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Sample records for surgery study protocol

  1. The use of study registration and protocols in plastic surgery research: A systematic review.

    Science.gov (United States)

    Pidgeon, Thomas Edward; Limb, Christopher; Agha, Riaz A; Whitehurst, Katharine; Chandrakumar, Charmilie; Wellstead, Georgina; Fowler, Alexander J; Orgill, Dennis P

    2017-08-01

    In 2013, the Declaration of Helsinki changed to mandate that all research studies involving human subjects, rather than just clinical trials alone, must have a protocol registered in a publicly accessible database prior to the enrolment of the first patient. The objective of this work was to assess the number of research studies involving human participants published in leading journals of plastic surgery that had either published a protocol or registered a protocol with a publicly accessible database. This systematic review examined all research articles involving human participants published in Plastic and Reconstructive Surgery, The Journal of Plastic Reconstructive and Aesthetic Surgery and The Annals of Plastic Surgery from 1st April 2014-31st March 2015. The primary outcome measure was whether each study had either published or registered a protocol with any mainstream registry database. ClinicalTrials.gov, the International Standard Randomized Control Trial Number (ISRCTN) registry, the WHO (World Health Organisation) International Clinical Trials Registry Platform, The Cochrane Collaboration, the Research Registry, PROSPERO and PubMed were all reviewed. Of 595 included articles, the most common study designs were case series (n = 185, 31.1%). There were 24 randomized controlled trials (RCTs, 4.0%). A total of 24 studies had a protocol registered (4.0%). The most common database to register a protocol was with ClinicalTrials.gov (n = 17). The study design that most commonly had a registered protocol was the RCT (n = 8 of 24, 33.3% of RCTs). Three studies published a protocol in a journal (0.6%). Publication or registration of protocols for recent studies involving human participants in major plastic surgery journals is low. There is considerable scope to improve this and guidance is provided. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  2. 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

  3. Effects of a prehabilitation program on patients? recovery following spinal stenosis surgery: study protocol for a randomized controlled trial

    OpenAIRE

    Marchand, Andr?e-Anne; Suitner, Margaux; O?Shaughnessy, Julie; Ch?tillon, Claude-?douard; Cantin, Vincent; Descarreaux, Martin

    2015-01-01

    Background Degenerative lumbar spinal stenosis is a prevalent condition in adults over the age of 65 and often leads to deconditioning. Although the benefits of surgery outweigh those of conservative approaches, physical rehabilitation may be used to improve function and to minimize the risk of persistent dysfunction. This study protocol was designed to establish the feasibility of a full-scale randomized controlled trial and to assess the efficacy of an active preoperative intervention progr...

  4. Digital protocol for reference-based guided surgery and immediate loading: a prospective clinical study

    NARCIS (Netherlands)

    Tahmaseb, A.; de Clerck, R.; Aartman, I.; Wismeijer, D.

    2012-01-01

    PURPOSE: To evaluate the performance of a computer-aided three-dimensional planning protocol in combination with previously inserted reference mini-implants and CAD/CAM technology to restore completely edentulous patients. The study evaluated implant and superstructure survival in a prospective

  5. An environmental scan of advance care planning decision AIDS for patients undergoing major surgery: a study protocol.

    Science.gov (United States)

    Aslakson, Rebecca A; Schuster, Anne L R; Miller, Judith; Weiss, Matthew; Volandes, Angelo E; Bridges, John F P

    2014-01-01

    Patients who undergo major surgery are at risk for perioperative morbidity and mortality. It would be appropriate to initiate advance care planning with patients prior to surgery, but surgeons may experience difficulty initiating such conversations. Rather than focus on changing clinician behavior, advance care planning decision aids can be an innovative vehicle to motivate advance care planning among surgical patients and their families. The purpose of this paper is to describe a study protocol for conducting an environmental scan concerning advance care planning decision aids that may be relevant to patients undergoing high-risk surgery. This study will gather information from written or verbal data sources that incorporate professional and lay perspectives: a systematic review, a grey literature review, key informant interviews, and patient and family engagement. It is envisioned that this study will generate three outcomes: a synthesis of current evidence, a summary of gaps in knowledge, and a taxonomy of existing advance care planning decision aids. This environmental scan will demonstrate principles of patient-centered outcomes research, and it will exemplify a pioneering approach for reviewing complex interventions. Anticipated limitations are that information will be gathered from a small sample of patients and families, and that potentially relevant information could also be missing from the environmental scan due to the inclusion/exclusion criteria. Outcomes from the environmental scan will inform future patient-centered research to develop and evaluate a new decision aid.

  6. Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.

    Science.gov (United States)

    Probst, Pascal; Grummich, Kathrin; Heger, Patrick; Zaschke, Steffen; Knebel, Phillip; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

    2016-03-24

    Blinding is a measure in randomized controlled trials (RCT) to reduce detection and performance bias. There is evidence that lack of blinding leads to overestimated treatment effects. Because of the physical component of interventions, blinding is not easily applicable in surgical trials. This is a protocol for a systematic review and empirical study about actual impact on outcomes and future potential of blinding in general and abdominal surgery RCT. A systematic literature search in CENTRAL, MEDLINE and Web of Science will be conducted to locate RCT between 1996 and 2015 with a surgical intervention. General study characteristics and information on blinding methods will be extracted. The risk of performance and detection bias will be rated as low, unclear or high according to the Cochrane Collaboration's tool for assessing risk of bias. The main outcome of interest will be the association of a high risk of performance or detection bias with significant trial results and will be tested at a level of significance of 5 %. Further, trials will be meta-analysed in a Mantel-Haenszel model comparing trials with high risk of bias to other trials at a level of significance of 5 %. Detection and performance bias distort treatment effects. The degree of such bias in general and abdominal surgery is unknown. Evidence on influence of missing blinding would improve critical appraisal and conduct of general and abdominal surgery RCT. PROSPERO 2015: CRD42015026837.

  7. Postoperative Delirium after elective and emergency surgery: analysis and checking of risk factors. A study protocol

    Directory of Open Access Journals (Sweden)

    Gagliardi Stefano

    2005-05-01

    Scale (GCS, Cognitive state (SPMSQ, Functional state (ADL and IADL, Psychological Distress (HADS, Cumulative Illness Rating Scale (CIRS, Hypotension (classified in: light; moderate and severe and duration, Blood loss (classified in: 2 lt, Blood transfusions ( 2 lt, Quantity of red cells and plasma transfusions, Visual VAS / SVS (timing: I-II-III post-operative day, Red cells and Plasma transfusions, Blood count evaluation and Saturation (O2%, Postoperative analgesia (Emilia-Romagna protocol, Presence of malignant tumoral disease, APACHE Score II. Moreover the presence of some relevant genetic polymorphisms will be studied in different genes such as IL-6, IL-10, TNF-alpha, and IL-1 cluster.

  8. Effects of a prehabilitation program on patients' recovery following spinal stenosis surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Marchand, Andrée-Anne; Suitner, Margaux; O'Shaughnessy, Julie; Châtillon, Claude-Édouard; Cantin, Vincent; Descarreaux, Martin

    2015-10-27

    Degenerative lumbar spinal stenosis is a prevalent condition in adults over the age of 65 and often leads to deconditioning. Although the benefits of surgery outweigh those of conservative approaches, physical rehabilitation may be used to improve function and to minimize the risk of persistent dysfunction. This study protocol was designed to establish the feasibility of a full-scale randomized controlled trial and to assess the efficacy of an active preoperative intervention program on the improvement of clinical parameters and functional physical capacity in patients undergoing surgery for lumbar spinal stenosis. Forty patients will be recruited and randomly allocated to one of the 2 treatment arms: 6 weeks supervised preoperative rehabilitation program (experimental group) or hospital standard preoperative management (control group). The intervention group will be trained three times per week, with each session aiming to improve strength, muscular endurance, spinal stabilization and cardiovascular fitness. Intensity and complexity of exercises will be gradually increased throughout the sessions, depending on each participant's individual progress. Primary outcomes are level of low back disability and level of pain. Secondary outcomes include the use of pain medication, quality of life, patient's global impression of change, lumbar extensor muscles endurance, maximum voluntary contraction of lumbar flexor and extensor muscles, maximum voluntary contraction of knee extensors, active lumbar ranges of motion, walking abilities, and cardiovascular capacity. Both the primary and secondary outcomes will be measured at baseline, at the end of the training program (6 weeks after baseline evaluation for control participants), and at 6 weeks, 3 and 6 months postoperatively. This study will inform the design of a future large-scale trial. Improvements of physical performances before undergoing lumbar surgery may limit functional limitations occurring after a surgical

  9. 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

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

    Directory of Open Access Journals (Sweden)

    Roseli Saraiva Moreira Bittar

    Full Text Available Abstract Introduction: Cochlear implants are undeniably an effective method for the recovery of hearing function in patients with hearing loss. Objective: To describe the preoperative vestibular assessment protocol in subjects who will be submitted to cochlear implants. Methods: 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. Results: 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. Conclusion: 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.

  11. 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

  12. 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

  13. Recommended protocol for failed back surgery syndrome

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    Fakhr Tabatabaei SA

    1996-06-01

    Full Text Available Failed back surgery syndrome (FBSS is many a times an intractable problem confronted in patients with surgical disease of lumbar spine and at the same time is a pressing problem for the physicians as well. This clinical entity is defined as continuation of pain in the lumbar region and lower extremities following surgery of the lumbar spine. Knowledge of the etiological factors and their prevention is the best line of treatment to overcome the evolution of this syndrome. During this study, which was conducted in Imam Khomeini hospital Tehran from the year 1989 till 1990, 43 out of 114 patients developed "FBSS". 23 cases responded to conservative treatment and psychotherapy whereas medical treatment failed to achieve fruitful results in the rest. The latter underwent extensive radiological investigations and repeat surgery. According to this study, we recommend that in the initial management of these patients. The surgeon should observe the dictum of "5-mis" to overcome and minimize the "FBSS" entity

  14. 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

  15. Temporary epicardial cardiac resynchronisation versus conventional right ventricular pacing after cardiac surgery: study protocol for a randomised control trial

    Directory of Open Access Journals (Sweden)

    Russell Stuart J

    2012-02-01

    Full Text Available Abstract Background Heart failure patients with stable angina, acute coronary syndromes and valvular heart disease may benefit from revascularisation and/or valve surgery. However, the mortality rate is increased- 5-30%. Biventricular pacing using temporary epicardial wires after surgery is a potential mechanism to improve cardiac function and clinical endpoints. Method/design A multi-centred, prospective, randomised, single-blinded, intervention-control trial of temporary biventricular pacing versus standard pacing. Patients with ischaemic cardiomyopathy, valvular heart disease or both, an ejection fraction ≤ 35% and a conventional indication for cardiac surgery will be recruited from 2 cardiac centres. Baseline investigations will include: an electrocardiogram to confirm sinus rhythm and measure QRS duration; echocardiogram to evaluate left ventricular function and markers of mechanical dyssynchrony; dobutamine echocardiogram for viability and blood tests for renal function and biomarkers of myocardial injury- troponin T and brain naturetic peptide. Blood tests will be repeated at 18, 48 and 72 hours. The principal exclusions will be subjects with permanent atrial arrhythmias, permanent pacemakers, infective endocarditis or end-stage renal disease. After surgery, temporary pacing wires will be attached to the postero-lateral wall of the left ventricle, the right atrium and right ventricle and connected to a triple chamber temporary pacemaker. Subjects will be randomised to receive either temporary biventricular pacing or standard pacing (atrial inhibited pacing or atrial-synchronous right ventricular pacing for 48 hours. The primary endpoint will be the duration of level 3 care. In brief, this is the requirement for invasive ventilation, multi-organ support or more than one inotrope/vasoconstrictor. Haemodynamic studies will be performed at baseline, 6, 18 and 24 hours after surgery using a pulmonary arterial catheter. Measurements will be

  16. Association of industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.

    Science.gov (United States)

    Probst, Pascal; Grummich, Kathrin; Ulrich, Alexis; Büchler, Markus W; Knebel, Phillip; Diener, Markus K

    2014-11-27

    Industry sponsorship has been identified as a factor correlating with positive research findings in several fields of medical science. To date, the influence of industry sponsorship in general and abdominal surgery has not been fully studied. This protocol describes the rationale and planned conduct of a systematic review to determine the association between industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery. A literature search in the Cochrane Library, MEDLINE and EMBASE and additional hand searches in relevant citations will be conducted. In order to cover all relevant areas of general and abdominal surgery, a new literature search strategy called multi-PICO search strategy (MPSS) has been developed. No language restriction will be applied. The search will be limited to publications between January 1985 and July 2014. Information on funding source, outcome, study characteristics and methodological quality will be extracted.The association between industry sponsorship and positive outcome will be tested by a chi-squared test. A multivariate logistic regression analysis will be performed to control for possible confounders, such as number of study centres, multinational trials, methodological quality, journal impact factor and sample size. This study was designed to clarify whether industry-sponsored trials report more positive outcomes than non-industry trials. It will be the first study to evaluate this topic in general and abdominal surgery. The findings of this study will enable surgical societies, in particular, to give advice about cooperation with the industry and disclosure of funding source based on empirical evidence. PROSPERO CRD42014010802.

  17. 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, Søren Thorgaard; Lind, Martin; Hölmich, Per

    2017-01-01

    : 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...

  18. 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 protocol group (P protocol significantly decreased the total antibiotic dose used in the perioperative period (P protocol group patients required this additional change in the antibiotic regimen (P protocol based on preoperative kidney function effectively prevents SSIs in patients undergoing open heart surgery.

  19. 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.

  20. 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).......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...... after initiation of the AHA protocol as standard care. The intervention cohort was compared with a predefined, consecutive historical cohort of patients from the same department. The protocol involved continuous staff education, consultant-led attention and care, early resuscitation and high...

  1. Network Authentication Protocol Studies

    Science.gov (United States)

    2009-04-01

    This is called the “Decision Diffie-Hellman Problem” ( DDH ) [68]. For the protocols discussed in this paper, the cryptographic strength of the generated...group key is solely dependent upon the strength of the underlying two-party protocols. That said, we will not address the DDH problem further in this

  2. 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).

  3. 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.

  4. AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery

    DEFF Research Database (Denmark)

    Sort, Rune; Brorson, Stig; Gögenur, Ismail

    2017-01-01

    INTRODUCTION: Ankle fracture surgery is a common procedure, but the influence of anaesthesia choice on postoperative pain and quality of recovery is poorly understood. Some authors suggest a benefit of peripheral nerve block (PNB) in elective procedures, but the different pain profile following...... acute fracture surgery and the rebound pain on cessation of the PNB both remain unexplored. We present an ongoing randomised study aiming to compare primary PNB anaesthesia with spinal anaesthesia for ankle fracture surgery regarding postoperative pain profiles and quality of recovery....... Morphine consumption and pain scores are registered in the first 27 hours and reported as an integrated pain score as the primary endpoint. Pain score intervals are 3 hours and we will use the area under curve to get a longitudinal measure of pain. Secondary outcomes include rebound pain on cessation...

  5. Results of Implementing an Enhanced Recovery After Bariatric Surgery (ERABS) Protocol

    NARCIS (Netherlands)

    G.H.H. Mannaerts (Guido); S. van Mil (Stefanie); P.S. Stepaniak (Pieter); M. Dunkelgrun (Martin); M. de Quelerij (Marcel); S.J.C. Verbrugge (Serge); H. Zengerink (Hans); L.U. Biter (L. Ulas)

    2016-01-01

    textabstractBackground: With the increasing prevalence of morbid obesity and healthcare costs in general, interest is shown in safe, efficient, and cost-effective bariatric care. This study describes an Enhanced Recovery After Bariatric Surgery (ERABS) protocol and the results of implementing such

  6. 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/

  7. 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

  8. Evaluation of low-level laser at auriculotherapy points to reduce postoperative pain in inferior third molar surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Sampaio-Filho, Hélio; Sotto-Ramos, Juliane; Pinto, Erika Horácio; Cabral, Marcia Regina; Longo, Priscila Larcher; Tortamano, Isabel Peixoto; Marcos, Rodrigo Labat; Silva, Daniela Fátima Teixeira; Pavani, Christine; Horliana, Anna Carolina Ratto Tempestini

    2016-09-02

    A comfortable postoperative return to daily activities has increased the need to control inflammation after third molar surgery. Anti-inflammatory drugs and analgesics are not exempt from adverse effects such as allergies and chronic gastritis, and they are not without cost. The association between low-level laser and auricular acupuncture can be an alternative when conventional drugs are contraindicated. Among its advantages, we can mention the low risk of side effects, low cost and simplicity of application. The objective of this study is to evaluate the efficiency of low-level laser at auriculotherapy points in reducing postoperative pain in lower third molar surgery. Ninety bilateral, symmetrical lower third molar surgeries will be performed in 45 healthy patients. Each patient will be their own control, through a split-mouth crossover study. One side of the mouth will be randomly chosen and, immediately after surgery, will be treated with low-level laser. After 21 days, the contralateral side will be operated on with low-level laser simulation used postoperatively. This regimen (laser application or not) will be repeated at 24 and 48 h after surgery. All patients will be requested to take analgesics (acetaminophen) if they have pain, i.e. in case of pain. Neither the surgeon nor the patients will know the assigned treatment. The primary variable will be postoperative pain assessed using a Visual Analog Scale, and the secondary variables will be trismus, edema, local temperature, dysphagia, presence of infection and painkiller ingestion. These variables will be assessed at baseline, 24 h, 48 h and 7 days after surgery. Blood samples for systemic inflammatory cytokine (TNF-α, IL-1, IL-6 and IL-8) analysis will be assessed at baseline and 24 h after surgery. Some authors believe that using a wavelength of 633 to 670 nm is a good option for laser therapy in the field of acupuncture. This wavelength can penetrate biological tissue to a depth of about 3 mm. However

  9. A randomised control trial assessing the impact of an investment based intervention on weight-loss, beliefs and behaviour after bariatric surgery: study protocol.

    Science.gov (United States)

    Hollywood, Amelia; Ogden, Jane; Hashemi, Majid

    2015-01-01

    Although obesity surgery is currently the most effective method for achieving weight loss, not all patients lose the desired amount of weight and some show weight regain. Previous research shows that successful weight loss may be associated with the amount of investment the patient feels that they have made in their operation. For example, those who feel that it has taken more time and effort to organise, has cost more money, has been more disruptive to their lives and has caused pain are more likely to lose weight after their operation. Therefore, it seems as if the greater the sense of investment, the greater the motivation to make the operation a success. The present study aims to build on these findings by encouraging weight loss surgery patients to focus on the investment they have made, thus making their investment more salient to them and a means to improve weight loss outcomes. The study involves an open randomised parallel group control trial with patients allocated either to the control or investment intervention group. Using third party blinded randomization, half the patients will be asked to rate and describe the investment they have made in their operation just before surgery then 3 and 6 months after surgery. All patients will record their weight, beliefs about food, intentions to change and actual eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. Patients will be recruited from the bariatric surgery pre-assessment clinic at University College Hospital, London. The primary outcome is to explore the impact of the investment based intervention on patient's weight and BMI, with secondary outcomes of patients' beliefs about foods, behavioural intentions and diet and exercise behaviours. It is predicted that the investment intervention will improve excess weight loss post-surgery, together with beliefs about food, intentions to change and actual change in diet and exercise behaviour. This has cost implications for the NHS and

  10. 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.

    2011-01-01

    Background The Skin Products Assessment Research (SPAR) Committee was created by the Plastic Surgery Educational Foundation (PSEF) in 2006. SPAR study aims were to (1) develop an infrastructure for PSEF-conducted, industry sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System (ONDS) versus conventional therapy as treatment adjuncts for facial resurfacing procedures. Methods The SPAR study was designed as a multi-center, double-blind, randomized controlled trial (RCT). The study was conducted in women with Fitzpatrick type I-IV skin, moderate to severe facial photo damage, and peri-ocular and/or peri-oral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to ONDS or a standard care regimen. The study endpoints were time to re-epithelization, erythema, and pigmentation changes. Results Fifty-six women were enrolled and 82% were followed beyond re-epithelization. There were no significant differences in mean time to re-epithelialization between ONDS and control groups. The ONDS group had a significantly higher median erythema score on day of surgery (after 4 weeks of product use) which did not persist after surgery. Test-retest photo evaluations demonstrated that both inter- and intra-rater reliability were adequate for primary study outcomes. Conclusions In a clinical RCT, we demonstrated no significant difference in time to re-epithelization between patients who used the ONDS or a standard care regimen as an adjunct to facial resurfacing procedures. The SPAR research team has also provided a discussion of future challenges for PSEF sponsored clinical research for readers of this article. PMID:21364435

  11. 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.

  12. Feasibility and acceptability of PrE-operative Physical Activity to improve patient outcomes After major cancer surgery: study protocol for a pilot randomised controlled trial (PEPA Trial).

    Science.gov (United States)

    Steffens, Daniel; Young, Jane; Beckenkamp, Paula R; Ratcliffe, James; Rubie, Freya; Ansari, Nabila; Pillinger, Neil; Solomon, Michael

    2018-02-17

    There is a need for evidence of the effectiveness of pre-operative exercise for patients undergoing major cancer surgery; however, recruitment to such trials can be challenging. The PrE-operative Physical Activity (PEPA) Trial will establish the feasibility and acceptability of a pre-operative exercise programme aimed to improve patient outcomes after cytoreductive surgery and pelvic exenteration. The secondary aim is to obtain pilot data on the likely difference in key outcomes (post-operative complications, length of hospital stay, post-operative functional capacity and quality of life) to inform the sample size calculation for the substantive randomised clinical trial. Twenty patients undergoing cytoreductive surgery and pelvic exenteration at the Royal Prince Alfred Hospital, Sydney will be recruited and randomly allocated (1:1 ratio) to either 2 to 6 weeks' pre-operative exercise programme (intervention group) or usual care (control group). Those randomised to the intervention group will receive up to six individualised, 1-h physiotherapy sessions (including aerobic and endurance exercises, respiratory muscle exercises, stretching and flexibility exercises), home exercises (instruction and recommendations on how to progress the exercises at home) and encouragement to be more active by using an activity tracker to measure the number of steps walked daily. Patients allocated to the control group will not receive any specific advice about exercise training. Feasibility will be assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the exercise programme. Acceptability of the exercise programme will be assessed with a semi-structured questionnaire. The following measures of the effectiveness of the intervention will be collected at baseline (2 to 6 weeks pre-operative), a week before surgery, during hospital stay and pre hospital discharge: post-operative complication rates (Clavien-Dindo), post

  13. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wang, Yanan; Liu, Ruoyan; Zhang, Ze; Xue, Qi; Yan, Jun; Yu, Jiang; Liu, Hao; Zhao, Liying; Mou, Tingyu; Deng, Haijun; Li, Guoxin

    2015-11-30

    Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer. This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is

  14. 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.

  15. APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Conceição, Eva M; Machado, Paulo P P; Vaz, Ana Rita; Pinto-Bastos, Ana; Ramalho, Sofia; Silva, Cátia; Arrojado, Filipa

    2016-03-01

    Despite evidence of successful weight loss for bariatric surgery patients, some patients experience considerable weight regain over the long term. Given the strong association between post-surgery health behaviors and outcomes, aftercare intervention to address key behaviors appears to be a reasonable relapse-prevention strategy. As the burden of obesity rates increases in healthcare centers, an internet-based program appears to be a reasonable strategy for supporting bariatric surgery patients in the long term. The primary purpose of the current project is to develop and test the efficacy and perceived utility of APOLO-Bari. This study is a randomized control trial, which will be conducted in two hospital centers in the North of Portugal; it includes a control group receiving treatment as usual and an intervention group receiving the APOLO-Bari program for one year in addition to treatment as usual. A total of 180 male and female participants who underwent bariatric surgery (gastric sleeve or gastric bypass surgery) for 12 to 20 months will be recruited. Both groups will complete a similar set of questionnaires at baseline, every 4 months until the end of the intervention, and at 6 and 12 months follow-up. Assessment includes anthropometric variables and psychological self-report measures. The primary outcome measure will be weight regain measured at the end of treatment, and at 6 and 12 months follow-up. The secondary aims are to test the cost-effectiveness of the intervention and to investigate psychological predictors and trajectories of weight regain. APOLO-Bari was developed to address the weight regain problem in the bariatric population by offering additional guidance to bariatric patients during the postoperative period. The program includes: (a) a psychoeducational cognitive-behavioral-based self-help manual, (b) a weekly feedback messaging system that sends a feedback statement related to information reported by the participant, and (c) interactive chat

  16. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design.

    Science.gov (United States)

    Sihvonen, Raine; Paavola, Mika; Malmivaara, Antti; Järvinen, Teppo L N

    2013-03-09

    present and discuss our study design, focusing particularly on the internal and external validity of our trial and the ethics of carrying out a placebo surgery controlled trial. The protocol has been approved by the institutional review board of the Pirkanmaa Hospital District and the trial has been duly registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations. ClinicalTrials.gov, number NCT00549172.

  17. 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

  18. 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

  19. Advanced vulvar carcinoma: is it worth operating? A perioperative management protocol for radical and reconstructive surgery.

    Science.gov (United States)

    Fanfani, Francesco; Garganese, Giorgia; Fagotti, Anna; Lorusso, Domenica; Gagliardi, Maria Lucia; Rossi, Marco; Salgarello, Marzia; Scambia, Giovanni

    2006-11-01

    The aim of this study was to characterize the means whereby the results could be improved and the morbidity and side-effects minimized, of radical and extensive surgery performed together with plastic reconstruction, in the treatment of locally advanced and relapsed vulvar carcinoma. Between May 2000 and November 2004, twenty-three patients with locally advanced or relapsed vulvar carcinoma underwent major radical or extended vulvectomy, requiring reconstructive surgery. A consistent protocol for the perioperative management of these patients, including precautionary measures to reduce the rate of early complications, was introduced in the second study period (from November 2003) to verify the benefit on surgical outcome. An analysis of the medical reports showed an improvement in the median time of the postoperative course and related morbidity as a consequence of a strict application of the management protocol, with consequent decrease of early complications. Reconstructive surgery, which broadens the spectrum of available operative therapy in primary and locally recurrent vulvar cancer, is characterized by a high complication rate. The application of a strict perioperative protocol could reduce the number and the clinical impact of such complications.

  20. 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

  1. The impact of a structured preoperative protocol on day of surgery cancellations.

    Science.gov (United States)

    Turunen, Elina; Miettinen, Merja; Setälä, Leena; Vehviläinen-Julkunen, Katri

    2018-01-01

    To evaluate the impact of implementing an evidence-based, structured preoperative protocol on day of surgery cancellations in 13 operative specialties. Surgery cancellations cause unnecessary harm for patients and organisations as many cancellations could be prevented. Preoperative care has developed in recent years, and several preoperative interventions have been introduced. However, the optimal model for organising preoperative care remains unknown. Cancellations are a commonly used indicator when evaluating the success of preoperative care. Observational study with two study phases: before and after. The cancellation data were collected from the hospital register from 1 September 2013-31 May 2014 (n = 591) and from September 2015-May 2016 (n = 542). The compliance rate of the preoperative protocol was evaluated in group sessions (n = 13) during spring 2016 using the participation of preoperative healthcare professionals (n = 49). The data were analysed statistically. Cancellation rates varied between 1.6%-9.7% (in the first phase) and between 1.5%-7.7% (in the second phase). A remarkable decrease was found in patients who failed to attend their scheduled procedures. The mean of compliance to the preoperative protocol across all specialties was 82.3%. A correlation between the rate of cancellation and the rate of compliance with the preoperative protocol was found. A preoperative protocol promotes the scheduled arrival of surgical patients to the hospital and therefore decreases cancellation rates. An evidence-based preoperative care protocol should be introduced for all healthcare professionals working in preoperative care to ensure smooth, safe and high-quality care for surgical patients. © 2017 John Wiley & Sons Ltd.

  2. APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial

    OpenAIRE

    Concei??o, Eva M.; Machado, Paulo P. P.; Vaz, Ana Rita; Pinto-Bastos, Ana; Ramalho, Sofia; Silva, C?tia; Arrojado, Filipa

    2016-01-01

    Background Despite evidence of successful weight loss for bariatric surgery patients, some patients experience considerable weight regain over the long term. Given the strong association between post-surgery health behaviors and outcomes, aftercare intervention to address key behaviors appears to be a reasonable relapse-prevention strategy. As the burden of obesity rates increases in healthcare centers, an internet-based program appears to be a reasonable strategy for supporting bariatric sur...

  3. The DOMUS study protocol

    DEFF Research Database (Denmark)

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

    2014-01-01

    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...... is a controlled randomized clinical trial with a balanced parallel-group randomization (1:1). The planned sample size is 340 in- and outpatients treated at the Department of Oncology at Copenhagen University Hospital. Patients are randomly assigned either to: a) standard care plus SPC enriched with a standardized...... 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...

  4. 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

  5. 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...

  6. 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

  7. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

    Science.gov (United States)

    Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

    2015-12-15

    Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and

  8. Description and Results of a Comprehensive Care Protocol for Overnight-Stay Spine Surgery in Adults.

    Science.gov (United States)

    Bednar, Drew A

    2017-07-15

    This is a prospective cohort study. The aim of this study was to define the probability of successful morning-after discharge after adult spine surgery achieved with a standard care protocol as applied to patients with a large variety of common degenerative spine disorders. Qualifying criteria for ambulatory or overnight-stay adult spine surgery are not well defined in either the spine or anesthesia literature. Most reports simply go to American Society of Anesthesiology risk classification or surgical technique alternatives and do not present a clearly defined patient care and case management protocol. A standardized protocol of patient preparation, preoperative comorbidities optimization, and perioperative care was applied in a prospective cohort of 126 patients including 83 lumbar and 41 cervical procedures. Office and hospital chart records were reviewed for relevant outcomes. Fully 122 of 124 appropriately selected cases were able to successfully achieve uneventful same-day discharge without any need for readmission, unscheduled early emergency room or clinic visits, or other major complications. Both failures were for urinary retention in senior males and resolved after a single-day admission to the main hospital. A wide variety of common degenerative spinal pathology in adults can be routinely and safely managed on an overnight-stay basis without requirement for formal hospital inpatient admission in patients appropriately selected and pre-educated to the experience and whose major comorbidities are preoperatively optimized. N/A.

  9. A randomised control trial assessing the impact of an investment based intervention on weight-loss, beliefs and behaviour after bariatric surgery: study protocol.

    OpenAIRE

    Hollywood, A; Ogden, J; Hashemi, M

    2015-01-01

    BACKGROUND: Although obesity surgery is currently the most effective method for achieving weight loss, not all patients lose the desired amount of weight and some show weight regain. Previous research shows that successful weight loss may be associated with the amount of investment the patient feels that they have made in their operation. For example, those who feel that it has taken more time and effort to organise, has cost more money, has been more disruptive to their lives and has caused ...

  10. Laparoscopic Gastrectomy with Enhanced Recovery After Surgery Protocol: Single-Center Experience.

    Science.gov (United States)

    Pisarska, Magdalena; Pędziwiatr, Michał; Major, Piotr; Kisielewski, Michał; Migaczewski, Marcin; Rubinkiewicz, Mateusz; Budzyński, Piotr; Przęczek, Krzysztof; Zub-Pokrowiecka, Anna; Budzyński, Andrzej

    2017-03-23

    BACKGROUND Surgery remains the mainstay of gastric cancer treatment. It is, however, associated with a relatively high risk of perioperative complications. The use of laparoscopy and the Enhanced Recovery After Surgery (ERAS) protocol allows clinicians to limit surgically induced trauma, thus improving recovery and reducing the number of complications. The aim of the study is to present clinical outcomes of patients with gastric cancer undergoing laparoscopic gastrectomy combined with the ERAS protocol. MATERIAL AND METHODS Fifty-three (21 female/32 male) patients who underwent elective laparoscopic total gastrectomy due to cancer were prospectively analyzed. Demographic and surgical parameters were assessed, as well as the compliance with ERAS protocol elements, length of hospital stay, number of complications, and readmissions. RESULTS Mean operative time was 296.4±98.9 min, and mean blood loss was 293.3±213.8 mL. In 3 (5.7%) cases, conversion was required. Median length of hospital stay was 5 days. Compliance with ERAS protocol was 79.6±14.5%. Thirty (56.6%) patients tolerated an early oral diet well within 24 h postoperatively; in 48 (90.6%) patients, mobilization in the first 24 hours was successful. In 17 (32.1%) patients, postoperative complications occurred, with 7 of them (13.2%) being serious (Clavien-Dindo 3-5). The 30-day readmission rate was 9.4%. CONCLUSIONS The combination of laparoscopy and the ERAS protocol in patients with gastric cancer is feasible and allows achieving good clinical outcomes.

  11. Effect of variations in depth of neuromuscular blockade on rating of surgical conditions by surgeon and anesthesiologist in patients undergoing laparoscopic renal or prostatic surgery (BLISS trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Boon, Martijn; Martini, Christian H; Aarts, Leon P H J; Bevers, Rob F M; Dahan, Albert

    2013-03-01

    Surgical conditions in laparoscopic surgery are largely determined by the depth of neuromuscular relaxation. Especially in procedures that are confined to a narrow working field, such as retroperitoneal laparoscopic surgery, deep neuromuscular relaxation may be beneficial. Until recently, though, deep neuromuscular block (NMB) came at the expense of a variety of issues that conflicted with its use. However, with the introduction of sugammadex, rapid reversal of a deep NMB is feasible. In the current protocol, the association between the depth of NMB and rating of surgical conditions by the surgeon and anesthesiologist is studied. This is a single-center, prospective, randomized, blinded, parallel group and controlled trial. Eligible patients are randomly assigned to one of two groups: (1) deep NMB (post-tetanic count, one or two twitches; n = 12) and (2) moderate NMB (train-of-four, 1 to 2 twitches, n = 12) by administration of high-dose rocuronium in Group 1 and a combination of atracurium and mivacurium in Group 2. The NMB in Group 1 is reversed by 4 mg/kg sugammadex; the NMB in Group 2 by 1 mg neostigmine and 0.5 mg atropine. Patients are eligible if they are over 18 years, willing to sign the informed consent form, and are scheduled to undergo an elective laparoscopic renal procedure or laparoscopic prostatectomy. A single surgeon performs the surgeries and rates the surgical conditions on a five-point surgical rating scale (SRS) ranging from 1 (poor surgical conditions) to 5 (excellent surgical conditions). The intra-abdominal part of the surgeries is captured on video and a group of five anesthesiologists and ten surgical experts will rate the videos using the same SRS. The primary analysis will be an intention-to-treat analysis. Evaluation will include the association between the level of NMB and SRS, as obtained by the surgeon performing the procedure and the agreement between the scoring of the images by anesthesiologists and surgeons. We aim to show that

  12. 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.

  13. Results of Implementing an Enhanced Recovery After Bariatric Surgery (ERABS) Protocol.

    Science.gov (United States)

    Mannaerts, Guido H H; van Mil, Stefanie R; Stepaniak, Pieter S; Dunkelgrün, Martin; de Quelerij, Marcel; Verbrugge, Serge J; Zengerink, Hans F; Biter, L Ulas

    2016-02-01

    With the increasing prevalence of morbid obesity and healthcare costs in general, interest is shown in safe, efficient, and cost-effective bariatric care. This study describes an Enhanced Recovery After Bariatric Surgery (ERABS) protocol and the results of implementing such protocol on procedural times, length of stay in hospital (LOS), and the number of complications, such as readmissions and reoperations. Results of implementing an ERABS protocol were analyzed by comparing a cohort treated according to the ERABS protocol (2012-2014) with a cohort treated before implementing ERABS (2010-2012). Differences between both cohorts were analyzed using independent t tests and chi-squared tests. A total of 1.967 patients (mean age 43.3 years, 80% female) underwent a primary bariatric procedure between 2010 and 2014, of which 1.313 procedures were performed after implementation of ERABS. A significant decrease of procedural times and a significantly decreased LOS, from 3.2 to 2.0 nights (p complications were seen post-ERABS (16.1 vs. 20.7%, p = 0.013), although no significant differences were seen in the number of major complications. Implementation of ERABS can result in shorter procedural times and a decreased LOS, which may lead to more efficient and cost-effective bariatric care. The increase in complications was possibly due to better registration of complications. The main goal of an ERABS protocol is efficient, safe, and evidence-based bariatric care, which can be achieved by standardization of the total process.

  14. 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

  15. 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

    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.

  16. 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.

  17. 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

  18. 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

  19. 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

  20. Optimizing sonication protocols for transthoracic focused ultrasound surgery

    Science.gov (United States)

    Gao, J.; Volovick, A.; Cao, R.; Nabi, G.; Cochran, S.; Melzer, A.; Huang, Z.

    2012-11-01

    During transthoracic focused ultrasound surgery (TFUS), the intervening ribs absorb and reflect the majority of the ultrasound energy excited by an acoustic source, resulting in pain, bone injuries and insufficient energy delivered to the target organs of liver, kidney, and pancreas. Localized hot spots may also exist at the interfaces between the ribs and soft tissue and in the highly absorptive regions such as the skin and connective tissue. The aims of this study were to clarify the effects of focal beam distortion and frequency-dependent rib heating in TFUS and to propose possible techniques to reduce the side-effects of rib heating and increase ultrasound efficacy. Frequency-dependent heating at the target and the ribs were estimated using finite element analysis (PZFlex, Weidlinger Associates Inc, USA) along with experimental verification on a range of different phantoms. The ratio of ultrasonic power density at the target and the ribs, the time-varying spatial distribution of temperature, and the ablated focus of each sonication were taken as key indicators to determine the optimal operating frequency. Comparison with a patient specific model was also made. TFUS seems to be useful to treat tumours that are small and near the surface of the abdominal organs. For targets deep inside these organs, severe attenuation of energy occurs, suggesting that purely ultrasound thermal ablation with advanced heating patterns will have limited effects in improving the treatment efficacy. Results demonstrate that the optimal ultrasound frequency is around 0.8 MHz for the configurations considered, but this may shift to higher frequencies with changes in the axial and lateral positions of the tumours relative to the ribs. To date, we have elucidated the most important effects and correlated these with idealised anatomical geometry. The changes in frequency and other techniques such as selection of excited element patterns in FUS arrays had some effect. However, more advanced

  1. Use of autologous fat grafting for reconstruction postmastectomy and breast conserving surgery: a systematic review protocol.

    Science.gov (United States)

    Agha, Riaz A; Goodacre, Tim; Orgill, Dennis P

    2013-10-22

    There is growing interest in the potential use of autologous fat grafting (AFG) for the purposes of breast reconstruction. However, concerns have been raised regarding the technique's clinical effectiveness, safety and interference with screening mammography. The objective of this systematic review was to determine the oncological, clinical, aesthetic and functional, patient reported, process and radiological outcomes for AFG. All original studies, including randomised controlled trials, cohorts studies, case-control studies, case series and case reports involving women undergoing breast reconstruction. All AFG techniques performed for the purposes of reconstruction in the postmastectomy or breast conserving surgery setting will be considered. Outcomes are defined within this protocol along; oncological, clinical, aesthetic and functional, patient reported, process and radiological domains. The search strategy has been devised to find papers about 'fat grafting and breast reconstruction' and is outlined within the body of this protocol. The full search strategy is outlined within the body of the protocol. The following electronic databases will be searched from 1 January 1986 to 6 June 2013: PubMed, MEDLINE, EMBASE, SCOPUS, CINAHL, PsycINFO, SciELO, The Cochrane Library, including the Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effect (DARE), the Cochrane Methodology Register, Health Technology Assessment Database, the NHS Economic Evaluation Databases and Cochrane Groups, ClinicalTrials.gov, Current Controlled Trials Database, the World Health Organisation (WHO) International Clinical Trials Registry Platform, UpToDate.com, NHS Evidence and the York Centre for Reviews and Dissemination. Grey literature searches will also be conducted as detailed in our review protocol. Eligibility assessment occurred in two stages, title and abstract screening and then full text

  2. [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

  3. 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.

  4. [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.

  5. 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.

  6. 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.

  7. A protocol for management of blood loss in surgical treatment of peritoneal malignancy by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.

    Science.gov (United States)

    Sargant, N; Roy, A; Simpson, S; Chandrakumaran, K; Alves, S; Coakes, J; Bell, J; Knight, J; Wilson, P; Mohamed, F; Cecil, T; Moran, B

    2016-04-01

    The treatment of peritoneal malignancies with cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been shown to be associated with massive surgical blood loss. Maintaining high fibrinogen levels throughout surgery may reduce blood loss in these patients. The primary aim of the study was to see if Tranexamic Acid (TXA) and cryoprecipitate reduced surgical blood loss and hence red cell transfusions. A comparison was made with a cohort of patients treated with fresh frozen plasma (FFP) alone. The secondary aim was to measure the effect of both protocols on coagulation parameters and the incidence of arterial or venous thrombosis. We used prospectively collected data from 201 patients who had complete CRS with HIPEC for peritoneal malignancy using different protocols during two discrete 12-month time periods. The new transfusion protocol led to a higher average fibrinogen level intra-operatively and post-operatively, with a significant reduction in average RBC, FFP and platelet transfusion intra-operatively per patient from 4·2 to 1·8 units, 6·2 to 0·2 units and 0·1 to 0 units, respectively. No significant difference in PT or APTT was seen between patients treated with the standard and new protocols. Venous thrombosis occurred in seven patients treated with the standard protocol and five with the new protocol. A single case of arterial thrombosis was seen in both groups. Patients treated with upfront TXA and cryoprecipitate during CRS required less RBC transfusion than those treated with the standard protocol of early FFP. © 2016 British Blood Transfusion Society.

  8. Rehabilitation after surgery repair of flexor tendon injuries of the hand with Kleinert early passive mobilization protocol.

    Science.gov (United States)

    Hundozi, Hajrie; Murtezani, Ardiana; Hysenaj, Vale; Hysenaj, Vlore; Mustafa, Aziz

    2013-01-01

    Rehabilitation after surgery repair of flexor tendon injuries of the hand remains challenging and requires experienced professionals and interdisciplinary approaches. The aim of this study was to evaluate rehabilitation results after surgery repair of flexor tendon injuries in the hand with the early passive mobilization--Kleinert protocol. In this retrospective case-series study rehabilitation results of flexor tendon injuries in the hand with the early passive mobilization--Kleinert protocol were evaluated in 35 patients, treated in the Orthopaedic Clinic University Clinical Centre of Kosovo between December 2007 and November 2008. Patients had unilateral injuries on right hand without associated injuries. Patients were divided in three groups: patient with injury of FPL (n = 15), patient with injury of FDP and FDS dig. I-V (n = 10) and patient with injury of FDP and FDS dig.II (n = 10). Patients were included in a rehabilitation program using the Kleinert-early passive mobilization protocol. Functional evaluation was made using the mean improvement on MCP, PIP and DIP joints motion, mean functional are of motion (FAM) and total active motion (TAM) scoring system of The American Society of Surgery of Hand. The functional outcomes were analyzed by Paired t-test, and One way Analysis of Variance, while the mean TAM score were compared using the Wilcoxon Matched-Pairs Signed-Ranks test with significance set at p hand.

  9. Evaluating the Implementation of a Preemptive, Multimodal Analgesia Protocol in a Plastic Surgery Office.

    Science.gov (United States)

    Tinsbloom, Brandi; Muckler, Virginia C; Stoeckel, William T; Whitehurst, Robert L; Morgan, Brett

    Many patients undergoing plastic surgery experience significant pain postoperatively. The use of preemptive, multimodal analgesia techniques to reduce postoperative pain has been widely described in the literature. This quality improvement project evaluated the implementation of a preemptive, multimodal analgesia protocol in an office-based plastic surgery facility to decrease postoperative pain, decrease postoperative opioid consumption, decrease postanesthesia care time, and increase patient satisfaction. The project included adult patients undergoing surgical procedures at an outpatient plastic and cosmetic surgery office, and the protocol consisted of oral acetaminophen 1,000 mg and gabapentin 1,200 mg. Using a pre-/postintervention design, data were collected from patient medical records and telephone interviews of patients receiving the standard preoperative analgesia regimen (preintervention group: n = 24) and the evidence-based preemptive, multimodal analgesia protocol (postintervention group: n = 23). Results indicated no significant differences between the pre- and postintervention groups for any of the outcomes measured. However, results showed that patients in both groups experienced moderate to severe pain postoperatively. In addition, adverse side effects such as dizziness and drowsiness were higher in the postintervention group than in the preintervention group. Although this quality improvement project did not meet the goals it set out to achieve for patients undergoing plastic surgery, it did illustrate the substantial presence of pain after surgical procedures. Thus, clinicians need to continue to focus on identifying targeted treatment plans that use multimodal, non-opioid-based strategies to manage and prevent postoperative pain.

  10. 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.

  11. 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.

  12. 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.

  13. Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure™ (SAWHI-V.A.C.®-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Seidel, Dörthe; Lefering, Rolf; Neugebauer, Edmund A M

    2013-11-20

    A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, which demonstrated through systematic reviews and meta-analysis of previous study projects, that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists. Further studies were therefore indicated. The study is designed as a multinational, multicenter, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint. Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors (in- and outpatient care) will be evaluated. The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy (intervention group) and standard conventional wound therapy (control group) in the treatment of subcutaneous abdominal wounds after surgery. The aim of the SAWHI-VAC® study is to compare the clinical, safety and economic results of both treatment arms. The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy. Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors. Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648.

  14. 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...

  15. 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.

  16. Needlestick and Sharps Injuries in Dermatologic Surgery: A Review of Preventative Techniques and Post-exposure Protocols.

    Science.gov (United States)

    Rizk, Christopher; Monroe, Holly; Orengo, Ida; Rosen, Theodore

    2016-10-01

    Background: Needlestickand sharps injuries are the leading causes of morbidity in the dermatologicfield. Among medical specialties, surgeons and dermatologists have the highest rates of needlestickand sharps injuries.The high rates of needlestickand sharps injuries in dermatology not only apply to physicians, but also to nurses, physician assistants, and technicians in the demnatologic field. Needlestickand sharps injuries are of great concern due to the monetary, opportunity, social, and emotional costs associated with their occurrence. Objective: A review of preventative techniques and post-exposure protocols for the majortypes of sharps injuries encountered in dermatologic practice. Design: The terms "needle-stick injuryT'sharps injuryTdermatologic surgery? "post-exposure prophylaxis,"and "health-care associated injury" were used in combinations to search the PubMed database. Relevant studies were reviewed for validity and included. Results The authors discuss the major types of sharps injuries that occur in the dermatologic surgery setting and summarize preventative techniques with respect to each type of sharps injury.The authors also summarize and discuss relevant post-exposure protocols in the event of a sharps injury. Conclusion: The adoption of the discussed methods, techniques, practices, and attire can result in the elimination of the vast majority of dermatologic sharps injuries.

  17. The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Luger, Maria; Kruschitz, Renate; Marculescu, Rodrig; Haslacher, Helmuth; Hoppichler, Friedrich; Kallay, Enikö; Kienbacher, Christian; Klammer, Carmen; Kral, Melanie; Langer, Felix; Luger, Eva; Prager, Gerhard; Trauner, Michael; Traussnigg, Stefan; Würger, Tanja; Schindler, Karin; Ludvik, Bernhard

    2015-08-05

    Beyond its classical role in calcium homoeostasis and bone metabolism, vitamin D deficiency has been found to be associated with several diseases, including diabetes, non-alcoholic fatty liver disease, and even obesity itself. Importantly, there are limited data on therapeutic strategies for vitamin D deficiency in bariatric patients, and the procedure-specific guidelines may not be sufficient. To improve long-term outcomes, nutritional screening and appropriate supplementation to prevent nutrient deficiencies are urgently needed. Therefore, the aim of this study is to examine effects and safety of a forced dosing regimen of vitamin D versus conventional dose supplementation on vitamin D levels and other parameters in bariatric patients. The study includes loading plus repeat dosing compared with repeated administration of vitamin D without a loading dose, according to guidelines, in a prospective, double-blind, randomized controlled trial. Up to a triple oral loading dose is given on day 1, then 2 and 4 weeks after surgery (100,000 IU dose each time), followed by an oral maintenance dose (3420 IU/day). The control group (n = 25) will receive placebo, followed by administration of a standard dose (3420 IU/day). We hypothesize that a significant increase in vitamin D levels will occur in patients in the treatment group (n = 25) by 24 weeks after surgery. Further measurements are aimed at evaluating changes in inflammation, bone turnover, insulin resistance, blood pressure, liver, mental health, and gut microbiota of patients undergoing omega-loop gastric bypass surgery. Furthermore, possible associations between concentrations of vitamin D, the involved enzymes, or vitamin D receptor in adipose and/or liver tissues will be determined. To our knowledge, this trial is the first of its kind with this type of vitamin D supplementation in bariatric patients. Its major strength is the design and implementation of evaluation of influencing factors such as liver

  18. 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 qu...... the statistical principles for trial protocols in terms of design, analysis, and reporting of findings....

  19. 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.

  20. Implementation of the Spanish National Enhanced Recovery Program (ERAS) in Bariatric Surgery: A Pilot Study.

    Science.gov (United States)

    Ruiz-Tovar, Jaime; Royo, Pablo; Muñoz, José L; Duran, Manuel; Redondo, Elisabeth; Ramirez, Jose M

    2016-12-01

    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. A multicentric prospective pilot study was performed, including 125 consecutive patients undergoing bariatric surgery at 3 Spanish hospitals between January and June 2015, after the Spanish National ERAS protocol in bariatric surgery. Compliance with the protocol, morbidity, mortality, hospital stay, and readmission were evaluated. Bariatric techniques performed included 68 Roux-en-Y gastric bypass (54.4%) and 57 laparoscopic sleeve gastrectomy (45.6%) cases. All surgeries were laparoscopically performed with conversion in only 1 case (0.8%). Median postoperative pain evaluated by visual analogic scale 24 hours after surgery was 2 (range, 0 to 5). Postoperative nausea or vomiting appeared in 7 patients (5.6%). Complications appeared in 6 patients (4.8%). The reoperation rate was 4%. The mortality rate was 0.8%. The median hospital stay was 2 days (range, 2 to 10 d) and readmission rate was 2.4%. The compliance of all the items of the protocol was achieved in 78.4% of the patients. The Spanish National ERAS protocol is a safe issue with a high implementation rate. It can be recommended to establish this protocol to other institutions.

  1. Influence of early goal-directed therapy using arterial waveform analysis on major complications after high-risk abdominal surgery : study protocol for a multicenter randomized controlled superiority trial

    NARCIS (Netherlands)

    Montenij, Leonard; de Waal, Eric; Frank, Michael; van Beest, Paul; de Wit, Ardine; Kruitwagen, Cas; Buhre, Wolfgang; Scheeren, Thomas

    2014-01-01

    Background:  Early goal-directed therapy refers to the use of predefined hemodynamic goals to optimize tissue oxygen delivery in critically ill patients. Its application in high-risk abdominal surgery is, however, hindered by safety concerns and practical limitations of perioperative hemodynamic

  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 qu...... the statistical principles for trial protocols in terms of design, analysis, and reporting of findings.......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...

  3. What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata.

    Science.gov (United States)

    Durand, Marie-Anne; Yen, Renata West; O'Malley, A James; Politi, Mary C; Dhage, Shubhada; Rosenkranz, Kari; Weichman, Katie; Margenthaler, Julie; Tosteson, Anna N A; Crayton, Eloise; Jackson, Sherrill; Bradley, Ann; Volk, Robert J; Sepucha, Karen; Ozanne, Elissa; Percac-Lima, Sanja; Song, Julia; Acosta, Jocelyn; Mir, Nageen; Elwyn, Glyn

    2018-02-13

    Breast cancer is the most commonly diagnosed malignancy in women. Mastectomy and breast-conserving surgery (BCS) have equivalent survival for early stage breast cancer. However, each surgery has different benefits and harms that women may value differently. Women of lower socioeconomic status (SES) diagnosed with early stage breast cancer are more likely to experience poorer doctor-patient communication, lower satisfaction with surgery and decision-making, and higher decision regret compared to women of higher SES. They often play a more passive role in decision-making and are less likely to undergo BCS. Our aim is to understand how best to support women of lower SES in making decisions about early stage breast cancer treatments and to reduce disparities in decision quality across socioeconomic strata. We will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES and clinician-level randomization. At four large cancer centers in the United States, 1100 patients (half higher SES and half lower SES) will be randomized to: (1) Option Grid, (2) Picture Option Grid, or (3) usual care. Interviews, field-notes, and observations will be used to explore strategies that promote the interventions' sustained use and dissemination. Community-Based Participatory Research will be used throughout. We will include women aged at least 18 years of age with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES, provided they speak English, Spanish, or Mandarin Chinese. Our primary outcome measure is the 16-item validated Decision Quality Instrument. We will use a regression framework, mediation analyses, and multiple informants analysis. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed. Currently, women of lower SES are more likely to make treatment decisions based on incomplete or uninformed preferences, potentially

  4. Hypocarotenemia after bariatric surgery: a preliminary study.

    Science.gov (United States)

    Granado-Lorencio, F; Herrero-Barbudo, C; Olmedilla-Alonso, B; Blanco-Navarro, I; Pérez-Sacristán, B

    2009-07-01

    Dietary carotenoids have attracted a great deal of attention due to their potential clinical relevance in conditions such as age-related maculopathy, osteoporosis, cardiovascular disease, and cancer. Surgical procedures have become the primary treatment of severe obesity, although nutrient deficiencies are common and long-term metabolic sequelae remain unknown. Thus, our aim was to assess the carotenoid status in serum of subjects after obesity surgery. We evaluated the status of lutein, zeaxanthin, alpha- and beta-cryptoxanthin, lycopene, alpha- and beta-carotene, and fat-soluble vitamins by a quality-controlled high-performance liquid chromatography method in serum of 53 patients. Subjects were consecutively included as they were monitored for nutritional status after Roux-en-Y gastric bypass (RYGBP) or biliopancreatic diversion (BPD). Average follow-up time was 18 and 14 months for each protocol, respectively. After obesity surgery, a consistent and continuous decline in all carotenoids to almost undetectable levels occurs, especially in those who underwent BPD diversion who, on average, displayed serum levels about one half to one third of those found in RYGBP patients. The hypocarotenemia observed after bariatric surgery may compromise the availability of carotenoids to tissues and the vitamin A status, reducing the fat-soluble antioxidant capacity and constituting an additional risk factor for several clinical conditions. Given the emerging role of carotenoids in disease prevention, dietary advice on carotenoid-rich and fortified foods or the use of supplements in these patients should be considered.

  5. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    (rigorous) protocol writing too troublesome, will realize that they have already written the first half of the final paper if they follow these recommendations; authors simply need to change the protocols future tense into past tense. Thus, the aim of this clinical commentary is to describe and explain...

  6. Standardizing care for high-risk patients in spine surgery: the Northwestern high-risk spine protocol.

    Science.gov (United States)

    Halpin, Ryan J; Sugrue, Patrick A; Gould, Robert W; Kallas, Peter G; Schafer, Michael F; Ondra, Stephen L; Koski, Tyler R

    2010-12-01

    Review article of current literature on the preoperative evaluation and postoperative management of patients undergoing high-risk spine operations and a presentation of a multidisciplinary protocol for patients undergoing high-risk spine operation. To provide evidence-based outline of modifiable risk factors and give an example of a multidisciplinary protocol with the goal of improving outcomes. Protocol-based care has been shown to improve outcomes in many areas of medicine. A protocol to evaluate patients undergoing high-risk procedures may ultimately improve patient outcomes. The English language literature to date was reviewed on modifiable risk factors for spine surgery. A multidisciplinary team including hospitalists, critical care physicians, anesthesiologists, and spine surgeons from neurosurgery and orthopedics established an institutional protocol to provide comprehensive care in the pre-, peri-, and postoperative periods for patients undergoing high-risk spine operations. An example of a comprehensive pre-, peri-, and postoperative high-risk spine protocol is provided, with focus on the preoperative assessment of patients undergoing high-risk spine operations and modifiable risk factors. Standardizing preoperative risk assessment may lead to better outcomes after major spine operations. A high-risk spine protocol may help patients by having dedicated physicians in multiple specialties focusing on all aspects of a patients care in the pre-, intra-, and postoperative phases.

  7. 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

  8. Protocolo eletrônico multiprofissional em cirurgia bariátrica Multiprofessional electronic protocol in bariatric surgery

    Directory of Open Access Journals (Sweden)

    Denise Serpa Bopp Nassif

    2011-09-01

    protocolo eletrônico e suas coletas foram disponibilizados para visualização via internet utilizando SINPE WEB©.BACKGROUND: Obesity is a multi factorial disease. Data collection plays a fundamental role for conducting papers with high level of quality and obesity surgery lacks the means to carry out prospective studies with high reliability. Data from electronic protocols are more complete, have fewer errors, are more consistent and have a low percentage of violations in relation to paper charts. AIM: 1 To create a theoretical basis of clinical data regarding the multiprofessionalism on metabolic and bariatric surgery; 2 to computerize this basis by transforming it into electronic multi professional protocol; 3 to incorporate it into the SINPE©; 4 to provide the protocol address and their collections for viewing via the Internet using SINPE WEB©. METHOD: The creation of the theoretical background was done in Word© - later transformed into digital form to be used as electronic protocol - based on literature review of nine textbooks in morbid obesity, bariatric surgery and metabolic multi professionalism books, special books in psychology and nutrition applied to the subject. Was added systematic review of the literature based on scientific articles published over the last five years in Medline/Pubmed, Lilacs and Scielo and in theses and dissertations done with electronic protocols. Thus, 10,306 items were computerized in a hierarchical and branched containing data related to medicine, physiotherapy, psychology and nutrition applied to the subject. RESULTS: The complete protocol can be accessed to view in site www.sinpe.com.br CONCLUSIONS: 1 It was possible to create electronic database regarding the clinical multi professionalism on bariatric and metabolic surgery to collect standardized information; 2 it was possible to computerized the database; 3 it is incorporated into the SINPE©; 4 the electronic protocol and its collections were made available for viewing via

  9. Enhanced recovery in colorectal surgery: a multicentre study

    Directory of Open Access Journals (Sweden)

    Casal José E

    2011-04-01

    Full Text Available Abstract Background Major colorectal surgery usually requires a hospital stay of more than 12 days. Inadequate pain management, intestinal dysfunction and immobilisation are the main factors associated with delay in recovery. The present work assesses the short and medium term results achieved by an enhanced recovery program based on previously published protocols. Methods This prospective study, performed at 12 Spanish hospitals in 2008 and 2009, involved 300 patients. All patients underwent elective colorectal resection for cancer following an enhanced recovery program. The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilisation, and the taking of oral fluids in the early postoperative period. Perioperative morbidity and mortality data were collected and the length of hospital stay and protocol compliance recorded. Results The median age of the patients was 68 years. Fifty-two % of the patients were women. The distribution of patients by ASA class was: I 10%, II 50% and III 40%. Sixty-four % of interventions were laparoscopic; 15% required conversion to laparotomy. The majority of patients underwent sigmoidectomy or right hemicolectomy. The overall compliance to protocol was approximately 65%, but varied widely in its different components. The median length of postoperative hospital stay was 6 days. Some 3% of patients were readmitted to hospital after discharge; some 7% required repeat surgery during their initial hospitalisation or after readmission. The most common complications were surgical (24%, followed by septic (11% or other medical complications (10%. Three patients (1% died during follow-up. Some 31% of patients suffered symptoms that delayed their discharge, the most common being vomiting or

  10. Bariatric Surgery and Infertility: A Prospective Study.

    Science.gov (United States)

    Consalvo, Vincenzo; Canero, Antonio; Salsano, Vincenzo

    2017-12-22

    Obesity is a worldwide disease affecting 13% of the world's adult female population. The reasons and the fetal risk are still unclear. The effect of weight loss as a result of bariatric surgery seems to induce an improvement in fertility in obese women. The main purpose of this prospective study is to demonstrate if there is an association between bariatric surgery-induced weight loss and an improvement in the fertility of women at reproductive age. From June 2013 to April 2016, all bariatric female patients from our institutes were prospectively evaluated for suitability in this study. A pool of 52 eligible patients was extracted from our database in the recruitment period. Of these, 28 underwent bariatric surgery and 24 did not. Both groups were observed for two-year follow-up. During follow-up, anthropometrics parameters, blood analysis, and comorbidities were checked and a gynaecological consultation was prescribed. Fifty participants were studied. Twenty-seven successfully underwent bariatric surgery with a percentage of excess weight loss (EWL) >70% at 24 months, while 23 accepted the observation and control for 24 months as an integral part of the pre-surgical bariatric program. The contingency table analysis showed an extremely significant association (Pbariatric surgery) and event (pregnancy), with a relative risk (RR) = 15.33 and confidence interval (CI) 95%=2.213 to 106.26. Bariatric surgery improves fertility in obese women at two years' postoperative. Every obese woman with difficulties becoming pregnant should undergo a bariatric surgery consultation. Further studies are necessary to confirm our results.

  11. 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

  12. 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

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

    OpenAIRE

    Ashikali, E.-M.; Dittmar, H.; Ayers, S.

    2016-01-01

    This study examined adolescent girls’ views of cosmetic surgery. Seven focus groups were run with girls aged 15 to 18 (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)\\ud 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 cosm...

  15. 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.

  16. 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 ...

  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. SAFETY AND EFFICACY OF A PERI-OPERATIVE PROTOCOL FOR PATIENTS WITH DIABETES TREATED WITH CONTINUOUS SUBCUTANEOUS INSULIN INFUSION WHO ARE ADMITTED FOR SAME-DAY SURGERY.

    Science.gov (United States)

    Sobel, Sandra I; Augustine, Marilyn; Donihi, Amy C; Reider, Jodie; Forte, Patrick; Korytkowski, Mary

    2015-11-01

    The number of people with diabetes using continuous subcutaneous insulin infusions (CSII) with an insulin pump has risen dramatically, creating new challenges when these patients are admitted to the hospital for surgical or other procedures. There is limited literature guiding CSII use during surgical procedures. The study was carried out in a large, urban, tertiary care hospital. We enrolled 49 patients using insulin pump therapy presenting for 57 elective surgeries. We developed a CSII peri-operative glycemic management protocol (PGMP) to standardize insulin pump management in patients admitted to a same-day surgery unit (SDSU). The purpose was evaluate the safety (% capillary blood glucose (CBG) operative steroid use on postoperative glycemic control. Overall, 63% of patients treated according to the CSII PGMP had a first postoperative CBG ≤200 mg/dL. There were no episodes of intra- or postoperative hypoglycemia. For patients treated with the CSII PGMP, the mean postoperative CBG was lower in patients with anticipated or actual surgical length ≤120 minutes (158.1 ± 53.9 vs. 216 ± 77.7 mg/dL, P<.01). No differences were observed with admission CBG, type of anesthesia, or steroid use. This study demonstrates that a CSII PGMP is both safe and effective for patients admitted for elective surgical procedures and provides an example of a standardized protocol for use in clinical practice.

  19. 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.

  20. 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

  1. Current peripheral bypass surgery: various clinical studies

    NARCIS (Netherlands)

    Slaa, Alexander te

    2011-01-01

    Substantial post-operative edema occurs in the majority of patients who undergo peripheral bypass surgery due to severe peripheral arterial disease (PAD). The pathophysiological mechanisms that underlay edema formation following peripheral bypass surgery include hyperemia, an increased capillary

  2. 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.

  3. LIHNCS - Lugol's iodine in head and neck cancer surgery: a multicentre, randomised controlled trial assessing the effectiveness of Lugol's iodine to assist excision of moderate dysplasia, severe dysplasia and carcinoma in situ at mucosal resection margins of oral and oropharyngeal squamous cell carcinoma: study protocol for a randomised controlled trial.

    Science.gov (United States)

    McCaul, James A; Cymerman, James A; Hislop, Stuart; McConkey, Chris; McMahon, Jeremy; Mehanna, Hisham; Shaw, Richard; Sutton, David N; Dunn, Janet

    2013-09-24

    Oral cavity and oropharynx cancer are increasing in incidence worldwide but survival outcomes have not significantly improved over the last three decades. The presence of dysplasia or carcinoma in situ at surgical margins following resection of squamous carcinoma of the mucosal surfaces of the head and neck has been shown to be associated with a higher incidence of local recurrence and reduced survival. While invasive carcinoma in mucosal surfaces can usually be distinguished from adjacent normal mucous membrane, pre-malignant disease is much less readily distinguished at operation. We describe a protocol for a randomised, controlled trial in which we will assess the effectiveness of Lugol's iodine staining in allowing visualisation and excision of cancer margin dysplasia at time of primary surgery. We will recruit 300 patients diagnosed with oral cavity or oropharynx squamous cell carcinoma. All participants will be planned for primary surgery with curative intent. After completion of baseline assessment participants will be randomised into either a standard surgical treatment arm or surgical treatment including Lugol's iodine staining. This paper describes the rationale and design of a unique trial in head and neck surgical oncology. If margin dysplasia visualisation with Lugol's iodine allows complete excision of high-risk, pre-cancer mucosa at time of primary surgery, this may lead to a reduction in local recurrence and improved survival. Current Controlled Trials ISRCTN03712770.

  4. LIHNCS - Lugol’s iodine in head and neck cancer surgery: a multicentre, randomised controlled trial assessing the effectiveness of Lugol’s iodine to assist excision of moderate dysplasia, severe dysplasia and carcinoma in situ at mucosal resection margins of oral and oropharyngeal squamous cell carcinoma: study protocol for a randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background Oral cavity and oropharynx cancer are increasing in incidence worldwide but survival outcomes have not significantly improved over the last three decades. The presence of dysplasia or carcinoma in situ at surgical margins following resection of squamous carcinoma of the mucosal surfaces of the head and neck has been shown to be associated with a higher incidence of local recurrence and reduced survival. While invasive carcinoma in mucosal surfaces can usually be distinguished from adjacent normal mucous membrane, pre-malignant disease is much less readily distinguished at operation. We describe a protocol for a randomised, controlled trial in which we will assess the effectiveness of Lugol’s iodine staining in allowing visualisation and excision of cancer margin dysplasia at time of primary surgery. Methods/Design We will recruit 300 patients diagnosed with oral cavity or oropharynx squamous cell carcinoma. All participants will be planned for primary surgery with curative intent. After completion of baseline assessment participants will be randomised into either a standard surgical treatment arm or surgical treatment including Lugol’s iodine staining. Discussion This paper describes the rationale and design of a unique trial in head and neck surgical oncology. If margin dysplasia visualisation with Lugol’s iodine allows complete excision of high-risk, pre-cancer mucosa at time of primary surgery, this may lead to a reduction in local recurrence and improved survival. Trial registration Current Controlled Trials ISRCTN03712770. PMID:24063578

  5. 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...

  6. 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.

  7. Recurrent melanotic neuroectodermal tumor of infancy: a proposal for treatment protocol with surgery and adjuvant chemotherapy.

    NARCIS (Netherlands)

    Neven, J.; Hulsbergen-van de Kaa, C.A.; Groot-Loonen, J.J.; Wilde, P.C.M. de; Merkx, M.A.W.

    2008-01-01

    The case of a 4-month-old male infant treated with combined surgery and chemotherapy for an aggressive recurrent melanotic neuroectodermal tumor of infancy (MNTI) on the top of the alveolar process of the mandible with a long-term follow-up is presented. Initial treatment comprised conservative

  8. 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

  9. Earplugs during the first night after cardiothoracic surgery may improve a fast-track protocol.

    Science.gov (United States)

    Menger, Johannes; Urbanek, Bernhard; Skhirtladze-Dworschak, Keso; Wolf, Viktoria; Fischer, Arabella; Rinösl, Harald; Dworschak, Martin

    2018-01-01

    Sleep deprivation after major surgery is common and associated with worse outcome. Noise is one important reason for sleep fragmentation, which contributes to enhanced morbidity. The purpose of this work was to evaluate the impact of earplugs on patients' sleep quality during their first night after cardiothoracic surgery to eventually improve an existing fast-track concept. Sixty-three patients undergoing cardiothoracic surgery eligible for a postoperative fast-track regimen on our cardiothoracic post anesthesia care unit (C-PACU) were prospectively included. They were randomized to either sleep with or without earplugs. Quality of sleep was measured using questionnaires for patients and nurses. Required pain medications, pain intensity, and length of hospital stay were secondary outcome variables. Twenty-seven patients were randomized to the intervention group (earplugs) and 36 to the control group. Mean (SD) age was 61 (12) years. Self-reported quality of sleep was better in the intervention group (median, IQR [range]: 3, 2-4 [1-5] vs. 4, 3-5 [1-5]; scale: 1, "excellent," to 5, "very poor"; P=0.025). Patients of the intervention group also experienced less severe pain (P=0.047) despite similar dosages of administered analgesics and expressed improved satisfaction regarding their C-PACU stay (P=0.032). Implementation of the use of earplugs in a fast-track concept following cardiothoracic surgery is efficient and easy. Earplugs improved the quality of sleep as well as patient satisfaction and attenuated pain intensity. They may thereby contribute to a faster recovery, less morbidity, and reduced costs.

  10. 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.

  11. The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled Trial (VeRDiCT Trial).

    Science.gov (United States)

    Clout, Madeleine; Harris, Tracy; Rogers, Chris; Culliford, Lucy; Taylor, Jodi; Angelini, Gianni; Narayan, Pradeep; Reeves, Barnaby; Hillier, James; Ashton, Kate; Sarkar, Kunal; Ascione, Raimondo

    2017-06-19

    Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients. The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to "fit for discharge", incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated. In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann's solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were "fit for discharge", which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources. Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017. VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol

  12. 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...

  13. Relationship between Arm Morbidity and Patient-Reported Outcomes Following Surgery in Women with Node-Negative Breast Cancer: NSABP Protocol B-32

    Science.gov (United States)

    Kopec, Jacek A.; Colangelo, Linda H.; Land, Stephanie R.; Julian, Thomas B.; Brown, Ann M.; Anderson, Stewart J.; Krag, David N.; Ashikaga, Takamaru; Costantino, Joseph P.; Wolmark, Norman; Ganz, Patricia A.

    2012-01-01

    Background The impact of arm morbidity following breast cancer surgery on patient-observed changes in daily functioning and health-related quality of life (HRQoL) have not been well-studied. Objective To examine the association of objective measures such as range of motion (ROM) and lymphedema, with patient-reported outcomes (PROs) in the arm and breast, upper extremity function, activities, and HRQoL. Methods The National Surgical Adjuvant Breast and Bowel Project Protocol B-32 was a randomized trial comparing sentinel node resection (SNR) with axillary dissection (AD) in women with node-negative breast cancer. ROM and arm volume were measured objectively. PROs included symptoms; arm function; limitations in social, recreational, occupational, and other regular activities; and a global index of HRQoL. Statistical methods included cross-tabulations and multivariable linear regression models. Results In all, 744 women provided at least 1 postsurgery assessment. About one-third of the patients experienced arm mobility restrictions. A similar number of patients avoided the use of the arm 6 months after surgery. Limitations in work and other regular activities were reported by about a quarter of the patients. In this multivariable analysis, arm mobility and sensory neuropathy were predictors of patient-reported arm function and overall HRQoL. Predictors for activity limitations also included side of surgery (dominant vs nondominant). Edema was not significant after adjustment for sensory neuropathy and ROM. Limitations Arm mobility and edema were measured simultaneously only once during the follow-up (6 months). Conclusion Clinical measures of sensory neuropathy and restrictions in arm mobility following breast cancer surgery are associated with self-reported limitations in activity and reductions in overall HRQoL. PMID:22951047

  14. Randomized clinical trial of laxatives and oral nutritional supplements within an enhanced recovery after surgery protocol following liver resection.

    Science.gov (United States)

    Hendry, P O; van Dam, R M; Bukkems, S F F W; McKeown, D W; Parks, R W; Preston, T; Dejong, C H C; Garden, O J; Fearon, K C H

    2010-08-01

    Routine laxatives may expedite gastrointestinal recovery and early tolerance of food within an enhanced recovery after surgery (ERAS) programme. Combined with carbohydrate loading and oral nutritional supplements (ONS), it may further enhance recovery of gastrointestinal function and promote earlier overall recovery. Seventy-four patients undergoing liver resection were randomized in a two-by-two factorial design to receive either postoperative magnesium hydroxide as a laxative, preoperative carbohydrate loading and postoperative ONS, their combination or a control group. Patients were managed within an ERAS programme of care. The primary outcome measure was time to first passage of stool. Secondary outcome measures were gastric emptying, postoperative oral calorie intake, time to functional recovery and length of hospital stay. Sixty-eight patients completed the trial. The laxative group had a significantly reduced time to passage of stool: median (interquartile range) 4 (3-5) versus 5 (4-6) days (P = 0.034). The ONS group showed a trend towards a shorter time to passage of stool (P = 0.076) but there was no evidence of interaction in patients randomized to the combination regimen. Median length of hospital stay was 6 (4-7) days. There were no differences in secondary outcomes between groups. Within an ERAS protocol for patients undergoing liver resection, routine postoperative laxatives result in an earlier first passage of stool but the overall rate of recovery is unaltered. Copyright (c) 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

  15. Preventing hypothermia in elective arthroscopic shoulder surgery patients: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Duff Jed

    2012-07-01

    Full Text Available Abstract Background Patients having arthroscopic shoulder surgery frequently experience periods of inadvertent hypothermia. This common perioperative problem has been linked to adverse patient outcomes such as myocardial ischaemia, surgical site infection and coagulopathy. International perioperative guidelines recommend patient warming, using a forced air warming device, and the use of warmed intraoperative irrigation solutions for the prevention of hypothermia in at-risk patient groups. This trial will investigate the effect of these interventions on patients’ temperature, thermal comfort, and total recovery time. Method/Design The trial will employ a randomised 2 x 2 factorial design. Eligible patients will be stratified by anaesthetist and block randomised into one of four groups: Group one will receive preoperative warming with a forced air warming device; group two will receive warmed intraoperative irrigation solutions; group three will receive both preoperative warming and warmed intraoperative irrigation solutions; and group four will receive neither intervention. Participants in all four groups will receive active intraoperative warming with a forced air warming device. The primary outcome measures are postoperative temperature, thermal comfort, and total recovery time. Primary outcomes will undergo a two-way analysis of variance controlling for covariants such as operating room ambient temperature and volume of intraoperative irrigation solution. Discussion This trial is designed to confirm the effectiveness of these interventions at maintaining perioperative normothermia and to evaluate if this translates into improved patient outcomes. Australian New Zealand Clinical Trials Registry number ACTRN12610000591055

  16. 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.

  17. 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.

  18. Surgery

    Science.gov (United States)

    ... and sterile gloves. Before the surgery begins, a time out is held during which the surgical team confirms ... the Consumer Version. DOCTORS: Click here for the Professional Version What Participants Need to Know About Clinical ...

  19. 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

  20. 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.

  1. The TeaM (Therapeutic Mammaplasty study: Protocol for a prospective multi-centre cohort study to evaluate the practice and outcomes of therapeutic mammaplasty

    Directory of Open Access Journals (Sweden)

    Elizabeth Baker

    2016-01-01

    Ethics and dissemination: Research ethics approval is not required for this study. This has been confirmed by the on-line Health Research Authority decision tool. This study will provide novel information regarding the practice and outcomes of TM in the UK. This will inform decision-making for patients and surgeons and inform future research. Dissemination of the study protocol will be via the Mammary Fold Academic and Research Collaborative, the Reconstructive Surgery Trials Network and the professional associations, the Association of Breast Surgery and British Association of Plastic, Reconstructive and Aesthetic Surgeons. Results will be presented at relevant surgical conferences and published in peer-reviewed journals.

  2. 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

  3. Multivariable predictors of postoperative cardiac adverse events after general and vascular surgery: results from the patient safety in surgery study.

    Science.gov (United States)

    Davenport, Daniel L; Ferraris, Victor A; Hosokawa, Patrick; Henderson, William G; Khuri, Shukri F; Mentzer, Robert M

    2007-06-01

    Cardiac adverse events (CAEs) are relatively infrequent, but highly lethal, after noncardiac operations. The value of available risk scoring systems is uncertain and these systems can be outdated. We used the Patient Safety in Surgery Study database to develop and test a model to predict patient risk for CAEs after general and vascular surgical operations. As part of the Patient Safety in Surgery Study, following the National Surgical Quality Improvement Program's protocol, multiple demographic, preoperative, perioperative, and outcomes variables were measured during a 3-year period. Data from 128 Veterans Affairs medical center hospitals and from 14 academic medical centers on 183,069 patients were used in a logistic regression analysis to model multivariable predictors of serious CAEs (cardiac arrest or acute myocardial infarction within 30 days of operation). CAEs occurred in 2,362 patients (1.29%) and of these, 59.44% expired. Multivariable stepwise logistic regression identified 20 independent predictors of CAEs, which excluded most cardiac-specific risk factors. The most important multivariable predictors of CAE were American Society of Anesthesiologists physical status classification, work relative value units of the most complex procedure, age, and type of operation. A risk prediction scoring system using the logistic regression odds ratios proved to be a useful prediction tool when tested using a random sample from the database. CAEs after noncardiac operations are relatively infrequent but highly lethal. Operation type and urgency and American Society of Anesthesiologists physical status assessment are important independent predictors of cardiac morbidity, but angina, recent MI, and earlier cardiac operation are not. A prediction scoring system based on the Patient Safety in Surgery Study multivariable odds ratios is likely to be predictive of future events in a similar population requiring noncardiac procedures. This risk model can also serve as a tool

  4. Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial.

    Science.gov (United States)

    Garg, Amit X; Vincent, Jessica; Cuerden, Meaghan; Parikh, Chirag; Devereaux, P J; Teoh, Kevin; Yusuf, Salim; Hildebrand, Ainslie; Lamy, Andre; Zuo, Yunxia; Sessler, Daniel I; Shah, Pallav; Abbasi, Seyed Hesameddin; Quantz, Mackenzie; Yared, Jean-Pierre; Noiseux, Nicolas; Tagarakis, Georgios; Rochon, Antoine; Pogue, Janice; Walsh, Michael; Chan, Matthew T V; Lamontagne, Francois; Salehiomran, Abbas; Whitlock, Richard

    2014-03-05

    Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump. At the time of surgery, compared with placebo, methylprednisolone divided into two intravenous doses of 250 mg each may reduce the risk of postoperative acute kidney injury (AKI). With respect to the study schedule, over 7000 substudy eligible patients from 81 centres in 18 countries were randomised in December 2013. The authors will use a logistic regression to estimate the adjusted OR of methylprednisolone versus placebo on the primary outcome of AKI in the 14 days following surgery (a postoperative increase in serum creatinine of ≥50%, or ≥26.5 μmol/L, from the preoperative value). The stage of AKI will also be considered, as will the outcome of AKI in those with and without preoperative chronic kidney disease. After receipt of grant funding, the authors began to record additional perioperative serum creatinine measurements in consecutive patients enrolled at substudy participating centres, and patients were invited to enroll in a 6-month serum creatinine collection. In these trial subpopulations, the authors will consider the outcome of AKI defined in alternate ways, and the outcome of a 6-month change in kidney function from the preoperative value. The authors were competitively awarded a grant from the Canadian Institutes of Health Research for this SIRS AKI substudy. Ethics approval was obtained for additional serum creatinine recordings in consecutive patients enrolled at participating centres. The additional kidney data collection first began for patients enrolled after 1 March 2012. In patients who provided consent, the last 6-month kidney outcome data will be collected in 2014. The results will be reported no later than 2015. Number NCT00427388.

  5. Surgery

    Science.gov (United States)

    ... surgery has several common causes, including the following: Infections at the operative site Lung problems such as pneumonia or collapsed lung ... the trauma of an operation. The risk of infections at the operative site, DVTs, and UTIs can be decreased by meticulous ...

  6. 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.

  7. 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.

  8. 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...

  9. 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, Ptransverse colon cancer. Therefore, laparoscopic surgery offers a safe alternative to open surgery in patients with transverse colon cancer.

  10. 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.

  11. 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.

  12. Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

    Directory of Open Access Journals (Sweden)

    Wollermann C

    2006-09-01

    Full Text Available Abstract Background Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT. Methods/design CLIVIT (Clips versus Ligatures in Thyroid Surgery is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers. Discussion As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice.

  13. 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] red blood cell transfusion in the presence of anemia during cardiac surgery done with cardiopulmonary bypass. www.clinicaltrials.gov; clinical trial registration number NCT 02042898.

  14. 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

  15. [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.

  16. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures.

    Science.gov (United States)

    Gerbershagen, Hans J; Aduckathil, Sanjay; van Wijck, Albert J M; Peelen, Linda M; Kalkman, Cor J; Meissner, Winfried

    2013-04-01

    Severe pain after surgery remains a major problem, occurring in 20-40% of patients. Despite numerous published studies, the degree of pain following many types of surgery in everyday clinical practice is unknown. To improve postoperative pain therapy and develop procedure-specific, optimized pain-treatment protocols, types of surgery that may result in severe postoperative pain in everyday practice must first be identified. This study considered 115,775 patients from 578 surgical wards in 105 German hospitals. A total of 70,764 patients met the inclusion criteria. On the first postoperative day, patients were asked to rate their worst pain intensity since surgery (numeric rating scale, 0-10). All surgical procedures were assigned to 529 well-defined groups. When a group contained fewer than 20 patients, the data were excluded from analysis. Finally, 50,523 patients from 179 surgical groups were compared. The 40 procedures with the highest pain scores (median numeric rating scale, 6-7) included 22 orthopedic/trauma procedures on the extremities. Patients reported high pain scores after many "minor" surgical procedures, including appendectomy, cholecystectomy, hemorrhoidectomy, and tonsillectomy, which ranked among the 25 procedures with highest pain intensities. A number of "major" abdominal surgeries resulted in comparatively low pain scores, often because of sufficient epidural analgesia. Several common minor- to medium-level surgical procedures, including some with laparoscopic approaches, resulted in unexpectedly high levels of postoperative pain. To reduce the number of patients suffering from severe pain, patients undergoing so-called minor surgery should be monitored more closely, and postsurgical pain treatment needs to comply with existing procedure-specific pain-treatment recommendations.

  17. 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

  18. 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

  19. A Comparative Study of Various Routing Protocols in VANET

    OpenAIRE

    Kumar, Rakesh; Dave, Mayank

    2011-01-01

    Vehicular Ad Hoc Networks (VANET) is a subclass of Mobile ad hoc networks which provides a distinguished approach for Intelligent Transport System (ITS). The survey of routing protocols in VANET is important and necessary for smart ITS. This paper discusses the advantages / disadvantages and the applications of various routing protocols for vehicular ad hoc networks. It explores the motivation behind the designed, and traces the evolution of these routing protocols. F inally the paper conclud...

  20. Critical illness outcome study: an observational study of protocols and mortality in intensive care units

    Directory of Open Access Journals (Sweden)

    Sevransky J

    2011-09-01

    Full Text Available Naeem A Ali1, David Gutteridge2, Sajid Shahul3, William Checkley4, Jonathan Sevransky4, Greg S Martin2 1The Ohio State University Medical Center, Columbus, OH; 2Emory University, Atlanta, GA; 3Beth Israel Deaconess Medical Center, Boston, MA; 4Johns Hopkins University, Baltimore, MD, USA Abstract: Individual intensive care unit (ICU characteristics including staffing, expertise, continuity, and team structure, have been associated with patient outcomes. Separately, some aspects of care in ICUs have been implemented through treatment protocols. The United States Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS was designed to determine whether the extent of protocol use in ICUs is associated with hospital survival in a large number of US ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS steering committee. USCIITG-CIOS is a prospective, observational, ecological, multicentered study of mixed ICUs in the US. The data to be collected include organizational information for the ICU (eg, protocol availability and utilization, multidisciplinary staffing assessment, and patient level information (eg, demographics, acute and chronic medical conditions. The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high-protocol and low-protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize multivariable regression approaches to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. We anticipate at least 60 ICUs participating in USCIITG-CIOS to enroll approximately 6000 study subjects. USCIITG-CIOS is a multicenter study

  1. 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.

  2. Cognitive investigation study of patients admitted for cosmetic surgery: information, expectations, and consent for treatment.

    Science.gov (United States)

    Barone, Mauro; Cogliandro, Annalisa; La Monaca, Giuseppe; Tambone, Vittoradolfo; Persichetti, Paolo

    2015-01-01

    In 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. An 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. Candidates 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). This 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.

  3. Mobile Ad Hoc Networks: A Comparative Study of QoS Routing Protocols

    OpenAIRE

    Gangwar, Sanjeev; Pal, Saurabh; Kumar, Krishan

    2012-01-01

    This Article presents a thorough overview of QoS routing metrics, resources and factors affecting performance of QoS routing protocols. The relative strength, weakness, and applicability of existing QoS routing protocols are also studied and compared. QoS routing protocols are classified according to the QoS metrics used type of QoS guarantee assured.

  4. 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.

  5. Recommended Protocol for Round Robin Studies in Additive Manufacturing.

    Science.gov (United States)

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

    2016-03-01

    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.

  6. Study protocol for the Cities Changing Diabetes programme

    DEFF Research Database (Denmark)

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

    2017-01-01

    . 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......INTRODUCTION: 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...... 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...

  7. 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.)

  8. 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.)

  9. 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

  10. 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.

  11. Patient experiences of perioperative nutrition within an Enhanced Recovery After Surgery programme for colorectal surgery: a qualitative study.

    Science.gov (United States)

    Short, V; Atkinson, C; Ness, A R; Thomas, S; Burden, S; Sutton, E

    2016-02-01

    Nutrition is an important element of the Enhanced Recovery After Surgery (ERAS) programme. Patients have previously indicated that nutrition is a key component of ERAS that requires improvement. Our aim was to explore the perioperative nutrition experiences of colorectal surgical patients to identify barriers and facilitators to the integration of nutrition within ERAS. Sixteen individuals undergoing colorectal surgery participated in a semi-structured interview between postoperative day three and hospital discharge. The topic guide was developed iteratively throughout the study; topics included preoperative counselling, carbohydrate loading, fasting and postoperative nutrition. A constant comparison technique was employed during coding, and an inductive thematic analysis was used. Validity was ensured by double coding a sample of transcripts. Findings are presented in the context of the following clinical themes: preoperative information, preoperative fasting, carbohydrate loading and nutritional drinks, postoperative diet and discharge. Individuals received too much general information which was repetitive, contradictory and not disease specific; this formed a key barrier affecting nutrition. Other barriers were negative experiences of nutritional drinks, stoma management, nausea and vomiting, and challenges from the hospital environment. Facilitators included interactions with staff, food accessibility and choice, and motivation for discharge. The key barrier to adherence of perioperative nutrition protocols was poor provision of information. Targeted information regarding postoperative diet, stoma management and coping with nausea and vomiting would be beneficial for colorectal surgical patients. Easily accessible food provided by ward staff was considered a facilitator. © 2015 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.

  12. 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

  13. Cirurgia ortognática de modelos: protocolo para mandíbula Orthognathic model surgery: mandibular protocol

    OpenAIRE

    Eduardo Sant'Ana; Moacyr Tadeu Vicente Rodrigues; Gabriel Ramalho Ferreira; Júlio de Araújo Gurgel

    2007-01-01

    INTRODUÇÃO: o ensaio em modelos de gesso tem grande importância para o planejamento em cirurgia ortognática. OBJETIVO: neste artigo, será apresentado, passo-a-passo, uma técnica de cirurgia de modelos iniciando pela mandíbula, destacando aspectos importantes e as vantagens deste procedimento.INTRODUCTION: The cast surgery has great importance in orthognatic surgery treatment planning. AIM: In this article, a step by step lower model surgery will be presented, emphasizing important details and...

  14. 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.

  15. 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

  16. Robotic consolle for ocular surgery: a preliminary study

    Science.gov (United States)

    Rossi, Francesca; Pini, Roberto; Menabuoni, Luca; Lenzetti, Ivo; Russo, Sheila; Menciassi, Arianna; Fortuna, Damiano

    2014-02-01

    Minimally invasive surgery has recently been improved by the use of robot-assisted procedures in several medical fields. Among the ocular surgeries there are a few examples of sophisticated vitreoretinal procedures, while robotic-assisted surgery of the anterior eye segment is still under study. In this paper we propose a new approach to the robotic assisted ocular surgery: a CO2 laser system is equipped with a micromanipulator and scanner, and it is proposed to induce photothermal effects for the removal of neoformations. A sensorized tool is connected to the patient eye and to the robotic arm. This tool is equipped with force and position sensors: by the use of the spatial information from the robotic console and from the patient it is possible to control the position of the target itself and to block it in the correct position for performing surgery. The system is provided by a feedback alarm that remove the block of the patient head in any moment. The optimized robotic consolle can be used in performing scleral cuts and in the treatment of pterigium or neoformations.

  17. [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.

  18. Inconsistent Reporting Between Meta-analysis Protocol and Publication - A Cross-Sectional Study.

    Science.gov (United States)

    Delgado, Alberto Falk; Delgado, Anna Falk

    2017-09-01

    Inconsistent reporting in published meta-analyses compared to registered protocol are poorly understood. The aim of the study was to assess inconsistencies between registered protocols and published reports among oncology drug meta-analyses. A cross-sectional study was performed including oncology drug meta-analyses published between January 1st and November 14th 2016 with a published protocol. Two investigators extracted data on: selection criteria, outcome(s) and statistical plan in protocol and manuscript, plus self-acknowledgement of inconsistent reporting between protocol and publication. Protocol registration was present in 19% (23/119) of all oncology drug meta-analyses. In meta-analyses with protocol (n=23), 70% (16/23) had issues with inconsistent reporting between protocol and published report concerning; inclusion criteria, comparator group, intervention, outcome (PICO) or statistical analysis. Self-acknowledgement of changes between protocol and publication was found in 50% (8/16). In meta-analyses with protocol, discrepancies between registered protocols and publications are frequent. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  19. 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.

  20. Exploring information provision in reconstructive breast surgery: A qualitative study.

    Science.gov (United States)

    Potter, Shelley; Mills, Nicola; Cawthorn, Simon; Wilson, Sherif; Blazeby, Jane

    2015-12-01

    Women considering reconstructive breast surgery (RBS) require adequate information to make informed treatment decisions. This study explored patients' and health professionals' (HPs) perceptions of the adequacy of information provided for decision-making in RBS. Semi-structured interviews with a purposive sample of patients who had undergone RBS and HPs providing specialist care explored participants' experiences of information provision prior to RBS. Professionals reported providing standardised verbal, written and photographic information about the process and outcomes of surgery. Women, by contrast, reported varying levels of information provision. Some felt fully-informed but others perceived they had received insufficient information about available treatment options or possible outcomes of surgery to make an informed decision. Women need adequate information to make informed decisions about RBS and current practice may not meet women's needs. Minimum agreed standards of information provision, especially about alternative types of reconstruction, are recommended to improve decision-making in RBS. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. How to design a (good) epidemiological observational study: epidemiological research protocol at a glance.

    Science.gov (United States)

    Fronteira, Ines

    2013-01-01

    In this article, we propose a general structure for designing a research protocol of an observational epidemiological study. We start by highlighting the importance of the research protocol, namely in accounting for some bias and guaranteeing methodologic rigor and study reproductability. Next, we reflect on some of the essential elements of a research protocol no matter its objective. We further present some specific issues to be included according to the type of study: cross-sectional, case-control and cohort.

  2. A Case Study on Idiopathic Orbital Pseudotumor: Surgery and ...

    African Journals Online (AJOL)

    A Case Study on Idiopathic Orbital Pseudotumor: Surgery and Steroid Treatment. ... Plain and contrast-enhanced magnetic resonance imaging (MRI) were used to examine the orbital fat and enlargement of the right optic nerve sheath along with orbital magnetic resonance imaging diagnostic test. The visual acuity (VA) of ...

  3. 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; 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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

  4. Bariatric Surgery in Moderately Obese Patients: A Prospective Study

    Directory of Open Access Journals (Sweden)

    M. Cerci

    2013-01-01

    Full Text Available Introduction. Moderate obesity (BMI 30–35 kg/m2 affects 25% of the western population. The role of bariatric surgery in this context is currently debated, reserved for patients with comorbidity, as an alternative to conservative medical treatment. We describe our experience in moderately obese patients treated with bariatric surgery. Materials and Methods. Between September 2011 and September 2012, 25 patients with grade I obesity and comorbidities underwent bariatric surgery: preoperative mean BMI 33.2 kg/m2, 10 males, mean age 42 years. In presence of type 2 diabetes mellitus (T2DM (56%, gastric bypass was performed; in cases with hypertension (64% and obstructive sleep apnea (OSA (12%, sleeve gastrectomy was performed. All operations were performed laparoscopically. Results. Mean follow-up was 12.4 months. A postoperative complication occurred: bleeding from the trocar site was resolved with surgery in local anesthesia. Reduction in average BMI was 6 points, with a value of 27.2 kg/m2. Of the 14 patients with T2DM, 12 (86% discontinued medical therapy because of a normalization of glycemia. Of the 16 patients with arterial hypertension, 14 (87% showed remission and 2 (13% improvement. Complete remission was observed in patients with OSAS. Conclusions. The results of our study support the validity of bariatric surgery in patients with BMI 30–35 kg/m2. Our opinion is that, in the future, bariatric surgery could be successful in selected cases of moderately obese patients.

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

    Science.gov (United States)

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

    2016-12-01

    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. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

  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. 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

  8. 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.

  9. 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.

  10. Micronutrient Levels and Supplement Intake in Pregnancy after Bariatric Surgery: A Prospective Cohort Study

    OpenAIRE

    Devlieger, Roland; Guelinckx, Isabelle; Jans, Goele; Voets, Willy; Vanholsbeke, Caroline; Vansant, Greet

    2014-01-01

    Background Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery. Objective To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery. Design A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened duri...

  11. 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

  12. Costs and clinical outcomes of implant placement during ablative surgery and postponed implant placement in curative oral oncology : A five-year retrospective cohort study

    NARCIS (Netherlands)

    Wetzels, Jan Willem G H; Meijer, Gert J.; Koole, Ron; Adang, Eddy M.; Merkx, Matthias A W; Speksnijder, Caroline M.

    2017-01-01

    Objectives: The aim of this study was to compare costs and clinical outcomes of two protocols for implant placement in edentulous oral cancer patients: implant placement during ablative surgery and postponed implant placement. Material and methods: All edentulous patients who underwent curative

  13. 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.

  14. Is the "sterile cockpit" concept applicable to cardiovascular surgery critical intervals or critical events? The impact of protocol-driven communication during cardiopulmonary bypass.

    Science.gov (United States)

    Wadhera, Rishi K; Parker, Sarah Henrickson; Burkhart, Harold M; Greason, Kevin L; Neal, James R; Levenick, Katherine M; Wiegmann, Douglas A; Sundt, Thoralf M

    2010-02-01

    There is general enthusiasm for applying strategies from aviation directly to medical care; the application of the "sterile cockpit" rule to surgery has accordingly been suggested. An implicit prerequisite to the evidence-based transfer of such a concept to the clinical domain, however, is definition of periods of high mental workload analogous to takeoff and landing. We measured cognitive demands among operating room staff, mapped critical events, and evaluated protocol-driven communication. With the National Aeronautics and Space Administration Task Load Index and semistructured focus groups, we identified common critical stages of cardiac surgical cases. Intraoperative communication was assessed before (n = 18) and after (n = 16) introduction of a structured communication protocol. Cognitive workload measures demonstrated high temporal diversity among caregivers in various roles. Eight critical events during cardiopulmonary bypass were then defined. A structured, unambiguous verbal communication protocol for these events was then implemented. Observations of 18 cases before implementation including 29.6 hours of cardiopulmonary bypass with 632 total communication exchanges (average 35.1 exchanges/case) were compared with observations of 16 cases after implementation including 23.9 hours of cardiopulmonary bypass with 748 exchanges (average 46.8 exchanges/case, P = .06). Frequency of communication breakdowns per case decreased significantly after implementation (11.5 vs 7.3 breakdowns/case, P = .008). Because of wide variations is cognitive workload among caregivers, effective communication can be structured around critical events rather than defined intervals analogous to the sterile cockpit, with reduction in communication breakdowns. 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  15. 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

  16. 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).

  17. Precision of maxillary repositioning during orthognathic surgery: a prospective study.

    Science.gov (United States)

    Bouchard, Carl; Landry, Pierre-Éric

    2013-05-01

    The purpose of this study was to evaluate the accuracy of surgical splints and an external reference point to reposition the maxilla during orthognathic surgery. Before surgery, a radiological marker was inserted inside the orthodontic bracket of the first right maxillary molar. A surgical splint was utilized to reposition the maxilla in the sagittal and coronal planes after the osteotomy. The vertical position was established by measuring the distance between a Kirschner wire inserted at bony nasion and the orthodontic wire. Preoperative and postoperative cephalometric radiographs were obtained and manually traced. The radiological marker and the tip of the right maxillary incisor were used as specific landmarks. Their displacement on the pre- and postoperative radiographs was measured. The actual surgical movement of the maxilla was compared to the initial surgical planning. 23 patients met the inclusion criteria to participate in the study. The mean difference between the planned and executed movements of the maxilla was 0.1mm (p=0.71). The difference was not statistically significant for any given movements of the maxilla. The use of surgical splints made from model surgery combined with an external reference point at bony nasion is accurate methods for repositioning the maxilla during orthognathic surgery. Copyright © 2012 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  18. Case study: BIM protocol for Skanska (Czech Republic

    Directory of Open Access Journals (Sweden)

    Kvirenc, Patrik

    2017-06-01

    Full Text Available The research paper introduces the problems of technical support of a model in projects in the area of BIM. Planning Requirements (BIM protocol describe the technical preparedness of models, data repletion, information sharing, communications and other processes in construction projects. This BIM protocol was developed for Skanska Inc. It consists of several parts, which are described in the article. At the introduction Skanska Inc. is presented together with its position in the area of BIM in the Czech market. The research analyzed the document itself, including its annexes. Another section is devoted to the importance of BIM protocol in project management of company Skanska. The document was prepared in cooperation with Skanska Inc. It applies only to commercial and residential projects in the area of building construction.

  19. Prophylactic aortic root surgery in patients with Marfan syndrome : 10 years' experience with a protocol based on body surface area

    NARCIS (Netherlands)

    Aalberts, Jan J. J.; van Tintelen, J. Peter; Hillege, Hans L.; Boonstra, Piet W.; van den Berg, Maarten P.; Waterbolk, T

    Background: Current guidelines recommending prophylactic aortic root replacement in Marfan syndrome are based on absolute diameters of the aortic root. However, aortic root diameter is a function of body surface area (BSA). Here, we report our experience with a protocol for prophylactic aortic root

  20. Bariatric surgery outcomes in the elderly: an ACS NSQIP study.

    Science.gov (United States)

    Dorman, Robert B; Abraham, Anasooya A; Al-Refaie, Waddah B; Parsons, Helen M; Ikramuddin, Sayeed; Habermann, Elizabeth B

    2012-01-01

    Mortality and complications following bariatric surgery occur at acceptable rates, but its safety in the elderly population is unknown. We hypothesized that short-term operative outcomes in bariatric surgery patients ≥65 years would be comparable to younger persons. Patients with a body mass index ≥35 kg/m(2) who underwent bariatric surgery in the 2005-2009 American College of Surgeons National Surgical Quality Improvement Program were identified. Controlling for confounders, multivariate regression was used to predict the impact of age on mortality, major events and prolonged length of stay at 30 days. We identified 48,378 patients who underwent bariatric procedures between 2005 and 2009. Multivariate regression analysis demonstrated advancing age trended towards predicting mortality, but was not statistically significant. Additionally, patients ≥65 years did not experience higher risk of major complications for either open or laparoscopic procedures. However, patients age ≥65 years were more likely to experience prolonged length of stay for both open and laparoscopic procedures. This multi-hospital study demonstrates older age predicts short-term prolonged length of stay but not major events following bariatric surgery. Older age trends toward predicting mortality, but it is not statistically significant.

  1. Lumbar spine fusion surgery and stroke: a national cohort study.

    Science.gov (United States)

    Wu, Jau-Ching; Chen, Yu-Chun; Liu, Laura; Huang, Wen-Cheng; Thien, Peck-Foong; Chen, Tzeng-Ji; Cheng, Henrich; Lo, Su-Shun

    2012-12-01

    To investigate the incidence and risk of stroke after lumbar spinal fusion surgery. Study subjects were identified from a nationwide cohort of 1 million people from 2000 to 2005 and were divided into the lumbar spinal fusion group (n = 2,015), who received posterior lumbar spinal fusion surgery, and the comparison group (n = 16,120) composed of age-, sex-, and propensity score-matched control subjects. The matching process was intended to adjust for demographics, comorbidities, and other immeasurable covariates to minimize selection bias. All subjects were followed up for 3 years for stroke, including hemorrhagic and ischemic strokes. Kaplan-Meier and Cox regression analyses were performed. The overall incidence rate of stroke in the cohort was 9.99 per 1,000 person-year. The lumbar spinal fusion group was less likely to have any stroke (adjusted hazard ratio (HR) = 0.83, p = 0.293), hemorrhagic stroke (adjusted HR = 0.74, p = 0.739) and ischemic stroke (adjusted HR = 0.81, p = 0.250) than the comparison group, but without significance. Three years post-operatively, patients who received lumbar spinal fusion had stroke incidence rates similar to those without surgery. Posterior lumbar spinal fusion surgery is not associated with increased risks for any kind of stroke.

  2. Improving outpatient safety through effective electronic communication: a study protocol.

    Science.gov (United States)

    Hysong, Sylvia J; Sawhney, Mona K; Wilson, Lindsey; Sittig, Dean F; Esquivel, Adol; Watford, Monica; Davis, Traber; Espadas, Donna; Singh, Hardeep

    2009-09-25

    Health information technology and electronic medical records (EMRs) are potentially powerful systems-based interventions to facilitate diagnosis and treatment because they ensure the delivery of key new findings and other health related information to the practitioner. However, effective communication involves more than just information transfer; despite a state of the art EMR system, communication breakdowns can still occur. [1-3] In this project, we will adapt a model developed by the Systems Engineering Initiative for Patient Safety (SEIPS) to understand and improve the relationship between work systems and processes of care involved with electronic communication in EMRs. We plan to study three communication activities in the Veterans Health Administration's (VA) EMR: electronic communication of abnormal imaging and laboratory test results via automated notifications (i.e., alerts); electronic referral requests; and provider-to-pharmacy communication via computerized provider order entry (CPOE). Our specific aim is to propose a protocol to evaluate the systems and processes affecting outcomes of electronic communication in the computerized patient record system (related to diagnostic test results, electronic referral requests, and CPOE prescriptions) using a human factors engineering approach, and hence guide the development of interventions for work system redesign. This research will consist of multiple qualitative methods of task analysis to identify potential sources of error related to diagnostic test result alerts, electronic referral requests, and CPOE; this will be followed by a series of focus groups to identify barriers, facilitators, and suggestions for improving the electronic communication system. Transcripts from all task analyses and focus groups will be analyzed using methods adapted from grounded theory and content analysis.

  3. Studying privacy in electronic voting protocols and comparing its ...

    African Journals Online (AJOL)

    Then results of the investigations were given and the methods of providing privacy in the protocols were introduced. In the end these methods were examined and compared and the homomorphic encryption was proposed as the best method. Keywords: electronic voting; privacy; homomorphic encryption; blind signature ...

  4. [Metal artifact reduction in post-operative spinal imaging using image acquisition protocol in multidetector computed tomography scans. Cohort study].

    Science.gov (United States)

    Romero Muñoz, L M; Alfonso Olmos, M; Villas Tomé, C

    2015-01-01

    In postoperative patients with metallic implants, CT scans can become less effective due to metal-related arti-facts. The purpose of our study was to evaluate the effectiveness of a specific metal artifact reduction image protocol, in order to reduce the metal artifact caused by titanium pedicular screws in patients undergoing lumbar pathology by lumbar fusion. This enables surgeons to make an accurate diagnosis of the exact placement of inserted pedicle screws, making this the preferred image modality for assessing screw position after surgery. In the first part of the study, CT scans were performed on 23 patients (103 titanium alloy pedicle screws) undergoing a lumbar instrumented fusion for treatment for degenerative disease with a standard image acquisition protocol evaluating the possible overdimension caused by the artifact. In the second part, a prospective study was performed using 64-slice multide-tector-row computed tomography (MDCT) on 18 patients (104 titanium alloy pedicle screws) undergoing a lumbar instrumented fusion using a specific image acquisition protocol. Our results show that in the sequential CT scan group, mean overdimension (on each side) due to brightness was 1.045 mm (SD 0.45). In the 64-slice multichannel CT group, mean overdimension (on each side) due to brightness was 0.005 mm at the proximal part of the screw and 0.025 mm at the distal part of the screw.

  5. [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

  6. 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

  7. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kaulhausen Thomas

    2011-10-01

    Full Text Available Abstract Background Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD. To date, there is no convincing evidence that these devices provide any patient benefits. Methods/Design The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off". Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually. Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI. In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration, postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided. Discussion New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these

  8. 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...

  9. 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.

  10. Protocol for bedside laparotomy in trauma and emergency general surgery: a low return to the operating room.

    Science.gov (United States)

    Diaz, Jose J; Mejia, Vicente; Subhawong, Andrea Proctor; Subhawong, Ty; Miller, Richard S; O'Neill, Patrick J; Morris, John A

    2005-11-01

    Bedside laparotomy (BSL) was introduced as a heroic procedure in trauma patients too unstable for safe transport to the operating room (OR). We hypothesize a BSL protocol would maintain patient safety while reducing OR use. Patients were prospectively entered into a BSL protocol from July 2002 to June 2003 and retrospectively reviewed. Protocol indications for BSL were abdominal compartment syndrome, decompensation due to hemorrhage, washout/closure, and sepsis in a patient too unstable for safe transport to the OR. Primary outcomes were mortality, emergent return to OR, and primary fascial closure (PFC). Trauma operating room charges and OR time were analyzed. One hundred thirty-three BSL were performed on 60 patients with an overall mortality of 23.3 per cent (14/60). There was an average of 2.2 BSL per patient (range 1-8). Indications for BSL were 1) explore/washout (n = 100, 75.2%), 2) decompression (n = 14, 10.5%), 3) infection/abscess (n = 12, 9.0%), 4) hemorrhage (n = 7, 5.3%). Five of 133 BSL (5.8%) were emergently returned to the OR because of perforation or compromised bowel. Trauma OR charges were dollar 5,300 per cases with 2.12 hours per cases. The protocol standardized the conduct of BSL procedure to allow for a low return to OR rate of 5.8 per cent and had an overall in-hospital mortality rate of 23.3 per cent. Primary fascial closure of the abdomen had a significantly reduced hospital stay. BSL allowed trauma OR charges of dollar 5,300 per cases with 2.12 hours per cases savings.

  11. Nonopioid versus opioid based general anesthesia technique for bariatric surgery: A randomized double-blind study

    Directory of Open Access Journals (Sweden)

    Mohamed Ahmed Mansour

    2013-01-01

    Full Text Available Objective: The objective of this study was to evaluate the efficacy and safety of giving general anesthesia without the use of any opioids either systemic or intraperitoneal in bariatric surgery. Methods: Prospective randomized controlled trial. Obese patients (body mass index >50 Kg/m 2 undergoing laparoscopic sleeve gastrectomies were recruited and provided an informed signed consent. Patients were randomized using a computer generated randomization table to receive either opioid or non-opioid based anesthesia. The patient and the investigator scoring patient outcome after surgery were blinded to the anesthetic protocol. Primary outcomes were hemodynamics in the form of "heart rate, systolic, diastolic, and mean arterial blood pressure" on induction and ½ hourly thereafter. Pain monitoring through visual analog scale (VAS 30 min after recovery, hourly for 2 h and every 4 h for 24 h was also recorded. Pain monitoring through VAS and post-operative nausea and vomiting 30 min after recovery were also recorded and finally patient satisfaction and acute pain nurse satisfaction. Results: There was no difference in background characteristics in both groups. There were no statistically significant differences in different outcomes as heart rate, mean blood pressure, O 2 saturation in different timings between groups at any of the determined eight time points but pain score and nurse satisfaction showed a trend to better performance with non-opioid treatment. Conclusion: Nonopioid based general anesthesia for Bariatric surgery is as effective as opioid one. There is no need to use opioids for such surgery especially that there was a trend to less pain in non-opioid anesthesia.

  12. Use of autologous fat grafting in reconstruction following mastectomy and breast conserving surgery: An updated systematic review protocol

    Directory of Open Access Journals (Sweden)

    Riaz A. Agha

    2017-01-01

    Ethics and dissemination: The systematic review will be published in a peer-reviewed journal and presented at national and international meetings within fields of plastic, reconstructive and aesthetic surgery, and surgical oncology. The work will be disseminated electronically and in print. Brief reports of the review and findings will be disseminated to interested parties through email and direct communication. The review aims to guide healthcare practice and policy.

  13. [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.

  14. 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.

  15. USE OF POWERED INSTRUMENTATION IN MICROLARYNGEAL SURGERY: A CLINICAL STUDY

    OpenAIRE

    Shankar; Benjamin Rajendra

    2015-01-01

    Micro laryngeal surgery is a common and relatively safe ENT surgery, certain laryngeal conditions require surgery for correction. Surgery for voice problems is quite uncommon, most of the voice disorders can be treated with voice therapy or medical treatment. However there are certain conditions may required operative measures. We have been doing micro laryngeal surgery(MLS) in our institute for quite a long time, but use of powered instruments like, microdebrider technique in...

  16. The bakery protocol : a comparitive case-study in formal verification

    NARCIS (Netherlands)

    W.O.D. Griffioen; H.P. Korver

    1995-01-01

    textabstractA Comparative Case-Study in Formal Verification Groote and the second author verified (a version of) the Bakery Protocol in $muCRL$. Their process-algebraic verification is rather complex compared to the protocol. Now the question is: How do other verification techniques perform on this

  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...

  18. 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.

  19. Folk medicinal plant mixtures: Establishing a protocol for further studies.

    Science.gov (United States)

    Gras, Airy; Parada, Montse; Rigat, Montse; Vallès, Joan; Garnatje, Teresa

    2018-03-25

    Most ethnobotanical research bases its analyses on individual taxa catalogues and their uses, rather than on mixtures. However, mixtures constitute an important chapter of our different lines of research and they represent a large volume of information. The relevance of these data in folk medicine could be explained as a response to the cure of multicausal etiology diseases or by a possible polyvalent effect of the mixture as opposed to the effect of each taxon alone. The main goals are: i) to perform qualitative and quantitative analyses of these mixtures; ii) to carry out a comparison among the mixtures in two Catalan territories and their floristic composition; iii) to assess the worth of families association; and, iv) to evaluate whether the plants claimed to be used in mixtures have contraindications or possible negative interactions according to phytopharmaceutical literature. The ultimate goal is to test a protocol that can be implemented in similar studies. We have used data on medicinal plant mixtures obtained from two extensive ethnobotanical field studies carried out in two Catalan districts, Alt Empordà and Ripollès. The quantitative analyses by means of descriptive statistics were carried out with Excel. New contributions like the implementation of the Shannon index to quantify the diversity of families in plant combinations, the creation of a new index to calculate the taxon importance in mixtures, or the use of a social network analysis to study the connection between botanical families have been employed in this work. In total, a set of 484 mixtures from Alt Empordà and Ripollès (Catalonia, Iberian Peninsula) have been analysed: 462 for human use and 22 for veterinary. Thymus vulgaris and Rosmarinus officinalis are among the most commonly used species in mixtures. The aerial part of the plant is the most used, and the anticatarrhal usage is the most frequent in both territories. A wide diversity of families has been observed in mixtures and

  20. Peri-operative blood glucose management in general surgery - a potential element for improved diabetic patient outcomes - an observational cohort study.

    Science.gov (United States)

    McCavert, M; Mone, F; Dooher, M; Brown, R; O'Donnell, M E

    2010-01-01

    Hyperglycaemia impairs many of the physiological processes involved in recovery from surgery but there is limited research on the effect of optimal peri-operative glucose control in diabetic general surgery patients. The objectives of this study were to assess blood glucose management in diabetic general surgical patients and to determine if protocol deviations were associated with adverse outcomes. All diabetic patients undergoing elective and emergency general surgical procedures between August 2007 and July 2008 were included in the study. The hospital protocol for peri-operative blood glucose control was based on the Alberti Regimen. Data was collected regarding blood glucose measurements, adherence to protocol and complications following surgery. A total of 69 adult patients (M = 44, F = 25; median age 61, range 15-93 years; T1DM = 35, T2DM = 34) were included. 38 patients underwent elective surgery (cholecystectomy, hernia repair, varicose vein surgery) and 31 underwent emergency surgical procedures (laparotomy, incision and drainage of abscess). 10.3% of capillary blood glucose readings were less than 6.1 mmol/l, 32.8% were between 6.1 and 10.0 mmol/l, 44.6% were greater than 10.0 mmol/l 12.3% of scheduled blood glucose measurements were not completed. An insulin-dextrose infusion was indicated in 30 patients, of which 14 (46.7%) were treated according to protocol. In the 16 protocol-deviation cases, insulin was generally either administered according to a sliding scale (6 patients) or not at all during their time on the ward. While an insulin-dextrose infusion was not indicated in 39 patients, 14 (35.9%) of these patients were inappropriately given insulin either as an infusion (8 patients) or according to a sliding scale (6 patients). Overall, only 39 (56.5%) patients were treated according to protocol. The overall complication rate was 29%, which included 7 out of 39 (17.9%) and 13 out of 30 (43.3%) protocol-based and protocol

  1. 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.

  2. 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.

  3. 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...... of this study was to compare the early results of SPLS versus RALS in the treatment of rectal cancer. METHODS: We performed a retrospective analysis of prospectively collected data on patients who had undergone SPLS (n = 36) or RALS (n = 56) in the period between 2010 and 2012. Operative and short...

  4. "Hardware breakage in spine surgery (A retrospective clinical study "

    Directory of Open Access Journals (Sweden)

    "Sadat MM

    2001-11-01

    Full Text Available This was a retrospective review of a consecutive series of patients with spinal disease in year 2000, who underwent posterior fusion and instrumentation with Harrington distraction and Cotrel-Dobousset system to evaluate causes of hardware failure. Many cases of clinical failure has been observed in spinal instrumentation used in spinal disorder like spondylolisthesis, fractures, deformities, … . Thirty six cases that were operated because of spinal disorders like spondylolisthesis, fractures, deformities, …, were included in this study. Seventeen of this cases had breakage of device. Factors like age at surgery, type of instrumentation, angles before and after surgery and …, were compared in two groups of patients. The most common instrument breakage was pedicle screw breakage. Pseudoarthrosis was the main factor that was presented in failure group (P value<0.001. Other important causes were, age of patient at surgery (P value=0.04, pedicle screw placement off center in the sagittal or coronal plane of the pedicle (P value=0.04. Instrumentation loads increased significantly as a direct result of variations in surgical technique that produce pseudoarthrosis, pedicle screw placement off center in the sagittal plane of the pedicle, or using less than 6 mm diameter screw. This factor can be prevented with meticulous surgical technique and using proper devices.

  5. Methodologic assessment of studies on endoscopic sinus surgery.

    Science.gov (United States)

    Lieu, Judith E Cho; Piccirillo, Jay F

    2003-11-01

    Functional endoscopic sinus surgery (ESS) has become the procedure of choice for surgical treatment of chronic rhinosinusitis. Does the published literature support the claims of greater efficacy than medical treatment alone or older sinus procedures? To analyze the methodology of the published literature regarding the efficacy of ESS. MEDLINE search for primary studies published in 1987 through 2001, written in the English language, reporting results on more than 100 patients, using the MeSH (medical subject headings) terms sinusitis [subheadings surgery or therapy] and endoscopy. Of 512 studies initially identified, 29 studies met the inclusion and exclusion criteria for further assessment of methodologic criteria. An additional 6 studies were found when the reference lists of reviews or included studies were searched. Articles were evaluated for 4 core (inclusion/exclusion criteria, control group, intervention, and clear outcome measure) methodologic criteria essential to the determination of efficacy of ESS. Eight additional methodologic criteria were also used to rate the articles. Three studies met all 4 core methodologic criteria. Only 4 of 35 studies used a control group to evaluate efficacy of ESS to treat chronic sinusitis. Mean number of criteria met was 7.2, with a range of 2 to 11. Absence of a control group is the most important reason that studies are unable to scientifically assess the comparative efficacy of ESS to medical therapy or other sinus procedures. The methodologic criteria described here can be used to evaluate studies of interventions for other disorders.

  6. 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 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 19 organochlorine pesticides by gas chromatography. Only three of these samples had detectable pesticide concentrations. A separate sample of A-horizon soil was collected for microbial characterization by phospholipid fatty acid analysis (PLFA), soil enzyme assays, and determination of selected human and agricultural pathogens

  7. 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

  8. Quality of life following aesthetic plastic surgery: a prospective study.

    Science.gov (United States)

    Papadopulos, N A; Kovacs, L; Krammer, S; Herschbach, P; Henrich, G; Biemer, E

    2007-01-01

    The objective of this study was the prospective evaluation of quality of life in patients undergoing aesthetic plastic surgery procedures. We examined pre- and postoperative changes in quality of life, and performed a comparison of our data with a representative random sample. 228 patients agreed to participate in the present study. Measurements were taken preoperatively as well as 3 and 6 months postoperatively. One hundred and thirty two patients completed the three months postoperative evaluation (T1), 82 answered the 6 months follow-up evaluation (T2). The testing instrument included a standardised self-assessment test on satisfaction and quality of life (FLZ(M)), consisting of three modules: satisfaction with general life, health and appearance. Further, a postoperative complication questionnaire was used in order to evaluate the satisfaction with the surgical outcome and to estimate postoperative complications and side effects. Significantly increasing values in two aspects of quality of life were found: health and appearance. Whereas the positive influence on health is persistent, there is a diminishing influence of appearance 6 months postoperatively. Although higher values for some of the individual items of the FLZ(M) modules of the norm data were found in comparison to our study group, a general preoperative lower level of quality of life of the aesthetic surgery patients could not be confirmed. Over 84% were satisfied or very satisfied with the aesthetic result. 85% would undergo the same treatment again and 94% of the patients would further recommend their operation. More than half of the study group did not report a decrease in physical fitness or reduced social contacts in the direct postoperative period. Our study reveals that aesthetic plastic surgery increases most aspects of quality of life, especially regarding body satisfaction and health. It is very well tolerated by the patients and is therefore a recommended option.

  9. 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.

  10. A comparative study of wireless sensor networks and their routing protocols.

    Science.gov (United States)

    Bhattacharyya, Debnath; Kim, Tai-hoon; Pal, Subhajit

    2010-01-01

    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.

  11. 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.

    Science.gov (United States)

    Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Vale, Luke; Norrie, John; Kinsella, John; Cook, Jonathan; Brittenden, Julie; Grant, Adrian

    2010-04-16

    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. 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. 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 number - ISRCTN32188676.

  12. 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

  13. Nurse compliance with a protocol for safe injectable medication administration: comparison of two multicentre observational studies

    Science.gov (United States)

    Schutijser, Bernadette; Jongerden, Irene; Spreeuwenberg, Peter; Wagner, Cordula; de Bruijne, Martine

    2018-01-01

    Objectives Medication administration errors with injectable medication have a high risk of causing patient harm. To reduce this risk, all Dutch hospitals implemented a protocol for safe injectable medication administration. Nurse compliance with this protocol was evaluated as low as 19% in 2012. The aim of this second evaluation study was to determine whether nurse compliance had changed over a 4-year period, what factors were associated over time with protocol compliance and which strategies have been implemented by hospitals to increase protocol compliance. Methods In this prospective observational study, conducted between November 2015 and September 2016, nurses from 16 Dutch hospitals were directly observed during intravenous medication administration. Protocol compliance was complete if nine protocol proceedings were conducted correctly. Protocol compliance was compared with results from the first evaluation. Multilevel logistic regression analyses were used to assess the associations over time between explanatory variables and complete protocol compliance. Implemented strategies were classified according to the five components of the Systems Engineering Initiative for Patient Safety (SEIPS) model. Results A total of 372 intravenous medication administrations were observed. In comparison with 2012, more proceedings per administration were conducted (mean 7.6, 95% CI 7.5 to 7.7 vs mean 7.3, 95% CI 7.3 to 7.4). No significant change was seen in complete protocol compliance (22% in 2016); compliance with the proceedings ‘hand hygiene’ and ‘check by a second nurse’ remained low. In contrast to 2012, the majority of the variance was caused by differences between wards rather than between hospitals. Most implemented improvement strategies targeted the organisation component of the SEIPS model. Conclusions Compliance with ‘hand hygiene’ and ‘check by a second nurse’ needs to be further improved in order to increase complete protocol compliance. To do

  14. Prospective study of filtering blebs after XEN45 surgery.

    Science.gov (United States)

    Olate-Pérez, Á; Pérez-Torregrosa, V T; Gargallo-Benedicto, A; Neira-Ibáñez, P; Cerdà-Ibáñez, M; Osorio-Alayo, V; Barreiro-Rego, A; Duch-Samper, A

    2017-08-01

    To qualitatively analyse the evolution of filtering blebs after XEN surgery, by using anterior segment optical coherence tomography (AS-OCT). A prospective study was performed on filtering blebs of 30 eyes with cataracts and glaucoma, surgically operated on using phacoemulsification and XEN45 implantation (PHACO-XEN). AS-OCT was used to analyse bleb morphology and reflectivity at 3, 6, and 12 months after surgery. Functionality was studied considering an intraocular pressure (IOP)≤18mmHg without antihypertensive medication. The IOP enabled the blebs to be classified into non-functional: flat (6.67%) and encapsulated (3.33%); and functional (90%), which were then divide by their morphology into cystic (5/27), diffuse (2/27), and layered (20/27). Cystic types had a mean IOP of 12.8, 12.6, and 14.0mmHg at 3, 6 and 12 months, respectively. In the diffuse type, the mean IOP was 13.0, 11.5 and 13.0mmHg at 3, 6 and 12 months, respectively. In the layers pattern the mean IOP was 14.45, 14.55 and 14.8mmHg at 3, 6 and 12 months respectively. The percentage of blebs with high reflectivity was 48.15%, 62.96%, and 77.78%, at 3, 6 and 12 months, with a mean IOP of 14.23, 14.59, and 15.14mmHg in each time period, respectively. AS-OCT could be a good predictor of bleb functionality in PHACO-XEN surgery. Those with a cystic pattern or low reflectivity seem to have better post-operative success. Nevertheless, more long-term studies are required. Copyright © 2017 Sociedad Española de Oftalmología. Publicado por Elsevier España, S.L.U. All rights reserved.

  15. a comparative study between manual small incision cataract surgery ...

    African Journals Online (AJOL)

    ... October 2012 to October 2014 for cataract surgery were followed up for 6 weeks after surgery. They were divided into two groups based on the type of surgical procedure opted by the patients. Group A consisted of 50 patients who underwent Manual Small Incision Cataract. Surgery with rigid Polymethyl Methacrylate IOL ...

  16. 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

  17. A large multicenter outcome study of female genital plastic surgery.

    Science.gov (United States)

    Goodman, Michael P; Placik, Otto J; Benson, Royal H; Miklos, John R; Moore, Robert D; Jason, Robert A; Matlock, David L; Simopoulos, Alex F; Stern, Bernard H; Stanton, Ryan A; Kolb, Susan E; Gonzalez, Federico

    2010-04-01

    Female Genital Plastic Surgery, a relatively new entry in the field of Cosmetic and Plastic Surgery, has promised sexual enhancement and functional and cosmetic improvement for women. Are the vulvovaginal aesthetic procedures of Labiaplasty, Vaginoplasty/Perineoplasty ("Vaginal Rejuvenation") and Clitoral Hood Reduction effective, and do they deliver on that promise? For what reason do women seek these procedures? What complications are evident, and what effects are noted regarding sexual function for women and their partners? Who should be performing these procedures, what training should they have, and what are the ethical considerations? This study was designed to produce objective, utilizable outcome data regarding FGPS. 1) Reasons for considering surgery from both patient's and physician's perspective; 2) Pre-operative sexual functioning per procedure; 3) Overall patient satisfaction per procedure; 4) Effect of procedure on patient's sexual enjoyment, per procedure; 5) Patient's perception of effect on her partner's sexual enjoyment, per procedure; 6) Complications. This cross-sectional study, including 258 women and encompassing 341 separate procedures, comes from a group of twelve gynecologists, gynecologic urologists and plastic surgeons from ten centers in eight states nationwide. 104 labiaplasties, 24 clitoral hood reductions, 49 combined labiaplasty/clitoral hood reductions, 47 vaginoplasties and/or perineoplasties, and 34 combined labiaplasty and/or reduction of the clitoral hood plus vaginoplasty/perineoplasty procedures were studied retrospectively, analyzing both patient's and physician's perception of surgical rationale, pre-operative sexual function and several outcome criteria. Combining the three groups, 91.6% of patients were satisfied with the results of their surgery after a 6-42 month follow-up. Significant subjective enhancement in sexual functioning for both women and their sexual partners was noted (p = 0.0078), especially in patients

  18. Study protocol for the Cities Changing Diabetes programme

    DEFF Research Database (Denmark)

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

    2017-01-01

    . 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......INTRODUCTION: 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...... 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...

  19. Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study.

    Science.gov (United States)

    Vischer, Nerina; Pfeiffer, Constanze; Kealy, Jennifer; Burri, Christian

    2017-01-01

    The trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa. We used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews. Protocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures. Our data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol

  20. Research Protocol for Systematic Review and Meta-Analysis of Elder Abuse Prevalence Studies.

    Science.gov (United States)

    Yon, Yongjie; Mikton, Christopher; Gassoumis, Zachary D; Wilber, Kathleen H

    2017-06-01

    Elder abuse is an important public health and human rights issue, yet its true extent is not well understood. To address this, we will conduct a systematic review and meta-analysis of elder abuse prevalence studies from around the world. This protocol describes the methodological approach to be adopted for conducting this systematic review and meta-analysis. In particular, the protocol describes the search strategies and eligibility criteria to be used to identify and select studies and how data from the selected studies will be extracted for analysis. The protocol also describes the analytical approach that will be used to calculate pooled prevalence estimates and discusses the use of meta-regression to assess how studies' characteristics influence the prevalence estimates. This protocol conforms to the Preferred Reporting Items for Systematic reviews and Meta-Analysis - or PRISMA - guidelines and has been registered with the PROSPERO International Prospective Register of systematic reviews.

  1. A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

    Science.gov (United States)

    Hamilton, Michelle D; Cola, Philip A; Terchek, Joshua J; Werner, James J; Stange, Kurt C

    2011-01-01

    The "card study," in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks. Because an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study institutional review board (IRB) approval. We developed a protocol for a study of the card study method, allowing new card study proposals of specific research questions to be submitted as addenda to the approved Card Study Protocol. Seven card studies were proposed and approved under the Card Study Protocol during the first year after implementation, contrasted with one-card study proposed in the previous year. New card study ideas submitted as addenda to an approved protocol appeared to increase IRB comfort with the card study as a minimal risk method while reducing the hurdles to developing new study ideas. A Card Study Protocol allowing new study questions to be submitted as addenda decreases time between idea generation and IRB approval. Shortened turn-around times may be useful for translating ideas into action while reducing regulatory burden.

  2. [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.

  3. 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.

  4. Visual acuity outcomes after cataract surgery in patients with age-related macular degeneration: age-related eye disease study report no. 27.

    Science.gov (United States)

    Forooghian, Farzin; Agrón, Elvira; Clemons, Traci E; Ferris, Frederick L; Chew, Emily Y

    2009-11-01

    To evaluate visual acuity outcomes after cataract surgery in patients with varying degrees of age-related macular degeneration (AMD). Cohort study. A total of 4757 participants enrolled in the Age-Related Eye Disease Study (AREDS), a prospective, multicenter, epidemiological study of the clinical course of cataract and AMD and a randomized controlled trial of antioxidants and minerals. Standardized lens and fundus photographs, performed at baseline and annual visits, were graded by a centralized reading center using standardized protocols for severity of AMD and lens opacities. History of cataract surgery was obtained every 6 months. Analyses were conducted using multivariate logistic regression. The change in best-corrected visual acuity (BCVA) after cataract surgery compared with preoperative BCVA. Visual acuity results were analyzed for 1939 eyes that had cataract surgery during AREDS. The mean time from cataract surgery to measurement of postoperative BCVA was 6.9 months. After adjustment for age at surgery, gender, type, and severity of cataract, the mean change in visual acuity at the next study visit after the cataract surgery was as follows: Eyes without AMD gained 8.4 letters of acuity (P<0.0001), eyes with mild AMD gained 6.1 letters of visual acuity (P<0.0001), eyes with moderate AMD gained 3.9 letters (P<0.0001), and eyes with advanced AMD gained 1.9 letters (P = 0.04). The statistically significant gain in visual acuity after cataract surgery was maintained an average of 1.4 years after cataract surgery. On average, participants with varying severity of AMD benefited from cataract surgery with an increase in visual acuity postoperatively. This average gain in visual acuity persisted for at least 18 months.

  5. 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.

  6. Accuracy study of new computer-assisted orthopedic surgery software

    Energy Technology Data Exchange (ETDEWEB)

    Sidon, Eli [Department of Orthopaedic Surgery, Beilinson-Rabin Medical Center, Petach Tikva (Israel); Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (Israel); Steinberg, Ely L., E-mail: steinberge@tasmc.health.gov.il [Department of Orthopaedic Surgery, Tel-Aviv Medical Center, Tel Aviv (Israel); Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (Israel)

    2012-12-15

    Purpose: The new computerized system is based on image analysis and designed to aid in orthopedic surgeries by virtual trajectory of the guide wire, intra-operative planning and various measurements. Validation of the accuracy and safety of any computer-aided surgery system is essential before implementing it clinically. We examined the accuracy of guide-wire length and angle measurements and fusion of multiple adjacent images (panoramic view image, PVI{sup ®}) of the new software. Methods: This is a 2-part study. Part I: twenty guide wires were drilled to various depths in a synthetic femur model and the results obtained by the software measurements were compared with manual measurements by a caliper and a depth gauge. Part II: a sawbone femur shaft was osteotomized and various inclinations of >10° to the varus or valgus angles were tested. The manually obtained measurements of angles and lengths were compared to the new computerized system software PVI. Results: There was a significant positive linear correlation between all groups of the computerized length and the control measurements (r > 0.983, p < 0.01). There was no significant difference among different distances, angles or positions from the image intensifier. There was a significant positive linear correlation between the angle and length measurement on the PVI and the control measurement (r > 0.993, p < 0.01). Conclusions: The new computerized software has high reliability in performing measurements of length using an aiming, positioning and referring device intra-operatively.

  7. [Complications in gynecologic laparoscopic surgery--retrospective and prospective study].

    Science.gov (United States)

    Gocevska, S; Gortchev, G; Tomov, S

    2011-01-01

    Laparoscopic surgery is a surgical approach with proven advantages in the contemporary treatment of gynaecological diseases. It is applied with proven results in oncologic patients in order to respect certain rules. Mini-invasive approach has less complication and therefore is widely recommended. In this respect, the constantly increasing interest in this surgery and additional training and education. Risk factors must be taken into consideration and patients should be informed about possible complications during surgery.

  8. 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

  9. 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

  10. TO STUDY THE INFLUENCE OF STRUCTURED EXERCISE PROTOCOL ON PHYSICAL ACTIVITY IN PERIMENOPAUSAL WOMEN

    Directory of Open Access Journals (Sweden)

    D. Manjusha

    2014-08-01

    Full Text Available Background: Peri-menopause is the stage immediately preceding menopause & lasts on average 4yrs. The hormonal changes in peri-menopausal women alter the cardiovascular status & increase the incidence of obesity. The purpose of this study is to improve physical activity of women to combat this risk in peri-menopausal women by using structured exercise protocol. Methods: A total of thirty peri-menopausal women who met inclusive criteria participated in this study with age between 35-45yrs. They were randomly divided into 2 groups-experimental group (group 1, n=15 and control group (group 2, n=15, a 12-week exercise protocol were given under supervision for experimental group. The experimental group underwent the protocol of warm up for 10min following 25min exercise protocol and 10min of cool down period. The same exercise protocols were followed by control group without supervision. Results: According to data analysis, a significant difference was found between pre and post values of BMI, WHR, Physical activity level and vo2 peak in both experimental and control groups(p<0.05, but comparatively more significant changes were found in experimental rather than control group(p<0.05. Conclusion: There was a significant change in physical factors like BMI, WHR and physical activity level and functional factors like vo2 peak. Hence, it is concluded that 12weeks exercise protocol is effective in peri-menopausal women.

  11. 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

  12. 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

  13. Enhanced Recovery After Surgery (ERAS) multimodal programme as experienced by pancreatic surgery patients: Findings from an Italian qualitative study.

    Science.gov (United States)

    Galli, Emanuele; Fagnani, Cristina; Laurora, Ilaria; Marchese, Carmen; Capretti, Giovanni; Pecorelli, Nicolò; Marzo, Elisabetta; Palese, Alvisa; Zannini, Lucia

    2015-11-01

    ERAS has recently been implemented in pancreatic surgery settings, but there is little evidence regarding the effects as perceived by patients. Given the lack of the knowledge in the field, the aim of this study was to capture the experience of patients undergoing pancreatic surgery who received perioperative care based on the ERAS programme. We designed a qualitative study undertaken in the pancreatic surgery unit of San Raffaele Hospital in Milan, Italy. Twenty-two consecutive patients were invited to participate in the study and 13 patients were interviewed. Data was collected between March and December 2012 either through face-to-face or semi-structured telephone follow-up from three to six weeks after discharge. Data was analysed using the interpretative phenomenological approach. Patients who underwent surgical pancreatic procedures and treated with ERAS programme reported experiences based on four themes: (1) Feeling prepared to face surgery, (2) Being actively "inside" or "outside" the programme, (3) Healing at home: the best setting, and (4) "Perceiving the ordinary as extraordinary": reaching independence, once at home. According to the findings, uncomplicated pancreatic surgery patients may benefit from the ERAS programme. Preadmission counselling should help patients to assume an active role. Once the patient returns home, the availability of a caregiver should be thoroughly assessed to guarantee the support needed by patients to successfully complete the ERAS(programme. Surgery and nursing staff should carefully monitor patients and suggest whether they continue, interrupt, or individualise the scheduled ERAS interventions in accordance with a patient's clinical condition and preferred personal timing. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  14. Use of Laparoscopy in Gastrointestinal Surgery in Sweden 1998-2014: A Nationwide Study.

    Science.gov (United States)

    Sundbom, M; Hedberg, J

    2017-03-01

    One by one, minimally invasive alternatives to established gastrointestinal procedures have become clinical routine. We have studied the use of laparoscopy in four common procedures-cholecystectomy, appendectomy, reflux surgery, and bariatric surgery-as well as in major resectional gastrointestinal surgery in Sweden. The National Patient Registry was used to identify all in-hospital procedures performed in patients above the age of 15 during 1998-2014, meeting our inclusion criteria. For each group, the annual number of procedures and proportion of laparoscopic surgery were studied, as well as applicable subgroups. Differences in age, gender, as well as geographical differences were evaluated in the most recent 3-year period (2012-2014). In total, 537,817 procedures were studied, 43% by laparoscopic approach. In 2012-2014, the proportion of laparoscopic surgery ranged from high rates in the four common procedures (cholecystectomy 81%, appendectomy 47%, reflux surgery 72%, and bariatric surgery 97%) to rather low numbers in resectional surgery (4%-10%), however, increasing in the last years. In appendectomy and cholecystectomy, men were less likely to have laparoscopic surgery (42% versus 51% and 74% versus 85%, respectively, p laparoscopy were also noted, for example, the proportion of laparoscopic appendectomy varied from 11% to 76% among the 21 different Swedish counties. The proportion of laparoscopy was high in the four common procedures and low, but rising, in major resectional surgery. A large variation in the proportion of laparoscopic surgery by age, gender, and place of residence was noted.

  15. 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 reduction in fatigue/drowsiness on POD 0 and 1 (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

  16. 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

  17. Design of a protocol for large-scale epidemiological studies in individual sports: the Swedish Athletics injury study.

    Science.gov (United States)

    Jacobsson, Jenny; Timpka, Toomas; Ekberg, Joakim; Kowalski, Jan; Nilsson, Sverker; Renström, Per

    2010-12-01

    Epidemiological studies have mainly been performed on team sports. The authors set out to develop a protocol for large-scale epidemiological studies of injuries among elite athletics athletes. An argument-based method for investigation of complex design problems was used to structure the collection and analysis of data. Specification of the protocol was preceded by an examination of requirements on injury surveillance in individual sports and iterated drafting of protocol specifications, and followed by formative evaluations. The requirements analysis shows that the central demand on the protocol is to allow for detailed epidemiological analyses of overuse injuries, which subsequently requires regular collection of self-reported data from athletes. The resulting study protocol is centred on a web-based weekly athlete e-diary enabling continual collection of individual-level data on exposure and injuries. To be able to interpret the self-reported data on injury events, collection of a wide range of personal baseline data from the athlete, including a psychological profile, is included in the protocol. The resulting protocol can be employed in intervention programmes that can prevent suffering among both adult elite and youth talent athletes who have made considerable life investments in their sport.

  18. A longitudinal study of patient and surgeon goal achievement 2 years after surgery following pelvic floor dysfunction surgery.

    Science.gov (United States)

    Srikrishna, S; Robinson, D; Cardozo, L

    2010-11-01

    To compare patient goal achievement in prolapse and continence surgery with objective/subjective outcomes; secondarily, to compare patient goal achievement with overall satisfaction and with that of the surgeon. Prospective longitudinal observational study, over 2 years. Tertiary urogynaecology centre. Women with prolapse or stress incontinence due for surgery. Patients and surgeons listed five goals that they hoped to achieve following surgery. Objective assessment was with Pelvic Organ Prolapse Quantification System (POP-Q) and videocystourethrography (VCU). Quality of life (QoL) was assessed with a Prolapse QoL questionnaire (PQoL), Kings Health questionnaire (KHQ) and Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and satisfaction was assessed with the Patient Global Impression of Improvement (PGI-I). Goal achievement was measured on a 100-mm visual analogue scale (VAS); objective cure of prolapse by POP-Q and of stress incontinence by VCU; QoL was assessed by KHQ, PQoL and GRISS; and satisfaction by PGI-I. Complete data were available for 112 women. POP-Q scores significantly improved (Pobjective cure of incontinence (from VCU) was 88.8%. All QoL questionnaires and PGI-I scores showed significant improvement (Pmeasures of success than continence surgery. Continence-related goals based on symptom relief were achieved more than those based on body image and sexuality. Surgeons reported a high achievement rate in anatomical restoration and functional improvement goals. Patient goal achievement correlates significantly with other measures of 'success' as well as with overall satisfaction. Surgeons and women have varying expectations of the outcome of surgery. Nearly 90% of goals are still achieved 2 years following surgery. © 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.

  19. 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

    . 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...... of Life (ADRQL), the Cohen-Mansfield Agitation Inventory (CMAI), and the Neuro-Psychiatric Inventory (NPI), and related to case descriptions and video analyses. Results: Recommendations for a mixed method research protocol focused on measuring the effect of music therapy with persons with frontotemporal......, 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...

  20. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol.

    Science.gov (United States)

    Hensel, Kendi L; Carnes, Michael S; Stoll, Scott T

    2016-11-01

    The structural and physiologic changes in a woman's body during pregnancy can predispose pregnant women to low back pain and its associated disability, as well as to complications of pregnancy, labor, and delivery. Anecdotal and empirical evidence has indicated that osteopathic manipulative treatment (OMT) may be efficacious in improving pain and functionality in women who are pregnant. Based on that premise, the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was designed as a prospective, randomized, placebo-controlled, and blinded clinical trial to evaluate the efficacy of an OMT protocol for pain during third-trimester pregnancy. The OMT protocol developed for the PROMOTE study was based on physiologic theory and the concept of the interrelationship of structure and function. The 12 well-defined, standardized OMT techniques used in the protocol are commonly taught at osteopathic medical schools in the United States. These techniques can be easily replicated as a 20-minute protocol applied in conjunction with usual prenatal care, thus making it feasible to implement into clinical practice. This article presents an overview of the study design and treatment protocols used in the PROMOTE study.

  1. Protocol: optimisation of a grafting protocol for oilseed rape (Brassica napus) for studying long-distance signalling.

    Science.gov (United States)

    Ostendorp, Anna; Pahlow, Steffen; Deke, Jennifer; Thieß, Melanie; Kehr, Julia

    2016-01-01

    Grafting is a well-established technique for studying long-distance transport and signalling processes in higher plants. While oilseed rape has been the subject of comprehensive analyses of xylem and phloem sap to identify macromolecules potentially involved in long-distance information transfer, there is currently no standardised grafting method for this species published. We developed a straightforward collar-free grafting protocol for Brassica napus plants with high reproducibility and success rates. Micrografting of seedlings was done on filter paper. Grafting success on different types of regeneration media was measured short-term after grafting and as the long-term survival rate (>14 days) of grafts after the transfer to hydroponic culture or soil. We compared different methods for grafting B. napus seedlings. Grafting on filter paper with removed cotyledons, a truncated hypocotyl and the addition of low levels of sucrose under long day conditions allowed the highest grafting success. A subsequent long-term hydroponic cultivation of merged grafts showed highest survival rates and best reproducibility.

  2. The Evolution of Communication Protocols in an Online Web Discussion Site: A Case Study.

    Science.gov (United States)

    Bray, Marty

    This case study describes the use of World Wide Web discussion pages and examines the evaluation of online communication protocols in one graduate class. The study begins by describing the theories and grounding literature that guided the development of the online discussion site. The study also describes the process used to develop the online…

  3. 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

  4. Pain and disability following first-time lumbar fusion surgery for degenerative disorders: a systematic review protocol

    NARCIS (Netherlands)

    Koenders, N.H.J.; Rushton, A.; Heneghan, N.; Verra, M.L.; Willems, P.; Hoogeboom, T.J.; Staal, J.B.

    2016-01-01

    BACKGROUND: Lumbar spinal fusion for degenerative disorders of the lumbar spine is frequently used, despite current research presenting inconclusive evidence. This study aims to systematically review and meta-analyse the natural course of pain and disability in patients with degenerative disorders

  5. 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.

  6. Pain and disability following first-time lumbar fusion surgery for degenerative disorders: a systematic review protocol

    OpenAIRE

    Koenders, N.H.J.; Rushton, A.; Heneghan, N.; Verra, M.L.; Willems, P.; Hoogeboom, T.J.; Staal, J.B.

    2016-01-01

    Background Lumbar spinal fusion for degenerative disorders of the lumbar spine is frequently used, despite current research presenting inconclusive evidence. This study aims to systematically review and meta-analyse the natural course of pain and disability in patients with degenerative disorders of the lumbar spine such as spinal stenosis, spondylolisthesis, disc herniation, or discogenic low back pain to improve lumbar spinal fusion management. Methods/design An electronic database search w...

  7. 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

  8. 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

  9. Psychosocial changes after cosmetic surgery: a 5-year follow-up study.

    Science.gov (United States)

    von Soest, Tilmann; Kvalem, Ingela L; Skolleborg, Knut C; Roald, Helge E

    2011-09-01

    Most studies examining psychosocial changes after cosmetic surgery have short follow-up periods and therefore provide limited information about long-term effects of such surgery. Moreover, studies that identify whether preexisting patient characteristics are associated with poor psychosocial outcomes after cosmetic surgery are lacking. The current study provides information about both of these issues. Questionnaire data from 130 female Norwegian cosmetic surgery patients were obtained before and 5 years after surgery. The questionnaire consisted of measures on appearance satisfaction, self-esteem, psychological problems, and patients' evaluation of the outcome of surgery. Data from a representative sample of 838 Norwegian women, aged 22 to 55 years, were used for comparison purposes. Analyses revealed an improvement in both general appearance satisfaction and satisfaction with the body part operated on 5 years after surgery. A small increase in self-esteem was observed as well. High rates of preoperative psychological problems and low self-esteem were related to more negative changes in some of the psychosocial measures after surgery compared with patients with better psychological health. Furthermore, factors associated with the actual decision to undergo surgery were related to changes in psychological health and patients' evaluation of the outcome of surgery. This study indicates that cosmetic surgery has positive long-term effects on appearance-related variables. However, surgeons should be particularly aware of patients with psychological problems, as these may compromise patient satisfaction with the effects of cosmetic surgery. Factors affecting the decision itself to undergo cosmetic surgery may also be relevant for subsequent psychosocial outcomes. Therapeutic, II.

  10. 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

    2018-02-16

    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 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 © 2017. Published by Elsevier B.V.

  11. Epilepsy surgery series: a study of 502 consecutive patients from a developing country.

    Science.gov (United States)

    Alsemari, Abdulaziz; 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.

  12. [Remifentanil does not increase urine output during oral surgery, contrary to its effect during other surgeries - a cohort study].

    Science.gov (United States)

    Ouchi, Kentaro; Sugiyama, Kazuna

    An increase in urine output by remifentanil injection during laparoscopic procedures and surgeries such as cardiac and gynecological procedures, due to suppression of the stress response to surgery, has been reported. The aim of our prospective, observational, cohort study was to assess the effect of remifentanil analgesia on urine output during dental and minor oral surgery by comparing intraoperative urine output under defined infusion volumes with and without the use of remifentanil. Dental patients aged 16 years or older, American Society of Anesthesiologists physical status 1, with no renal diseases or abnormal blood values of serum creatinine and BUN, not on treatment with diuretic drugs, and undergoing minor oro-maxillofacial surgery or dental treatment under inhalation general anesthesia were included in this study. Urethral catheterization was performed after anesthesia induction, and urine output was measured every 30minutes. We measured urine volume (mL) and rate of urine output (mL.kg -1 .h -1 ) intraoperatively, and compared these parameters between patients who did and did not receive remifentanil during the intraoperative period. Eighty-seven patients were categorized into the remifentanil group (n=43) or remifentanil non-use group (n=44). Both volume of urine (mL) and rate of urine output (mL.kg -1 .h -1 ) were not significantly different between the two groups (remifentanil group, 372.3±273.5mL, 1.8±1.1mL.kg -1 .h -1 ; remifentanil non-use group, 343.3±283.3mL, 1.9±1.2mL.kg -1 .h -1 ; p=0.63; 0.57). Our results show that use of remifentanil during dental and minor oral surgeries does not increase urine output. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  13. Comparative study of chemotherapeutic protocols for advanced breast cancer

    International Nuclear Information System (INIS)

    Perveen, S.; Ilyas, N.; Shahid, M.A.; Asgar, S.

    2002-01-01

    Objective: To compare the efficacy and toxicity of epirubicin the two-dose levels with combination of standard chemotherapy drugs. Design: A single center trial conducted under the sponsorship of Pakistan oncology co-operative group (POCG). Place and Duration of Study: The trial was conducted at the Institute of Nuclear Medicine and Oncology Lahore (INMOL). The study started in October 1995 and patient accrual was completed in June 1997. Patients and Methods: Breast cancer patients presenting with distant metastases were randomized to receive either single agent epirubicin, 120 mg/ m/sup 2/ weekly (arm A), epirubicin 40 mg/m/sup 2/, (Arm B), standard CMF regimen (Arm C) or standard FEC regimen (Arm D). Efficacy of each regimen, its toxicity and the quality of life of the patients were the factors compared. Results: FEC showed a response rate of 68% with median duration of 14 months, CMF showed 57% response rate with median duration of 8 months. High dose epirubicin 120 mg/m/sup 2/ showed a response rate of 31% with response duration of 2.5 months, while epirubicin 40 mg/m/sup 2/ showed partial response (pr) in 17% of patients with response duration of 1.7 months. Both FEC and CMF arms were found to be more effective (p<0.05) than the epirubicin regimens. Conclusion: FEC regimen was most effective in producing long lasting palliation. Single agent regimens produced low response rare and intolerable toxicity amongst metastatic breast cancer patients. (author)

  14. Structured Wii protocol for rehabilitation of shoulder impingement syndrome: A pilot study.

    Science.gov (United States)

    Rizzo, John-Ross; Thai, Peter; Li, Edward J; Tung, Terence; Hudson, Todd E; Herrera, Joseph; Raghavan, Preeti

    2017-11-01

    To determine the feasibility and efficacy of using a structured Nintendo Wii protocol to improve range of motion, strength, and quality of life in patients with shoulder impingement syndrome. A total of 14 patients with shoulder pain were randomized to perform a structured Wii protocol (n=8) or conventional therapy (n=6). Pain-free shoulder range of motion, strength, shoulder pain and disability, and quality of life were assessed pre- and post-treatment. All 8 patients completed the Wii protocol, and 3 completed conventional therapy. The Wii protocol conferred significant improvements in shoulder range of motion, pain and disability, and quality of life but not strength, whereas conventional therapy conferred a significant improvement in strength. As compared to conventional treatment, the structured Wii protocol implemented in this pilot study was a viable adjunct to therapy for shoulder impingement syndrome. Gaming may have a supplemental benefit by increasing motivation, pleasure, and/or adherence. Further investigation in larger cohorts is warranted. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  15. 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

  16. Study protocol: effects of school gardens on children's physical activity.

    Science.gov (United States)

    Wells, Nancy M; Myers, Beth M; Henderson, Charles R

    2014-01-01

    Childhood obesity is an epidemic. Strategies are needed to promote children's healthy habits related to diet and physical activity. School gardens have the potential to bolster children's physical activity and reduce time spent in sedentary activity; however little research has examined the effect of gardens on children's physical activity. This randomized controlled trial (RCT) examines the effect of school gardens on children's overall physical activity and sedentary behavior; and on children's physical activity during the school day. In addition, physical activity levels and postures are compared using direct observation, outdoors, in the garden and indoors, in the classroom. Twelve New York State schools are randomly assigned to receive the school garden intervention or to serve in the wait-list control group that receives gardens and lessons at the end of the study. The intervention consists of a raised bed garden; access to a curriculum focused on nutrition, horticulture, and plant science and including activities and snack suggestions; resources for the school including information about food safety in the garden and related topics; a garden implementation guide provided guidance regarding planning, planting and maintaining the garden throughout the year; gardening during the summer; engaging volunteers; building community capacity, and sustaining the program. Data are collected at baseline and 3 post-intervention follow-up waves at 6, 12, and 18 months. Physical activity (PA) "usually" and "yesterday" is measured using surveys at each wave. In addition, at-school PA is measured using accelerometry for 3 days at each wave. Direct observation (PARAGON) is used to compare PA during an indoor classroom lesson versus outdoor, garden-based lesson. Results of this study will provide insight regarding the potential for school gardens to increase children's physical activity and decrease sedentary behaviors. Clinicaltrial.gov # NCT02148315.

  17. Transgender Surgery in Denmark From 1994 to 2015: 20-Year Follow-Up Study.

    Science.gov (United States)

    Aydin, Dogu; Buk, Liv Johanne; Partoft, Søren; Bonde, Christian; Thomsen, Michael Vestergaard; Tos, Tina

    2016-04-01

    Gender dysphoria is a mismatch between a person's biological sex and gender identity. The best treatment is believed to be hormonal therapy and gender-confirming surgery that will transition the individual toward the desired gender. Treatment in Denmark is covered by public health care, and gender-confirming surgery in Denmark is centralized at a single-center with few specialized plastic surgeons conducting top surgery (mastectomy or breast augmentation) and bottom surgery (vaginoplasty or phalloplasty and metoidioplasty). To report the first nationwide single-center review on transsexual patients in Denmark undergoing gender-confirming surgery performed by a single surgical team and to assess whether age at time of gender-confirming surgery decreased during a 20-year period. Electronic patient databases were used to identify patients diagnosed with gender identity disorders from January 1994 through March 2015. Patients were excluded from the study if they were pseudohermaphrodites or if their gender was not reported. Gender distribution, age trends, and surgeries performed for Danish patients who underwent gender-confirming surgery. One hundred fifty-eight patients referred for gender-confirming surgery were included. Fifty-five cases (35%) were male-to-female (MtF) and 103 (65%) were female-to-male (FtM). In total, 126 gender-confirming surgeries were performed. For FtM cases, top surgery (mastectomy) was conducted in 62 patients and bottom surgery (phalloplasty and metoidioplasty) was conducted in 17 patients. For MtF cases, 45 underwent bottom surgery (vaginoplasty), 2 of whom received breast augmentation. The FtM:MtF ratio of the referred patients was 1.9:1. The median age at the time of surgery decreased from 40 to 27 years during the 20-year period. Gender-confirming surgery was performed on 65 FtM and 40 MtF cases at our hospital, and 21 transsexuals underwent surgery abroad. Mastectomy was performed in 62 FtM and bottom surgery in 17 FtM cases

  18. 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

  19. 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

  20. 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

  1. Study protocol for the Fukushima Health Management Survey.

    Science.gov (United States)

    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

  2. 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

    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...... 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 received 10 (n = 2), 30 (n = 2) or 60 (n = 2) mg melatonin intravenously in the intraoperative phase and 10 mg orally for three nights after surgery. Patients were monitored for hemodynamic parameters during and after surgery. Any unexpected events during the hospitalization were...

  3. 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.

  4. [Clinicopathological Study of Perforated Gastric Cancer Treated with Surgery].

    Science.gov (United States)

    Ishiguro, Toru; Fukuchi, Minoru; Kumagai, Youichi; Ishibashi, Keiichiro; Mochiki, Erito; Ishida, Hideyuki

    2018-02-01

    This retrospective study evaluated an appropriate surgical treatment in patients with perforated gastric cancer. The clinicopathological and survival data on 17 perforated gastric cancer patients treated with surgery were analyzed. The one-stage or two-stage gastrectomy was performed in 8 and 5 patients, respectively. The omental patch repair was performed in 4 patients. In univariate analysis, non-curative(R2)resection with gross residual tumor(p<0.01)and postoperative complications( p=0.01)were found to be significant unfavorable factors for overall survival(OS). In multivariate analysis, R2 resection was identified to be an only independent significant unfavorable factor for OS. Patients who underwent curative(R0) resection had long-term survival, while patients with R2 resection and postoperative complication had limited survival times. These results suggest that R0 resection may be optimal to improve survival in patients with perforated gastric cancer, regardless of whether patients underwent a one-stage or two-stage gastrectomy based on the patient's condition.

  5. The Utility of Outcome Studies in Plastic Surgery

    Science.gov (United States)

    Sinno, Hani; Dionisopoulos, Tassos; Slavin, Sumner A.; Ibrahim, Ahmed M. S.; Chung, Kevin C.

    2014-01-01

    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. PMID:25426372

  6. 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.

  7. 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

  8. Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Valkenet, Karin; Trappenburg, Jaap Ca; Gosselink, Rik; Sosef, Meindert N; Willms, Jerome; Rosman, Camiel; Pieters, Heleen; Scheepers, Joris Jg; de Heus, Saskia C; Reynolds, John V; Guinan, Emer; Ruurda, Jelle P; Rodrigo, Els He; Nafteux, Philippe; Fontaine, Marianne; Kouwenhoven, Ewout A; Kerkemeyer, Margot; van der Peet, Donald L; Hania, Sylvia W; van Hillegersberg, Richard; Backx, Frank Jg

    2014-04-27

    Esophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design. The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on

  9. Periodontal Plastic Surgery to Improve Aesthetics in Patients with Altered Passive Eruption/Gummy Smile: A Case Series Study

    Directory of Open Access Journals (Sweden)

    Francesco Cairo

    2012-01-01

    Full Text Available Altered passive eruption/gummy smile is a common challenge in patients requiring aesthetic treatment. A specific surgical protocol was designed and tested in patients with altered passive eruption. Standardized preoperative X-rays were used to assess crown length at baseline and to place submarginal incisions. Osseous respective therapy was performed to achieve biological width. Clinical outcomes were recorded 6 months after surgery. Eleven patients with a total of 58 teeth were treated with flap surgery and osseous resective therapy at upper anterior natural teeth. At the last followup, a significant and stable improvement of crown length was obtained when compared to the baseline (P<0.0001. All patients rated as satisfactory in the final outcomes (final VAS value = 86.6. In conclusion, this study showed that periodontal plastic surgery including osseous resection leads to predictable outcomes in the treatment of altered passive eruption/gummy smile: A careful preoperative planning avoids unpleasant complications and enhances postsurgical stability of the gingival margin.

  10. Oncoplastic breast surgery does not delay the onset of adjuvant chemotherapy: a population-based study.

    Science.gov (United States)

    Klit, Anders; Tvedskov, Tove Filtenborg; Kroman, Niels; Elberg, Jens Jørgen; Ejlertsen, Bent; Henriksen, Trine Foged

    2017-05-01

    Only a few studies of limited size have examined whether oncoplastic breast surgery delays the onset of adjuvant chemotherapy as compared to conventional breast surgery. We investigated whether oncoplastic breast surgery causes a delay in the onset of adjuvant chemotherapy in comparison to lumpectomy and mastectomy. The study is a population-based cohort study. Within the nationwide registry of the Danish Breast Cancer Group (DBCG), we identified 1798 patients who received adjuvant chemotherapy following mastectomy, lumpectomy or oncoplastic breast surgery for early and unilateral invasive breast cancer. Women treated with neoadjuvant chemotherapy were excluded. We found no significant difference between the three groups (mastectomy, lumpectomy, oncoplastic breast surgery) in the time from biopsy to surgery (mean time 17.9, 17.0 and 18.3 days, respectively), the time from surgery to onset of adjuvant chemotherapy, nor total time from biopsy to the onset of adjuvant chemotherapy (mean time 52.7, 51.9 and 53.2 days, respectively). Our study shows that oncoplastic breast surgery does not delay the onset of adjuvant chemotherapy in comparison with mastectomy and lumpectomy. Accordingly, patients should not be excluded from treatment with oncoplastic breast surgery due to concerns of delay in adjuvant chemotherapy.

  11. Collaborating to increase access to clinical and educational resources for surgery: a case study.

    Science.gov (United States)

    Tomasko, Jonathan M; Adams, Nancy E; Garritano, Frank G; Santos, Mary C; Dillon, Peter W

    2014-01-01

    A case study is described in which collaborations between a Department of Surgery, a Department of Information Technology, and an academic health sciences library resulted in the development of an electronic surgical library available at the bedside, the deployment of tablet devices for surgery residents, and implementation of a tablet-friendly user interface for the institution's electronic medical record. Copyright © 2014 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  12. 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 (pCAR 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.

  13. 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.

  14. 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

  15. Immediate loading of maxillary prostheses using flapless surgery, implant placement in predetermined positions, and prefabricated provisional restorations. Part 2: a retrospective 10-year clinical study.

    Science.gov (United States)

    Rocci, Antonio; Rocci, Marta; Scoccia, Andrea; Martignoni, Massimiliano; Gottlow, Jan; Sennerby, Lars

    2012-01-01

    Immediate loading has become a widely reported practice in implant dentistry. The aim of this study is to report on the 10-year clinical and radiographic outcomes of an immediate-loading treatment protocol that included flapless surgery. Forty-six patients were treated with 97 immediately loaded Mk IV implants (Nobel Biocare) with machined surface in the maxilla. Presurgically, a three-dimensional model of each patient's soft tissue and underlying alveolar bone anatomy was created and a surgical template was fabricated. A circular mucotome was used to punch out a 5-mm hole in the mucosa to avoid flap elevation. Control examinations were performed on the day of surgery and at 1, 2, 3, 6, 8, and 10 years after surgery. All prepared implant sites had intact buccal and lingual bone walls. The prefabricated provisional restorations showed excellent fit. Nine implants failed within 8 weeks of loading, resulting in a cumulative survival rate of 91% after 10 years of loading. The survival rates were 94% for implants supporting partial prostheses and 81% for implants supporting single restorations. Average marginal bone resorption was 1 mm during the first year, 0.4 mm during the second year, and 0.1 mm during the third year and after 10 years. The unchanged survival rate and the low average bone loss after 10 years confirm the feasibility of an immediate loading treatment protocol in the maxilla that included flapless surgery.

  16. 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…

  17. Use and Evaluation of a Cooling Aid in Laser-Assisted Dental Surgery: An Innovative Study.

    Science.gov (United States)

    Bernardi, Sara; Mummolo, Stefano; Zeka, Keti; Pajewski, Leonardo; Continenza, Maria Adelaide; Marzo, Giuseppe

    2016-06-01

    The aim of this study was to evaluate the beneficial effect of NeoHeal during laser-assisted oral surgery. Laser-assisted surgery is a less invasive technique than conventional surgery using a blade; however, the heat produced by the laser can damage tissue proximal to the treated area. We hypothesized the hydrogel NeoHeal could be applied during oral surgery and have similar benefits as those already described for dermatological surgery. In our randomized controlled trial, we first selected 30 patients who were to undergo laser surgical intervention using a diode laser. Both at the end of intervention and at follow-up, each patient filled out a questionnaire comprising two questions. The answers to the questions were statistically analyzed with regard to frequency of each response, and validated by the Wilcoxon test with a p value cooling aid in laser-assisted dental surgery.

  18. Study protocol

    DEFF Research Database (Denmark)

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

    2013-01-01

    healthy classmates as ambassadors to facilitate the normalization of social life in the hospital. For children with cancer, RESPECT contributes to expanding knowledge on rehabilitation that can also facilitate rehabilitation of other children undergoing hospitalization for long-term illness....... intervention includes an educational program aimed at the child with cancer, the child’s schoolteachers and classmates, and the child’s parents. Children with cancer will each have two ambassadors assigned from their class. The ambassadors visit the child with cancer at the hospital at alternating 2-week...... intervals and participate in the intervention program. The physical and social intervention examines the effect of early, structured, individualized, and continuous physical activity from diagnosis throughout the treatment period. The patients are tested at diagnosis, at 3 and 6 months after diagnosis...

  19. Study protocol

    DEFF Research Database (Denmark)

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

    2017-01-01

    that target movements and activities patients find fearful and painful. High-quality research on exercise prescription in relation to pain mechanisms, not directed at specific tissue pathology, and dose response clearly warrants further investigation. Our primary aim is to establish the feasibility...... and acceptability of conducting a definitive RCT which will evaluate the clinical and cost-effectiveness of a loaded self-managed exercise programme for people with patellofemoral pain. METHOD: This is a single-centred, multiphase, sequential, mixed-methods trial that will evaluate the feasibility of running...... 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...

  20. Study protocol

    DEFF Research Database (Denmark)

    Madsen, Helle Østergaard; Dam, Ole Henrik; Hageman, Ida

    2012-01-01

    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...... in persons with severe visual impairments or blindness and to compare the results to a control group without visual impairments. Moreover, the authors wish to investigate whether SAD is correlated to the degree of impairment or to the diagnosis. METHODS AND ANALYSIS: 2781 persons with visual impairments...... in a relevant scientific journal and be communicated to respondents and relevant institutions through cooperation with the Danish Association of the Blind....

  1. 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

  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. 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

  4. 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.

  5. Coagulation and fibrinolysis during lung surgery:an experimental study

    DEFF Research Database (Denmark)

    Trabjerg, Theis B; Sander, Klaus D; Nybo, Mads

    2014-01-01

    OBJECTIVES: Postoperative thromboembolism is a serious complication, but the incidence following surgery for lung cancer appears to be much lower compared with other surgical specialties. The reason is unknown and one may speculate that the lungs are reservoirs of anticoagulants or fibrinolytic s...

  6. Anesthesia practices in intracranial mass surgery: a retrospective study

    Directory of Open Access Journals (Sweden)

    Ozlem Ozmete

    2017-03-01

    Conclusion: Several anesthetic techniques may be used successfully to provide anesthesia for resection of intracranial mass surgery. To reduced morbidity and mortality, the possible complications must be recognized and treated early with invasive monitoring, strict hemodynamics and blood gas monitoring. [Cukurova Med J 2017; 42(1.000: 86-91

  7. 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

  8. Bioindicators in the MIDUS National Study: Protocol, Measures, Sample, and Comparative Context

    Science.gov (United States)

    Love, Gayle Dienberg; Seeman, Teresa E.; Weinstein, Maxine; Ryff, Carol D.

    2010-01-01

    Objectives MIDUS is a national study of health and aging among individuals aged 25 to 74 at baseline(1995/96). Longitudinal survey assessments (2004/05), were followed by biological assessments on a subsample aged 35–85. To facilitate public use, we describe the protocol, measures, and sample. Methods Respondents traveled to clinics for a two-day data collection protocol that included fasting blood specimens, 12-hour urine specimen, medical history, physical exam, bone densitometry, a laboratory challenge (heart rate variability, blood pressure, respiration, salivary cortisol). Results Response rates for the biological protocol (N = 1,255) were 39.3%, or 43.1% (adjusting for those who could not be located or contacted). Reasons for non-participation were travel, family obligations, and being too busy. Respondents were comparable to the recruitment pool on most demographic characteristics and health assessments. Discussion Strengths of the protocol vis-à-vis other similar studies include opportunities to link biological factors with diverse content from other MIDUS projects. PMID:20876364

  9. 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...

  10. 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...

  11. 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

  12. The Epidemiology of District Surgery in Malawi: a Two Year Study of ...

    African Journals Online (AJOL)

    Paul

    East and Central African Journal of Surgery 1997: Vol. 3, No.1 pp.33-41. The Epidemiology of District Surgery in Malawi: a Two Year. Study of Surgical Rates and Indices in Rural Africa. Paul M Fenton, DTM&H, FFARCS(I). Formerly Professor and Head, Department of Anaesthesia, College of Medicine, Malawi. 1986-2001.

  13. 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.

  14. Bone Mineral Density Measurements Around Osseointegrated Implants: A Precision Study and Validation of Scan Protocol for Transfemoral Amputees.

    Science.gov (United States)

    Hansen, Rehne Lessmann; Langdahl, Bente Lomholt; Jørgensen, Peter Holmberg; Petersen, Klaus Kjær; Søballe, Kjeld; Stilling, Maiken

    Visual evaluation of bone changes around an osseointegration (OI) implant in femoral amputees examined on plain radiographs shows that periprosthetic bone resorption takes place during the first years after OI surgery, but the bone mineral density (BMD) change has not been previously quantified by dual-energy X-ray absorptiometry (DXA). Precision is vital when monitoring BMD changes around implants, and thus the aim of this study was to evaluate the precision and feasibility of a scan protocol for BMD measurements in proximity of OI implants. The proximal part of 2 human cadaveric femoral bones (specimens A and B) with OI implants were mounted in a positioning jig and DXA scans were repeated 5 times in increments of 5° from neutral (0°) to 20° flexion and rotation. BMD changes as a result of change in leg position were evaluated. Repeated patient examinations (n = 20) were conducted in a clinical setting and the precision error was calculated for each of 7 periprosthetic custom-made regions of interest (ROIs). The precision of cadaveric BMD measurements in neutral position was square standard deviation ranged from 0.031 g/cm 2 to 0.047 g/cm 2 and %CV ranged from 3.12% to 6.57% depending on ROI. Simulated hip flexion or rotation of the femur affected periprosthetic BMD measurements around OI implants in cadaveric femoral bones, which stresses the importance of a reproducible set-up during DXA scans to reduce measurement errors caused by variation in leg position. Adherence to the scan protocol with a relaxed position of the residual limb resulted in an acceptable short-term precision below 6.6%. Copyright © 2017 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.

  15. 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.

  16. Reconstructive surgery after female genital mutilation: a prospective cohort study.

    Science.gov (United States)

    Foldès, Pierre; Cuzin, Béatrice; Andro, Armelle

    2012-07-14

    Women who have undergone female genital mutilation rarely have access to the reconstructive surgery that is now available. Our objective was to assess the immediate and long-term outcomes of this surgery. Between 1998 and 2009, we included consecutive patients with female genital mutilation aged 18 years or older who had consulted a urologist at Poissy-St Germain Hospital, France. We used the WHO classification to prospectively include patients with type II or type III mutilation. The skin covering the stump was resected to reveal the clitoris. The suspensory ligament was then sectioned to mobilise the stump, the scar tissue was removed from the exposed portion and the glans was brought into a normal position. All patients answered a questionnaire at entry about their characteristics, expectations, and preoperative clitoris pleasure and pain, measured on a 5-point scale. Those patients who returned at 1 year for follow-up were questioned about clitoris pain and functionality. We compared data from the 1-year group with the total group of patients who had surgery. We operated on 2938 women with a mean age of 29·2 (SD 7·77 years; age at excision 6·1, SD 3·5 years). Mali, Senegal, and Ivory Coast were the main countries of origin, but 564 patients had undergone female genital mutilation in France. The 1-year follow-up visit was attended by 866 patients (29%). Expectations before surgery were identity recovery for 2933 patients (99%), improved sex life for 2378 patients (81%), and pain reduction for 847 patients (29%). At 1-year follow-up, 363 women (42%) had a hoodless glans, 239 (28%) had a normal clitoris, 210 (24%) had a visible projection, 51 (6%) had a palpable projection, and three (0·4%) had no change. Most patients reported an improvement, or at least no worsening, in pain (821 of 840 patients) and clitoral pleasure (815 of 834 patients). At 1 year, 430 (51%) of 841 women experienced orgasms. Immediate complications after surgery (haematoma, suture

  17. A prospective study of immediate functional loading, following the Teeth in a Day protocol: a case series of 55 consecutive edentulous maxillas.

    Science.gov (United States)

    Balshi, Stephen F; Wolfinger, Glenn J; Balshi, Thomas J

    2005-01-01

    Immediate loading of dental implants is increasingly gaining recognition as a viable option for both patient and clinician. The aim of this study was to evaluate the results of 55 patients in a clinical investigation of immediate functional loading of Brånemark System implants (Nobel Biocare USA, Yorba Linda, CA) in edentulous maxillas. Its further purpose is to suggest a reliable and evidence-based protocol for immediate implant loading of full-arch prostheses in the maxilla. A total of 552 Brånemark System implants were placed in immediate extraction or healed sites; a mean number of 10 implants were placed per patient. The healthy subjects in need of full-arch maxillary implant reconstruction were treated between December 1999 and February 2004; 522 of the 552 implants were immediately loaded with screw-retained all-acrylic fixed prostheses at the time of surgery. Approximately 4 to 6 months later, the 30 submerged implants were uncovered, and a definitive metal-reinforced prosthesis was delivered to each patient. The immediately loaded implant cumulative survival rate was 99.0% for these patients. The prosthesis survival rate was 100%. The results of this prospective study of full-arch maxillary immediate loading suggests that this protocol is suitable for most patients in need of full maxillary implant reconstruction. The protocol, as shown in this study, is highly successful in providing a lasting state of osseointegration as the foundation for long-term stability of screw-retained fixed prostheses.

  18. 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

  19. Plain packaging of cigarettes and smoking behavior: study protocol for a randomized controlled study.

    Science.gov (United States)

    Maynard, Olivia M; Leonards, Ute; Attwood, Angela S; Bauld, Linda; Hogarth, Lee; Munafò, Marcus R

    2014-06-25

    Previous research on the effects of plain packaging has largely relied on self-report measures. Here we describe the protocol of a randomized controlled trial investigating the effect of the plain packaging of cigarettes on smoking behavior in a real-world setting. In a parallel group randomization design, 128 daily cigarette smokers (50% male, 50% female) will attend an initial screening session and be assigned plain or branded packs of cigarettes to smoke for a full day. Plain packs will be those currently used in Australia where plain packaging has been introduced, while branded packs will be those currently used in the United Kingdom. Our primary study outcomes will be smoking behavior (self-reported number of cigarettes smoked and volume of smoke inhaled per cigarette as measured using a smoking topography device). Secondary outcomes measured pre- and post-intervention will be smoking urges, motivation to quit smoking, and perceived taste of the cigarettes. Secondary outcomes measured post-intervention only will be experience of smoking from the cigarette pack, overall experience of smoking, attributes of the cigarette pack, perceptions of the on-packet health warnings, behavior changes, views on plain packaging, and the rewarding value of smoking. Sex differences will be explored for all analyses. This study is novel in its approach to assessing the impact of plain packaging on actual smoking behavior. This research will help inform policymakers about the effectiveness of plain packaging as a tobacco control measure. Current Controlled Trials ISRCTN52982308 (registered 27 June 2013).

  20. 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

    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...... 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......-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...

  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. Vitamin K1 monitoring in pregnancies after bariatric surgery: a prospective cohort study.

    Science.gov (United States)

    Jans, Goele; Guelinckx, Isabelle; Voets, Willy; Galjaard, Sander; Van Haard, Paul M M; Vansant, Greet M; Devlieger, Roland

    2014-01-01

    Neonatal intracranial bleedings and birth defects have been reported, possibly related to maternal vitamin K1 deficiency during pregnancy after bariatric surgery. The objective of this study was to investigate the effects of screening and supplementation on K1 serum levels in pregnant women with bariatric surgery, and to compare K1 levels and prothrombin time (PT %) in the first trimester with pregnant women without bariatric surgery. A prospective cohort study including 49 pregnant women with bariatric surgery. Nutritional deficiencies were prospectively screened. In case of observed low K1 serum levels, supplementation was provided. K1 serum levels and PT (%) during the first trimester were compared with a nonsurgical control group of 27 women. During the first trimester, most women had low K1 serum levels (surgery group showed a higher mean PT compared to the controls (111.3 versus 98.9%; Pbariatric surgery. Supplementation during pregnancy can restore vitamin K1 in women with bariatric surgery, potentially protecting the fetus and newborn against intracranial hemorrhage. Copyright © 2014 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  3. 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.

  4. Colorectal Cancer Prognosis Following Obesity Surgery in a Population-Based Cohort Study.

    Science.gov (United States)

    Tao, Wenjing; Konings, Peter; Hull, Mark A; Adami, Hans-Olov; Mattsson, Fredrik; Lagergren, Jesper

    2017-05-01

    Obesity surgery involves mechanical and physiological changes of the gastrointestinal tract that might promote colorectal cancer progression. Thus, we hypothesised that obesity surgery is associated with poorer prognosis in patients with colorectal cancer. This nationwide population-based cohort study included all patients with an obesity diagnosis who subsequently developed colorectal cancer in Sweden from 1980 to 2012. The exposure was obesity surgery, and the main and secondary outcomes were disease-specific mortality and all-cause mortality, respectively. Cox proportional hazard survival models were used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs), adjusted for sex, age, calendar year and education level. The exposed and unexposed cohort included 131 obesity surgery and 1332 non-obesity surgery patients with colorectal cancer. There was a statistically significant increased rate of colorectal cancer deaths following obesity surgery (disease-specific HR 1.50, 95% CI 1.00-2.19). When analysed separately, the mortality rate was more than threefold increased in rectal cancer patients with prior obesity surgery (disease-specific HR 3.70, 95% CI 2.00-6.90), while no increased mortality rate was found in colon cancer patients (disease-specific HR 1.10, 85% CI 0.67-1.70). This population-based study among obese individuals found a poorer prognosis in colorectal cancer following obesity surgery, which was primarily driven by the higher mortality rate in rectal cancer.

  5. A qualitative study of life events and psychological needs underlying the decision to have cosmetic surgery.

    Science.gov (United States)

    Locatelli, Katia; Boccara, David; De Runz, Antoine; Fournier, Mathilde; Chaouat, Marc; Villa, François; Mimoun, Maurice

    2017-01-01

    Objective A thorough psychological assessment of patients requesting cosmetic surgery can help to protect them from the risk of postoperative dissatisfaction and the onset and/or aggravation of psychiatric disorders. This study seeks to shed more light on why people desire cosmetic surgery and thus help surgeons, psychiatrists, and psychologists to conduct assessments before surgery. Methods In-depth interviews were conducted with 35 subjects who requested cosmetic surgery. The interviews were recorded and transcribed and then analyzed qualitatively with Grounded Theory. Themes and categories were identified and compared in logical order, to build a consistent theoretical model. Results In each interview, we identified one or more recent events that the subjects considered to be contributing factors in their decisions to have cosmetic surgery. We observed that 33 of 35 patients said they sought cosmetic surgery at a time when they were experiencing, or had just experienced, one or more major changes in their bodies or their relationships. Recent life events triggered or strengthened specific psychological needs in the subjects: to cope with the past and with change, attain a consistent identity, find or regain a positive self-image, alter others' perceptions, define themselves in relation to others, or please themselves or others. Patients said that they chose plastic surgery to fulfill one or more of these needs. Conclusions This study identifies the role of recent events in inciting individuals to resort to cosmetic surgery. This factor provides new perspectives for surgeons to understand those patients and opens new avenues for research.

  6. Cataract Surgery and Visual Acuity in Elderly Japanese: Results of Fujiwara-kyo Eye Study

    Directory of Open Access Journals (Sweden)

    Kimie Miyata

    2017-04-01

    Full Text Available The aim of this study was to determine the presence of prior cataract surgery and best-corrected visual acuity (BCVA in an elderly Japanese cohort. The Fujiwara-kyo Eye Study was a prospective, population-based, cross-sectional epidemiological study. The subjects were ≥68 years who lived in the Nara Prefecture and responded to recruitment notices. All of the subjects underwent comprehensive ophthalmological examinations, and the sociodemographic information and medical history, including prior cataract surgery, were obtained by answers to a questionnaire. The associations between the BCVA, age, sex, and history of cataract surgery were determined. A total of 2,873 subjects whose mean age was 76.3 ± 4.9 (mean ± standard deviation years were studied. The mean BCVA was −0.020 ± 0.14 logarithm of the minimum angle of resolution units, and it was significantly better in the group with education ≥13 years (p < 0.01. Overall, 24.2% of the subjects had undergone cataract surgery, and 41.7% of the subjects ≥80 years had undergone cataract surgery. The incidence of prior cataract surgery increased with increasing age (p < 0.001 for trend. The mean BCVA of eyes with cataract surgery was significantly better than that of eyes without cataract surgery in subjects ≥80 years (p < 0.01. Visual acuity was generally good in this cohort of elderly Japanese subjects. In this cohort, 24.2% of the subjects had undergone cataract surgery, and the subjects ≥80 years had better BCVA than those without cataract surgery.

  7. The patient safety in surgery study: background, study design, and patient populations.

    Science.gov (United States)

    Khuri, Shukri F; Henderson, William G; Daley, Jennifer; Jonasson, Olga; Jones, R Scott; Campbell, Darrell A; Fink, Aaron S; Mentzer, Robert M; Steeger, Janet E

    2007-06-01

    The purpose of this article is to describe the background, design, and patient populations of the Patient Safety in Surgery Study, as a preliminary to the articles in this journal that will report the results of the Study. The Patient Safety in Surgery Study was a prospective cohort study. Trained nurses collected preoperative risk factors, operative variables, and 30-day postoperative mortality and morbidity outcomes in patients undergoing major general and vascular operations at 128 Veterans Affairs (VA) medical centers and 14 selected university medical centers between October 1, 2001 and September 30, 2004. An Internet-based data collection system was used to input data from the different private medical centers. Semiannual feedback of observed to expected mortality and morbidity ratios was provided to the participating medical centers. During the 3-year study, total accrual in general surgery was 145,618 patients, including 68.5% from the VA and 31.5% from the private sector. Accrual in vascular surgery totaled 39,225 patients, including 77.8% from the VA and 22.2% from the private sector. VA patients were older and included a larger proportion of male patients and African Americans and Hispanics. The VA population included more inguinal, umbilical, and ventral hernia repairs, although the private-sector population included more thyroid and parathyroid, appendectomy, and operations for breast cancer. Preoperative comorbidities were similar in the two populations, but the rates of comorbidities were higher in the VA. American Society of Anesthesiologists classification tended to be higher in the VA. The National Surgical Quality Improvement Program methodology was successfully implemented in the 14 university medical centers. The data from the study provided the basis for the articles in this issue of the Journal of the American College of Surgeons.

  8. Sentinel node in ovarian cancer: study protocol for a phase 1 study

    Directory of Open Access Journals (Sweden)

    Kleppe Marjolein

    2013-02-01

    Full Text Available Abstract Background The concept of sentinel lymph node surgery is to determine whether the cancer has spread to the very first lymph node or sentinel node. If the sentinel node does not contain cancer, then there is a high likelihood that the cancer has not spread to other lymph nodes. The sentinel node technique has been proven to be effective in different types of cancer. In this study we want to determine whether a sentinel node procedure in patients with ovarian cancer is feasible when the tracers are injected into the ovarian ligaments. Methods/Design Patients with a high likelihood of having an ovarian malignancy in whom a median laparotomy and a frozen section analysis is planned and patients with endometrial cancer in whom a staging laparotomy is planned will be included. Before starting the surgical staging procedure, blue dye and radioactive colloid will be injected into the ligamentum ovarii proprium and the ligamentum infundibulo-pelvicum. In the analysis we calculate the percentage of patients in whom it is feasible to identify sentinel nodes. Other study parameters are the anatomical localization of the sentinel node(s and the incidence of false negative lymph nodes. Trial registration Approval number: NL40323.068.12 Name: Medical Ethical Committee Maastricht University Hospital, University of Maastricht Affiliation: Maastricht University Hospital Board Chair Name: Medisch Ethische Commissie azM/UM

  9. 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.

  10. 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

  11. Protocol for the OUTREACH trial: a randomised trial comparing delivery of cancer systemic therapy in three different settings - patient's home, GP surgery and hospital day unit

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2011-10-01

    Full Text Available Abstract Background The national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP surgeries. Methods/design Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm, or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire, as well as secondary end points: patient satisfaction, safety and health economics. Discussion The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key

  12. 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

  13. Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract : the FACT trial protocol

    NARCIS (Netherlands)

    Day, Alexander C; Burr, Jennifer M; Bunce, Catey; Doré, Caroline J; Sylvestre, Yvonne; Wormald, Richard P L; Round, Jeff; McCudden, Victoria; Rubin, Gary; Wilkins, Mark R; Schilder, Anne|info:eu-repo/dai/nl/09110906X

    2015-01-01

    INTRODUCTION: Cataract is one of the leading causes of low vision in the westernised world, and cataract surgery is one of the most commonly performed operations. Laser platforms for cataract surgery are now available, the anticipated advantages of which are broad and may include better visual

  14. 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

  15. 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.

  16. Longer Immediate Recovery Time After Anesthesia Increases Risk of Respiratory Complications After Laparotomy for Bariatric Surgery: a Randomized Clinical Trial and a Cohort Study.

    Science.gov (United States)

    Sudré, Eliana C M; de Batista, Priscila R; Castiglia, Yara M M

    2015-11-01

    We compared the effects of two anesthesia protocols in both immediate recovery time (IRT) and postoperative respiratory complications (PRCs) after laparotomy for bariatric surgery, and we determined the association between the longer IRT and the increase of PRC incidence. We conducted the study in two stages: (i) in a randomized controlled trial (RCT), patients received either intervention (sevoflurane-remifentanil-rocuronium-ropivacaine) or control protocol (isoflurane-sufentanil-atracurium-levobupivacaine). All patients received general anesthesia plus continuous epidural anesthesia and analgesia. Treatment was masked for all, except the provider anesthesiologist. We defined IRT as time since anesthetics discontinuation until tracheal extubation. Primary outcomes were IRT and PRCs incidence within 15 days after surgery. We also analyzed post-anesthesia care unit (PACU) and hospital length of stays; (ii) after the end of the RCT, we used the available data in an extension cohort study to investigate IRT > 20 min as exposure factor for PRCs. Control protocol (n = 152) resulted in longer IRT (30.4 ± 7.9 vs 18.2 ± 9.6 min; p  20 min (n = 190) presented higher incidence of PRCs (7.37 vs 0.62 %; p bariatric patients. We identified a 4.5-fold increase in the relative risk of PRCs when morbid obese patients are exposed to an IRT > 20 min.

  17. A feasibility study comparing two chiropractic protocols in the treatment of patellofemoral pain syndrome.

    Science.gov (United States)

    Brantingham, James W; Globe, Gary A; Jensen, Muffit L; Cassa, Tammy K; Globe, Denise R; Price, Jennifer L; Mayer, Stephan N; Lee, Felix T

    2009-09-01

    The purpose of this pilot study was to determine the feasibility of (1) using the existing clinic, clinicians, interns, faculty, and staff from our college in conducting all components of a planned randomized controlled clinical trial; (2) successfully recruiting patients with patellofemoral pain syndrome (PFPS); and (3) consistently, effectively, and safely implementing the study protocols and therapy. Diagnostic, treatment, and blind assessment procedures were carried out while recruitment and administrative techniques for managing long-term storage of data and files were developed. Thirty-one patients were randomized into a local manipulative group (group A) or to a full kinetic chain manipulative therapy group (group B), each combined with exercise and soft tissue treatment. The Anterior Knee Pain Scale, visual analog scale, and Patient Satisfaction Scale were used. All phases of the feasibility study including use of the clinic, staff, recruitment techniques, treatment protocols, data collection, input, and analysis were effectively and safely carried out. A feasibility study investigating the ability to conduct a randomized controlled trial of a manipulative therapy protocol for PFPS using available chiropractic college infrastructure was accomplished. A fully powered PFPS trial is feasible and merited.

  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. Incidence of cardiovascular complications in knee arthroplasty patients before and after implementation of a ropivacaine local infiltration analgesia protocol: A retrospective study.

    Science.gov (United States)

    Lameijer, Joost R C; Verboom, Frederik; Grefkens, Joost; Jansen, Joris

    2016-10-01

    Local infiltration analgesia (LIA) during total knee arthroplasty has been shown to give statistically significant reduction in post-operative pain. The effects of using high volumes of ropivacaine combined with adrenaline as LIA on cardiovascular parameters in knee replacement have not been described before. The objective of this study was to investigate the cardiovascular safety of ropivacaine as part of high volume local infiltration analgesia (LIA) in total knee replacement surgery. This is a retrospective observational comparative cohort study conducted in two independent cohorts, one treated without and one treated with a local infiltration analgesia protocol, containing a total of 744 patients with a mean age of 68years (42 to 89) and 68years (21 to 88) respectively with a follow-up of 12months. No statistical difference in bradycardia during surgery, post-operative cardiovascular complications, and mortality was found after use of LIA. A statistically significant lower incidence of hypotension was found in the LIA group (Plocal infiltration analgesia during total knee replacement surgery. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Mammalian Toxicology Testing: Problem Definition Study, AMTR Protocol/Pricing Report.

    Science.gov (United States)

    1981-04-01

    excretory . behavioral or other activity. as well as signs indicating an adverse effect on the central nervous system 54 ic Systcm, li". PROTOCOL Test No...A0-A112 832 LIFE SYSTEMS INC CLEVELAND OH F/G 6/20 MAMMA LIAN TOXICOLOGY TESTING: PROBLEM DEFINITION STUDY, AMTR PR--ETC(U) UNCLASSIFIED LSI-TR-477...S. PERFORMING ORGANIZATION NAME AND ADDRESS 10. PROGRAM ELEMENT. PROJECT, TASK AREA & WORK UNIT NUMBERS LIEL SYSTEMS , INC. ..... 24755 Highpoint Road

  1. 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

  2. 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.

  3. Two years of experience with robot-assisted anti-reflux surgery: A retrospective cohort study.

    Science.gov (United States)

    Jensen, Jonas Sanberg; Antonsen, Henning Kold; Durup, Jesper

    2017-03-01

    Robot-assisted anti-reflux surgery (RAAS) is an alternative to conventional laparoscopic anti-reflux surgery (CLAS). The purpose of this study was to evaluate initial Danish experiences with robot-assisted anti-reflux surgery compared to conventional laparoscopic anti-reflux surgery incorporating follow-up and evaluation of possible learning curve. Patients undergoing primary RAAS or CLAS at The Department of Surgery A, Odense University Hospital and The Department of General Surgery, Kolding Hospital from April 2013 to April 2015 was included. Demographic data, comorbidity, docking time, length of procedure, type of fundic wrap as well as perioperative complications and postoperative complications, need for reoperation or any upper gastrointestinal endoscopy from surgery to final follow-up was retrospectively extracted from patient records. 103 patients were included in this study. 39 patients underwent RAAS and 64 patients underwent CLAS. There were no statistically significant differences in demographic data or comorbidities except distribution of heart disease (RAAS: 5.1% vs. CLAS: 18.8%, p = 0.05) and previous abdominal surgery (RAAS: 28.2% vs. CLAS: 48.4%, p = 0.04). Duration of surgery was significantly increased in patients undergoing RAAS (RAAS: 135 ± 27 min vs. CLAS: 86 ± 19 min, p surgery as robot-assisted procedures neither intra-operatively nor at follow-up. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  4. 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

  5. A follow-up study of heroin addicts (VEdeTTE2: study design and protocol

    Directory of Open Access Journals (Sweden)

    Lampis Fabio

    2007-03-01

    Full Text Available Abstract Background In Italy, a large cohort study (VEdeTTE1 was conducted between 1998–2001 to evaluate the effectiveness of treatments in reducing mortality and increasing treatment retention among heroin addicts. The follow-up of this cohort (VEdeTTE2 was designed to evaluate the effectiveness of treatments on long-term outcomes, such as rehabilitation and social re-integration. The purpose of this paper is to describe the protocol of the VEdeTTE2 study, and to present the results of the pilot study carried out to assess the feasibility of the study and to improve study procedures. Methods The source population for the VEdeTTE2 study was the VEdeTTE1 cohort, from which a sample of 2,200 patients, traced two or more years after enrolment in the cohort, were asked to participate. An interview investigates drug use; overdose; family and social re-integration. Illegal activity are investigated separately in a questionnaire completed by the patient. Patients are also asked to provide a hair sample to test for heroin and cocaine use. Information on treatments and HIV, HBV and HCV morbidity are obtained from clinical records. A pilot phase was planned and carried out on 60 patients. Results The results of the pilot phase pointed out the validity of the procedures designed to limit attrition: the number of traced subjects was satisfactory (88%. Moreover, the pilot phase was very useful in identifying possible causes of delays and attrition, and flaws in the instruments. Improvements to the procedures and the instruments were subsequently implemented. Sensitivity of the biological test was quite good for heroin (78% but lower for cocaine (42.3%, highlighting the need to obtain a hair sample from all patients. Conclusion In drug addiction research, studies investigating health status and social re-integration of subjects at long-term follow-up are lacking. The VEdeTTE2 study aims to investigate these outcomes at long-term follow-up. Results of the

  6. 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.

  7. 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

  8. Prospective observational study comparing traditional laparoscopy and three-dimensional laparoscopy in gynecologic surgery.

    Science.gov (United States)

    Lara-Domínguez, Maria D; López-Jiménez, Araceli; Grabowski, Jacek P; Arjona-Berral, Jose E; Zapardiel, Ignacio

    2017-03-01

    To compare perioperative details among patients who underwent gynecologic surgery between traditional laparoscopy and three-dimensional laparoscopy. The present prospective non-randomized study enrolled all consecutive patients diagnosed with gynecologic pathology who underwent laparoscopic surgery at Reina Sofia Hospital, Cordoba, Spain between January 1 and April 30, 2014. Perioperative data, adverse events, and patient satisfaction were compared between patients who underwent treatment with two-dimensional and three-dimensional laparoscopic surgery techniques. The study enrolled 60 consecutive patients; 31 (52%) patients who underwent three-dimensional surgery and 29 (48%) who underwent traditional two-dimensional surgery. No significant differences were observed in the adverse-event rate, operating time, or perioperative parameters. A higher use of sealing devices was recorded among patients who underwent three-dimensional laparoscopy (P=0.021). No difference was recorded in patient satisfaction between the two patient groups. Although there was no impact on surgical outcomes, three-dimensional surgery could give a more accurate view of the surgical field. Performing three-dimensional surgery could be beneficial for more complex procedures although further comparative studies are required to investigate this hypothesis. © 2016 International Federation of Gynecology and Obstetrics.

  9. Femoral component rotation in patellofemoral joint replacement: a study protocol for a prospective observational study.

    Science.gov (United States)

    Westerbeek, Robin E; Derks, Rosalie P H; Zonneveld, Bas J G L; van Jonbergen, Hans-Peter W

    2015-01-01

    Patellofemoral joint replacement is a successful treatment option for isolated patellofemoral osteoarthritis. The short and mid-term outcomes are related to malposition and unexplained pain. Whether external rotation of the femoral component in isolated patellofemoral joint replacement is required is unclear. The primary aim of this study is to determine the CT-measured femoral component rotation of patellofemoral joint replacement relative to the transepicondylar axis. The secondary aim is to correlate the CT-measured femoral component rotation with the clinical outcomes at 1-year follow-up as assessed with the KOOS questionnaire. We designed a prospective observational study with medical research ethics committee and institutional review board approval. A total of 40 patients who will be treated with patellofemoral joint replacement for isolated patellofemoral osteoarthritis will be included. Intra-operatively, rotation of the femoral component will be assessed using anatomical landmarks including the epicondylar axis, Whiteside's line, and lower leg axis. The aim is to insert the femoral component between 3 and 6 degrees external rotation relative to the transepicondylar axis. Two experienced musculoskeletal radiologists will measure the angle between the transepicondylar axis and the femoral component, two to three days after surgery. The primary outcome is the CT-based femoral component rotation of the prosthesis relative to the transepicondylar axis. The secondary outcome is the patient reported KOOS questionnaire at 1-year follow-up. Successful completion of this study will provide data on the actual amount of femoral component rotation in patellofemoral joint replacement, and its relationship with clinical results. (Netherlands Trial Register NTR4175).

  10. 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...

  11. 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

  12. Estimations of isoprenoid emission capacity from enclosure studies: measurements, data processing, quality and standardized measurement protocols

    Science.gov (United States)

    Niinemets, Ü.; Kuhn, U.; Harley, P. C.; Staudt, M.; Arneth, A.; Cescatti, A.; Ciccioli, P.; Copolovici, L.; Geron, C.; Guenther, A.; Kesselmeier, J.; Lerdau, M. T.; Monson, R. K.; Peñuelas, J.

    2011-08-01

    The capacity for volatile isoprenoid production under standardized environmental conditions at a certain time (ES, the emission factor) is a key characteristic in constructing isoprenoid emission inventories. However, there is large variation in published ES estimates for any given species partly driven by dynamic modifications in ES due to acclimation and stress responses. Here we review additional sources of variation in ES estimates that are due to measurement and analytical techniques and calculation and averaging procedures, and demonstrate that estimations of ES critically depend on applied experimental protocols and on data processing and reporting. A great variety of experimental setups has been used in the past, contributing to study-to-study variations in ES estimates. We suggest that past experimental data should be distributed into broad quality classes depending on whether the data can or cannot be considered quantitative based on rigorous experimental standards. Apart from analytical issues, the accuracy of ES values is strongly driven by extrapolation and integration errors introduced during data processing. Additional sources of error, especially in meta-database construction, can further arise from inconsistent use of units and expression bases of ES. We propose a standardized experimental protocol for BVOC estimations and highlight basic meta-information that we strongly recommend to report with any ES measurement. We conclude that standardization of experimental and calculation protocols and critical examination of past reports is essential for development of accurate emission factor databases.

  13. Variable impact of complications in general surgery : A prospective cohort study

    NARCIS (Netherlands)

    Bosma, E.; Veen, E.J.; de Jongh, M.A.; Roukema, J.A.

    2012-01-01

    Background: Registering complications is important in surgery, since complications serve as outcome measures and indicators of quality of care. Few studies have addressed the variation in severity and consequences of complications. We hypothesized that complications show much variation in

  14. Factors associated with reoperation in hypospadias surgery — A nationwide, population-based study

    Directory of Open Access Journals (Sweden)

    Yu-Chuan Lu

    2017-03-01

    Conclusion: The type of hypospadias and the surgeon caseload volume were significantly associated with the need for secondary hypospadias surgery. The findings of this study provide important information on the outcomes of hypospadias repair for parents and specialists.

  15. 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.

  16. Reoperation rate after surgery for lumbar spinal stenosis without spondylolisthesis: a nationwide cohort study.

    Science.gov (United States)

    Kim, Chi Heon; Chung, Chun Kee; Park, Choon Seon; Choi, Boram; Hahn, Seokyung; Kim, Min Jung; Lee, Kun Sei; Park, Byung Joo

    2013-10-01

    Lumbar spinal stenosis is one of the most common degenerative spine diseases. Surgical options are largely divided into decompression only and decompression with arthrodesis. Recent randomized trials showed that surgery was more effective than nonoperative treatment for carefully selected patients with lumbar stenosis. However, some patients require reoperation because of complications, failure of bony fusion, persistent pain, or progressive degenerative changes, such as adjacent segment disease. In a previous population-based study, the 10-year reoperation rate was 17%, and fusion surgery was performed in 10% of patients. Recently, the lumbar fusion surgery rate has doubled, and a substantial portion of the reoperations are associated with a fusion procedure. With the change in surgical trends, the longitudinal surgical outcomes of these trends need to be reevaluated. To provide the longitudinal reoperation rate after surgery for spinal stenosis and to compare the reoperation rates between decompression and fusion surgeries. Retrospective cohort study using national health insurance data. A cohort of patients who underwent initial surgery for lumbar stenosis without spondylolisthesis in 2003. The primary end point was any type of second lumbar surgery. Cox proportional hazards regression modeling was used to compare the adjusted reoperation rates between decompression and fusion surgeries. A national health insurance database was used to identify a cohort of patients who underwent an initial surgery for lumbar stenosis without spondylolisthesis in 2003; a total of 11,027 patients were selected. Individual patients were followed for at least 5 years through their encrypted unique resident registration number. After adjusting for confounding factors, the reoperation rates for decompression and fusion surgery were compared. Fusion surgery was performed in 20% of patients. The cumulative reoperation rate was 4.7% at 3 months, 7.2% at 1 year, 9.4% at 2 years, 11.2% at

  17. 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.

  18. 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

  19. Are Burnt-out Doctors Prone to Seek Cosmetic Surgery? A Cross-Sectional Study.

    Science.gov (United States)

    Milothridis, Panagiotis; Pavlidis, Leonidas; Panagopoulou, Efharis

    2017-12-01

    Studies have so far examined several psychosocial factors associated with an interest in aesthetic plastic surgery. Among them, gender, teasing history, marital status, education, social networks and body dysmorphic disorders are all predictors of interest in cosmetic surgery. Given the fact that professional status can influence health-related attitudes, our objective was firstly to identify if medical professionals are more likely to express interest in plastic surgery compared to non-medical professionals. Secondary, given the high rate of burn-out among physicians, the study examined the association between burn-out and interest in plastic surgery. One hundred doctors and 100 non-medical professionals with a University degree completed a questionnaire regarding their interest in undergoing cosmetic plastic surgery, in particular minimally invasive procedures and 9 specific aesthetic operations. Additionally, doctors completed the standardized Maslach burn-out inventory. The sample consisted of 40.5% men and 59.5% women (mean age = 34 years). Data analysis using the Mann-Whitney test revealed that women and medical professionals were more likely to express interest in cosmetic plastic surgery (p cosmetic procedures and burn-out syndrome (r = 0.53 p surgery may be attributed to their familiarity with invasive procedures. The correlation between burn-out syndrome and interest in cosmetic surgery could reveal a way of coping with the work demands. Results of this study can be used for the development of clinical tools for the screening of patients for elective cosmetic surgery. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  20. 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...

  1. 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

  2. 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.

  3. Articaine versus lidocaine for third molar surgery: A randomized clinical study

    Science.gov (United States)

    Santos, Thiago-de-S; Santos, Jadson-A.; Maia, Marcelo-C; Mendonça, Carla-G

    2012-01-01

    Objective: Pain reduction has been the subject of continuous research in the field of oral and maxillofacial surgery since postoperative pain with ranging of intensity and duration may affects the patient submitted in an oral surgical procedure. The aim of present study was to compare the analgesic effectiveness between two different anesthetic solutions (articaine and lidocaine) in third molar surgery. Study Design: A prospective, randomized and clinical study with patients submitted to third molar surgery at two distinct times. The visual analogue scale, the McGill Pain Questionnaire and the analgesic consumption record were used to measure the pain after each surgical time. Results: Duration of surgery, latency, the amount of anesthetic used and analgesic consumption showed clinical differences with highlights of articaine, though statistical significance was not observed (Pthird molar. PMID:22157664

  4. 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)

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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 .

  11. Pregnancy after diabetes obesity surgery (PADOS): Qualitative study of pre-pregnancy care.

    Science.gov (United States)

    Shawe, J; Cooke, D; Hart, K; McGowan, B M; Pring, C; Subramanian, D; Whyte, M

    2014-07-01

    Half of all bariatric surgical procedures are in women of childbearing age. Surgery may improve fertility yet exacerbate nutritional deficiencies, that may be disadvantageous to the fetus. A frequently encountered subgroup of obese women have type 2 diabetes. The health risks, to both mother and child, of diabetes in pregnancy are well described including 4.7× risk of stillbirth and 2× risk of congenital abnormality. What is not clear is whether bariatric surgery mitigates or complicates the health consequences of women with obesity and diabetes in pregnancy. In addition the influence of the type of surgery, the optimal interval between surgery and conception and evidence based preconception recommendations are unknown. This study complements wider research aiming to inform optimal management of this patient population. Obese diabetic women require clear guidance regarding pregnancy planning after surgery. This study will develop an understanding of the barriers and facilitators (psychological, behavioural, attitudinal and nutritional) to achieving effective pre-pregnancy health and care in women with type 2 diabetes who have undergone metabolic surgery. Currently women's perception of fertility issues and risks after bariatric surgery is unknown and thus a qualitative interpretive paradigm was chosen. Interviews with the target population will explore decision-making processes; experience regarding metabolic surgery and perceived pregnancy risk. Interviews with a broad range of health professionals involved in bariatric care will include rationale for selected surgical procedure and post surgery referral processes e.g. contraceptive care. This will advance understanding of how to provide targeted support and monitoring. Copyright © 2014.

  12. 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 burnout scores (disengagement, P Burnout Inventory exhaustion (P = 0.02), and USMLE step 1 and 2 scores (P = 0.007 and 0.0001, respectively). Residents who perform higher on the ABSITE have a regular study schedule throughout the year, report less burnout because of exhaustion, study away from home, and have shown success in prior standardized tests. Further study is needed to determine the effects of burnout on clinical duties, career advancement, and satisfaction. Copyright © 2017

  13. 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

  14. 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

  15. Exploring interprofessional practices in rapid response systems: a case study protocol.

    Science.gov (United States)

    Allen, Emily; Jackson, Debra; Elliott, Doug

    2015-01-01

    To describe the development of a proposed case study protocol investigating interprofessional relationships in a rapid response system (RRS) in a socioculturally complex clinical environment. Suboptimal care of deteriorating ward patients remains a concern for many acute healthcare organisations. Despite the advent of RRSs, emergency response teams are not always used to their full potential. How and why interprofessional relationships influence practices associated with the care and management of ward patients at risk of clinical deterioration requires investigation. Theoretical and empirical literature describing case study research and RRSs. Review methods An integrative review approach of the literature, focusing on key terms relating to 'case study research' and 'rapid response system', provided context and informed development of the study protocol. A single-site mixed-method instrumental case study protocol was developed using methodological triangulation and a multi-level model to examine interprofessional relationships between a broad range of stakeholders. Concurrent data collection and analysis will occur using document review of clinical scenarios, non-participant observations and semi-structured interviews. Case study research is an effective method for investigating socioculturally complex clinical environments. A strength of this approach is the flexibility in the choice of methods, which allows the researcher to build the design most suitable for the subjects or phenomena being investigated. Although this flexibility may be considered a potential weakness, rigour can be achieved by application of the strategies described. Findings from this research will provide rich descriptive insights into RRS relationships and healthcare professional practices during day-to-day management of acute ward patients at risk of or experiencing clinical deterioration. Description of this structured case study research approach will also inform other researchers.

  16. A pilot study on the biomechanical assessment of obstructive sleep apnea pre and post bariatric surgery.

    Science.gov (United States)

    Al-Jumaily, Ahmed M; Ashaat, Sherif; Martin, Bryn; Pohle-Krauza, Rachael; Krauza, Matthew; Dan, Adrian; Zografakis, John

    2018-04-01

    Obesity is a major risk factor for obstructive sleep apnea patients. In obese patients the severity of this risk can be reduced by bariatric surgery. This pilot study investigates the perioperative effects of bariatric surgery on obstructive sleep apnea and on the physical and biomechanical characteristics of the upper airway. Polysomnography and computer tomography data for 10 morbid obese patients promoted for bariatric surgery were conducted before surgery and at 6 and 12 months postoperatively for assessment of the oropharyngeal anatomy, and subsequent three-dimensional modelling of the airway. Mean values for the apnea/hypopnea index and body mass index significantly reduced after surgery. To combine the effect of changes in the upper airway volume and body mass index, a new volume body mass index is introduced. This index increases with a successful bariatric surgery. Although bariatric surgery leads to an effective weight reduction for all age groups, for obstructive sleep apnea patients it may be effective for middle age, less effective for 50-60 years, and further less effective for patients over the age of 60 years. Copyright © 2018 Elsevier B.V. All rights reserved.

  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. 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

  20. Weight Status Measures Collected in the Healthy Communities Study: Protocols and Analyses.

    Science.gov (United States)

    Sroka, Christopher J; McIver, Kerry L; Sagatov, Robyn D F; Arteaga, S Sonia; Frongillo, Edward A

    2015-10-01

    The Healthy Communities Study is one of the largest studies to assess the relationship between characteristics of community programs and policies to prevent childhood obesity and obesity-related outcomes. The purpose of this paper is to describe the protocol that was developed for collecting the anthropometric data for the study and the procedures for analyzing the data. Data were collected from 2013 to 2015 and analyses will be completed by mid-2016. During in-home visits, Healthy Communities Study staff collected height, weight, and waist circumference measurements from child participants and height and weight measurements from adult participants. The protocol for obtaining these measurements was adapted from the protocol used by the National Health and Nutrition Examination Survey, with modifications to accommodate assessments conducted in homes rather than in a Mobile Examination Center. In addition to anthropometric data from in-home visits, the Healthy Communities Study collected retrospective height and weight measurements from the medical records of child participants. These data were used to calculate trajectories of BMI and BMI z-scores. The study implemented procedures for ensuring the accuracy of the in-home measurements and abstracted medical data. These procedures included automatically checking the ranges on entered data, reviewing data for end-digit patterns, and abstracting selected medical records using two independent abstractors to assess agreement. The collection of longitudinal height and weight measures will allow researchers to address several pressing questions related to how characteristics of community programs and policies are associated with obesity-related outcomes among children. Copyright © 2015 American Journal of Preventive Medicine. All rights reserved.

  1. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery

    DEFF Research Database (Denmark)

    Bulut, O; Aslak, K K; Levic, K

    2015-01-01

    BACKGROUND: Potential benefits of single-port laparoscopic surgery may include improved cosmetic results, less postoperative pain, surgical trauma and faster recovery. Results of randomized prospective studies with a focus on single-port rectal surgery have not yet been presented. The aim...... of the present study was to compare single-port and conventional laparoscopic surgery for rectal cancer in terms of short-term outcomes including postoperative pain and trauma-induced changes in certain bioactive substances. METHODS: Patients with non-metastasized rectal cancer were prospectively randomized...... to single-port (n = 20) or conventional laparoscopic rectal surgery (n = 20). Postoperative pain was assessed at rest, at coughing and during mobilization, with a numeric pain ranking score and was recorded at 6 h after the operation and subsequently every morning daily for 4 days. Levels of C...

  2. Where Words Fail, Music Speaks: A Mixed Method Study of an Evidence-Based Music Protocol.

    Science.gov (United States)

    Daniels, Ruby A; Torres, David; Reeser, Cathy

    2016-01-01

    Despite numerous studies documenting the benefits of music, hospice social workers are often unfamiliar with evidence-based music practices that may improve end of life care. This mixed method study tested an intervention to teach hospice social workers and chaplains (N = 10) an evidence-based music protocol. Participants used the evidence-based practice (EBP) for 30 days, recording 226 journal entries that described observations of 84 patients and their families. There was a significant increase in EBP knowledge (35%). Prompting behavioral and emotional responses, music was described frequently as a catalyst that facilitated deeper dialogue between patients, families, social workers, and chaplains.

  3. Effects of two different post-surgical protocols including either 0.05 % chlorhexidine herbal extract or 0.1 % chlorhexidine on post-surgical plaque control, early wound healing and patient acceptance following standard periodontal surgery and implant placement.

    Science.gov (United States)

    Laugisch, Oliver; Ramseier, Christoph A; Salvi, Giovanni E; Hägi, Tobias T; Bürgin, Walter; Eick, Sigrun; Sculean, Anton

    2016-11-01

    The aim of this study was to compare early wound healing, tooth staining and patient acceptance with two different post-surgical maintenance protocols. Forty patients scheduled for flap surgery to treat periodontal pockets or accommodate dental implants were randomly assigned to receive the following two different post-surgical maintenance protocols: (a) 2 weeks rinsing with a 0.05 % chlorhexidine digluconate (CHX)/herbal extract combination (test) or (b) a 0.1 % CHX solution (control). Early wound healing was evaluated clinically and immunologically. Tooth staining and patient acceptance were assessed by means of visual analogue scale (VAS). Both groups presented with comparable wound healing profiles. No statistically significant differences were observed between the two protocols regarding early wound healing and plaque index (p > 0.05). However, in the control group, statistically significantly more patients felt discomfort due to tooth staining (p = 0.0467). Compared with patients from the test group, patients in the control group reported statistically significant more irritation of taste at week 1 (p = 0.0359) and at week 2 (p = 0.0042). The present findings indicate that the two CHX protocols resulted in comparable healing and inhibition of plaque formation. Tooth staining and subjective discomfort related to irritation of taste were more frequent in the control group. A post-operative protocol including 0.05 % CHX/herbal extract may have the potential to improve patient compliance during post-operative maintenance.

  4. Fast-track surgery in India.

    Science.gov (United States)

    Nanavati, Aditya J; Nagral, Sanjay; Prabhakar, Subramaniam

    2014-01-01

    Fast-track surgery or 'enhanced recovery after surgery' or 'multimodal rehabilitation after surgery' is a form of protocol-based perioperative care programme. It is an amalgamation of evidence-based practices that have been proven to improve patient outcome independently and exert a synergistic effect when applied together. The philosophy is to treat the patient's pathology with minimal disturbance to the physiology. Several surgical subspecialties have now adopted such protocols with good results. The role of fast-track surgery in colorectal procedures has been well demonstrated. Its application to other major abdominal surgical procedures is not as well defined but there are encouraging results in the few studies conducted. There has been resistance to several aspects of this programme among gastrointestinal and general surgeons. There is little data from India in the available literature on the application of fast-tracking in gastrointestinal surgery. In a country such as India the existing healthcare structure stands to gain the most by widespread adoption of fast-track methods. Early discharge, early ambulation, earlier return to work and increased hospital efficiency are some of the benefits. The cost gains derived from this programme stand to benefit the patient, doctor and government as well. The practice and implementation of fast-track surgery involves a multidisciplinary team approach. It requires policy formation at an institutional level and interdepartmental coordination. More research is required in areas like implementation of such protocols across India to derive the maximum benefit from them. Copyright 2014, NMJI.

  5. 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

  6. Spouses’ involvement in older patients’ fast-track programmes during total hip replacement using case management intervention. A study protocol of the SICAM-trial

    DEFF Research Database (Denmark)

    Berthelsen, Connie Bøttcher; Kristensson, Jimmie

    2015-01-01

    Aim To present the protocol of a two-group quasi-experimental study of spouses’ involvement through case management (The SICAM-trial) in older patients’ fast-track programmes during total hip replacement. Background Patients in fast-track programmes are required to take an active part...... and subsequently include the intervention group to avoid contamination of the control group. A case manager will be recruited to perform the case management intervention. Data will be collected from both groups at baseline, 2 weeks and 3 months after surgery. Outcome measures for patients include: functional...... to education of the health professionals in their need to include relatives in fast-track programmes. The study was funded by the Novo Nordisk Foundation and the Regional Health Scientific Foundation of Sealand....

  7. Weight regain among women after metabolic and bariatric surgery: a qualitative study in Brazil

    Directory of Open Access Journals (Sweden)

    Ataliba de Carvalho Jr.

    2014-09-01

    Full Text Available INTRODUCTION: Due to the increased number of bariatric surgeries over the years, aspects contributing or hindering the achievement of outcomes, among them weight regain, have acquired increased significance. Psychological factors directly influence on this unwanted situation, but there are few studies and controversies about the degree of participation of these factors. We propose a qualitative investigation to analyze the meanings of weight regain after surgery among women and how these factors influence this outcome.METHOD: This study uses the clinical-qualitative method, by means of a semi-structured interview with open questions in an intentional sample, closed by saturation, with eight women who underwent surgery at the Bariatric Surgery Outpatient Clinic of Hospital das Clínicas, Universidade Estadual de Campinas (UNICAMP, in the state of São Paulo, Brazil.RESULTS: A feeling of defeat and failure emerges with weight regain, which contributes to social isolation; there is no regret, but gratitude for the surgery; among patients, there is a sense of feeling rejected greater than a rejection that actually exists.CONCLUSION: We found out the need for further qualitative studies that help the health team to better understand the dynamic psychological factors involved in the meaning of weight regain after bariatric surgery among women, in order to adopt appropriate conducts to deal with this problem.

  8. A comparative study of routing protocols of heterogeneous wireless sensor networks.

    Science.gov (United States)

    Han, Guangjie; Jiang, Xu; Qian, Aihua; Rodrigues, Joel J P C; Cheng, Long

    2014-01-01

    Recently, heterogeneous wireless sensor network (HWSN) routing protocols have drawn more and more attention. Various HWSN routing protocols have been proposed to improve the performance of HWSNs. Among these protocols, hierarchical HWSN routing protocols can improve the performance of the network significantly. In this paper, we will evaluate three hierarchical HWSN protocols proposed recently--EDFCM, MCR, and EEPCA--together with two previous classical routing protocols--LEACH and SEP. We mainly focus on the round of the first node dies (also called the stable period) and the number of packets sent to sink, which is an important aspect to evaluate the monitoring ability of a protocol. We conduct a lot of experiments and simulations on Matlab to analyze the performance of the five routing protocols.

  9. Optional Protocol on the Sale of Children, Child Prostitution and Child Pornography: A Study on Iran's Accession to the Protocol

    Directory of Open Access Journals (Sweden)

    Seyyed Masoud Noori

    2007-03-01

    Full Text Available Reviewing this Protocol and comparing it with Iranian law, this article seeks to respond to the question of the possible consequences of Iran's accession to the Protocol. Examining the content of the Protocol shows that Iran's accession not only is not in contrary to moral principles, the statutes and the practical procedures of Iranian Government; but it will rather promote Iranian position in the international sphere. بسیاری از پیمان‌نامه‌های مهم بین‏المللی دارای اسناد ضمیمه‌ای به نام پروتکل هستند که موضوعات سند اصلی را تشریح می‌کنند. برای کنوانسیون حقوق کودک نیز که بیش از هر سند بین‌المللی به امضای کشورها رسیده، دو پروتکل الحاقی تدوین شده است: یکی دربارة بکارگیری کودکان در مناقشات مسلّحانه و دیگری دربارة خرید و فروش، خود فروشی و هرزه‌نگاری کودکان. مجلس شورای اسلامی الحاق جمهوری اسلامی ایران به پیمان‌نامة حقوق کودک را تصویب کرده است. یکی از توصیه‌های کمیتة حقوق کودک هنگام بررسی دومین گزارش ادواری ایران این بود که ایران پروتکل‌های مذکور را تصویب کند. مجلس شورای اسلامی در جلسه 9/5/1386 الحاق دولت ایران به پروتکل مربوط به فروش، فحشاء و هرزه‌نگاری کودکان را تصویب کرده است. مقاله حاضر با مروری بر این پروتکل و مطالعة تطبیقی آن با قوانین موضوعة ایران، در صدد است این پرسش را پاسخ گوید که اجابت درخواست کمیتة حقوق کودک و امضای آن پروتکل توسط دولت ایران، چه نتایجی در

  10. Safe Surgery Checklist, Patient Safety, Teamwork, and Responsibility—Coequal Demands? A Focus Group Study

    Science.gov (United States)

    Willassen, Elin Thove; Jacobsen, Inger Lise Smith; Tveiten, Sidsel

    2018-01-01

    The use of World Health Organization’s (WHO’s) Safe Surgery checklist is an established practice worldwide and contributes toward ensuring patient safety and collaborative teamwork. The aim of this study was to elucidate operating room nurses’ and operating room nursing students’ experiences and opinions about execution of and compliance with checklists. We chose a qualitative design with semistructured focus group discussions. Qualitative content analysis was conducted. Two main themes were identified; the Safe Surgery checklists have varied influence on teamwork and patient safety, and taking responsibility for executing the checks on the Safe Surgery checklist entails practical and ethical challenges. The experiences and opinions of operating room nurses and their students revealed differences of practices and attitudes toward checklist compliance and the intentions of checklist procedures. These differences are related to cultural and professional distances between team members and their understanding of the Safe Surgery checklists as a tool for patient safety. PMID:29623287

  11. Radiation Dose Index of Renal Colic Protocol CT Studies in the United States

    Science.gov (United States)

    Lukasiewicz, Adam; Bhargavan-Chatfield, Mythreyi; Coombs, Laura; Ghita, Monica; Weinreb, Jeffrey; Gunabushanam, Gowthaman; Moore, Christopher L.

    2016-01-01

    Purpose To determine radiation dose indexes for computed tomography (CT) performed with renal colic protocols in the United States, including frequency of reduced-dose technique usage and any institutional-level factors associated with high or low dose indexes. Materials and Methods The Dose Imaging Registry (DIR) collects deidentified CT data, including examination type and dose indexes, for CT performed at participating institutions; thus, the DIR portion of the study was exempt from institutional review board approval and was HIPAA compliant. CT dose indexes were examined at the institutional level for CT performed with a renal colic protocol at institutions that contributed at least 10 studies to the registry as of January 2013. Additionally, patients undergoing CT for renal colic at a single institution (with institutional review board approval and informed consent from prospective subjects and waiver of consent from retrospective subjects) were studied to examine individual renal colic CT dose index patterns and explore relationships between patient habitus, demographics, and dose indexes. Descriptive statistics were used to analyze dose indexes, and linear regression and Spearman correlations were used to examine relationships between dose indexes and institutional factors. Results There were 49 903 renal colic protocol CT examinations conducted at 93 institutions between May 2011 and January 2013. Mean age ± standard deviation was 49 years ± 18, and 53.9% of patients were female. Institutions contributed a median of 268 (interquartile range, 77–699) CT studies. Overall mean institutional dose-length product (DLP) was 746 mGy · cm (effective dose, 11.2 mSv), with a range of 307–1497 mGy · cm (effective dose, 4.6–22.5 mSv) for mean DLPs. Only 2% of studies were conducted with a DLP of 200 mGy · cm or lower (a “reduced dose”) (effective dose, 3 mSv), and only 10% of institutions kept DLP at 400 mGy · cm (effective dose, 6 mSv) or less in at

  12. Study protocol. A prospective cohort study of unselected primiparous women: the pregnancy outcome prediction study

    Directory of Open Access Journals (Sweden)

    White Ian R

    2008-11-01

    Full Text Available Abstract Background There have been dramatic changes in the approach to screening for aneuploidy over the last 20 years. However, the approach to screening for other complications of pregnancy such as intra-uterine growth restriction, pre-eclampsia and stillbirth remains largely unchanged. Randomised controlled trials of routine application of high tech screening methods to the general population have generally failed to show improvement in outcome. We have previously reviewed this and concluded it was due, in large part, to poor performance of screening tests. Here, we report a study design where the primary aim is to generate clinically useful methods to screen women to assess their risk of adverse pregnancy outcome. Methods/design We report the design of a prospective cohort study of unselected primiparous women recruited at the time of their first ultrasound scan. Participation involves serial phlebotomy and obstetric ultrasound at the dating ultrasound scan (typically 10–14 weeks, 20 weeks, 28 weeks and 36 weeks gestation. In addition, maternal demographic details are obtained; maternal and paternal height are measured and maternal weight is serially measured during the pregnancy; maternal, paternal and offspring DNA are collected; and, samples of placenta and membranes are collected at birth. Data will be analysed as a prospective cohort study, a case-cohort study, and a nested case-control study. Discussion The study is expected to provide a resource for the identification of novel biomarkers for adverse pregnancy outcome and to evaluate the performance of biomarkers and serial ultrasonography in providing clinically useful prediction of risk.

  13. 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

  14. Computerized method of visual acuity testing: adaptation of the amblyopia treatment study visual acuity testing protocol.

    Science.gov (United States)

    Moke, P S; Turpin, A H; Beck, R W; Holmes, J M; Repka, M X; Birch, E E; Hertle, R W; Kraker, R T; Miller, J M; Johnson, C A

    2001-12-01

    To report a computerized method for determining visual acuity in children using the Amblyopia Treatment Study visual acuity testing protocol. A computerized visual acuity tester was developed that uses a programmed handheld device that uses the Palm operating system (Palm, Inc, Santa Clara, California). The handheld device communicates with a personal computer running a Linux operating system and 17-inch monitor. At a test distance of 3 m, single letters can be displayed from 20/800 to 20/12. A C program on the handheld device runs the Amblyopia Treatment Study visual acuity testing protocol. Using this method, visual acuity was tested in both the right and left eyes, and then the testing was repeated in 156 children age 3 to 7 years at four clinical sites. Test-retest reliability was high (r =.92 and 0.95 for and right and left eyes, respectively), with 88% of right eye retests and 94% of left eye retests within 0.1 logarithm of minimal angle of resolution (logMAR) units of the initial test. The 95% confidence interval for an acuity score was calculated to be the score +/- 0.13 logMAR units. For a change between two acuity scores, the 95% confidence interval was the difference +/- 0.19 logMAR units. We have developed a computerized method for measurement of visual acuity. Automation of the Amblyopia Treatment Study visual acuity testing protocol is an effective method of testing visual acuity in children 3 to 7 years of age.

  15. The SCIentinel study - prospective multicenter study to define the spinal cord injury-induced immune depression syndrome (SCI-IDS) - study protocol and interim feasibility data

    Science.gov (United States)

    2013-01-01

    Background Infections are the leading cause of death in the acute phase following spinal cord injury and qualify as independent risk factor for poor neurological outcome (“disease modifying factor”). The enhanced susceptibility for infections is not stringently explained by the increased risk of aspiration in tetraplegic patients, neurogenic bladder dysfunction, or by high-dose methylprednisolone treatment. Experimental and clinical pilot data suggest that spinal cord injury disrupts the balanced interplay between the central nervous system and the immune system. The primary hypothesis is that the Spinal Cord Injury-induced Immune Depression Syndrome (SCI-IDS) is 'neurogenic’ including deactivation of adaptive and innate immunity with decreased HLA-DR expression on monocytes as a key surrogate parameter. Secondary hypotheses are that the Immune Depression Syndrome is i) injury level- and ii) severity-dependent, iii) triggers transient lymphopenia, and iv) causes qualitative functional leukocyte deficits, which may endure the post-acute phase after spinal cord injury. Methods/Design SCIentinel is a prospective, international, multicenter study aiming to recruit about 118 patients with acute spinal cord injury or control patients with acute vertebral fracture without neurological deficits scheduled for spinal surgery. The assessment points are: i) trauma. Assessment includes infections, concomitant injury, medication and neurological classification using American Spinal Injury Association impairment scale (AIS) and neurological level. Laboratory analyses comprise haematological profiling, immunophenotyping, including HLA-DR expression on monocytes, cytokines and gene expression of immune modulators. We provide an administrative interim analysis of the recruitment schedule of the trial. Discussion The objectives are to characterize the dysfunction of the innate and adaptive immune system after spinal cord injury and to explore its proposed 'neurogenic’ origin

  16. [Minimally invasive surgery for Chance fractures: Three case studies].

    Science.gov (United States)

    Blondel, B; Fuentes, S; Rambolarimanana, T; Metellus, P; Dufour, H

    2010-02-01

    Chance fractures are quite rare injuries that require surgical treatment in cases of spinal instability. Development of percutaneous and minimally invasive procedures can alter the management of such lesions, resulting in fewer related soft tissue lesions and morbidities. We present our experience with three patients who underwent percutaneous posterior osteosynthesis associated with a minimally invasive anterior graft for discal lesion. The first two cases presented fracture through the disc and osteosynthesis was done on a single mobile level. In the third case with a bony Chance fracture, we performed a short-segment fixation one level above and below the fractured vertebra. In all three cases, operative blood loss was minimal and clinical outcomes were favorable, with tolerable postoperative pain. Fusion and consolidation were visible for all the patients without loss of correction or implant failure. Percutaneous osteosynthesis and minimally invasive surgery can be an advantageous alternative for the management of Chance fractures. They allow early mobilization of the patient with less soft tissue trauma and morbidities associated with open procedures. Copyright 2009 Elsevier Masson SAS. All rights reserved.

  17. The Bakery Protocol: A Comparative Case-Study in Formal Verification

    NARCIS (Netherlands)

    Griffioen, D.; Korver, H.

    Groote and the second author verified (a version of) the Bakery Protocol in μCRL. Their process-algebraic verification is rather complex compared to the protocol. Now the question is: How do other verification techniques perform on this protocol? In this paper we present a new correctness proof by

  18. Pregnancy and foetal outcome after bariatric surgery: a review of recent studies.

    Science.gov (United States)

    Dalfrà, Maria Grazia; Busetto, Luca; Chilelli, Nino Cristiano; Lapolla, Annunziata

    2012-09-01

    It is well known that maternal obesity has adverse effects on the health of offspring, causing immediate and long-term morbidities. The various types of procedure coming under the heading of bariatric surgery have proved effective in preventing some maternal and foetal complications in morbidly obese pregnant women. This review aims to assess the role, the risks and the benefits of bariatric surgery for mothers and offspring. According to recent findings, pregnancy and neonatal outcomes in morbidly obese women who have undergone bariatric surgery depend to some extent on the type of surgery used. Maternal complications, nutritional defects and intestinal obstruction are more frequently reported after Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) than after laparoscopic adjustable gastric banding (LAGB) procedures, whereas caesarean section, preterm delivery and neonatal death are more commonly reported after RYGB than after LAGB. The authors of the only long-term follow-up study conducted on this subject reported that the rate of obesity in the children dropped by 52% after bariatric surgery for the mother, and the cases of severe obesity decreased by 45%. Data on pregnancy and bariatric surgery confirm that the procedure is more effective than dietary measures alone in morbidly obese women, and that pregnancy outcome is generally favorable after surgery. Some studies have indicated, nonetheless, that pregnancies after bariatric surgery are at higher risk: the women affected require special medical attention, particularly as concerns gastrointestinal symptoms and vitamin deficiencies, warranting nutritional/dietary counselling by a multidisciplinary team before, during and after pregnancy.

  19. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cerritelli, Francesco; Cicchitti, Luca; Martelli, Marta; Barlafante, Gina; Renzetti, Cinzia; Pizzolorusso, Gianfranco; Lupacchini, Mariacristina; D'Orazio, Marianna; Marinelli, Benedetta; Cozzolino, Vincenzo; Fusilli, Paola; D'Incecco, Carmine

    2015-03-08

    Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy

  20. Pilot study: Assessing the effect of continual position monitoring technology on compliance with patient turning protocols

    OpenAIRE

    Schutt, Suann Cirigliano; Tarver, Christine; Pezzani, Michelle

    2017-01-01

    Abstract Aim The study aim was to evaluate if continual patient position monitoring, taking into account self‐turns and clinician‐assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. Background While patient turning has clinical benefits, current models to help staff remember to turn patients, such as “turn clocks” and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2‐hr windo...

  1. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  2. Iatrogenic newborn weight loss: knowledge translation using a study protocol for your maternity setting

    Directory of Open Access Journals (Sweden)

    Woodend A Kirsten

    2011-08-01

    Full Text Available Abstract Background In our original study of newborn weight loss, we determined there were positive correlations among newborn weight loss, neonatal output, and the IV fluids mothers received before their babies' birth. Basically, an increase in maternal IV fluids is correlated to an increase in neonatal output and newborn weight loss. When assessing newborn weight change, our recommendation is to change baseline from birth weight to a weight measured at 24 hours. The purpose of this paper is to provide a protocol for clinicians to collect and analyze data from their own maternity site to determine if the newborns experience such an iatrogenic weight loss and to make decisions about how to assess newborn weight changes. Methods We recommend a prospective observational study with data collected about maternal fluids, neonatal output, and newborn weight measurements. The methods we suggest include specifics about recruitment, data collection, and data analysis. Discussion Quality assurance and research ethics considerations are described. We also share practical information that we learned from our original study. Ultimately, to encourage knowledge translation and research uptake, we provide a protocol and sound advice to do a research study in your maternity setting.

  3. Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols

    Energy Technology Data Exchange (ETDEWEB)

    Verger, Antoine; Karcher, Gilles [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Djaballah, Wassila [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Fourquet, Nicolas [Clinique Pasteur, Toulouse (France); Rouzet, Francois; Le Guludec, Dominique [AP-HP, Hopital Bichat, Department of Nuclear Medicine, Paris (France); INSERM U 773 Inserm and Denis Diderot University, Paris (France); Koehl, Gregoire; Roch, Veronique [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Imbert, Laetitia [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Centre Alexis Vautrin, Department of Radiotherapy, Vandoeuvre (France); Poussier, Sylvain [INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Fay, Renaud [INSERM, Centre d' Investigation Clinique CIC-P 9501, Nancy (France); Marie, Pierre-Yves [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); INSERM U961, Nancy (France); Hopital de Brabois, CHU-Nancy, Medecine Nucleaire, Vandoeuvre-les-Nancy (France)

    2013-03-15

    The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving {sup 201}Tl (n = 120) or {sup 99m}Tc-sestamibi injected at low dose at stress ({sup 99m}Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ({sup 99m}Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, {sup 201}Tl 92 %, {sup 99m}Tc-Low 86 %, {sup 99m}Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p < 0.001). This larger extent was mainly observed in 50 obese patients who were in the {sup 201}Tl or {sup 99m}Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 {+-} 101 kcounts) and dramatically enhanced with CZT SPECT (+279 {+-} 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT. (orig.)

  4. Estimations of isoprenoid emission capacity from enclosure studies: measurements, data processing, quality and standardized measurement protocols

    Directory of Open Access Journals (Sweden)

    Ü. Niinemets

    2011-08-01

    Full Text Available The capacity for volatile isoprenoid production under standardized environmental conditions at a certain time (ES, the emission factor is a key characteristic in constructing isoprenoid emission inventories. However, there is large variation in published ES estimates for any given species partly driven by dynamic modifications in ES due to acclimation and stress responses. Here we review additional sources of variation in ES estimates that are due to measurement and analytical techniques and calculation and averaging procedures, and demonstrate that estimations of ES critically depend on applied experimental protocols and on data processing and reporting. A great variety of experimental setups has been used in the past, contributing to study-to-study variations in ES estimates. We suggest that past experimental data should be distributed into broad quality classes depending on whether the data can or cannot be considered quantitative based on rigorous experimental standards. Apart from analytical issues, the accuracy of ES values is strongly driven by extrapolation and integration errors introduced during data processing. Additional sources of error, especially in meta-database construction, can further arise from inconsistent use of units and expression bases of ES. We propose a standardized experimental protocol for BVOC estimations and highlight basic meta-information that we strongly recommend to report with any ES measurement. We conclude that standardization of experimental and calculation protocols and critical examination of past reports is essential for development of accurate emission factor databases.

  5. Postpartum physiology, psychology and paediatric follow up study (P4 Study) - Study protocol.

    Science.gov (United States)

    Davis, Gregory K; Roberts, Lynne; Mangos, George; Henry, Amanda; Pettit, Franziska; O'Sullivan, Anthony; Homer, Caroline S E; Craig, Maria; Harvey, Samuel B; Brown, Mark A

    2016-10-01

    Women who have had hypertension in pregnancy are at greater risk of long term cardiovascular disease (CVD). Little is known about their cardiovascular risk postpartum or the effects on the woman's mental health and the outcomes of their infants. In this project we will study the physiological and psychological health of women and the physical health and development of their infants six months, two years and five years after birth. We will establish normal blood pressure (BP) and metabolic function for women who were normotensive in pregnancy and use these to assess women who had gestational hypertension (GH) or preeclampsia (PE). Women will be asked to participate if they have given birth in the preceding six months. They will be excluded if they had diabetes, hypertension, renal or other serious maternal disease prior to pregnancy or congenital anomaly in the pregnancy. We will recruit 292 women who were normotensive and their babies, 100 who had GH and 100 who had PE and their babies. They will be assessed at six months, two and five years after birth. At each assessment mothers will have their blood pressure (BP) assessed peripherally with a liquid crystal sphygmomanometer and 24h ambulatory blood pressure monitoring (ABPM), and centrally with non-invasive applanation tonometry. Additional physiological testing will include: body composition; energy balance; vascular compliance; cardiac function; liver and renal function, lipids and biochemistry; glucose and insulin; and urinalysis. Psychological status will be assessed with validated self-report questionnaires for depression, anxiety, post-traumatic stress disorder (PTSD) and mother-infant bonding. The babies will have a medical examination by a paediatrician at each assessment. Their behavioural development will be assessed with an Ages and Stages Questionnaire completed by their mother at each assessment and a developmental assessment by a child psychologist at two and five years. This study will re

  6. 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

  7. The POWERPLAY workplace physical activity and nutrition intervention for men: Study protocol and baseline characteristics.

    Science.gov (United States)

    Caperchione, Cristina M; Sharp, Paul; Bottorff, Joan L; Stolp, Sean; Oliffe, John L; Johnson, Steven T; Jones-Bricker, Margaret; Errey, Sally; Christian, Holly; Healy, Theresa; Medhurst, Kerensa; Lamont, Sonia

    2015-09-01

    Many health promotion programs hold little "manly" appeal and as a consequence fail to influence men's self-health practices. That said, the workplace can provide an important delivery point for targeted health promotion programs by supporting positive aspects of masculinity. The purpose of this article is to, a) describe the intervention design and study protocol examining the feasibility of a gender-sensitive workplace health promotion intervention focusing on physical activity and healthy eating in male-dominated rural and remote worksites, and b) report baseline findings. This study is a non-randomized quasi-experimental intervention trial examining feasibility and acceptability, and estimated intervention effectiveness. The POWERPLAY program was developed through consultations with men and key workplace personnel, and by drawing on a growing body of men's health promotion research. The program includes masculine print-based messaging, face-to-face education sessions, friendly competition, and self-monitoring concerning physical activity and healthy eating. Male participants (N=139) were recruited from four worksites in northern British Columbia, Canada. Baseline data were collected via computer assisted telephone interview (CATI) survey which assessed physical activity, dietary behavior and workplace environment. This protocol will also be used to collect follow-up data at 6months. A process evaluation, using semi-structured interviews, will be undertaken to assess feasibility and acceptability among participants and worksites. Study outcomes will guide intervention refinement and further testing in a sufficiently powered randomized control trial. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  8. 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.

  9. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

    Science.gov (United States)

    Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-06-27

    Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

  10. 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.

  11. Pilot study: Assessing the effect of continual position monitoring technology on compliance with patient turning protocols.

    Science.gov (United States)

    Schutt, Suann Cirigliano; Tarver, Christine; Pezzani, Michelle

    2018-01-01

    The study aim was to evaluate if continual patient position monitoring, taking into account self-turns and clinician-assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. While patient turning has clinical benefits, current models to help staff remember to turn patients, such as "turn clocks" and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2-hr windows (such as turning on "even" hours) rather than on individual patient activity, including self-turns. This is a first inpatient, non-randomized, pre-/postintervention study. Data collection occurred from May 2013-February 2014 on a 39-bed medical unit in a community hospital. Baseline patient turning data were recorded by a sensor; however, the patient data were not displayed at the nurses' station to establish compliance with the hospital's turning protocol. Postintervention, patient position information was wirelessly displayed on nurses' station computer monitors in real time. A Student t test was used to compare baseline to postintervention "mean time in compliance." Data from 138 patients ( N  =   7,854 hr of monitoring) were collected. The baseline phase yielded 4,322 hr of position monitoring data and the postintervention phase yielded 3,532 hr of data. Statistically significant improvement was demonstrated in the percentage of time a patient's position changed at least every 2 hr from baseline to postintervention.

  12. Effect of Iranian Ministry of Health protocols on cesarean section rate: a quasi-experimental study.

    Science.gov (United States)

    Yavangi, Mahnaz; Sohrabi, Mohammad-Reza; Alishahi Tabriz, Amir

    2013-05-29

    High Cesarean section rate is a major health problem in developing countries. This study was established to evaluate the effectiveness of Iranian Ministry of Health and Medical Education protocols on Cesarean section rate trend. Through a non-concurrent controlled quasi-experimental study, Cesarean section rate in Shohada-e-Tajrish and Taleghani hospitals in Tehran was compared during 2008-2009. Intervention group included 578 participants hospitalized because of premature rupture of membranes, prolonged pregnancy, pre-eclampsia, intra-uterine growth retardation, vaginal bleeding and premature labor in first and second trimester underwent interventions based on MOHME new protocol. On the other hand 594 cases as control group were selected during the same time before the intervention and underwent routine treatments. Descriptive statics, t-test, chi square and univariate analysis were used when appropriate. Basic characteristics in two groups had no statistically significant difference. Cesarean section applied for 360 (67.8%) women in case group and on the other hand, 270 (48.8%) Cesarean sections were done for control group (PComplication of pregnancies had increased by 6% in intervention group (PCesarean section rate. Providing appropriate service may increase the ability of service providers to find more indications for Cesarean section.

  13. Pilot study of a robotic protocol to treat shoulder subluxation in patients with chronic stroke

    Science.gov (United States)

    2013-01-01

    Background Shoulder subluxation is a frequent complication of motor impairment after stroke, leading to soft tissue damage, stretching of the joint capsule, rotator cuff injury, and in some cases pain, thus limiting use of the affected extremity beyond weakness. In this pilot study, we determined whether robotic treatment of chronic shoulder subluxation can lead to functional improvement and whether any improvement was robust. Methods 18 patients with chronic stroke (3.9 ± 2.9 years from acute stroke), completed 6 weeks of robotic training using the linear shoulder robot. Training was performed 3 times per week on alternate days. Each session consisted of 3 sets of 320 repetitions of the affected arm, and the robotic protocol alternated between training vertical arm movements, shoulder flexion and extension, in an anti-gravity plane, and training horizontal arm movements, scapular protraction and retraction, in a gravity eliminated plane. Results Training with the linear robot improved shoulder stability, motor power, and resulted in improved functional outcomes that were robust 3 months after training. Conclusion In this uncontrolled pilot study, the robotic protocol effectively treated shoulder subluxation in chronic stroke patients. Treatment of subluxation can lead to improved functional use of the affected arm, likely by increasing motor power in the trained muscles. PMID:23914834

  14. Comparative study of agar gel immunodiffusion (AGID protocols for the diagnosis of equine infectious anemia in Brazil

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    Fernanda Gonçalves Oliveira

    2014-02-01

    Full Text Available To evaluate the Equine Infectious Anemia (EIA agar gel immunodiffusion (AGID protocols, two different kits commercially available in Brazil were used: an imported kit (kit A and a domestically produced kit (kit B. Kit A was submitted to the protocols recommended by the World Organization for Animal Health (OIE and the protocol recommended by the Ministério da Agricultura Pecuária e Abastecimento (MAPA. Kit B, the Brazilian kit, was submitted only to the MAPA-recommended protocol and was used as a reference in this study. A total of 345 equid serum samples, including field samples, serum sets from official laboratories and a weak positive serum control from National Veterinary Services Laboratories (NVSL, were used. Parameters such as the sensitivity of kit A in the two protocols, the detection limit of kits and the occurrence of nonspecific reactions or non-identity were evaluated. When Kit A was used for an AGID procedure performed according to the OIE-recommended protocol, the kit demonstrated good agreement with kit B and 99 % relative sensitivity. However, when kit A was processed according to the MAPA-recommended protocol, it failed to detect 1.16 % of weak positive samples and its relative sensitivity decreased to 96 %. The detection limit of kit A was lower than the detection limit of kit B for weak positive samples in both protocols. The occurrence of nonidentity reactions was higher with kit B than with kit A. The training of veterinarians to ensure the correct execution of the AGID test protocol should be intensified in Brazil.

  15. Patients' experiences after bariatric surgery: a qualitative study at 12-month follow-up.

    Science.gov (United States)

    da Silva, Susana Sofia Pereira; Maia, Ângela da Costa

    2013-12-01

    This study used a qualitative approach to understand patients' experiences in post-surgery adaptation related to bariatric surgery, 12 months after this procedure. The study population included 30 obese adults, with a mean age of 40.17 years, who were interviewed 12 months after bariatric surgery. Individual interviews, using open-ended questions, were audiotaped, transcribed and coded according to the grounded theory methodology. The data showed that the subjects described themselves as belonging to one of two opposite and separate groups: success or failure. In both groups, two core categories emerged from the data: outcomes and treatment. Previous expectations were reached by the patients who described themselves as successful, with some remaining concerns related to future weight maintenance and aesthetics issues. The failure group emphasized their unmet expectations and the expectancy that surgery would change their lives remained. Treatment in the successful cases integrated lifestyle changes and bariatric surgery, highlighting the personal commitment required to achieve the objectives. The failure group emphasized bariatric surgery without personal commitment, and healthy eating behaviour was understood as a sacrifice. The post-surgical adaptation experiences were diverse: the cases that were described as a success highlighted lifestyle changes, personal efforts and commitment with the global treatment process. External understanding and the desire for a miracle surgery characterized the cases described as a failure. According to these results, it is necessary to promote adequate information about the whole process and skills required to ensure commitment in all treatment dimensions. © 2013 The Authors. Clinical Obesity © 2013 International Association for the Study of Obesity.

  16. Prevalence of acute neuropathic pain after cancer surgery: A prospective study

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    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.

  17. A Comprehensive study of a New Multipath Energy Aware Routing Protocol for Mobile Ad-hoc Networks

    OpenAIRE

    Chettibi, Saloua

    2009-01-01

    S. Chettibi, M. Benmohammed, "A comprehensive study of a new multipath energy aware routing protocol for mobile ad-hoc networks"; International Conference on Systems and Information Processing, ICSIP'09, May 02 – 04, 2009, Guelma, Algeria; Maximizing network lifetime is a very challenging issue in routing protocol design for Mobile Ad-hoc NETworks (MANETs), since mobile nodes are powered by limited-capacity batteries. Furthermore, replacing or recharging batteries is often impossible in criti...

  18. Improved protocols for the study of urinary electrolyte excretion and blood pressure in rodents: use of gel food and stepwise changes in diet composition.

    Science.gov (United States)

    Nizar, Jonathan M; Bouby, Nadine; Bankir, Lise; Bhalla, Vivek

    2018-01-10

    Many experimental protocols in rodents require the comparison of groups that are fed different diets. Changes in dietary electrolyte and/or fat content can influence food intake, which can potentially introduce bias or confound the results. Unpalatable diets slow growth or cause weight loss, which is exacerbated by housing the animals in individual metabolic cages or by surgery. For balance studies in mice, small body weight and food intake, and low urinary flow can amplify these challenges. Powder food can be administered as a gel with the addition of a desired amount of water, electrolytes, drugs (if any), and a small amount of agar. We describe here how the use of gel food, to vary water, Na, K, and fat content can reduce weight loss and improve reproducibility of intake, urinary excretion, and blood pressure in rodents. In addition, mild food restriction reduces the inter-individual variability and inter-group differences in food intake and associated variables, thus, improving the statistical power of the experiment. Finally, we also demonstrate the advantages of using gel food for weight-based drug dosing. These protocols can improve the accuracy and reproducibility of experimental data where dietary manipulations are needed, and are especially advisable in rodent studies related to water balance, obesity and blood pressure.

  19. Plastic surgery in bariatric patients: a nationwide study of 17,000 patients on the national administrative database.

    Science.gov (United States)

    Lazzati, Andrea; Katsahian, Sandrine; Maladry, David; Gerard, Emma; Gaucher, Sonia

    2018-01-12

    Bariatric patients are often candidates for plastic surgery. However, the rate of postbariatric procedures is not known. The aim of this study was to analyze the rate of plastic surgery, and factors related to surgery, in bariatric patients. University hospital, France. This was a cohort study based on administrative data. All adult patients who received bariatric surgery in France between 2007 and 2013 were included to estimate the rate of plastic surgery and related predictive factors. Data are reported according to the reporting of studies conducted using observational routinely collected data guidelines for observational studies on administrative data. Among the 183,514 patients who underwent bariatric surgery in the study period, 23,120 plastic surgeries were performed on 17,695 patients, including abdominoplasty (62%), dermolipectomy of the upper or lower limbs (25%), and reconstruction of the breast (14%). The rates of plastic surgery were 13%, 18%, and 21% at 3, 5, and 7 years post-bariatric surgery, respectively. Multivariate analysis revealed that patients who had a biliopancreatic diversion or a gastric bypass had a hazard ratio of 2.67 and 2.67 for subsequent plastic surgery, respectively, compared with patients who had adjustable gastric banding. Women had a 2-fold probability of surgery compared with men (hazard ratio 2.02). Important variability in the rate of surgery was found among different hospitals; rates ranged from 6.1% to 41.3% at 5 years. This study showed that 21% of bariatric patients undergo plastic surgery. Large variability exists among hospitals, suggesting that several unmeasured factors may limit access to contouring surgery. Copyright © 2018. Published by Elsevier Inc.

  20. Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis.

    Science.gov (United States)

    Alanazi, Adwan; Elleithy, Khaled

    2015-09-02

    Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol.

  1. Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Henaux, Pierre-Louis; Le Reste, Pierre-Jean; Laviolle, Bruno; Morandi, Xavier

    2017-06-05

    Chronic subdural hematoma (CSDH) is a common neurological pathology, especially in older patients. The actual "gold standard" of treatment is surgical evacuation, with various techniques used across neurosurgical teams. Over the years, there has been growing evidence that inflammatory processes play a major role in the pathogenesis of CSDH. In that context, the use of corticosteroids has been proposed alone or as an adjuvant treatment to surgery. However, this practice remains very empirical and there is a need for high-quality-of-evidence studies to clarify the role of corticosteroids in the management of CSDH. We propose a double-blind, randomized controlled trial comparing methylprednisolone versus placebo in the treatment of CSDH without clinical and/or radiological signs of severity. The treatment will be administered daily for a duration of 3 weeks, at a dose of 1 mg/kg. The primary endpoint will be the delay of occurrence of surgical treatment at 1 month following the introduction of the treatment. Secondary endpoints will include the rate of recourse to surgery, survival rate, quality of life and functional assessments, occurrence of systemic secondary effects and radiological assessment of the response to treatment. This multimodal assessment will be done at 1, 3 and 6 months. Two hundred and two patients (101 per arm) are expected to be included considering our primary hypotheses. This trial started in June 2016; its results may open interesting alternatives to surgery in the management of patients harboring a CSDH, and may provide insights into the natural history of this common pathology. ClinicalTrials.gov, ID: NCT02650609 . Registered on 4 January 2016. Graphical output of the OBF boundaries.

  2. Awakening: a qualitative study on maintaining weight loss after bariatric surgery.

    Science.gov (United States)

    Liebl, Lori; Barnason, Susan; Brage Hudson, Diane

    2016-04-01

    To describe the experiences of adults who were successful in maintaining weight loss after bariatric surgery. The majority of studies examine a homogenous demographic group of postbariatric surgical patients who have gone through initial weight loss, which occurs within the first 12-24 months post surgery. Maintenance of weight loss begins 24 months after bariatric surgery; however, there is a paucity of research examining experiences during this period. The lack of conclusive research related to interactions between intrapersonal, behavioural and environmental influences suggests a need to develop a better understanding of patients' experiences related to weight loss maintenance post bariatric surgery. Bandura's Social Cognitive Theory provided the framework for the semi-structured interviews for this qualitative descriptive study. In-person interviews with n = 14 participants who were able to maintain weight loss at least 24 months after a bariatric surgery. Participants experienced an awakening and gained a new perspective on their life. They identified negative attitudes, influences and behaviours and modified their environment to support their desired healthy behaviour. To maintain weight loss, an individual must seek out and be surrounded by positive family and peer support influences. Positive support may provide the opportunity for an individual to place personal health needs as a priority. Therapeutic education and counselling for individuals, couples and families should occur during all phases of bariatric surgery. Communication techniques may empower clients to deflect negative comments and influences in a constructive manner. Support groups should accommodate the various phases of bariatric surgery. Clients should be prepared for how to work through emotions associated with weight fluctuations. © 2016 John Wiley & Sons Ltd.

  3. Expectations and patients’ experiences of obesity prior to bariatric surgery: a qualitative study

    Science.gov (United States)

    Homer, Catherine Verity; Thompson, Andrew R; Allmark, Peter; Goyder, Elizabeth

    2016-01-01

    Objectives This study aimed to understand the experiences and expectations of people seeking bariatric surgery in England and identify implications for behavioural and self-management interventions. Design A qualitative study using modified photovoice methods, triangulating photography with semistructured indepth interviews analysed using framework techniques. Setting Areas served by two bariatric surgery multidisciplinary teams in the north of England. Participants 18 adults (14 women and 4 men) who accepted for bariatric surgery, and were aged between 30 and 61 years. Participants were recruited through hospital-based tier 4 bariatric surgery multidisciplinary teams. Results The experiences of participants indicates the nature and extent of the burden of obesity. Problems included stigmatisation, shame, poor health, physical function and reliance on medications. Participants expected surgery to result in major physical and psychological improvement. They described how this expectation was rooted in their experiences of stigma and shame. These feelings were reinforced by previous unsuccessful weight loss attempts. Participants expected extreme and sometimes unrealistic levels of sustained weight loss, as well as improvements to physical and mental health. The overall desire and expectation of bariatric surgery was of ‘normality’. Participants had received previous support from clinicians and in weight management services. However, they reported that their expectations of surgery had not been reviewed by services, and expectations appeared to be unrealistic. Likewise, their experience of stigmatisation had not been addressed. Conclusions The unrealistic expectations identified here may negatively affect postoperative outcomes. The findings indicate the importance of services addressing feelings of shame and stigmatisation, and modifying patient's expectations and goals for the postoperative period. PMID:26857104

  4. Bensal HP for Second Intention Healing Following Mohs Micrographic Surgery or Shave Skin Biopsy: An Open-label Pilot Study.

    Science.gov (United States)

    Mordorski, Breanne; Friedman, Adam J; Kircik, Leon H

    2016-10-01

    Dermatologists frequently create cutaneous defects that heal by second intention, yet there is no universal protocol for wound care in this setting. Several ointments commonly used for wound healing are not cost effective as they contain known contact allergens, contribute to antimicrobial resistance, and do not enhance the healing process. Recent studies indicate that Bensal HP, a commercially available ointment used for a variety of dermatologic conditions, may be useful for wound healing; although clinical data is currently limited. In this single-center open-label pilot study, Bensal HP was evaluated for second intention healing over 8 weeks following either Mohs micrographic surgery or shave skin biopsy in 20 patients. Results indicate that Bensal HP is effective for second intention healing as demonstrated by increased Global Assessment of Efficacy scores and decreased wound measurements, with 16 patients achieving full closure. Patient symptoms overall improved over the study period, and Bensal HP was well tolerated with no adverse effects associated with its use. By providing critical data regarding the safety and efficacy of Bensal HP, this study may provide useful information to guide further assessment in future large-scale comparative wound healing studies. J Drugs Dermatol. 2016;15(10):1197-1202.

  5. Three United Laparoscopic Surgery for the Treatment of Gastric Cardia Cancer-A Comparative Study with Laparotomy and Laparoscopy-Assisted Surgery.

    Science.gov (United States)

    Zhang, Zhanxue; Sun, Shuyuan; Qi, Jinchun; Qiu, Shaofan; Wang, Haijun; Ru, Lina; Lin, Lin; Li, Zhong; Zhao, Zongmao

    2017-02-01

    Gastric cancer is a leading cause of cancer-related mortality worldwide. We have invented a novel hand-assist device that allows the placement of surgical instruments and the maneuvering of the surgeon's hand, and we have established a new hand-assisted laparoscopic technique called Three United Laparoscopic Surgery (TULS) for laparoscopic dissection of advanced gastric cancer. The present study aimed at exploring the usefulness of TULS in the treatment of advanced gastric cardia cancer. A retrospective study on 100 patients with advanced gastric cardia cancer admitted from January 2014 to June 2015 was done. There were 38 cases of TULS, 30 cases of laparotomy, and 32 cases of laparoscopy-assisted surgery. Statistical comparisons between three treatment groups in operative time, incision length, amount of bleeding, number of lymph nodes dissected, time to flatus after surgery, rate of postoperative complications, hospital stay, and expense were done. For lymph node dissection, there were no significant differences between TULS, laparotomy, and laparoscopy-assisted surgery. However, compared with conventional laparotomy, TULS and laparoscopy-assisted surgery were found to be able to minimize incision length, reduce blood loss during surgery, lower postoperative complication rate, and shorten time to flatus and hospital stay. The differences were statistically significant (P laparoscopy-assisted surgery (P < .05), and it was comparable to that of laparotomy. TULS is as efficient as laparotomy in lymph node dissection, and it shows the advantages of minimally invasive surgery. It can be considered a novel and promising surgical intervention for treatment of advanced gastric cancer.

  6. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    Directory of Open Access Journals (Sweden)

    Fayers Peter

    2010-09-01

    Full Text Available Abstract Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1 To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2 To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1 To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1 in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2 To conduct patient focus group discussions at each of these (Phase 1 to determine care received. 3 To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2. 4 To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2. 5 To undertake document

  7. Outcomes after major surgery in patients with myasthenia gravis: A nationwide matched cohort study.

    Science.gov (United States)

    Chang, Yi-Wen; Chou, Yi-Chun; Yeh, Chun-Chieh; Hu, Chaur-Jong; Hung, Chih-Jen; Lin, Chao-Shun; Chen, Ta-Liang; Liao, Chien-Chang

    2017-01-01

    To validate the comprehensive features of adverse outcomes after surgery for patients with myasthenia gravis. Using reimbursement claims from Taiwan's National Health Insurance Research Database, we analyzed 2290 patients who received major surgery between 2004 and 2010 and were diagnosed with myasthenia gravis preoperatively. Surgical patients without myasthenia gravis (n = 22,900) were randomly selected by matching procedure with propensity score for comparison. The adjusted odds ratios and 95% confidence intervals of postoperative adverse events associated with preoperative myasthenia gravis were calculated under the multiple logistic regressions. Compared with surgical patients without myasthenia gravis, surgical patients with myasthenia gravis had higher risks of postoperative pneumonia (OR = 2.09; 95% CI: 1.65-2.65), septicemia (OR = 1.31; 95% CI: 1.05-1.64), postoperative bleeding (OR = 1.71; 95% CI: 1.07-2.72), and overall complications (OR = 1.70; 95% CI: 1.44-2.00). The ORs of postoperative adverse events for patients with myasthenia gravis who had symptomatic therapy, chronic immunotherapy, and short-term immunotherapy were 1.76 (95% CI 1.50-2.08), 1.70 (95% CI 1.36-2.11), and 4.36 (95% CI 2.11-9.04), respectively. Patients with myasthenia gravis had increased risks of postoperative adverse events, particularly those experiencing emergency care, hospitalization, and thymectomy for care of myasthenia gravis. Our findings suggest the urgency of revising protocols for perioperative care for these populations.

  8. Postoperative outcomes following preoperative inspiratory muscle training in patients undergoing open cardiothoracic or upper abdominal surgery: protocol for a systematic review

    Directory of Open Access Journals (Sweden)

    Mans Christina M

    2012-12-01

    Full Text Available Abstract Background In patients undergoing open cardiothoracic and upper abdominal surgery, postoperative pulmonary complications remain an important cause of postoperative morbidity and mortality, impacting upon hospital length of stay and health care resources. Adequate preoperative respiratory muscle strength may help protect against the development of postoperative pulmonary complications and therefore preoperative inspiratory muscle training has been suggested to be of potential value in improving postoperative outcomes. Methods/Design A systematic search of electronic databases will be undertaken to identify randomized trials of preoperative inspiratory muscle training in patients undergoing elective open cardiothoracic and upper abdominal surgery. From these trials, we will extract available data for a list of predefined outcomes, including postoperative pulmonary complications, hospital length of stay and respiratory muscle strength. We will meta-analyze comparable results where possible, and report a summary of the available pool of evidence. Discussion This review will provide the most comprehensive answer available to the question of whether preoperative inspiratory muscle training is clinically useful in improving postoperative outcomes in patients undergoing cardiothoracic and upper abdominal surgery. It will help inform clinicians working in the surgical arena of the likely effectiveness of instituting preoperative inspiratory muscle training programs to improve postoperative outcomes.

  9. Micronutrient Levels and Supplement Intake in Pregnancy after Bariatric Surgery: A Prospective Cohort Study

    Science.gov (United States)

    Devlieger, Roland; Guelinckx, Isabelle; Jans, Goele; Voets, Willy; Vanholsbeke, Caroline; Vansant, Greet

    2014-01-01

    Background Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery. Objective To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery. Design A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened during pregnancy. Results The total population included 18 women in the restrictive and 31 in the malabsorptive group. Most micronutrients were depleted and declined significantly during pregnancy. The proportion of women with low vitamin A and B-1 levels increased to respectively 58 and 17% at delivery (P = 0.005 and 0.002). The proportion of women with vitamin D deficiency decreased from 14% at trimester 1 to 6% at delivery (P = 0.030). Mild anemia was found in respectively 22 and 40% of the women at trimester 1 and delivery. In the first trimester, most women took a multivitamin (57.1%). In the second and third trimester, the majority took additional supplements (69.4 and 73.5%). No associations were found between supplement intake and micronutrient deficiencies. Conclusion Pregnant women with bariatric surgery show frequent low micronutrient levels. Supplementation partially normalizes low levels of micronutrients. PMID:25470614

  10. Micronutrient levels and supplement intake in pregnancy after bariatric surgery: a prospective cohort study.

    Directory of Open Access Journals (Sweden)

    Roland Devlieger

    Full Text Available Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery.To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery.A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened during pregnancy.The total population included 18 women in the restrictive and 31 in the malabsorptive group. Most micronutrients were depleted and declined significantly during pregnancy. The proportion of women with low vitamin A and B-1 levels increased to respectively 58 and 17% at delivery (P = 0.005 and 0.002. The proportion of women with vitamin D deficiency decreased from 14% at trimester 1 to 6% at delivery (P = 0.030. Mild anemia was found in respectively 22 and 40% of the women at trimester 1 and delivery. In the first trimester, most women took a multivitamin (57.1%. In the second and third trimester, the majority took additional supplements (69.4 and 73.5%. No associations were found between supplement intake and micronutrient deficiencies.Pregnant women with bariatric surgery show frequent low micronutrient levels. Supplementation partially normalizes low levels of micronutrients.

  11. Micronutrient levels and supplement intake in pregnancy after bariatric surgery: a prospective cohort study.

    Science.gov (United States)

    Devlieger, Roland; Guelinckx, Isabelle; Jans, Goele; Voets, Willy; Vanholsbeke, Caroline; Vansant, Greet

    2014-01-01

    Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery. To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery. A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened during pregnancy. The total population included 18 women in the restrictive and 31 in the malabsorptive group. Most micronutrients were depleted and declined significantly during pregnancy. The proportion of women with low vitamin A and B-1 levels increased to respectively 58 and 17% at delivery (P = 0.005 and 0.002). The proportion of women with vitamin D deficiency decreased from 14% at trimester 1 to 6% at delivery (P = 0.030). Mild anemia was found in respectively 22 and 40% of the women at trimester 1 and delivery. In the first trimester, most women took a multivitamin (57.1%). In the second and third trimester, the majority took additional supplements (69.4 and 73.5%). No associations were found between supplement intake and micronutrient deficiencies. Pregnant women with bariatric surgery show frequent low micronutrient levels. Supplementation partially normalizes low levels of micronutrients.

  12. Risk factors of sepsis after open congenital cardiac surgery in infants: a pilot study

    Directory of Open Access Journals (Sweden)

    Dicky Fakhri

    2016-10-01

    Full Text Available Background: Postsurgical sepsis is one of the main causes of the high mortality and morbidity after open congenital heart surgery in infants.  This study aimed to evaluate the role of cardiopulmonary bypass duration, thymectomy, surgical complexity, and nutritional status on postsurgical sepsis after open congenital cardiac surgery in infants.Methods: A total of 40 patients <1 year of age with congenital heart disease, Aristotle Basic Score (ABS ≥6 were followed for clinical and laboratory data before and after surgery until the occurrence of signs or symptoms of sepsis or until a maximum of 7 days after surgery. Bivariate analyses were performed. Variables with p≤0.200 were then included for logistic regression.Results: Duration of cardiopulmonary bypass ≥90 minutes was associated with 5.538 increased risk of postsurgical sepsis in comparison to those ≤90 minutes (80% vs 25%, RR=5.538, p=0.006. No association was observed between the incidence of postsurgical sepsis with poor nutritional status (86% vs 84%, RR=1.059, p=1.000, thymectomy (and 50% vs 76%, RR=0.481, p=0.157, and Aristotle Basic Score (p=0.870.Conclusion: Cardiopulmonary bypass time influences the incidence of sepsis infants undergoing open congenital cardiac surgery. Further studies are needed to elaborate a number of risk factors associated with the incidence of sepsis in this population.

  13. Open surgery versus retroperitoneal laparoscopic nephrectomy for renal tuberculosis: a retrospective study of 120 patients

    Directory of Open Access Journals (Sweden)

    Su Zhang

    2016-11-01

    Full Text Available Background Laparoscopic renal surgery has been widely used in the treatment of renal diseases. However, there is still little research about its application in addressing renal tuberculosis. The purpose of this study is to retrospectively investigate the surgical results of laparoscopic and open surgery for nonfunctional tuberculous kidneys. Methods Between May 2011 and June 2016, 120 nephrectomies were performed in patients with a nonfunctional tuberculous kidney. Of these, 69 patients underwent retroperitoneal laparoscopic nephrectomy, and 51 patients underwent open nephrectomy. Data about the patients’ characteristics and surgical outcomes were collected from their electronic medical records. Outcomes were compared between these two groups. Results Our results showed that a number of renal tuberculosis patients presented no significant symptoms during their disease. Lower urinary tract symptoms (LUTS were the most common at a rate of 73/120, followed by flank pain or accidently discovery (66/120, urine abnormality (30/120 and fever (27/120. Patients who underwent open surgery were similar to laparoscopic patients with regard to sex, BMI, location, previous tuberculous history, grade, anemia, adhesion, hypertension, diabetes and preoperative serum creatinine level, but were generally older than laparoscopic patients. There were no significant differences between open and laparoscopic surgery in estimated blood loss, transfusion, postoperative hospital days and perioperative complication rate. However, the median operation time of laparoscopic operation was much longer than open surgery (180 [150–225] vs 135 [120–165] minutes, P < 0.01. Seven of the 69 laparoscopic operations were converted to open surgery because of severe adhesions. Conclusion Laparoscopic nephrectomy is as an effective treatment as open surgery for a nonfunctional tuberculous kidney, although it requires more time during the surgical procedure. No significant

  14. Complications of Impulse Generator Exchange Surgery for Deep Brain Stimulation: A Single-Center, Retrospective Study.

    Science.gov (United States)

    Helmers, Ann-Kristin; Lübbing, Isabel; Birkenfeld, Falk; Witt, Karsten; Synowitz, Michael; Mehdorn, Hubertus Maximilian; Falk, Daniela

    2018-05-01

    Nonrechargeable deep brain stimulation impulse generators (IGs) with low or empty battery status require surgical IG exchange several years after initial implantation. The aim of this study was to investigate complication rates after IG exchange surgery and identify risk factors. We retrospectively analyzed complications following IG exchange surgery from 2008 to 2015 in our department. Medical records of all patients who underwent IG exchange surgery were systematically reviewed. The shortest follow-up time was 19 months. From 2008 to 2015, 438 IGs were exchanged in 319 patients. Overall complication rate was 8.90%. Infection developed in 12 patients (2.74%). Six patients (1.37%) experienced local wound erosions. Hardware malfunctions were present in 11 patients (2.51%), and local hemorrhage was observed in 3 cases (0.68%). Repeated fixation of the IG was required in 2 patients (0.46%). Traction of the connecting cables necessitated surgical revision in 2 patients (0.46%). In 2 cases (0.46%), the IG was placed abdominally or exchanged for a smaller device owing to patient discomfort resulting from the initial positioning. One 80-year-old patient (0.23%) had severely worsening heart failure and died 4 days after IG exchange surgery. IG exchange surgery, although often considered a minor surgery, was associated with a complication rate of approximately 9% in our center. Patients and physicians should understand the complication rates associated with IG exchange surgery because this information might facilitate selection of a rechargeable IG. Copyright © 2018 Elsevier Inc. All rights reserved.

  15. Factors Affecting Visual Field Outcome Post-Surgery in Sellar Region Tumors: Retrospective Study.

    Science.gov (United States)

    Sriram, Prabu Rau; Sellamuthu, Puliventhan; Ghani, Abdul Rahman Izani

    2017-12-01

    Despite the broad category of differentials for sellar region, most of them present with similar clinical signs and symptoms. Headache and visual disturbance are among the frequently seen as presenting symptom. Visual field (VF) assessment is one of the crucial component of neuroophtalmologic assessment and mean deviation (MD) value from automated perimetry allows quantification of the visual field defect. We formulated a study to look into the factors that affect the visual field outcome after surgery. All patients with sellar region tumor who has underwent surgery in Queen Elizabeth Hospital from July 2010 to July 2016 were retrospectively analysed through hospital notes. VF assessment via Humphrey visual assessment for these patient pre and post-surgery were reviewed for MD value. Eighty four patients were recruited and out of them, 151 eyes were taken into analysis after excluding eyes with missing data. Mean age of patients were 45.4 years with 70.2% of them were male. Visual disturbance is the commonest presenting symptom with mean duration of symptom prior to surgery is 9.7 months. Majority of them were pituitary adenomas (75%) followed by sellar meningioma (19%), craniopharyngioma (4.8%), and rathke cleft cyst (1.2%). 70.9% of patients showed improvement in VF based on MD outcome. Mean MD for pre surgery and post-surgery were -14.0 dB and -12.4 dB, respectively. Univariate analysis reveals younger age, female sex, shorter duration of symptom, pituitary adenoma, transsphenoidal approach, and transcranial approach favours improvement in VF. Multivariate analysis shows only shorter symptom duration, transphenoidal approach, and transcranial approach are significant for favourable VF outcome when other factors adjusted. Symptom duration and surgical approach were independent factors that affects the visual field after surgery in patients with sellar region tumors.

  16. Obesity and treatment meanings in bariatric surgery candidates : a qualitative study

    OpenAIRE

    Silva, Susana Sofia P.; Maia, Ângela

    2012-01-01

    Background This study used a qualitative approach to comprehend how the morbid obese conceptualize and deal with obesity and obesity treatment, with the particular aim of exploring the expectations and beliefs about the exigencies and the impact of bariatric surgery. Methods The study population included 30 morbid obese patients (20 women and 10 men) with a mean age of 39.17 years (SD = 8.81) and a mean body mass index of 47.5 (SD = 8.2) interviewed individually before surgery using ...

  17. [Comparative study on the historical evolution of field surgery between China and Russia].

    Science.gov (United States)

    Li, Yong; Luo, Chang-kun; Xiao, Nan

    2010-03-01

    Russian field surgery with its long history and distinctive characteristics has accumulated great experience in the long-time practice of warfare. Chinese field surgery was established and developed on the basis of studying from the Russian model, which opened up new areas of traffic medi