidal surgery in pediatric patients with craniopharyngiomas: a single-center study.

    Science.gov (United States)

    Yamada, Shozo; Fukuhara, Noriaki; Yamaguchi-Okada, Mitsuo; Nishioka, Hiroshi; Takeshita, Akira; Takeuchi, Yasuhiro; Inoshita, Naoko; Ito, Junko

    2018-03-30

    OBJECTIVE The aim of this study was to analyze the outcomes of transsphenoidal surgery (TSS) in a single-center clinical series of pediatric craniopharyngioma patients treated with gross-total resection (GTR). METHODS The authors retrospectively reviewed the surgical outcomes for 65 consecutive patients with childhood craniopharyngiomas (28 girls and 37 boys, mean age 9.6 years) treated with TSS (45 primary and 20 repeat surgeries) between 1990 and 2015. Tumors were classified as subdiaphragmatic or supradiaphragmatic. Demographic and clinical characteristics, including extent of resection, complications, incidence of recurrence, pre- and postoperative visual disturbance, pituitary function, and incidence of diabetes insipidus (DI), as well as new-onset obesity, were analyzed and compared between the primary surgery and repeat surgery groups. RESULTS Of the 45 patients in the primary surgery group, 26 (58%) had subdiaphragmatic tumors and 19 had supradiaphragmatic tumors. Of the 20 patients in the repeat surgery group, 9 (45%) had subdiaphragmatic tumors and 11 had supradiaphragmatic tumors. The only statistically significant difference between the 2 surgical groups was in tumor size; tumors were larger (mean maximum diameter 30 mm) in the primary surgery group than in the repeat surgery group (25 mm) (p = 0.008). GTR was accomplished in 59 (91%) of the 65 cases; the GTR rate was higher in the primary surgery group than in the repeat surgery group (98% vs 75%, p = 0.009). Among the patients who underwent GTR, 12% experienced tumor recurrence, with a median follow-up of 7.8 years, and recurrence tended to occur less frequently in primary than in repeat surgery patients (7% vs 27%, p = 0.06). Of the 45 primary surgery patients, 80% had deteriorated pituitary function and 83% developed DI, whereas 100% of the repeat surgery patients developed these conditions. Among patients with preoperative visual disturbance, vision improved in 62% but worsened in 11%. Visual

  4. Electrophysiological evaluation of phrenic nerve injury during cardiac surgery – a prospective, controlled, clinical study

    Directory of Open Access Journals (Sweden)

    Ege Turan

    2004-01-01

    Full Text Available Abstract Background According to some reports, left hemidiaphragmatic paralysis due to phrenic nerve injury may occur following cardiac surgery. The purpose of this study was to document the effects on phrenic nerve injury of whole body hypothermia, use of ice-slush around the heart and mammary artery harvesting. Methods Electrophysiology of phrenic nerves was studied bilaterally in 78 subjects before and three weeks after cardiac or peripheral vascular surgery. In 49 patients, coronary artery bypass grafting (CABG and heart valve replacement with moderate hypothermic (mean 28°C cardiopulmonary bypass (CPB were performed. In the other 29, CABG with beating heart was performed, or, in several cases, peripheral vascular surgery with normothermia. Results In all patients, measurements of bilateral phrenic nerve function were within normal limits before surgery. Three weeks after surgery, left phrenic nerve function was absent in five patients in the CPB and hypothermia group (3 in CABG and 2 in valve replacement. No phrenic nerve dysfunction was observed after surgery in the CABG with beating heart (no CPB or the peripheral vascular groups. Except in the five patients with left phrenic nerve paralysis, mean phrenic nerve conduction latency time (ms and amplitude (mV did not differ statistically before and after surgery in either group (p > 0.05. Conclusions Our results indicate that CPB with hypothermia and local ice-slush application around the heart play a role in phrenic nerve injury following cardiac surgery. Furthermore, phrenic nerve injury during cardiac surgery occurred in 10.2 % of our patients (CABG with CPB plus valve surgery.

  5. Dosimetry study on the conventional and three dimensional conformal radiation treatment planning protocols for rectal cancer

    International Nuclear Information System (INIS)

    Cai Yong; He Yuxiang; Han Shukui; Wu Hao; Gong Jian; Xu Bo

    2007-01-01

    Objective: To compare the dose distribution of clinical target volume (CTV), in normal tissues and organs for patients with rectal cancer on the conventional radiotherapy (2D) and three dimension- al conformal radiation treatment (3DCRT). Methods: The CT image data of 36 rectal cancer patients treated with 3DCRT were studied. The CTV, small bowel, colon, bladder, pelvic bone marrow, and femoral head and neck were contoured on consecutive axial slices of CT images. Two 3DCRT and three conventional treatment planning protocols were simulated using three dimensional treatment planning system (CMS Focus 2.31), were defined as 3D-3, 3D-4, 2D-2, 2D-3, 2D-4. The difference of five treatment planning protocols on the CTV and normal structure by analysis of dose-volume histograms (DVHs) were compared. Results: The D 95 and V 95 of these five protocols all exceeded 97%. The conformity index(CI) of 3D was obviously larger than that of 2D protocol. The dose inhomogeneity(DI) in 4 DCRT was less than that of 3 DCRT. The 3D as compared with the 2D, significantly reduced the mean dose of 45 Gy to the small bowel and colon. The 3D-3 as compared with the 2D-3, the 3D-4 as compared with the 2D-4, the mean dose of small bowel and colon was reduced by 28.5% and 25.7%, respectively. The 3D-3 as compared with the 2D-2, the 3D-3 as compared with the 2D-3 and the 3D4 as compared with the 2D-4, the percentage volume of small bowel and colon which received 45 Gy was reduced by 80.8% , 51.1% and 54.7% , respectively. Either the mean dose, or the percentage volume receiving 35 Gy and 45 Gy to the pelvic bone and bladder, the 3D planning protocols had advanage over the 2D planning protocols. The V 45 of bladder in 2D-2 planning proto- col was the highest in all planning protocols, exceeding 98%, but the highest V 45 of bladder was only 50% in the other planning protocols. Conclusions: Even though the difference in pelvic CTV of rectal cancer patients between the conventional radiotherapy and 3

  6. Carotid Artery Injury in Anterior Cervical Spine Surgery: Multicenter Cohort Study and Literature Review

    OpenAIRE

    H?rtl, Roger; Alimi, Marjan; Abdelatif Boukebir, Mohamed; Berlin, Connor D.; Navarro-Ramirez, Rodrigo; Arnold, Paul M.; Fehlings, Michael G.; Mroz, Thomas E.; Riew, K. Daniel

    2017-01-01

    Study Design: Retrospective study and literature review. Objective: To provide more comprehensive data about carotid artery injury (CAI) or cerebrovascular accident (CVA) related to anterior cervical spine surgery. Methods: We conducted a retrospective, multicenter, case series study involving 21 high-volume surgical centers from the AOSpine North America Clinical Research Network. Medical records of 17?625 patients who went through cervical spine surgery (levels from C2 to C7) between Januar...

  7. Recurrent Laryngeal Nerve Palsy After Cervical Spine Surgery: A Multicenter AOSpine Clinical Research Network Study

    OpenAIRE

    Gokaslan, Ziya L.; Bydon, Mohamad; De la Garza-Ramos, Rafael; Smith, Zachary A.; Hsu, Wellington K.; Qureshi, Sheeraz A.; Cho, Samuel K.; Baird, Evan O.; Mroz, Thomas E.; Fehlings, Michael; Arnold, Paul M.; Riew, K. Daniel

    2017-01-01

    Study Design: Multicenter retrospective study. Objectives: To investigate the risk of symptomatic recurrent laryngeal nerve palsy (RLNP) following cervical spine surgery, to examine risk factors for its development, and to report its treatment and outcomes. Methods: A multicenter study from 21 high-volume surgical centers from the AOSpine North America Clinical Research Network was performed. Each center screened for rare complications following cervical spine surgery, including RLNP. Patient...

  8. Outcomes after corrective surgery for congenital dextro-transposition of the great arteries using the arterial switch technique: a protocol for a scoping systematic review

    Science.gov (United States)

    Mbuagbaw, Lawrence; Forlemu-Kamwa, Doris; Chu, Angela; Thabane, Lehana; Dillenberg, Rejane

    2014-01-01

    Introduction Dextro-transposition of the great arteries (d-TGA) is a life-threatening congenital health defect that requires rapid surgery. The most widely used approach is the arterial switch operation (ASO) developed by Jatene in the 1970s. The first set of children who received this intervention are now adults. The objective of this scoping review of the literature was to document the short-term (less than 1 year), medium-term (1–20 years) and long-term (more than 20 years) outcomes in children who underwent the ASO. Our primary income is survival, but we will explore other secondary surgical, cardiovascular, reproductive and quality-of-life outcomes. Methods and analyses Using a systematic scoping review approach, we will conduct a systematic search of the published literature for experimental and observational studies published on children who received the ASO intervention for classic d-TGA. We will search MEDLINE, Excerpta Medica Database (EMBASE), Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Literatura Latino Americana em Ciências da Saúde (LILACS) from 1973 (date of the first successful ASO) to February 2014. Identified articles will be screened in duplicate and full text for selected articles will be retrieved. Data extraction will be carried out in duplicate. Discrepancies will be resolved by consensus or by consulting a third author. Where possible, proportions will be pooled using the inverse variance method. Our findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis Of Observational studies in Epidemiology (MOOSE) guidelines. Ethics and dissemination The results of this paper will be disseminated as peer-reviewed publications, at conferences and at clinical rounds. Our findings may answer important questions for surgeons who perform the ASO intervention and for clinicians who take care of patients after surgery and throughout their

  9. A comparative study on the short-term clinicopathologic outcomes of laparoscopic surgery versus conventional open surgery for transverse colon cancer.

    Science.gov (United States)

    Kim, H J; Lee, I K; Lee, Y S; Kang, W K; Park, J K; Oh, S T; Kim, J G; Kim, Y H

    2009-08-01

    The long-term oncologic stability of laparoscopic surgery for colon cancer was established, and laparoscopic surgery was accepted as an alternative to conventional open surgery for colon cancer. However, transverse colon cancer was excluded from the majority of the previous prospective studies. As a result, debate on laparoscopic surgery for transverse colon cancer continues. This study aimed to compare the clinicopathologic outcome of laparoscopic surgery with that of conventional open surgery for transverse colon cancer. From August 2004 to December 2007, 106 cases of transverse colon cancer were managed by resection at our institution, and 89 of these cases were included in this study. Age, sex, body mass index (BMI), operation time, blood loss, time to first flatus, time to start of diet, hospital stay, complications, tumor size, distal resection margin, proximal resection margin, and number of nodes harvested were compared between the two groups. No significant differences were found between the laparoscopic and conventional groups in terms of age, sex, BMI, operation time, or hospital stay. The mean blood loss during the operations was significantly less in the laparoscopic group (113.8 +/- 128.9 ml) than in the conventional group (278.8 +/- 268.7 ml; p transverse colon cancer, and the oncologic quality of laparoscopic surgery was found to be acceptable compared with conventional open surgery.

  10. Clinicopathological study on refractory epilepsy treated by several epilepsy surgeries

    Directory of Open Access Journals (Sweden)

    Yan LI

    2018-04-01

    Full Text Available Objective To observe and investigate the clinicopathological features and types of refractory epilepsy treated by several epilepsy surgeries. Methods There were 19 patients with age less than 20 years who underwent 2 (16/19 or 3 (3/19 epilepsy surgeries. After pathological examination, pathological diagnosis and subtype was made according to focal cortical dysplasia (FCD classification proposed by International League Against Epilepsy (ILAE Diagnostic Methods Commission in 2011 and World Health Organization (WHO Classification of Tumors of Central Nervous System in 2007. Results The operation intervals were 1-10 years (average 4.24 years. The pathological diagnoses after first operation were FCDⅠb in 2 cases (2/19, FCDⅡa in 2 cases (2/19, FCDⅢa in one case (1/19, FCDⅢd in one case (1/19, 5 cases of tumor lesions [2 (2/19 of astrocytoma, one (1/19 of oligoastrocytoma, one (1/ 19 of mixed germ cell tumor, one (1/19 of hysembryoplastic neuroepithelial tumor (DNT], one case (1/19 of hamartoma, one case (1/19 of angioma, one case (1/19 of heterotopic gray matter, and 4 cases (4/19 of ulegyria. The last one (1/19 underwent corpus callosal incision. Pathological diagnoses after reoperation were FCDⅢa in 4 cases (4/19, FCDⅢb in 4 cases (4/19, FCDⅢc in one case (1/19, FCDⅢd in 8 cases (8/19, dual pathology (FCDⅢa with oligoastrocytoma and with glial scar and/or ulegyria in 2 cases (2/19. Patients were followed up for 0.50-5.00 years after second or third operation (average 2.34 years, and the results showed Engel Ⅰ in 10 patients (10/19, Engel Ⅱ in 6 patients (6/19 and Engel Ⅲ in 3 patients (3/19. The rate of good prognosis was 84.21%. Conclusions The pathological diagnoses of brain tissue resected from patients accepting several epilepsy surgeries are mainly FCD Ⅲ and dual pathology. It is suggested that the second or third operation would be effective for refractory epilepsy patients who underwent surgery already. DOI: 10

  11. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

    OpenAIRE

    Smith Chad E.; Lyons Brian; Hannon James C.

    2014-01-01

    Purpose. Complex training (CT) involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the...

  12. A systematic review of protocol studies on conceptual design cognition: design as search and exploration

    OpenAIRE

    Hay, Laura; Duffy, Alex H.B.; McTeague, Chris; Pidgeon, Laura M.; Vuletic, Tijana; Grealy, Madeleine

    2017-01-01

    This paper reports findings from the first systematic review of protocol studies focusing specifically on conceptual design cognition, aiming to answer the following research question: What is our current understanding of the cognitive processes involved in conceptual design tasks carried out by individual designers? We reviewed 47 studies on architectural design, engineering design and product design engineering. This paper reports 24 cognitive processes investigated in a subset of 33 studie...

  13. A new small-animal model for the study of acquired heterotopic ossification after hip surgery.

    Science.gov (United States)

    Anthonissen, Joris; Ossendorf, Christian; Hock, Johanna Lisa; Ritz, Ulrike; Hofmann, Alexander; Rommens, Pol Maria

    2015-01-01

    Heterotopic ossification (HO)--the formation of bone in soft tissues--is a frequent problem after surgery of the hip and pelvis, but little is known about its underlying pathogenic mechanisms. It is vital to study the underlying pathogenesis in animal models to develop and evaluate new prophylactic regimens directed against HO. However, previously developed small-animal models for the study of HO imitate neither surgery nor trauma-mechanisms that potentially cause HO. Hence, the goal of this study was to develop a novel small-animal model imitating hip surgery that can reliably produce HO. Twenty male Wistar rats were subjected to surgery of the right hip during which the femoral canal was reamed in three steps up to 2 mm, and a muscle lesion was made. Twelve weeks after surgery, the amount of heterotopic bone was assessed using micro-computed tomography. Eighteen of 20 animals showed HO around the hip 12 weeks after surgery. The amount of heterotopic bone varied from very small particles up to near ankylosis. A rat model of hip/pelvic surgery that does not use exogenous osteogenic stimulus and can reliably produce HO was developed.

  14. Adolescent bariatric surgery program characteristics: the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study experience.

    Science.gov (United States)

    Michalsky, Marc P; Inge, Thomas H; Teich, Steven; Eneli, Ihuoma; Miller, Rosemary; Brandt, Mary L; Helmrath, Michael; Harmon, Carroll M; Zeller, Meg H; Jenkins, Todd M; Courcoulas, Anita; Buncher, Ralph C

    2014-02-01

    The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Data were obtained from the Teen-LABS database, and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. All centers had extensive multidisciplinary involvement in the assessment, pre-operative education, and post-operative management of adolescents undergoing WLS. Eligibility criteria and pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well-developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. The composition of clinical team and institutional resources is consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. © 2013 Published by Elsevier Inc.

  15. A novel protocol for dispatcher assisted CPR improves CPR quality and motivation among rescuers-A randomized controlled simulation study.

    Science.gov (United States)

    Rasmussen, Stinne Eika; Nebsbjerg, Mette Amalie; Krogh, Lise Qvirin; Bjørnshave, Katrine; Krogh, Kristian; Povlsen, Jonas Agerlund; Riddervold, Ingunn Skogstad; Grøfte, Thorbjørn; Kirkegaard, Hans; Løfgren, Bo

    2017-01-01

    Emergency dispatchers use protocols to instruct bystanders in cardiopulmonary resuscitation (CPR). Studies changing one element in the dispatcher's protocol report improved CPR quality. Whether several changes interact is unknown and the effect of combining multiple changes previously reported to improve CPR quality into one protocol remains to be investigated. We hypothesize that a novel dispatch protocol, combining multiple beneficial elements improves CPR quality compared with a standard protocol. A novel dispatch protocol was designed including wording on chest compressions, using a metronome, regular encouragements and a 10-s rest each minute. In a simulated cardiac arrest scenario, laypersons were randomized to perform single-rescuer CPR guided with the novel or the standard protocol. a composite endpoint of time to first compression, hand position, compression depth and rate and hands-off time (maximum score: 22 points). Afterwards participants answered a questionnaire evaluating the dispatcher assistance. The novel protocol (n=61) improved CPR quality score compared with the standard protocol (n=64) (mean (SD): 18.6 (1.4)) points vs. 17.5 (1.7) points, pCPR. A novel bundle of care protocol improved CPR quality score and motivation among rescuers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. Electroacupuncture for postoperative pain and gastrointestinal motility after laparoscopic appendectomy (AcuLap): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kim, Gangmi

    2015-10-14

    Acupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal motility and controlling pain after laparoscopic surgery. This study is a prospective randomized controlled trial with a three-arm, parallel-group structure evaluating the efficacy of electroacupuncture for gastrointestinal motility and postoperative pain after laparoscopic appendectomy. Patients with appendicitis undergoing laparoscopic surgery are included and randomized into three groups: 1) electroacupuncture group, 2) sham acupuncture group, and 3) control group. Patients receive 1) acupuncture with electrostimulation or 2) fake electroacupuncture with sham device twice a day or 3) no acupuncture after laparoscopic appendectomy. The primary outcome is time to first passing flatus after operation. Secondary outcomes include postoperative pain, analgesics, nausea/vomiting, bowel motility, time to tolerable diet, complications, hospital stay, readmission rates, time to recovery, quality of life, medical costs, and protocol failure rate. Patients and hospital staff (physicians and nurses) are blinded to which group the patient is assigned, electroacupuncture or sham acupuncture. Data analysis personnel are blinded to group assignment among all three groups. Estimated sample size to detect a minimum difference of time to first flatus with 80 % power, 5 % significance, and 10 % drop rate is 29 × 3 groups = 87 patients. Analysis will be performed according to the intention-to-treat principle. The AcuLap trial will provide evidence on the merits and/or demerits of electroacupuncture for bowel motility recovery and pain relief after laparoscopic appendectomy. The trial was registered in Clinical Research Information Service (CRiS), Republic of Korea ( KCT0001486

  17. Surgical reintervention after antireflux surgery for gastroesophageal reflux disease: a prospective cohort study in 130 patients

    NARCIS (Netherlands)

    Furnée, Edgar J. B.; Draaisma, Werner A.; Broeders, Ivo A. M. J.; Smout, Andre J. P. M.; Gooszen, Hein G.

    2008-01-01

    HYPOTHESIS: Surgical reintervention after antireflux surgery for gastroesophageal reflux disease is required in 3% to 6% of patients. The subjective outcome after reintervention has been reported in several studies, but objective results after these subsequent operations have rarely been published.

  18. The comparative study of epidural levobupivacaine and bupivacaine in major abdominal surgeries

    Directory of Open Access Journals (Sweden)

    Ali Uzuner

    2011-01-01

    Conclusions: The results of our study suggest that same concentration of epidural levobupivacaine and bupivacaine with fentanyl provide stable postoperative analgesia and both were found safe for the patients undergoing major abdominal surgery.

  19. A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

    Science.gov (United States)

    Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

    2018-05-15

    To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

  20. Stream Control Transmission Protocol as a Transport for SIP: a case study

    Directory of Open Access Journals (Sweden)

    Giuseppe De Marco

    2004-06-01

    Full Text Available The dominant signalling protocol both in future wireless and wired networks will be the Session Initiation Protocol (SIP, as pointed out in the 3G IP-based mobile networks specifications, entailing a fully Internet integrated network. The use of SIP in the IP Multimedia Subsytem (IMS of Release 5 involves the development of servers capable to handle a large number of call requests. The signaling traffic associated to such requests could explode, if an intelligent congestion control were not introduced. Stream Control Transmission Protocol (SCTP was born to support transport of SS7 signaling messages. However, many of the SCTP features are also useful for transport of SIP messages, as: congestion control mechanism, good separation among independent messages, multihoming. Indeed, adoption of SCTP as transport of SIP signaling might prove useful in some situations where usual transport protocols, like TCP and UDP, suffer performance degradation. In this paper, we analyse the general framework wherein SIP operates and we discuss the benefits of using SCTP as a transport for SIP, toward fair sharing of network resources. This study is carried on in the context of the implementation of an high-performance SIP Proxy Server. We also present some preliminar results of an implementation of SIP over SCTP/UDP in a real LAN environment.

  1. Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa: A Pilot Study in Burkina Faso.

    Science.gov (United States)

    Kabré, Yvette B; Traoré, Idriss S S; Kaboré, Flavien A R; Ki, Bertille; Traoré, Alain I; Ouédraogo, Isso; Bandré, Emile; Wandaogo, Albert; Ouédraogo, Nazinigouba

    2017-02-01

    Long surgical wait times and limited hospital capacity are common obstacles to surgical care in many countries in Sub-Saharan Africa (SSA). Introducing ambulatory surgery might contribute to a solution to these problems. The purpose of this study was to evaluate the safety and feasibility of introducing ambulatory surgery into a pediatric hospital in SSA. This is a cross-sectional descriptive study that took place over 6 months. It includes all patients assigned to undergo ambulatory surgery in the Pediatric University Hospital in Ouagadougou, Burkina Faso. Eligibility criteria for the ambulatory surgery program included >1 year of age, American Society of Anesthesiologists (ASA) 1 status, surgery with a low risk of bleeding, lasting anesthesia with halothane. Sixty-five percent also received regional or local anesthesia consisting of caudal block in 79.23% or nerve block in 20.77%. The average duration of surgery was 33 ± 17.47 minutes. No intraoperative complications were noted. All the patients received acetaminophen and a nonsteroidal anti-inflammatory drug in the recovery room. Twelve (11.7%) patients had complications in recovery, principally nausea and vomiting. Eight (7.8%) patients were admitted to the hospital. No serious complications were associated with ambulatory surgery. Its introduction could possibly be a solution to improving pediatric surgical access in low-income countries.

  2. Can Tranexamic Acid Reduce Blood Loss during Major Cardiac Surgery? A Pilot Study.

    Science.gov (United States)

    Compton, Frances; Wahed, Amer; Gregoric, Igor; Kar, Biswajit; Dasgupta, Amitava; Tint, Hlaing

    2017-09-01

    We examined the effectiveness of tranexamic acid in preventing intraoperative blood loss during major cardiac surgery. Out of initial 81 patients undergoing major cardiac surgery (both coronary artery bypass and valve repair procedures) at our teaching hospital, sixty-seven patients were selected for this study. We compared estimated blood loss, decrease in percent hemoglobin and hematocrit following surgery between two groups of patients (none of them received any blood product during surgery), one group receiving no tranexamic acid (n=17) and another group receiving tranexamic acid (n=25). In the second study, we combined these patients with patients receiving modest amounts of blood products (1-2 unit) and compared these parameters between two groups of patients (25 patients received no tranexamic acid, 42 patients received tranexamic acid). In patients who received no blood product during surgery, those who received no tranexamic acid showed statistically significant (independent t-test two tailed at p tranexamic acid (mean: 987.2 mL, SD: 459.9, n=25). We observed similar results when the patients receiving no blood products and patients receiving modest amount of blood products were combined based on the use of tranexamic acid or not. No statistically significant difference was observed in percent reduced hemoglobin or hematocrit following surgery in any group of patients. We conclude that intraoperative antifibrinolytic therapy with tranexamic acid does not reduce intraoperative blood loss during major cardiac surgery which contradicts popular belief. © 2017 by the Association of Clinical Scientists, Inc.

  3. Suicidal Ideation and Behaviours Among Adolescents Receiving Bariatric Surgery: A Case-Control Study.

    Science.gov (United States)

    McPhee, Jeanne; Khlyavich Freidl, Eve; Eicher, Julia; Zitsman, Jeffrey L; Devlin, Michael J; Hildebrandt, Tom; Sysko, Robyn

    2015-11-01

    This study examined the prevalence and correlates of suicidal ideation and behaviour (SI/B) among adolescents receiving bariatric surgery. Charts of 206 adolescents receiving bariatric surgery were reviewed. Cases with SI/B (current/lifetime reported at baseline or event occurring in the programme n = 31, 15%) were case matched on gender, age and surgery type to 31 adolescents reporting current or past psychiatric treatment and 31 adolescents denying lifetime SI/B or psychiatric treatment. Before surgery, adolescents with SI/B reported significantly lower total levels of health-related quality of life (p = 0.01) and greater depressive symptoms (p = 0.004) in comparison with candidates who never received psychiatric treatment. No significant differences were found between groups for the change in depressive symptoms or body mass index following surgery. As in studies of adults, a notable subset of adolescents receiving bariatric surgery indicated pre-operative or post-operative SI/B. It is critical that clinicians evaluate and monitor adolescent patients undergoing bariatric surgery for risk of SI/B. Copyright © 2015 John Wiley & Sons, Ltd and Eating Disorders Association.

  4. Suicidal Ideation and Behaviors among Adolescents Receiving Bariatric Surgery: A Case-Control Study

    Science.gov (United States)

    McPhee, Jeanne; Freidl, Eve Khlyavich; Eicher, Julia; Zitsman, Jeffrey L.; Devlin, Michael J.; Hildebrandt, Tom; Sysko, Robyn

    2015-01-01

    Objective This study examined the prevalence and correlates of suicidal ideation and behavior (SI/B) among adolescents receiving bariatric surgery. Method Charts of 206 adolescents receiving bariatric surgery were reviewed. Cases with SI/B (current/lifetime reported at baseline or event occurring in the program n= 31, 15%) were case-matched on gender, age, and surgery type to 31 adolescents reporting current or past psychiatric treatment, and 31 adolescents denying lifetime SI/B or psychiatric treatment. Results Before surgery, adolescents with SI/B reported significantly lower total levels of health-related quality of life (p=0.01) and greater depressive symptoms (p=0.004) in comparison to candidates who never received psychiatric treatment. No significant differences were found between groups for the change in depressive symptoms or body mass index following surgery. Conclusions As in studies of adults, a notable subset of adolescents receiving bariatric surgery indicated pre- or post-operative SI/B. It is critical that clinicians evaluate and monitor adolescent patients undergoing bariatric surgery for risk of SI/B. PMID:26377705

  5. Randomized controlled trial of postoperative exercise rehabilitation program after lumbar spine fusion: study protocol

    Directory of Open Access Journals (Sweden)

    Tarnanen Sami

    2012-07-01

    Full Text Available Abstract Background Lumbar spine fusion (LSF effectively decreases pain and disability in specific spinal disorders; however, the disability rate following surgery remains high. This, combined with the fact that in Western countries the number of LSF surgeries is increasing rapidly it is important to develop rehabilitation interventions that improve outcomes. Methods/design In the present RCT-study we aim to assess the effectiveness of a combined back-specific and aerobic exercise intervention for patients after LSF surgery. One hundred patients will be randomly allocated to a 12-month exercise intervention arm or a usual care arm. The exercise intervention will start three months after surgery and consist of six individual guidance sessions with a physiotherapist and a home-based exercise program. The primary outcome measures are low back pain, lower extremity pain, disability and quality of life. Secondary outcomes are back function and kinesiophobia. Exercise adherence will also be evaluated. The outcome measurements will be assessed at baseline (3 months postoperatively, at the end of the exercise intervention period (15 months postoperatively, and after a 1-year follow-up. Discussion The present RCT will evaluate the effectiveness of a long-term rehabilitation program after LSF. To our knowledge this will be the first study to evaluate a combination of strength training, control of the neutral lumbar spine position and aerobic training principles in rehabilitation after LSF. Trial registration ClinicalTrials.gov Identifier NCT00834015

  6. Loss of control eating and weight outcomes after bariatric surgery: a study with a Portuguese sample

    OpenAIRE

    Conceição, Eva Martins; Silva, Ana Isabel Pinto Bastos Leite; Brandão, Isabel; Vaz, Ana Rita Rendeiro Ribeiro; Ramalho, Sofia Marlene Marques; Arrojado, Filipa; Costa, José; Machado, Paulo P. P.

    2014-01-01

    The present study aim is to investigate the frequency of loss of control eating (LOC) episodes in three groups with different assessment times: one before, one at short and one at long-term after bariatric surgery; as well as to explore the association of postoperative problematic eating behaviors and weight outcomes and psychological characteristics. This cross-sectional study compared a group of preoperative bariatric surgery patients (n = 176) and two postoperative groups, one at short-ter...

  7. On a definition of the appropriate timing for surgical intervention in orthognathic surgery.

    Science.gov (United States)

    Hernández-Alfaro, F; Guijarro-Martínez, R

    2014-07-01

    Together with the introduction of new orthodontic techniques and minimally invasive surgery protocols, the emergence of modern patient prototypes has given way to novel timing schemes for the handling of dento-maxillofacial deformities. The aim of this study was to define, justify, and systematize the appropriate timing for orthognathic surgery. A retrospective analysis of orthognathic surgery procedures carried out over a 3-year period was performed. Six timing schemes were defined: 'surgery first', 'surgery early', 'surgery late', 'surgery last', 'surgery only', and 'surgery never'. Gender, age at surgery, main motivation for treatment, orthodontic treatment length, and number of orthodontic appointments were evaluated. A total of 362 orthognathic procedures were evaluated. The most common approach was 'surgery late'. While aesthetic improvement was the leading treatment motivation in 'surgery first', 'surgery early', and 'surgery last' cases, occlusal optimization was the chief aim of 'surgery late'. Sleep-disordered breathing was the main indication for treatment in 'surgery only'. Compared to 'surgery late', orthodontic treatment was substantially shorter in 'surgery early' and 'surgery first' cases, but the number of orthodontic appointments was similar. In conclusion, the skilful management of dento-maxillofacial deformities requires a comprehensive analysis of patient-, orthodontist-, and surgeon-specific variables. Each timing approach has well-defined indications, treatment planning considerations, and orthodontic and surgical peculiarities. Copyright © 2014 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  8. A Pilot Study on the effects of Music Therapy on Frontotemporal Dementia - developing a research protocol

    DEFF Research Database (Denmark)

    Ridder, Hanne Mette Ochsner; Wigram, Tony; Ottesen, Anne Marie

    2009-01-01

    , and pharmacological treatment of the psychiatric symptoms is difficult, requiring specialist proficiency in the field. Pilot study: As there is not yet sufficient research that examines the effects of non-pharmacologic treatment with this group there is a need to develop valid and reliable research protocols....... As an example of a non-pharmacologic treatment procedure music therapy was investigated. With the focus to develop a research protocol for a future larger population study a pilot study was carried out. In two case studies a combination of data collection methods were examined with the overall goal to document...... changes in intersubjectivity. In this pilot testing there was a specific interest in selecting a relevant and manageable dementia specific instrument for measuring quality of life and relating it with other instruments. Following three instruments were tested: the Altzheimers Disease-Related Quality...

  9. Disinfection Contact Time study plan (100-N Area tracer protocol). Revision 1

    International Nuclear Information System (INIS)

    Kretzschmar, S.P.; Bedi, G.S.; Martinez, P.; Ervin, K.

    1996-07-01

    Bechtel Hanford, Inc. will prepare an Engineering Tracer Study Protocol for the determination of contact time for the disinfection process at Group A Non-transient Non-community water treatment plant for the 100-N Water Plant at the Hanford Site in Richland, Washington. Included in this report are the results of a study that determine the actual detention time within the plant clearwell, and thus the disinfection contact time at several clearwell effluent flow rates

  10. Study protocol: Mother and Infant Nutritional Assessment (MINA) cohort study in Qatar and Lebanon.

    Science.gov (United States)

    Naja, Farah; Nasreddine, Lara; Al Thani, Al Anoud; Yunis, Khaled; Clinton, Michael; Nassar, Anwar; Farhat Jarrar, Sara; Moghames, Patricia; Ghazeeri, Ghina; Rahman, Sajjad; Al-Chetachi, Walaa; Sadoun, Eman; Lubbad, Nibal; Bashwar, Zelaikha; Bawadi, Hiba; Hwalla, Nahla

    2016-05-04

    The Middle East and North Africa region harbors significant proportions of stunting and wasting coupled with surging rates of non-communicable diseases (NCDs). Recent evidence identified nutrition during the first 1000 days of life as a common denominator not only for optimal growth but also for curbing the risk of NCDs later in life. The main objective of this manuscript is to describe the protocol of the first cohort in the region to investigate the association of nutrition imbalances early in life with birth outcomes, growth patterns, as well as early determinants of non-communicable diseases. More specifically the cohort aims to 1) examine the effects of maternal and early child nutrition and lifestyle characteristics on birth outcomes and growth patterns and 2) develop evidence-based nutrition and lifestyle guidelines for pregnant women and young children. A multidisciplinary team of researchers was established from governmental and private academic and health sectors in Lebanon and Qatar to launch the Mother and Infant Nutritional Assessment 3-year cohort study. Pregnant women (n = 250 from Beirut, n = 250 from Doha) in their first trimester are recruited from healthcare centers in Beirut, Lebanon and Doha, Qatar. Participants are interviewed three times during pregnancy (once every trimester) and seven times at and after delivery (when the child is 4, 6, 9, 12, 18, and 24 months old). Delivery and birth data is obtained from hospital records. Data collection includes maternal socio-demographic and lifestyle characteristics, dietary intake, anthropometric measurements, and household food security data. For biochemical assessment of various indicators of nutritional status, a blood sample is obtained from women during their first trimester. Breastfeeding and complementary feeding practices, dietary intake, as well as anthropometric measurements of children are also examined. The Delphi technique will be used for the development of the nutrition and lifestyle

  11. Anesthesia and critical-care delivery in weightlessness: A challenge for research in parabolic flight analogue space surgery studies

    Science.gov (United States)

    Ball, Chad G.; Keaney, Marilyn A.; Chun, Rosaleen; Groleau, Michelle; Tyssen, Michelle; Keyte, Jennifer; Broderick, Timothy J.; Kirkpatrick, Andrew W.

    2010-03-01

    BackgroundMultiple nations are actively pursuing manned exploration of space beyond low-earth orbit. The responsibility to improve surgical care for spaceflight is substantial. Although the use of parabolic flight as a terrestrial analogue to study surgery in weightlessness (0 g) is well described, minimal data is available to guide the appropriate delivery of anesthesia. After studying anesthetized pigs in a 0 g parabolic flight environment, our group developed a comprehensive protocol describing prolonged anesthesia in a parabolic flight analogue space surgery study (PFASSS). Novel challenges included a physically remote vivarium, prolonged (>10 h) anesthetic requirements, and the provision of veterinary operating room/intensive care unit (ICU) equivalency on-board an aircraft with physical dimensions of ethical approval, multiple ground laboratory sessions were conducted with combinations of anesthetic, pre-medication, and induction protocols on Yorkshire-cross specific pathogen-free (SPF) pigs. Several constant rate infusion (CRI) intravenous anesthetic combinations were tested. In each regimen, opioids were administered to ensure analgesia. Ventilation was supported mechanically with blended gradients of oxygen. The best performing terrestrial 1 g regime was flight tested in parabolic flight for its effectiveness in sustaining optimal and prolonged anesthesia, analgesia, and maintaining hemodynamic stability. Each flight day, a fully anesthetized, ventilated, and surgically instrumented pig was transported to the Flight Research Laboratory (FRL) in a temperature-controlled animal ambulance. A modular on-board surgical/ICU suite with appropriate anesthesia/ICU and surgical support capabilities was employed. ResultsThe mean duration of anesthesia (per flight day) was 10.28 h over four consecutive days. A barbiturate and ketamine-based CRI anesthetic regimen supplemented with narcotic analgesia by bolus administration offered the greatest prolonged hemodynamic

  12. Female plastic surgery patients prefer mirror-reversed photographs of themselves: A prospective study.

    Science.gov (United States)

    de Runz, Antoine; Boccara, David; Chaouat, Marc; Locatelli, Katia; Bertheuil, Nicolas; Claudot, Frédérique; Bekara, Farid; Mimoun, Maurice

    2016-01-01

    The use of a patient's image in plastic surgery is common today. Thus, plastic surgeons should master the use of the image and be aware of the implications of the patients' perception of themselves. The mere-exposure effect is a psychological phenomenon in which a person tends to rate things more positively merely because (s)he is familiar with them. Faces are asymmetric, so faces in photos are different from those observed in mirrors. The main objective of this study was to assess whether patients within a plastic surgery population, particularly those undergoing facial aesthetic surgery, preferred standard photographs or mirror-reversed photographs of themselves. A prospective study was conducted in a plastic surgery department, which included women who were admitted to the hospital the day before their procedures. The patients were separated into the following two groups: Group 1 was composed of patients who were undergoing facial aesthetic surgeries, and Group 2 consisted of other patients who presented to the plastic surgery department for surgery. The patients were required to rate their appreciation of their own faces and to choose between standard and mirror-reversed photos of themselves. A total of 214 patients participated. The median age was 47.9 years (interquartile range (IQR): 36.4-60.6), and the median face appreciation was 5 (IQR: 5-7). The preference for the mirror-reversed photograph was significantly different from chance (p < 0.001, binomial (214, 156, 0.5)); 73% of the patients preferred the mirror-reversed photographs. The proportions of patients who preferred the mirror-reversed photograph differed significantly (p = 0.047) between Groups 1 (84%) and 2 (70%). Plastic surgery patients have a significant preference for mirror-reversed photographs of themselves over standard photographs. This preference is even more pronounced among patients who are undergoing facial aesthetic surgery. III. Copyright © 2015 British Association of Plastic

  13. Three-dimensional surgical modelling with an open-source software protocol: study of precision and reproducibility in mandibular reconstruction with the fibula free flap.

    Science.gov (United States)

    Ganry, L; Quilichini, J; Bandini, C M; Leyder, P; Hersant, B; Meningaud, J P

    2017-08-01

    Very few surgical teams currently use totally independent and free solutions to perform three-dimensional (3D) surgical modelling for osseous free flaps in reconstructive surgery. This study assessed the precision and technical reproducibility of a 3D surgical modelling protocol using free open-source software in mandibular reconstruction with fibula free flaps and surgical guides. Precision was assessed through comparisons of the 3D surgical guide to the sterilized 3D-printed guide, determining accuracy to the millimetre level. Reproducibility was assessed in three surgical cases by volumetric comparison to the millimetre level. For the 3D surgical modelling, a difference of less than 0.1mm was observed. Almost no deformations (free flap modelling was between 0.1mm and 0.4mm, and the average precision of the complete reconstructed mandible was less than 1mm. The open-source software protocol demonstrated high accuracy without complications. However, the precision of the surgical case depends on the surgeon's 3D surgical modelling. Therefore, surgeons need training on the use of this protocol before applying it to surgical cases; this constitutes a limitation. Further studies should address the transfer of expertise. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  14. Implementation of the Spanish ERAS program in bariatric surgery.

    Science.gov (United States)

    Ruiz-Tovar, Jaime; Muñoz, José Luis; Royo, Pablo; Duran, Manuel; Redondo, Elisabeth; Ramirez, Jose Manuel

    2018-03-08

    The essence of Enhanced Recovery After Surgery (ERAS) programs is the multimodal approach, and many authors have demonstrated safety and feasibility in fast track bariatric surgery. According to this concept, a multidisciplinary ERAS program for bariatric surgery has been developed by the Spanish Fast Track Group (ERAS Spain). The aim of this study was to analyze the initial implementation of this Spanish National ERAS protocol in bariatric surgery, comparing it with a historical cohort receiving standard care. A multi-centric prospective study was performed, including 233 consecutive patients undergoing bariatric surgery during 2015 and following ERAS protocol. It was compared with a historical cohort of 286 patients, who underwent bariatric surgery at the same institutions between 2013 and 2014 and following standard care. Compliance with the protocol, morbidity, mortality, hospital stay and readmission were evaluated. Bariatric techniques performed were Roux-en-Y gastric bypass and sleeve gastrectomy. There were no significant differences in complications, mortality and readmission. Postoperative pain and hospital stay were significantly lower in the ERAS group. The total compliance to protocol was 80%. The Spanish National ERAS protocol is a safe issue, obtaining similar results to standard care in terms of complications, reoperations, mortality and readmissions. It is associated with less postoperative pain and earlier hospital discharge.

  15. Effects of a balanced energy and high protein formula diet (Vegestart complet®) vs. low-calorie regular diet in morbid obese patients prior to bariatric surgery (laparoscopic single anastomosis gastric bypass): a prospective, double-blind randomized study.

    Science.gov (United States)

    Carbajo, M A; Castro, Maria J; Kleinfinger, S; Gómez-Arenas, S; Ortiz-Solórzano, J; Wellman, R; García-Ianza, C; Luque, E

    2010-01-01

    Bariatric surgery is considered the only therapeutic alternative for morbid obesity and its comorbidities. High risks factors are usually linked with this kind of surgery. In order to reduce it, we consider that losing at least 10% of overweight in Morbid Obese (MO) and a minimum of 20% in Super- Obese patients (SO) before surgery, may reduce the morbidity of the procedure. The aim of our study is to demonstrate the effectiveness and tolerance of a balanced energy formula diet at the preoperative stage, comparing it against a low calorie regular diet. We studied 120 patients divided into two groups of 60 each, group A was treated 20 days prior to bariatric surgery with a balanced energy formula diet, based on 200 Kcal every 6 hours for 12 days and group B was treated with a low calorie regular diet with no carbs or fat. The last eight days prior to surgery both groups took only clear liquids. We studied the evolution of weight loss, the BMI, as well as behavior of co-morbidities as systolic blood pressure, diastolic blood pressure, glucose controls and tolerance at the protocol. The study shows that patients undergoing a balanced energy formula diet improved their comorbidities statistically significant in terms of decrease in weight and BMI loss, blood pressure and glucose, compared to the group that was treated before surgery with a low calorie regular diet. Nevertheless both groups improving the weight loss and co-morbidities with better surgical results and facilities. A correct preparation of the Morbid Obese patients prior of surgery can reduce the operative risks improving the results. Our study show that the preoperative treatment with a balanced energy formula diet as were included in our protocol in patients undergoing bariatric surgery improves statistical better their overall conditions, lowers cardiovascular risk and metabolic diseases that the patients with regular diet alone.

  16. The Zelnorm epidemiologic study (ZEST: a cohort study evaluating incidence of abdominal and pelvic surgery related to tegaserod treatment

    Directory of Open Access Journals (Sweden)

    Seeger John D

    2012-11-01

    Full Text Available Abstract Background Pre-marketing clinical studies of tegaserod suggested an increased risk of abdominal surgery, particularly cholecystectomy. We sought to quantify the association between tegaserod use and the occurrence of abdominal or pelvic surgery, including cholecystectomy. Methods This cohort study was conducted within an insured population. Tegaserod initiators and similar persons who did not initiate tegaserod were followed for up to six months for the occurrence of abdominal or pelvic surgery. Surgical procedures were identified from health insurance claims validated by review of medical records. The incidence of confirmed outcomes was compared using both as-matched and as-treated analyses. Results Among 2,762 tegaserod initiators, there were 94 abdominal or pelvic surgeries (36 gallbladder: among 2,762 comparators there were 134 abdominal or pelvic surgeries (37 gallbladder (hazard ratio HR] = 0.70, 95% confidence interval [C.I.] = 0.54-0.91 overall, HR = 0.98, 95% C.I. = 0.62-1.55 for gallbladder. Current tegaserod exposure compared to nonexposure was associated with a rate ratio [RR] of 0.68 (95% C.I. = 0.48-0.95 overall, while the RR was 0.99 (95% C.I. = 0.56-1.77 for gallbladder surgery. Conclusions In this study, tegaserod use was not found to increase the risk of abdominal or pelvic surgery nor the specific subset of gallbladder surgery.

  17. Gynecomastia Surgery-Impact on Life Quality: A Prospective Case-Control Study.

    Science.gov (United States)

    Kasielska-Trojan, Anna; Antoszewski, Bogusław

    2017-03-01

    To evaluate the results of surgical treatment of gynecomastia in the context of quality of life and satisfaction after the surgery. Fifty male patients (mean age, 25.1 years [SD = 8 years]) who underwent surgery for gynecomastia and completed both (preoperative and postoperative) stages of the study were included in the analysis. The quality-of-life evaluation instrument was The Short Form-36 Health Survey Questionnaire. Additionally, we used a short questionnaire including 2 questions about patient satisfaction with gynecomastia surgery. The overall change in life satisfaction after gynecomastia surgery was 1 point on Likert scale (sign test, P gynecomastia surgery scored significantly higher than before the procedure in all Short Form-36 Health Survey Questionnaire domains as well as in 2 main scales Psychical and Physical Health. The changes were especially visible for the domain social functioning and a scale Psychical Health (P Gynecomastia surgery significantly improved men's life quality in all aspects and especially in the social aspect and psychical health. This indicates that adult men with gynecomastia are a specific group of patients, in which surgery may result in life quality improvement even over the average scores.

  18. Cryotherapy and Topical Minocycline as Adjunctive Measures to Control Pain After Third Molar Surgery: An Exploratory Study

    Science.gov (United States)

    Gelesko, Savannah; Long, Leann; Faulk, Jan; Phillips, Ceib; Dicus, Carolyn; White, Raymond P.

    2013-01-01

    Purpose To assess the impact of cryotherapy or topical minocycline on patients’ perceptions of recovery from pain after third molar surgery in an exploratory comparative-effectiveness study. Patients and Methods Subjects aged at least 14 years who were having all 4 third molars removed were enrolled in 3 separate institutional review board–approved studies. Study groups included subjects treated with a passively applied cold wrap for 24 hours postoperatively, subjects treated with topical minocycline during surgery, and subjects enrolled in a nonconcurrent comparison group who had received neither topical minocycline nor directed cryotherapy. Third molar surgery was performed in all cases by trained surgeons using the same protocol. An exact Kruskal-Wallis test was used to compare the distributions of the worst and average pain scores and a Fisher exact test to compare verbal responses from Gracely pain scales among the 3 groups for postsurgical days (PSDs) 1 to 3. Results This study comprised 51 cryotherapy subjects (2005–2009), 63 minocycline subjects (2003–2004), and 92 comparison-group subjects (2002–2006) who were treated at academic centers and in community practices across the United States (N = 206). Demographic descriptors were similar among all groups. For PSDs 1 through 3 (unadjusted), the highest scores for worst pain (6–7 [out of 7] on Likert-type scale) were reported less frequently in each of the study groups than in subjects in the comparison group, although the numbers of subjects reporting the highest scores were few. The distribution of pain outcomes was significantly different among the 3 groups for worst pain and affective words on PSD 1 (P = .04 for both). However, the small number of subjects who reported the highest pain scores precluded adequate multivariate statistical analyses for all outcomes on PSD 1 to 3. Conclusions Data from this exploratory study suggest that adjunctive therapy to decrease postoperative pain

  19. The precautionary principle as a provisional instrument in environmental policy: The Montreal Protocol case study

    International Nuclear Information System (INIS)

    Jacobs, J. Roger

    2014-01-01

    Highlights: • I examine whether a policy invoked under the Precautionary Principle can move beyond provisional status. • I review the certainty of conclusions based upon the Global Ozone Research and Monitoring Project. • There is high certainty that anthropogenic ozone depletion has health consequences in polar regions. • Current research focuses on long term projections of risk that perpetuates high uncertainty. • Establishment of a community to generate Assessments acts to perpetuate the period of uncertainty. - Abstract: Environmental studies identify possible threats to the health of the public or the environment when the scientific certainty of risk is low, but the potential cost is high. Governments may respond by invoking the Precautionary Principle, holding that scientific certainty is not required to take actions that reduce possible risk. EU guidelines suggest that precautionary measures remain provisional until sufficient scientific certainty is generated. Here I study the Scientific Assessments produced for the Montreal Protocol, and the scientific community that generates them, and ask whether a long-standing program of scientific investigation and monitoring can generate sufficient scientific certainty to move beyond dependence on the Precautionary Principle. When the Montreal Protocol was ratified, many scientists strongly suspected that anthropogenic substances like chlorofluorocarbons were depleting stratospheric ozone. Although the risk was uncertain, the perceived cost to public health of ozone depletion was high. A quarter century after formulating the Montreal Protocol, science can define the conditions for ozone depletion with great certainty, but uncertainty remains in determining the scale and distribution of the attributable increase in damaging ultra-violet (UV) radiation. Organisations, such as NASA, and scientists that contribute to the Scientific Assessments comprise the community in which the scientific consensus of risk is

  20. A Comparative Study of Single-Port Laparoscopic Surgery Versus Robotic-Assisted Laparoscopic Surgery for Rectal Cancer

    DEFF Research Database (Denmark)

    Levic, Katarina; Donatsky, Anders Meller; Bulut, Orhan

    2015-01-01

    INTRODUCTION: Conventional laparoscopic surgery is the treatment of choice for many abdominal procedures. To further reduce surgical trauma, new minimal invasive procedures such as single-port laparoscopic surgery (SPLS) and robotic assisted laparoscopic surgery (RALS) have emerged. The aim...... in either of the groups. There was no difference in median follow-up time between groups (P = .58). CONCLUSION: Both SPLS and RALS may have a role in rectal surgery. The short-term oncological outcomes were similar, although RALS harvested more lymph nodes than the SPLS procedure. However, SPLS seems...

  1. Perioperative outcomes of adolescents undergoing bariatric surgery: the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study.

    Science.gov (United States)

    Inge, Thomas H; Zeller, Meg H; Jenkins, Todd M; Helmrath, Michael; Brandt, Mary L; Michalsky, Marc P; Harmon, Carroll M; Courcoulas, Anita; Horlick, Mary; Xanthakos, Stavra A; Dolan, Larry; Mitsnefes, Mark; Barnett, Sean J; Buncher, Ralph

    2014-01-01

    Severe obesity in childhood is a major health problem with few effective treatments. Weight-loss surgery (WLS) is being used to treat severely obese adolescents, although with very limited data regarding surgical safety for currently used, minimally invasive procedures. To assess the preoperative clinical characteristics and perioperative safety outcomes of severely obese adolescents undergoing WLS. This prospective, multisite observational study enrolled patients from February 28, 2007, through December 30, 2011. Consecutive patients aged 19 years or younger who were approved to undergo WLS (n = 277) were offered enrollment into the study at 5 academic referral centers in the United States; 13 declined participation and 22 did not undergo surgery after enrollment, thus the final analysis cohort consisted of 242 individuals. There were no withdrawals. This analysis examined preoperative anthropometrics, comorbid conditions, and major and minor complications occurring within 30 days of operation. All data were collected in a standardized fashion. Reoperations and hospital readmissions were adjudicated by independent reviewers to assess relatedness to the WLS procedure. The mean (SD) age of participants was 17.1 (1.6) years and the median body mass index (calculated as weight in kilograms divided by height in meters squared) was 50.5. Fifty-one percent demonstrated 4 or more major comorbid conditions. Laparoscopic Roux-en-Y gastric bypass, vertical sleeve gastrectomy, and adjustable gastric banding were performed in 66%, 28%, and 6% of patients, respectively. There were no deaths during the initial hospitalization or within 30 days of operation; major complications (eg, reoperation) were seen in 19 patients (8%). Minor complications (eg, readmission for dehydration) were noted in 36 patients (15%). All reoperations and 85% of readmissions were related to WLS. In this series, adolescents with severe obesity presented with abundant comorbid conditions. We observed

  2. Organizational Factors and Long-Term Mortality after Hip Fracture Surgery. A Cohort Study of 6143 Consecutive Patients Undergoing Hip Fracture Surgery

    DEFF Research Database (Denmark)

    Lund, Caterina A; Møller, Ann M; Wetterslev, Jørn

    2014-01-01

    OBJECTIVE: In hospital and health care organizational factors may be changed to reduce postoperative mortality. The aim of this study is to evaluate a possible association between mortality and 'length of hospital stay', 'priority of surgery', 'time of surgery', or 'surgical delay' in hip fracture...... surgery. DESIGN: Observational cohort study. SETTING: Prospectively and consecutively reported data from the Danish Anaesthesia Database were linked to The Danish National Registry of Patients and The Civil Registration System. Records on vital status, admittance, discharges, codes of diagnosis......; therefore cluster randomized clinical trials comparing different clinical set ups may be warranted evaluating health care organizational factors....

  3. Utilization of Body Contouring Procedures Following Weight Loss Surgery: A Study of 37,806 Patients.

    Science.gov (United States)

    Altieri, Maria S; Yang, Jie; Park, Jihye; Novikov, David; Kang, Lijuan; Spaniolas, Konstantinos; Bates, Andrew; Talamini, Mark; Pryor, Aurora

    2017-11-01

    Bariatric surgery has substantial health benefits; however, some patients desire body contouring (BC) procedures following rapid weight loss. There is a paucity of data regarding the true rate of BC following bariatric procedures. The purpose of our study is to examine the utilization of two common procedures, abdominoplasty, and panniculectomy, following bariatric surgery in New York State. The SPARCS longitudinal administrative database was used to identify bariatric procedures by using ICD-9 and CPT codes between 2004 and 2010. Procedures included sleeve gastrectomy, Roux-en-Y gastric bypass, and laparoscopic adjustable gastric banding. Using a unique patient identifier, we tracked those patients who subsequently underwent either abdominoplasty or panniculectomy with at least a 4-year follow-up (until 2014). Multivariable Cox proportional hazard model was used to evaluate predictors of follow-up BC surgery. 37,806 patients underwent bariatric surgery between 2004 and 2010. Only 5.58% (n = 2112) of these patients subsequently had a BC procedure, with 143 of them (6.8%) having ≥1 plastic surgery. The average time to plastic surgery after band, bypass, or sleeve was 1134.83 ± 671.09, 984.70 ± 570.53, and 903.02 ± 497.31 days, respectively (P 80%ile in yearly income were more likely to have plastic surgery after adjusting for age, race/ethnicity, comorbidities and complications (P values plastic surgery is completed by only 6% of patients following bariatric procedures. As insurance and income are associated with pursuing surgery, improved access may increase the number of patients who are able to undergo these reconstructive procedures.

  4. Oophorectomy by natural orifice transluminal endoscopic surgery: feasibility study in dogs.

    Science.gov (United States)

    Freeman, Lynetta J; Rahmani, Emad Y; Sherman, Stuart; Chiorean, Michael V; Selzer, Don J; Constable, Peter D; Snyder, Paul W

    2009-06-01

    Natural orifice transluminal endoscopic surgery (NOTES) represents a potentially less-invasive alternative to conventional or laparoscopic surgery. Our purpose was to develop a canine oophorectomy model for prospective evaluation of intraoperative complications, surgical stress, and postoperative pain and recovery with NOTES. Feasibility study. Academic preclinical research. Ten healthy female dogs. NOTES procedures were performed through gastric access with an electrocautery snare to resect and retrieve the ovaries. The gastrotomy was closed with prototype T-fasteners. Operative time; complications; postoperative pain scores, and nociceptive threshold; surgical stress markers (interleukin-6 [IL-6], C-reactive protein); systemic stress parameters (cortisol, glucose); necropsy evaluation at 10 to 14 days. The mean operative time was 154 minutes (SD +/- 58 minutes) and no animals died as a result of complications from the procedure. The primary difficulty was incomplete ovarian excision and conversion to an open procedure in 1 dog. Serum glucose concentrations increased after surgery and remained elevated for at least 36 hours. The serum cortisol concentration was transiently increased from baseline at 2 hours after surgery. The serum IL-6 concentration peaked at 2 hours after surgery and returned to the baseline value by 18 hours. The serum C-reactive protein concentration increased significantly from baseline, peaked at 12 hours after surgery, and then slowly declined toward baseline but remained elevated at 72 hours after surgery. Nociceptive threshold measurements indicated increased sensitivity to pain for 2 to 24 hours after surgery. At necropsy, surgical sites were healing uneventfully with no significant damage to surrounding organs, no significant growth on bacterial cultures, and no evidence of peritonitis. Small number of animals, single center. The NOTES approach to oophorectomy in dogs appears to be a reasonable alternative to traditional surgery

  5. Systematic Review Protocol to Assess the Effectiveness of Usability Questionnaires in mHealth App Studies.

    Science.gov (United States)

    Zhou, Leming; Bao, Jie; Parmanto, Bambang

    2017-08-01

    Usability questionnaires have a wide use in mobile health (mHealth) app usability studies. However, no systematic review has been conducted for assessing the effectiveness of these questionnaires. This paper describes a protocol for conducting a systematic review of published questionnaire-based mHealth app usability studies. In this systematic review, we will select recently published (2008-2017) articles from peer-reviewed journals and conferences that describe mHealth app usability studies and implement at least one usability questionnaire. The search strategy will include terms such as "mobile app" and "usability." Multiple databases such as PubMed, CINAHL, IEEE Xplore, ACM Digital Library, and INSPEC will be searched. There will be 2 independent reviewers in charge of screening titles and abstracts as well as determining those articles that should be included for a full-text review. The third reviewer will act as a mediator between the other 2 reviewers. Moreover, a data extraction form will be created and used during the full article data analysis. Notably, the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines will be followed in reporting this protocol. A preliminary search produced 1271 articles, 40 of which are duplicate records. The inclusion-exclusion criteria are being strictly followed in performing the ongoing study selection. Usability questionnaires are an important tool in mHealth app usability studies. This review will summarize the usability questionnaires used in published research articles while assessing the efficacy of these questionnaires in determining the usability of mHealth apps. ©Leming Zhou, Jie Bao, Bambang Parmanto. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.08.2017.

  6. Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

    Science.gov (United States)

    Napier, A David; Nolan, John J; Bagger, Malene; Hesseldal, Louise; Volkmann, Anna-Maria

    2017-11-08

    Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers. © Article author

  7. Prenatal diagnosis and prevention of toxoplasmosis in pregnant women in Northern Vietnam: study protocol.

    Science.gov (United States)

    Smit, G Suzanne A; Vu, Thi Lam Binh; Do, Trung Dung; Speybroeck, Niko; Devleesschauwer, Brecht; Padalko, Elizaveta; Roets, Ellen; Dorny, Pierre

    2017-05-25

    In Vietnam, no systematic prenatal toxoplasmosis screening is in place, and only few studies have assessed the prevalence and importance of this zoonotic parasite infection. In addition, no studies have been conducted to assess the risk factors associated with toxoplasmosis. This study protocol was developed to determine the seroprevalence of toxoplasmosis in pregnant women in Hanoi and Thai Binh, Northern Vietnam, and to evaluate the association with risk factors and congenital toxoplasmosis. The protocol was developed in a way that it could potentially evolve into a countrywide prenatal diagnosis and prevention program, with the main focus on primary prevention. The collaborating gynaecologists will invite eligible pregnant women attending antenatal care for the first time to participate in the study. At first consult, information about toxoplasmosis and its prevention will be provided. All participants will be asked to fill in a questionnaire, which is designed to analyse socio-demographic and biologically plausible risk factors associated with toxoplasmosis, and blood samples will be collected to determine the seroprevalence of toxoplasmosis in pregnant women. In case there is suspicion of a primary infection during pregnancy, the concerned women will be followed-up by the gynaecologists according to a predefined protocol. Every participant will be informed on her serological status, risk factors and prevention measures and is offered appropriate medical information and medical follow-up if required. The hypothesis is that congenital toxoplasmosis is an important but currently under-diagnosed public health problem in Vietnam. This study can strengthen sustainable control of toxoplasmosis in Vietnam, provide a protocol for prenatal diagnosis, boost overall awareness, improve the knowledge about toxoplasmosis prevention and can be essential for evidence-based health policy.

  8. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study.

    Science.gov (United States)

    Brehmer, Jess L; Husband, Jeffrey B

    2014-10-01

    There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation (ORIF). The purpose of this study was to compare the early postoperative outcomes (at zero to twelve weeks postoperatively) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture. We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol. From November 2007 to November 2010, eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture. Both groups began with gentle active range of motion at three to five days postoperatively. At two weeks, the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises, whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively. Patients were assessed at three to five days, two weeks, three weeks, four weeks, six weeks, eight weeks, twelve weeks, and six months postoperatively. Outcomes included Disabilities of the Arm, Shoulder and Hand (DASH) scores (primary outcome) and measurements of wrist flexion/extension, supination, pronation, grip strength, and palmar pinch. The patients in the accelerated group had better mobility, strength, and DASH scores at the early postoperative time points (zero to eight weeks postoperatively) compared with the patients in the standard rehabilitation group. The difference between the groups was both clinically relevant and statistically significant. Patients who follow an accelerated rehabilitation

  9. Dose Specification and Quality Assurance of Radiation Therapy Oncology Group Protocol 95-17; a Cooperative Group Study of Iridium-192 Breast Implants as Sole Therapy

    International Nuclear Information System (INIS)

    Ibbott, Geoffrey S.; Hanson, W.F.; O'Meara, Elizabeth; Kuske, Robert R.; Arthur, Douglas; Rabinovitch, Rachel; White, Julia; Wilenzick, Raymond M.; Harris, Irene; Tailor, Ramesh C.

    2007-01-01

    Purpose: The Radiation Therapy Oncology Group (RTOG) protocol 95-17 was a Phase I/II trial to evaluate multicatheter brachytherapy as the sole method of adjuvant breast radiotherapy for Stage I/II breast carcinoma after breast-conserving surgery. Low- or high-dose-rate sources were allowed. Dose prescription and treatment evaluation were based on recommendations in the International Commission on Radiation Units and Measurements (ICRU), Report 58 and included the parameters mean central dose (MCD), average peripheral dose, dose homogeneity index (DHI), and the dimensions of the low- and high-dose regions. Methods and Materials: Three levels of quality assurance were implemented: (1) credentialing of institutions was required before entering patients into the study; (2) rapid review of each treatment plan was conducted before treatment; and (3) retrospective review was performed by the Radiological Physics Center in conjunction with the study chairman and RTOG dosimetry staff. Results: Credentialing focused on the accuracy of dose calculation algorithm and compliance with protocol guidelines. Rapid review was designed to identify and correct deviations from the protocol before treatment. The retrospective review involved recalculation of dosimetry parameters and review of dose distributions to evaluate the treatment. Specifying both central and peripheral doses resulted in uniform dose distributions, with a mean dose homogeneity index of 0.83 ± 0.06. Conclusions: Vigorous quality assurance resulted in a high-quality study with few deviations; only 4 of 100 patients were judged as representing minor variations from protocol, and no patient was judged as representing major deviation. This study should be considered a model for quality assurance of future trials

  10. Technology-Enabled Remote Monitoring and Self-Management - Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol.

    Science.gov (United States)

    McGillion, Michael; Yost, Jennifer; Turner, Andrew; Bender, Duane; Scott, Ted; Carroll, Sandra; Ritvo, Paul; Peter, Elizabeth; Lamy, Andre; Furze, Gill; Krull, Kirsten; Dunlop, Valerie; Good, Amber; Dvirnik, Nazari; Bedini, Debbie; Naus, Frank; Pettit, Shirley; Henry, Shaunattonie; Probst, Christine; Mills, Joseph; Gossage, Elaine; Travale, Irene; Duquette, Janine; Taberner, Christy; Bhavnani, Sanjeev; Khan, James S; Cowan, David; Romeril, Eric; Lee, John; Colella, Tracey; Choinière, Manon; Busse, Jason; Katz, Joel; Victor, J Charles; Hoch, Jeffrey; Isaranuwatchai, Wanrudee; Kaasalainen, Sharon; Ladak, Salima; O'Keefe-McCarthy, Sheila; Parry, Monica; Sessler, Daniel I; Stacey, Michael; Stevens, Bonnie; Stremler, Robyn; Thabane, Lehana; Watt-Watson, Judy; Whitlock, Richard; MacDermid, Joy C; Leegaard, Marit; McKelvie, Robert; Hillmer, Michael; Cooper, Lynn; Arthur, Gavin; Sider, Krista; Oliver, Susan; Boyajian, Karen; Farrow, Mark; Lawton, Chris; Gamble, Darryl; Walsh, Jake; Field, Mark; LeFort, Sandra; Clyne, Wendy; Ricupero, Maria; Poole, Laurie; Russell-Wood, Karsten; Weber, Michael; McNeil, Jolene; Alpert, Robyn; Sharpe, Sarah; Bhella, Sue; Mohajer, David; Ponnambalam, Sem; Lakhani, Naeem; Khan, Rabia; Liu, Peter; Devereaux, P J

    2016-08-01

    Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT-VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom. Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT). CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative

  11. Randomized clinical study comparing piezosurgery and conventional rotatory surgery in mandibular cyst enucleation.

    Science.gov (United States)

    Pappalardo, Sabrina; Guarnieri, Renzo

    2014-07-01

    The aim of the present study is to compare piezoelectric surgery to the conventional rotatory surgery in mandibular cyst enucleation, and to determine the 2 method's suitability and the postoperative outcomes. Eighty patients were included in the study. 35 male and 45 female, which showed cystic mandibular lesions, compared with the inferior alveolar nerve or the mental nerve. The patients were randomly divided into two groups. In the test group, cystectomy was performed using conventional rotatory instrumentation (rotatory-group), and in the other one piezoelectric surgery (piezo-group). The swelling was documented 24/48/72 h and 1 week post-surgery and the patients recorded their subjective postoperative pain daily for 7 days using a Visual Analog Scale (VAS). Patients treated with piezoelectric technique have presented a lower VAS, minor swelling and less recovery time compared to the rotatory-group. No lesions of the mandible nerve were detected with piezosurgery whereas surgery with rotary instruments resulted in 8% hypesthesia at least up to one week. The results of this study suggest that piezosurgery may be considered effective in cyst enucleation compared to traditional procedures with burs, since it grants the patients significantly less post-surgical pain and swelling. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  12. Factors influencing ambulance nurses' adherence to a national protocol ambulance care: an implementation study in the Netherlands

    NARCIS (Netherlands)

    Ebben, R.H.; Vloet, L.C.M.; Grunsven, P.M. van; Breeman, W.; Goosselink, B.; Lichtveld, R.A.; Groot, J. de; Achterberg, T. van

    2015-01-01

    OBJECTIVES: Adherence to prehospital guidelines and protocols is suboptimal. Insight into influencing factors is necessary to improve adherence. The aim of this study was to identify factors that influence ambulance nurses' adherence to a National Protocol Ambulance Care (NPAC). METHODS: A

  13. Protocol for a multicentre, prospective, population-based cohort study of variation in practice of cholecystectomy and surgical outcomes (The CholeS study).

    Science.gov (United States)

    Vohra, Ravinder S; Spreadborough, Philip; Johnstone, Marianne; Marriott, Paul; Bhangu, Aneel; Alderson, Derek; Morton, Dion G; Griffiths, Ewen A

    2015-01-12

    Cholecystectomy is one of the most common general surgical operations performed. Despite level one evidence supporting the role of cholecystectomy in the management of specific gallbladder diseases, practice varies between surgeons and hospitals. It is unknown whether these variations account for the differences in surgical outcomes seen in population-level retrospective data sets. This study aims to investigate surgical outcomes following acute, elective and delayed cholecystectomies in a multicentre, contemporary, prospective, population-based cohort. UK and Irish hospitals performing cholecystectomies will be recruited utilising trainee-led research collaboratives. Two months of consecutive, adult patient data will be included. The primary outcome measure of all-cause 30-day readmission rate will be used in this study. Thirty-day complication rates, bile leak rate, common bile duct injury, conversion to open surgery, duration of surgery and length of stay will be measured as secondary outcomes. Prospective data on over 8000 procedures is anticipated. Individual hospitals will be surveyed to determine local policies and service provision. Variations in outcomes will be investigated using regression modelling to adjust for confounders. Research ethics approval is not required for this study and has been confirmed by the online National Research Ethics Service (NRES) decision tool. This novel study will investigate how hospital-level surgical provision can affect patient outcomes, using a cross-sectional methodology. The results are essential to inform commissioning groups and implement changes within the National Health Service (NHS). Dissemination of the study protocol is primarily through the trainee-led research collaboratives and the Association of Upper Gastrointestinal Surgeons (AUGIS). Individual centres will have access to their own results and the collective results of the study will be published in peer-reviewed journals and presented at relevant

  14. Study of the thermal comfort, of the energy consumption and of the indoor environment control in surgery rooms

    NARCIS (Netherlands)

    Melhado, M.D.A.; Beyer, P.O.; Hensen, J.L.M.; Siqueira, L.F.G.

    2005-01-01

    In this research were investigated the influence of different layouts of operating rooms on thermal comfort, on the indoor environment control and on energy consumption. The layouts studied were: Case 1 (a surgery room and a hallway); Case 2 (a surgery room and two hallways); and Case 3 (a surgery

  15. The impact of a bariatric rehabilitation service on weight loss and psychological adjustment - study protocol

    Directory of Open Access Journals (Sweden)

    Hollywood Amelia

    2012-04-01

    Full Text Available Abstract Background Bariatric surgery is currently the most effective form of obesity management for those whose BMI is greater than 40 (or 35 with co morbidities. A minority of patients, however, either do not show the desired loss of excess weight or show weight regain by follow up. Research highlights some of the reasons for this variability, most of which centres on the absence of any psychological support with patients describing how although surgery fixes their body, psychological issues relating to dietary control, self esteem, coping and emotional eating remain neglected. The present study aims to evaluate the impact of a health psychology led bariatric rehabilitation service (BRS on patient health outcomes. The bariatric rehabilitation service will provide information, support and mentoring pre and post surgery and will address psychological issues such as dietary control, self esteem, coping and emotional eating. The package reflects the rehabilitation services now common place for patients post heart attack and stroke which have been shown to improve patient health outcomes. Methods/Design The study is a randomised control trial and patients will be allocated to receive either usual care or the bariatric rehabilitation service pre and post bariatric surgery. Follow up measures of weight loss and psychological issues will be taken at baseline (2 weeks preoperatively, 3, 6 and 12 months postoperatively. The contents of the bariatric service and the follow up measures are based on previous pilot work and have been developed further by the research team working closely with two patient support groups (BOSPA & WLSinfo. This study will take place in St Richard's Hospital in Chichester in the UK. Discussion It is predicted that a bariatric rehabilitation service will improve weight loss following surgery and will also facilitate changes in other psychological variables such as quality of life, dietary control, self esteem, coping and

  16. Preoperative predictive model for acute kidney injury after elective cardiac surgery: a prospective multicentre cohort study.

    Science.gov (United States)

    Callejas, Raquel; Panadero, Alfredo; Vives, Marc; Duque, Paula; Echarri, Gemma; Monedero, Pablo

    2018-05-11

    Predictive models of CS-AKI include emergency surgery and patients with haemodynamic instability. Our objective was to evaluate the performance of validated predictive models (Thakar and Demirjian) in elective cardiac surgery and to propose a better score in the case of poor performance. A prospective, multicentre, observational study was designed. Data were collected from 942 patients undergoing cardiac surgery, after excluding emergency surgery and patients with an intraaortic balloon pump. The main outcome measure was CS-AKI defined by the composite of requiring dialysis or doubling baseline creatinine values. Both models showed poor discrimination in elective surgery (Thakar's model, AUROC = 0.57, 95% CI = 0.50-0.64 and Demirjian's model, AUROC= 0.64, 95% CI = 0.58-0.71). We generated a new model whose significant independent predictors were: anaemia, age, hypertension, obesity, congestive heart failure, previous cardiac surgery and type of surgery. It classifies patients with scores 0-3 as low risk ( 8 as high risk (>30%) of developing CS-AKI with a statistically significant correlation (p <0.001). Our model reflects acceptable discriminatory ability (AUC = 0.72, 95% CI = 0.66-0.78) which is significantly better than Thakar and Demirjian's models (p<0.01). We developed a new simple predictive model of CS-AKI in elective surgery based on available preoperative information. Our new model is easy to calculate and can be an effective tool for communicating risk to patients and guiding decision-making in the perioperative period. The study requires external validation.

  17. Replication protocol analysis: a method for the study of real-world design thinking

    DEFF Research Database (Denmark)

    Galle, Per; Kovacs, L. B.

    1996-01-01

    ’ is refined into a method called ‘replication protocol analysis’ (RPA), and discussed from a methodological perspective of design research. It is argued that for the study of real-world design thinking this method offers distinct advantages over traditional ‘design protocol analysis’, which seeks to capture......Given the brief of an architectural competition on site planning, and the design awarded the first prize, the first author (trained as an architect but not a participant in the competition) produced a line of reasoning that might have led from brief to design. In the paper, such ‘design replication...... the designer’s authentic line of reasoning. To illustrate how RPA can be used, the site planning case is briefly presented, and part of the replicated line of reasoning analysed. One result of the analysis is a glimpse of a ‘logic of design’; another is an insight which sheds new light on Darke’s classical...

  18. The longitudinal urban cohort ageing study (LUCAS: study protocol and participation in the first decade

    Directory of Open Access Journals (Sweden)

    Dapp Ulrike

    2012-07-01

    Full Text Available Abstract Background We present concept, study protocol and selected baseline data of the Longitudinal Urban Cohort Ageing Study (LUCAS in Germany. LUCAS is a long-running cohort study of community-dwelling seniors complemented by specific studies of geriatric patients or diseases. Aims were to (1 Describe individual ageing trajectories in a metropolitan setting, documenting changes in functional status, the onset of frailty, disability and need of care; (2 Find determinants of healthy ageing; (3 Assess long-term effects of specific health promotion interventions; (4 Produce results for health care planning for fit, pre-frail, frail and disabled elderly persons; (5 Set up a framework for embedded studies to investigate various hypotheses in specific subgroups of elderly. Methods/Design In 2000, twenty-one general practitioners (GPs were recruited in the Hamburg metropolitan area; they generated lists of all their patients 60 years and older. Persons not terminally ill, without daily need of assistance or professional care were eligible. Of these, n = 3,326 (48 % agreed to participate and completed a small (baseline and an extensive health questionnaire (wave 1. In 2007/2008, a re-recruitment took place including 2,012 participants: 743 men, 1,269 women (647 deaths, 197 losses, 470 declined further participation. In 2009/2010 n = 1,627 returned the questionnaire (90 deaths, 47 losses, 248 declined further participation resulting in a good participation rate over ten years with limited and quantified dropouts. Presently, follow-up data from 2007/2008 (wave 2 and 2009/2010 (wave 3 are available. Data wave 4 is due in 2011/2012, and the project will be continued until 2013. Information on survival and need of nursing care was collected continuously and cross-checked against official records. We used Fisher’s exact test and t-tests. The study served repeatedly to evaluate health promotion interventions and concepts. Discussion LUCAS

  19. The Work-It Study for people with arthritis: Study protocol and baseline sample characteristics.

    Science.gov (United States)

    Keysor, Julie J; AlHeresh, Rawan; Vaughan, Molly; LaValley, Michael P; Allaire, Saralynn

    2016-06-14

    People with arthritis are at risk of work disability. Job accommodation and educational programs delivered before imminent work loss can minimize work disability, yet are not currently being widely implemented. The Work-It Study is a randomized controlled trial testing the efficacy of a problem solving program delivered by physical and occupational therapy practitioners to prevent work loss over a two-year period among people with arthritis and rheumatological conditions. The purpose of this paper is to describe the protocol of the randomized controlled trial, and describe the baseline characteristics of the subjects and their work outcomes. 287 participants were recruited from the Boston area in Massachusetts, USA. Eligible participants were aged between 21-65, self-reported a physicians' diagnosis of arthritis, rheumatic condition, or chronic back pain, reported a concern about working now or in the near future due to your health, worked at least 15 hours a week, had plans to continue working, and worked or lived in Massachusetts. Subjects were recruited through community sources and rheumatology offices. Participants in the experimental group received a structured interview and an education and resource packet, while participants in the control received the resource packet only. The baseline characteristics and work related outcomes of the participants were analyzed. To our knowledge, the Work-It Study is the largest and most diverse randomized controlled trial to date aiming to identify and problem solve work-related barriers, promote advocacy, and foster work disability knowledge among people with chronic disabling musculoskeletal conditions. Despite advances in medical management of arthritis and other rheumatological and musculoskeletal conditions, many people still have concerns about their ability to remain employed and are seeking strategies to help them sustain employment.

  20. The Resident-Run Minor Surgery Clinic: A Pilot Study to Safely Increase Operative Autonomy.

    Science.gov (United States)

    Wojcik, Brandon M; Fong, Zhi Ven; Patel, Madhukar S; Chang, David C; Petrusa, Emil; Mullen, John T; Phitayakorn, Roy

    General surgery training has evolved to align with changes in work hour restrictions, supervision regulations, and reimbursement practices. This has culminated in a lack of operative autonomy, leaving residents feeling inadequately prepared to perform surgery independently when beginning fellowship or practice. A resident-run minor surgery clinic increases junior resident autonomy, but its effects on patient outcomes have not been formally established. This pilot study evaluated the safety of implementing a resident-run minor surgery clinic within a university-based general surgery training program. Single institution case-control pilot study of a resident-run minor surgery clinic from 9/2014 to 6/2015. Rotating third-year residents staffed the clinic once weekly. Residents performed operations independently in their own procedure room. A supervising attending surgeon staffed each case prior to residents performing the procedure and viewed the surgical site before wound closure. Postprocedure patient complications and admissions to the hospital because of a complication were analyzed and compared with an attending control cohort. Massachusetts General Hospital General in Boston, MA; an academic tertiary care general surgery residency program. Ten third-year general surgery residents. Overall, 341 patients underwent a total of 399 procedures (110 in the resident clinic vs. 289 in the attending clinic). Minor surgeries included soft tissue mass excision (n = 275), abscess incision and drainage (n = 66), skin lesion excision (n = 37), skin tag removal (n = 15), and lymph node excision (n = 6). There was no significant difference in the overall rate of patients developing a postprocedure complication within 30 days (3.6% resident vs. 2.8% attending; p = 0.65); which persisted on multivariate analysis. Similar findings were observed for the rate of hospital admission resulting from a complication. Resident evaluations overwhelmingly supported the rotation, citing

  1. Relationships between study habits, burnout, and general surgery resident performance on the American Board of Surgery In-Training Examination.

    Science.gov (United States)

    Smeds, Matthew R; Thrush, Carol R; McDaniel, Faith K; Gill, Roop; Kimbrough, Mary K; Shames, Brian D; Sussman, Jeffrey J; Galante, Joseph M; Wittgen, Catherine M; Ansari, Parswa; Allen, Steven R; Nussbaum, Michael S; Hess, Donald T; Knight, David C; Bentley, Frederick R

    2017-09-01

    The American Board of Surgery In-Training Examination (ABSITE) is used by programs to evaluate the knowledge and readiness of trainees to sit for the general surgery qualifying examination. It is often used as a tool for resident promotion and may be used by fellowship programs to evaluate candidates. Burnout has been associated with job performance and satisfaction; however, its presence and effects on surgical trainees' performance are not well studied. We sought to understand factors including burnout and study habits that may contribute to performance on the ABSITE examination. Anonymous electronic surveys were distributed to all residents at 10 surgical residency programs (n = 326). Questions included demographics as well as study habits, career interests, residency characteristics, and burnout scores using the Oldenburg Burnout Inventory, which assesses burnout because of both exhaustion and disengagement. These surveys were then linked to the individual's 2016 ABSITE and United States Medical Licensing Examination (USMLE) step 1 and 2 scores provided by the programs to determine factors associated with successful ABSITE performance. In total, 48% (n = 157) of the residents completed the survey. Of those completing the survey, 48 (31%) scored in the highest ABSITE quartile (≥75th percentile) and 109 (69%) scored less than the 75th percentile. In univariate analyses, those in the highest ABSITE quartile had significantly higher USMLE step 1 and step 2 scores (P shop compared with at home; P < 0.04), and used active rather than passive study strategies (P < 0.04). Gender, marital status, having children, and debt burden had no correlation with examination success. Backward stepwise multiple regression analysis identified the following independent predictors of ABSITE scores: study location (P < 0.0001), frequency of reading (P = 0.0001), Oldenburg Burnout Inventory exhaustion (P = 0.02), and USMLE step 1 and 2 scores (P = 0.007 and 0

  2. Reproductive studies with the anti-inflammatory agent, piroxicam: modification of classical protocols.

    Science.gov (United States)

    Perraud, J; Stadler, J; Kessedjian, M J; Monro, A M

    1984-02-14

    Reproductive toxicology studies were conducted in rabbits and rats given piroxicam, a non-steroidal anti-inflammatory agent (NSAI), orally at 2, 5 and 10 mg/kg/day. In teratology studies there was neither drug-related embryotoxicity nor teratogenicity. As piroxicam, like other NSAI, affects parturition in rats and leads to a progressive toxicity in lactating females, standard protocols were modified: dams of the female fertility study were treated from 2 weeks prior to mating until day 6 of gestation and females of the post-natal toxicity study were treated from parturition until day 12 of lactation. No other adverse effects on reproduction, fertility and postnatal development were observed.

  3. A Retrospective Study of Surgery and Reirradiation for Recurrent Ependymoma

    International Nuclear Information System (INIS)

    Merchant, Thomas E.; Boop, Frederick A.; Kun, Larry E.; Sanford, Robert A.

    2008-01-01

    Purpose: To report disease control for patients with recurrent ependymoma (EP) treated with surgery and a second course of radiation therapy (RT 2 ). Patients and Methods: Thirty-eight pediatric patients (median age, 2.7 years) with initially localized EP at the time of definitive RT underwent a second course of RT after local (n = 21), metastatic (n = 13), or combined (n = 4) failure. Reirradiation included radiosurgery (n = 6), focal fractionated reirradiation (n = 13), or craniospinal irradiation (CSI; n = 19). Results: Initial time to failure was 16 months, and median age at second treatment was 4.8 years. Radiosurgery resulted in significant brainstem toxicity and one death (median dose, 18 Gy). Progression-free survival ratio was greater than unity for 4 of 6 patients; there was one long-term survivor. Three of 13 patients treated using focal fractionated reirradiation (median combined dose, 111.6 Gy) experienced metastasis. The CSI was administered to 12 patients with metastatic failure, 3 patients with local failure, and 4 patients with combined failure. The 4-year event-free survival rate was 53% ± 20% for 12 patients with metastatic failure treated with CSI. Failure after CSI was observed in 1 of 3 patients with a history of local failure and 3 of 4 patients with a history of combined failure. Conclusion: Patients with locally recurrent EP experience durable local tumor control, but remain at risk of metastasis. Patients with metastatic EP failure may receive salvage therapy that includes a component of CSI. Durability of disease control and long-term effects from this approach require further follow-up

  4. Maternal and perinatal outcomes after bariatric surgery: a case control study.

    Science.gov (United States)

    de Alencar Costa, Laura Arrais Sydrião; Araujo Júnior, Edward; de Lucena Feitosa, Francisco Edson; Dos Santos, Andréa Cavalcante; Moura Júnior, Luiz Gonzaga; Costa Carvalho, Francisco Herlânio

    2016-05-01

    To compare the results of maternal and perinatal pregnancies of obese women after bariatric surgery. A retrospective cross-sectional study was carried out on 63 women who had undergone bariatric surgery and 73 obese women (control). Demographic data, the characteristics of the bariatric surgery, and the maternal and perinatal results were evaluated. The Student's t-test and chi-square test (χ2) were used to compare the groups. The gestational complications of the prevalence of gestational diabetes mellitus, anemia, and preeclampsia were analyzed using simple and multivariate logistical regression and odd ratios (OD) with their respective confidence intervals (CI) of 95%. The average body mass index (BMI) at the 1st prenatal appointment of the control group was 34.6±3.3 kg/m2 and that of the post-surgical group was 26.5±4.2 kg/m2. The Roux-en-Y Gastric Bypass was used in 100% of cases; no complications were observed during or after the surgeries. The average weight loss in patients with a prior bariatric surgery was statistically significant (P=0.000). The average weight at birth of the control group was significantly higher than in the post-bariatric surgery group (P=0.017). The women who had a prior bariatric surgery had a higher chance of anemia (OR=3.5; CI 95%: 1.5-8.3) and a reduced chance of macrosomia (OR=0.2; CI 95%:0.1-0.5), and prematurity (OR=0.3; CI 95%:0.1-0.7). Those women who had been submitted to bariatric surgery presented better maternal and perinatal results when compared to obese women.

  5. Better evidence for earlier assessment and surgical intervention for refractory epilepsy (The BEST study): a mixed methods study protocol.

    Science.gov (United States)

    Rapport, Frances; Shih, Patti; Mitchell, Rebecca; Nikpour, Armin; Bleasel, Andrew; Herkes, Geoffrey; Vagholkar, Sanjyot; Mumford, Virginia

    2017-08-21

    One-third of patients with refractory epilepsy may be candidates for resective surgery, which can lead to positive clinical outcomes if efficiently managed. In Australia, there is currently between a 6-month and 2-year delay for patients who are candidates for respective epilepsy surgery from the point of referral for surgical assessment to the eventual surgical intervention. This is a major challenge for implementation of effective treatment for individuals who could potentially benefit from surgery. This study examines implications of delays following the point of eligibility for surgery, in the assessment and treatment of patients, and the factors causing treatment delays. Mixed methods design: Observations of qualitative consultations, patient and healthcare professional interviews, and health-related quality of life assessments for a group of 10 patients and six healthcare professionals (group 1); quantitative retrospective medical records' reviews examining longitudinal outcomes for 50 patients assessed for, or undergoing, resective surgery between 2014 and 2016 (group 2); retrospective epidemiological study of all individuals hospitalised with a diagnosis of epilepsy in New South Wales (NSW) in the last 5 years (2012-2016; approximately 11 000 hospitalisations per year, total 55 000), examining health services' use and treatment for individuals with epilepsy, including refractory surgery outcomes (group 3). Ethical approval has been granted by the North Sydney Local Health District Human Research Ethics Committee (HREC/17/HAWKE/22) and the NSW Population & Health Services Research Ethics Committee (HREC/16/CIPHS/1). Results will be disseminated through publications, reports and conference presentations to patients and families, health professionals and researchers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  6. Re-birth after coronary bypass graft surgery: a hermeneutic-phenomenological study.

    Science.gov (United States)

    Abbasi, Mohammad; Mohammadi, Nooredin; Nasrabadi, Alireza Nikbakht; Fuh, Suh Boudouin; Sadeghi, Tahereh

    2014-03-31

    Although coronary artery bypass graft surgery has significant effects on reducing the symptoms of coronary artery disease, there is not enough knowledge and understanding of lived experience of patients after surgery. Understanding lived experience of this group of patients would be helpful for healthcare staff to provide better services to the patients. The aim of this study was to describe with a deeper understanding, the lived experiences of patients after Coronary Artery Bypass Graft Surgery. Using a hermeneutic phenomenological approach and a Van-Manen analysis method, in-depth semi-structured interviews were conducted with eleven participants who had lived experienced of at least six months post - coronary artery bypass graft surgery. Re-birth was the main theme that emerged in the process of data analysis. This theme was derived from four sub-themes including "feels younger", ''vigorous heart'', ''intrepid life'' and ''oriented to be healthy''. Life after a coronary artery bypass graft surgery is often appreciated as a re-birth by persons with these experiences as surgery did not only provide a feeling of wellness, but also added a sensation of youthfulness and improvement in the quality of life for these participants. In addition, they would actively participate in health promotional activities such as; adherence to medication and diet regimes, changes in lifestyle to maintain their health.

  7. Quality of life after surgery for intractable partial epilepsy in children: a cohort study with controls.

    Science.gov (United States)

    Mikati, Mohamad A; Ataya, Nour; Ferzli, Jessica; Kurdi, Rana; El-Banna, Diana; Rahi, Amal; Shamseddine, Alhan; Sinno, Durriyah; Comair, Youssef

    2010-08-01

    Investigate if quality of life (QOL) normalizes on long-term follow-up after surgery for partial epilepsy in children. This is a cohort study with controls in which a consecutive cohort of nineteen 2-14-year-old children who underwent focal resections for intractable partial seizures between 1996 and 2006, were matched with 19 non-surgery intractable partial epilepsy patients, and with 19 healthy subjects. The two epilepsy groups were matched for age, sex, socio-economic status (SES), cognitive level, seizure type, and seizure frequency. The healthy group was matched with the two epilepsy groups for age, sex, SES, and cognitive level. QOL was assessed using the QOLCE (Quality of Life in Childhood Epilepsy Questionnaire). In the surgery group (follow-up 3.84+/-2.26 years), 78.9% had Engel class-I versus 21.1% in non-surgery (p=0.01) (follow-up 3.44+/-2.95 years). Surgery patients were similar to healthy subjects in the social, emotional, cognitive, behavioral, and overall QOL (p>0.05) but had lower scores in the total QOL, physical, and health domains (p0.05, power>0.8). Our data indicate that epilepsy surgery for partial seizures in children is associated with better QOL as compared to children with intractable epilepsy who are not operated on, and suggest that in those who achieve seizure freedom normal QOL may at least potentially be possible.

  8. On shaky ground - A study of security vulnerabilities in control protocols

    Energy Technology Data Exchange (ETDEWEB)

    Byres, E. J. [Wurldtech Research Inc., 7178 Lancrest Tr., Lantzville, BC V0R 2H0 (Canada); Huffman, D. [Wurldtech Analytics Inc., 208-1040 Hamilton St., Vancouver, BC V6B 2R9 (Canada); Kube, N. [Univ. of Victoria, Dept. of Computer Science, PO Box 3055 STN CSC, Victoria BC V8W 3P6 (Canada)

    2006-07-01

    The recent introduction of information technologies such as Ethernet R into nuclear industry control devices has resulted in significantly less isolation from the outside world. This raises the question of whether these systems could be attacked by malware, network hackers or professional criminals to cause disruption to critical operations in a manner similar to the impacts now felt in the business world. To help answer this question, a study was undertaken to test a representative control protocol to determine if it had vulnerabilities that could be exploited. A framework was created in which a test could express a large number of test cases in very compact formal language. This in turn, allowed for the economical automation of both the generation of selectively malformed protocol traffic and the measurement of device under test's (DUT) behavior in response to this traffic. Approximately 5000 protocol conformance tests were run against two major brands of industrial controller. More than 60 categories of errors were discovered, the majority of which were in the form of incorrect error responses to malformed traffic. Several malformed packets however, caused the device to respond or communicate in inappropriate ways. These would be relatively simple for an attacker to inject into a system and could result in the plant operator losing complete view or control of the control device. Based on this relatively small set of devices, we believe that the nuclear industry urgently needs to adopt better security robustness testing of control devices as standard practice. (authors)

  9. On shaky ground - A study of security vulnerabilities in control protocols

    International Nuclear Information System (INIS)

    Byres, E. J.; Huffman, D.; Kube, N.

    2006-01-01

    The recent introduction of information technologies such as Ethernet R into nuclear industry control devices has resulted in significantly less isolation from the outside world. This raises the question of whether these systems could be attacked by malware, network hackers or professional criminals to cause disruption to critical operations in a manner similar to the impacts now felt in the business world. To help answer this question, a study was undertaken to test a representative control protocol to determine if it had vulnerabilities that could be exploited. A framework was created in which a test could express a large number of test cases in very compact formal language. This in turn, allowed for the economical automation of both the generation of selectively malformed protocol traffic and the measurement of device under test's (DUT) behavior in response to this traffic. Approximately 5000 protocol conformance tests were run against two major brands of industrial controller. More than 60 categories of errors were discovered, the majority of which were in the form of incorrect error responses to malformed traffic. Several malformed packets however, caused the device to respond or communicate in inappropriate ways. These would be relatively simple for an attacker to inject into a system and could result in the plant operator losing complete view or control of the control device. Based on this relatively small set of devices, we believe that the nuclear industry urgently needs to adopt better security robustness testing of control devices as standard practice. (authors)

  10. Efficiency of different protocols for enamel clean-up after bracket debonding: an in vitro study

    Directory of Open Access Journals (Sweden)

    Lara Carvalho Freitas Sigilião

    2015-10-01

    Full Text Available Objective: This study aimed to assess the efficiency of six protocols for cleaning-up tooth enamel after bracket debonding.Methods:A total of 60 premolars were divided into six groups, according to the tools used for clean-up: 12-blade bur at low speed (G12L, 12-blade bur at high speed (G12H, 30-blade bur at low speed (G30L, DU10CO ORTHO polisher (GDU, Renew System (GR and Diagloss polisher (GD. Mean roughness (Ra and mean roughness depth (Rz of enamel surface were analyzed with a profilometer. Paired t-test was used to assess Ra and Rz before and after enamel clean-up. ANOVA/Tukey tests were used for intergroup comparison. The duration of removal procedures was recorded. The association between time and variation in enamel roughness (∆Ra, ∆Rz were evaluated by Pearson's correlation test. Enamel topography was assessed by scanning electron microscopy (SEM.Results:In Groups G12L and G12H, original enamel roughness did not change significantly. In Groups G30L, GDU, GR and GD, a smoother surface (p < 0.05 was found after clean-up. In Groups G30L and GD, the protocols used were more time-consuming than those used in the other groups. Negative and moderate correlation was observed between time and (∆Ra, ∆Rz; Ra and (∆Ra, ∆Rz; Rz (r = - 0.445, r = - 0.475, p < 0.01.Conclusion:All enamel clean-up protocols were efficient because they did not result in increased surface roughness. The longer the time spent performing the protocol, the lower the surface roughness.

  11. Automated extraction protocol for quantification of SARS-Coronavirus RNA in serum: an evaluation study

    Directory of Open Access Journals (Sweden)

    Lui Wing-bong

    2006-02-01

    Full Text Available Abstract Background We have previously developed a test for the diagnosis and prognostic assessment of the severe acute respiratory syndrome (SARS based on the detection of the SARS-coronavirus RNA in serum by real-time quantitative reverse transcriptase polymerase chain reaction (RT-PCR. In this study, we evaluated the feasibility of automating the serum RNA extraction procedure in order to increase the throughput of the assay. Methods An automated nucleic acid extraction platform using the MagNA Pure LC instrument (Roche Diagnostics was evaluated. We developed a modified protocol in compliance with the recommended biosafety guidelines from the World Health Organization based on the use of the MagNA Pure total nucleic acid large volume isolation kit for the extraction of SARS-coronavirus RNA. The modified protocol was compared with a column-based extraction kit (QIAamp viral RNA mini kit, Qiagen for quantitative performance, analytical sensitivity and precision. Results The newly developed automated protocol was shown to be free from carry-over contamination and have comparable performance with other standard protocols and kits designed for the MagNA Pure LC instrument. However, the automated method was found to be less sensitive, less precise and led to consistently lower serum SARS-coronavirus concentrations when compared with the column-based extraction method. Conclusion As the diagnostic efficiency and prognostic value of the serum SARS-CoV RNA RT-PCR test is critically associated with the analytical sensitivity and quantitative performance contributed both by the RNA extraction and RT-PCR components of the test, we recommend the use of the column-based manual RNA extraction method.

  12. Early illness experiences related to unexpected heart surgery: A qualitative descriptive study.

    Science.gov (United States)

    Chang, Yu-Ling; Tsai, Yun-Fang

    2017-09-01

    Most studies on patients' experiences following emergency cardiac surgery focus on evaluation of patients after their discharge. Few studies have evaluated patients' experiences after being transferred from intensive care and before being discharged. This study aimed to describe patients' experiences in the early stages of recovery following emergency heart surgery. For this exploratory qualitative descriptive study, 13 patients were recruited from a medical centre in northern Taiwan. Participants had undergone emergency heart surgery and had resided in the cardiothoracic surgical ward for ≥6 days following transfer from the ICU; all expected to be discharged from the hospital within 3 days. Semi-structured, face-to-face interviews were conducted in private after the patients had been transferred to the cardiothoracic surgical wards. Audiotaped interviews were transcribed and analysed using content analysis. Data analysis identified four themes, which represented different recovery stages: sudden and serious symptoms, nightmares and vivid dreams, physical and emotional disturbances, and establishing a new life after emergency surgery. A fifth theme, support for a new lifestyle, occurred between the four stages. Participants experienced symptoms of physical and psychological stress during the early recovery stages following emergency heart surgery. A lack of understanding of the process of recovery increased these difficulties; participants wanted and needed multidisciplinary care and education. Emergency heart surgery does not allow healthcare professionals to inform patients of what to expect post-surgery. Our findings suggest that rather than waiting until discharge to offer disease information and treatment plans, multidisciplinary care should be initiated as soon as possible to facilitate recovery. Copyright © 2017 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

  13. A study of complications affecting surgery performance: an ISM-based roadmap to patient flow.

    Science.gov (United States)

    Dev, Navin K; Shankar, Ravi; Arvind, Kamal

    2013-01-01

    The aim of this study is to highlight the value of the success rate performance of a surgery while planning patient flow within a supply chain of a health care organization/hospital. The paper has considered one of the common surgeries, cataract, and the complications that subsequently result from this surgery. The study employs interpretive structural modeling (ISM) approach to draw a roadmap to study various complications causing cataract that subsequently help in planning and coordination of patient flow. The study finds that there is a hierarchy of causes and certain complications, the persistence of which gives a higher success rate performance in cataract surgery as compared to others. The paper provides leverage to the decision maker while organizing the patient flow depending upon the information of hierarchy of complication of a disease, and accordingly ensures the availability of resources to the patient. The study is of value in identifying the degree of complications from cataract surgery. Given the degree of complication, the patient logistics can be planned myopically in a health care organization which largely depends upon the degree of success rate. The paper attempts to suggest that the hierarchy obtained through ISM can be implemented in the modules of an enterprise resource planning (ERP) set up.

  14. Sevoflurane requirement during elective ankle day surgery: the effects of etirocoxib premedication, a prospective randomised study

    Directory of Open Access Journals (Sweden)

    Jakobsson Jan G

    2008-09-01

    Full Text Available Abstract Background Anti-inflammatory drugs, NSAIDs, have become an important part of the pain management in day surgery. The aim of the present study was to evaluate the effect of Coxib premedication on the intra-operative anaesthetic requirements in patients undergoing elective ankle surgery in general anaesthesia. Type of study Prospective, randomized study of the intra-operative anaesthetic-sparing effects of etoricoxib premedication as compared to no NSAID preoperatively. Methods The intra-operative requirement of sevoflurane was studied in forty-four ASA 1–2 patients undergoing elective ankle day surgical in balanced general anaesthesia. Primary study endpoint was end-tidal sevoflurane concentration to maintain Cerebral State Index of 40 – 50 during surgery. Results All anaesthesia and surgery was uneventful, no complications or adverse events were noticed. The mean end-tidal sevoflurane concentration intra-operatively was 1.25 (SD 0.2 and 0.91 (SD 0.2 for the pre and post-operative administered group of patients respectively (p Conclusion Coxib premedication before elective day surgery has an anaesthetic sparing potential.

  15. The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Senft, Jonas D; Warschkow, Rene; Diener, Markus K; Tarantino, Ignazio; Steinemann, Daniel C; Lamm, Sebastian; Simon, Thomas; Zerz, Andreas; Müller-Stich, Beat P; Linke, Georg R

    2014-11-20

    Natural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard. The TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection. Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible. The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale (VAS). Secondary outcomes include daily pain intensity and analgesic use, patient mobility, intraoperative complications, morbidity, length of stay, quality of life, and sexual function. Follow-up visits are scheduled 3, 12, and 36 months after surgery. A total sample size of 58 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat (ITT) principle. The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the

  16. The Healthy Primary School of the Future: study protocol of a quasi-experimental study.

    Science.gov (United States)

    Willeboordse, M; Jansen, M W; van den Heijkant, S N; Simons, A; Winkens, B; de Groot, R H M; Bartelink, N; Kremers, S P; van Assema, P; Savelberg, H H; de Neubourg, E; Borghans, L; Schils, T; Coppens, K M; Dietvorst, R; Ten Hoopen, R; Coomans, F; Klosse, S; Conjaerts, M H J; Oosterhoff, M; Joore, M A; Ferreira, I; Muris, P; Bosma, H; Toppenberg, H L; van Schayck, C P

    2016-07-26

    have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society. The study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with the reference number NCT02800616 .

  17. The Healthy Primary School of the Future: study protocol of a quasi-experimental study

    Directory of Open Access Journals (Sweden)

    M. Willeboordse

    2016-07-01

    nature and sound scientific foundation, these integrated programmes have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society. Trial registration The study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with the reference number NCT02800616 .

  18. The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study.

    Science.gov (United States)

    Fagher, Kristina; Jacobsson, Jenny; Timpka, Toomas; Dahlström, Örjan; Lexell, Jan

    2016-01-01

    Paralympic sport provides sporting opportunities for athletes with a disability, with the Paralympic Games as the main event. Participation in sport is, however, associated with a significant risk for sustaining injuries and illnesses. Our knowledge of sports-related injuries and illnesses in Paralympic sport is very limited and there are no large-scale epidemiological cohort studies. The purpose here is to present a protocol for a prospective longitudinal study: The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS). An argument-based method for investigation of design problems was used to structure the study protocol. The primary requirement of the protocol is to allow prospective studies over time and include exposure to both training and competition. To reflect the complexity of Paralympic sport with athletes' pre-existing impairments, use of assistive equipment, pain and other and medical issues, it is required that the data collection system is specifically adapted to Paralympic sport. To allow the collection of data, at the same time as there is limited access to coaches and medical personnel, it is advantageous that data can be collected online directly from the athletes. Based on this a self-report athlete monitoring system will be developed, where the athletes can enter data weekly via their mobile phones or lap-tops. Data will be collected from around 100 Swedish Paralympic athletes for approximately 1 year, which will allow us to i) prospectively estimate the annual incidence of sports-related injuries and illnesses and ii) explore risk factors and mechanisms for sustaining sports-related injuries and illnesses based on athlete exposure and training loads. For effective implementation of injury and illness prevention measures, comprehensive epidemiological knowledge is required. This study will be the first prospective longitudinal self-report study of sports-related injuries and illnesses in Paralympic sport over a longer period

  19. Carotid Artery Injury in Anterior Cervical Spine Surgery: Multicenter Cohort Study and Literature Review.

    Science.gov (United States)

    Härtl, Roger; Alimi, Marjan; Abdelatif Boukebir, Mohamed; Berlin, Connor D; Navarro-Ramirez, Rodrigo; Arnold, Paul M; Fehlings, Michael G; Mroz, Thomas E; Riew, K Daniel

    2017-04-01

    Retrospective study and literature review. To provide more comprehensive data about carotid artery injury (CAI) or cerebrovascular accident (CVA) related to anterior cervical spine surgery. We conducted a retrospective, multicenter, case series study involving 21 high-volume surgical centers from the AOSpine North America Clinical Research Network. Medical records of 17 625 patients who went through cervical spine surgery (levels from C2 to C7) between January 1, 2005, and December 31, 2011, were analyzed. Also, we performed a literature review using Medline and PubMed databases. The following terms were used alone, and in combination, to search for relevant articles: cervical, spine, surgery, complication, iatrogenic, carotid artery, injury, cerebrovascular accident, CVA, and carotid stenosis. Among 17 625 patients that were analyzed, no cases were reported to experienced CAI or CVA after cervical spine surgery. Nevertheless, in our PubMed search we found 157 articles, but only 5 articles matched our study objective criteria; 2 cases were reported to present CAI and 3 cases presented CVA. CAI and CVA related to anterior cervical spine surgeries are extremely rare. We were not able to find neither in our retrospective study nor in our literature research a correlation between the type or length of anterior cervical spine procedure with CVA or CAI complications. However, surgeons should be aware of the possibility of vascular complications and minimize intraoperative direct vascular manipulations or retraction. Preoperative screening for underlying vascular pathology and risk factors is also important.

  20. Prevalence of acute neuropathic pain after cancer surgery: A prospective study

    Directory of Open Access Journals (Sweden)

    P N Jain

    2014-01-01

    Full Text Available Background and Aims: Acute neuropathic pain (ANP is an under-recognised and under-diagnosed condition and often difficult to treat. If left untreated, it may further transform into persistent post-operative chronic pain leading to a disability. Aims: This prospective study was undertaken on 300 patients to identify the prevalence of ANP in the post-operative period by using a neuropathic pain detection questionnaire tool. Methods: This is an open-label study in which patients with six different types of cancer surgeries (Thoracic, gastro-intestinal, gynae/urology, bone/soft-tissue, head and neck and breast subgroups-50 each were included for painDETECT questionnaire tool on the 2 nd and 7 th day surgery. Results: This study found a 10% point prevalence of ANP. Analysis showed that 25 patients had ′possible′ ANP, the maximum from urological cancer surgery (6 followed by thoracic surgery (5. Five patients were found to have ′positive′ ANP including 2 groin node dissection, 2 hemipelvectomy and 1 oesophagectomy. Conclusion: Significant relationship between severity of post-operative pain was found with the occurrence of ANP in the post-operative period requiring a special attention to neuropathic pain assessment. Larger studies are required with longer follow-up to identify accurately the true prevalence and causative factors of ANP after surgery.

  1. Continuous sweep versus discrete step protocols for studying effects of wearable robot assistance magnitude.

    Science.gov (United States)

    Malcolm, Philippe; Rossi, Denise Martineli; Siviy, Christopher; Lee, Sangjun; Quinlivan, Brendan Thomas; Grimmer, Martin; Walsh, Conor J

    2017-07-12

    Different groups developed wearable robots for walking assistance, but there is still a need for methods to quickly tune actuation parameters for each robot and population or sometimes even for individual users. Protocols where parameters are held constant for multiple minutes have traditionally been used for evaluating responses to parameter changes such as metabolic rate or walking symmetry. However, these discrete protocols are time-consuming. Recently, protocols have been proposed where a parameter is changed in a continuous way. The aim of the present study was to compare effects of continuously varying assistance magnitude with a soft exosuit against discrete step conditions. Seven participants walked on a treadmill wearing a soft exosuit that assists plantarflexion and hip flexion. In Continuous-up, peak exosuit ankle moment linearly increased from approximately 0 to 38% of biological moment over 10 min. Continuous-down was the opposite. In Discrete, participants underwent five periods of 5 min with steady peak moment levels distributed over the same range as Continuous-up and Continuous-down. We calculated metabolic rate for the entire Continuous-up and Continuous-down conditions and the last 2 min of each Discrete force level. We compared kinematics, kinetics and metabolic rate between conditions by curve fitting versus peak moment. Reduction in metabolic rate compared to Powered-off was smaller in Continuous-up than in Continuous-down at most peak moment levels, due to physiological dynamics causing metabolic measurements in Continuous-up and Continuous-down to lag behind the values expected during steady-state testing. When evaluating the average slope of metabolic reduction over the entire peak moment range there was no significant difference between Continuous-down and Discrete. Attempting to correct the lag in metabolics by taking the average of Continuous-up and Continuous-down removed all significant differences versus Discrete. For kinematic and

  2. Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study

    Science.gov (United States)

    Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

    2016-06-01

    Objective. While promising, electroencephaloraphy based brain-computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users’ motor imagery based BCI (MI-BCI) control performance. Approach. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users’ spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Main results. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. Significance. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced

  3. Results of ERAS protocol in patients with colorectal cancer

    Directory of Open Access Journals (Sweden)

    A. O. Rasulov

    2016-01-01

    Full Text Available Objective: explore the use of enhanced recovery after surgery (ERAS in the treatment of patients with colorectal cancer, evaluate its efficacy and safety.Materials and methods. Prospective, single-site, randomized study for the implementation of enhanced recovery after surgery in patients with colorectal cancer has been conducted from October 2014 till the present time. All patients after laparoscopic surgeries undergo treatment according to ERAS protocol, patients after open surgeries are randomized (1:1 in groups of the standard treatment or treatment according to ERAS protocol. The study included patients with localized and locally disseminated colorectal cancer aged from 18 to 75 years, ECOG score ≤ 2. The primary evaluated parameters were the following: the number of postoperative complications (according to Clavien– Dindo classification, postoperative hospital days, incidence of complications and mortality in the 30-day period, timing of activation.Results. Up to date, the study includes 105 patients: laparoscopic group – 51 patients, open-surgery group of patients treated by ERAS protocol – 27 patients, open-surgery group of patients with the standard post-op treatment – 26 patients. Complications requiring emergency surgery for anastomotic leak (p = 0.159 developed in 3.7 % of patients with the standard post-op treatment and in 3.9 % of patients after laparoscopic surgery, while 1 patient required repeat hospitalization. The total number of complications was significantly lower in opensurgery group of patients treated by ERAS protocol compared with the standard post-op treatment (p = 0.021. However, there were no differences between laparoscopic and open-surgery group with the standard post-op treatment (p = 0.159. An average hospitalization stay in patients with the standard post-op treatment was equal to 10 days compared to 7 days in patients treated by ERAS protocol (p = 0.067 and 6 days after laparoscopic

  4. Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.

    Science.gov (United States)

    González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Riera, Antonio; Llorca, Ginés; Traver, Francisco; Haro, Gonzalo; Palop, Vicente; Lera, Guillem; Romeu, José Enrique; Botella, Cristina

    2015-10-31

    Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disor