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surgical trials

Colin F Royse, Leif Saager, Richard Whitlock, Jared Ou-Young, Alistair Royse, Jessica Vincent, P J Devereaux, Andrea Kurz, Ahmed Awais, Krit Panjasawatwong, Daniel I Sessler
BACKGROUND: Inflammation after cardiopulmonary bypass may contribute to postoperative delirium and cognitive dysfunction. The authors evaluated the effect of high-dose methylprednisolone to suppress inflammation on the incidence of delirium and postoperative quality of recovery after cardiac surgery. METHODS: Five hundred fifty-five adults from three hospitals enrolled in the randomized, double-blind Steroids in Cardiac Surgery trial were randomly allocated to placebo or 250 mg methylprednisolone at induction and 250 mg methylprednisolone before cardiopulmonary bypass...
October 24, 2016: Anesthesiology
Ian S Metzler, Rebecca Smith-Bindman, Michelle Moghadassi, Ralph C Wang, Marshall L Stoller, Thomas Chi
PURPOSE: In the emergency department (ED), ultrasonography (US) is emerging as an alternative to computed tomography (CT) for diagnosing patients with nephrolithiasis. In this multi-center randomized clinical trial, we examined rates of urologic referral and intervention to elucidate if initial diagnostic imaging modality affected management of nephrolithiasis. MATERIALS AND METHODS: Patients ages 18-76 years who presented to the ED with renal colic across 15 diverse treatment centers were randomized to receive either an abdominal US by an ED physician, a radiologist or an abdominal CT...
October 20, 2016: Journal of Urology
Cornelis R C Hogewoning, Louise A M Meij, Rob C M Pelger, Hein Putter, Esmée M Krouwel, Henk W Elzevier
OBJECTIVE: To provide a review of literature regarding the role of male slings in the treatment of stress urinary incontinence (SUI) following a transurethral resection of the prostate (TURP) and to evaluate the effects of the Virtue male sling in patients suffering from post TURP SUI. MATERIALS AND METHODS: A systematic review of literature was performed to identify all papers on the use of male slings in patients suffering from post TURP SUI. Secondly a prospective cohort study was conducted on 8 patients that received the Virtue as surgical treatment of post TURP SUI...
October 20, 2016: Urology
Francesco Nappi, Cristiano Spadaccio, Antonio Nenna, Mario Lusini, Massimiliano Fraldi, Christophe Acar, Massimo Chello
OBJECTIVE: The symmetry of mitral valve tethering and regional left ventricle wall dysfunction are reported to play a fundamental role in the outcomes and long-term durability of surgical repair in ischemic mitral regurgitation (IMR). We recently demonstrated in a randomized clinical trial (the Papillary Muscle Approximation trial) the superiority of papillary muscle approximation (PMA) in combination with standard restrictive annuloplasty (RA) in severe IMR over annuloplasty alone in terms of adverse left ventricular remodeling and mitral regurgitation (MR) recurrence...
September 24, 2016: Journal of Thoracic and Cardiovascular Surgery
Ashvarya Mangla, Saurabh Gupta
Transcatheter aortic valve replacement (TAVR) has rapidly emerged as the standard of care for severe symptomatic aortic stenosis in patients whose comorbidities put them at prohibitive risk for surgical aortic valve replacement (SAVR). Several trials have demonstrated superior outcomes with TAVR compared to medical management alone. TAVR has also shown favorable outcomes in patients at high risk for SAVR. TAVR can be associated with significant vascular complications, which adversely impact outcomes, and operators should be cognizant of their early recognition and appropriate management...
September 2016: Indian Heart Journal
Handoo Rhee, John Blazak, Chui Ming Tham, Keng Lim Ng, Benjamin Shepherd, Malcolm Lawson, John Preston, Ian Vela, Paul Thomas, Simon Wood
BACKGROUND: In this study, we prospectively evaluate the diagnostic potential of a gallium-68 (68Ga) prostate-specific membrane antigen (PSMA)-binding ligand and positron emission tomography (PET) in detecting metastatic lesions in patients with renal tumour. The secondary aim was to determine whether the findings would result in the alteration of patient management. RESULTS: Ten patients with renal lesion and potential metastatic disease on conventional imaging were recruited...
December 2016: EJNMMI Research
O T A Lyons, M Baguneid, T D Barwick, R E Bell, N Foster, S Homer-Vanniasinkam, S Hopkins, A Hussain, K Katsanos, B Modarai, J A T Sandoe, S Thomas, N M Price
OBJECTIVE/BACKGROUND: The management of aortic graft infection (AGI) is highly complex and in the absence of a universally accepted case definition and evidence-based guidelines, clinical approaches and outcomes vary widely. The objective was to define precise criteria for diagnosing AGI. METHODS: A process of expert review and consensus, involving formal collaboration between vascular surgeons, infection specialists, and radiologists from several English National Health Service hospital Trusts with large vascular services (Management of Aortic Graft Infection Collaboration [MAGIC]), produced the definition...
October 19, 2016: European Journal of Vascular and Endovascular Surgery
Luigi Olper, Elena Bignami, Ambra L Di Prima, Santina Albini, Simona Nascimbene, Luca Cabrini, Giovanni Landoni, Ottavio Alfieri
BACKGROUND: Noninvasive ventilation (NIV) is a common technique to manage patients with acute respiratory failure in the intensive care unit. However, use of NIV in general wards is less well described. The authors' aim was to demonstrate efficacy of NIV, applied in a cardiac surgery ward, in improving oxygenation in patients who developed hypoxemic acute respiratory failure after being discharged from the intensive care unit. DESIGN: Randomized, open-label trial...
August 10, 2016: Journal of Cardiothoracic and Vascular Anesthesia
John K Chan, James J Java, Katherine Fuh, Bradley J Monk, Daniel S Kapp, Thomas Herzog, Jeffrey Bell, Robert Young
OBJECTIVES: To determine the association between timing of adjuvant therapy initiation and survival of early stage ovarian cancer patients. METHODS: Data were obtained from women who underwent primary surgical staging followed by adjuvant therapy from two Gynecologic Oncology Group trials (protocols # 95 and 157). Kaplan-Meier estimates and Cox proportional hazards model adjusted for covariates were used for analyses. RESULTS: Of 497 stage I-II epithelial ovarian cancer patients, the median time between surgery and initiation of adjuvant therapy was 23days (25th-75th%: 12-33days)...
October 19, 2016: Gynecologic Oncology
Dewei Zhao, Frank Witte, Faqiang Lu, Jiali Wang, Junlei Li, Ling Qin
As a new generation of medical metallic material, magnesium (Mg) and its alloys with or without surface coating have attracted a great deal of attention due to its biodegradability and potential for avoiding a removal operation after the implant has fulfilled its function for surgical fixation of injured musculoskeletal tissues. Although a few clinical cases on Mg-based orthopaedic implants were reported more than a century ago, it was not until recently that clinical trials using these implants with improved physicochemical properties were carried out in Germany, China and Korea for bone fracture fixation...
October 11, 2016: Biomaterials
Eeva Kormi, Johanna Snäll, Anna-Maria Koivusalo, Anna Liisa Suominen, Hanna Thorén, Jyrki Törnwall
PURPOSE: To clarify the effect of systemic dexamethasone (DXM) on pain and postoperative opioid (oxycodone) consumption after blowout fracture surgery. MATERIALS AND METHODS: A prospective randomized observer-blinded trial of 20 patients who had a blowout fracture requiring surgical intervention was conducted. Patients were randomly assigned to receive a total dose of intravenous DXM 30 mg perioperatively or no DXM (controls). Pain was assessed postoperatively using a 10-cm visual analog scale (VAS) each time analgesics (acetaminophen every 6 hours or oxycodone upon request) were administered...
September 26, 2016: Journal of Oral and Maxillofacial Surgery
T Meng, Z Zhong, L Meng
Lumbar spinal surgery is most commonly performed under general anaesthesia. However, spinal anaesthesia has also been used. We aimed to systematically review the comparative evidence. We only included randomised, controlled trials in this meta-analysis and calculated the risk ratio or standardised mean difference for haemodynamics, blood loss, surgical time, analgesic requirement, nausea and/or vomiting, and length of hospital stay. Eight studies with a total of 625 patients were included. These were considered to be at high risk of bias...
October 22, 2016: Anaesthesia
James Anaissie, Wayne J G Hellstrom, Faysal A Yafi
The introduction of collagenase Clostridium histolyticum (CCH) as a treatment option for Peyronie's disease (PD), defined as the abnormal formation of collagen on the tunica albuginea of the penis, has provided patients with a promising new conservative therapy. Studies have shown that CCH improves curvature by an average of 17°, and although patient and sexual partner satisfaction is high, the improvement has arguable clinical implications. Similarly, the efficacy and cost of CCH contrasts strongly with more invasive surgical management, and is further limited by rare, but serious, complications and several contraindications...
October 21, 2016: Drugs
Cecilia Nilsson, Jette Led Sorensen, Lars Konge, Mikkel Westen, Morten Stadeager, Bent Ottesen, Flemming Bjerrum
BACKGROUND: Inexperienced operating assistants are often tasked with the important role of handling camera navigation during laparoscopic surgery. Incorrect handling can lead to poor visualization, increased operating time, and frustration for the operating surgeon-all of which can compromise patient safety. The objectives of this trial were to examine how to train laparoscopic camera navigation and to explore the transfer of skills to the operating room. MATERIALS AND METHODS: A randomized, single-center superiority trial with three groups: The first group practiced simulation-based camera navigation tasks (camera group), the second group practiced performing a simulation-based cholecystectomy (procedure group), and the third group received no training (control group)...
October 21, 2016: Surgical Endoscopy
S Gueli Alletti, M Petrillo, G Vizzielli, C Bottoni, F Nardelli, B Costantini, L Quagliozzi, V Gallotta, G Scambia, A Fagotti
OBJECTIVE: To further investigate the role of MIS comparing patients submitted to MI-IDS with a balanced population treated by standard laparotomy. METHODS: The investigational arm (Cases) includes 30 AEOC patients treated with MI-IDS. The Control arm included a consecutive series of 65 AEOC patients submitted to laparotomic IDS. Inclusion criteria were: age>18years, histologically proven EOC, clinical complete/partial response after NACT, and ECOG PS <2. Preoperative clinical data, perioperative and oncological outcomes were analyzed...
October 18, 2016: Gynecologic Oncology
Philip Tack, Jan Victor, Paul Gemmel, Lieven Annemans
BACKGROUND: Three-dimensional (3D) printing has numerous applications and has gained much interest in the medical world. The constantly improving quality of 3D-printing applications has contributed to their increased use on patients. This paper summarizes the literature on surgical 3D-printing applications used on patients, with a focus on reported clinical and economic outcomes. METHODS: Three major literature databases were screened for case series (more than three cases described in the same study) and trials of surgical applications of 3D printing in humans...
October 21, 2016: Biomedical Engineering Online
Fabrice Kwiatkowski, Pascal Dessenne, Claire Laquet, Jean-Pierre Daures, Mathilde Gay-Bellile, Yves-Jean Bignon
BACKGROUND: Young women exposed to a high hereditary breast and ovarian cancer (HBOC) risk are particularly vulnerable. They are ignored by health prevention measures but exposed to a stream of contradictory information (medicine, media, Internet). They may feel concerned about surgical prevention issues at a key moment of their identity construction (self, relationship, sexuality). We designed a special psychoeducational intervention to help these women cope better with these difficulties...
October 21, 2016: Trials
M Aurich, D Albrecht, P Angele, C Becher, S Fickert, J Fritz, P E Müller, P Niemeyer, M Pietschmann, G Spahn, M Walther
Background: Osteochondral lesions (OCL) of the ankle are a common cause of ankle pain. Although the precise pathophysiology has not been fully elucidated, it can be assumed that a variety of factors are responsible, mainly including traumatic events such as ankle sprains. Advances in arthroscopy and imaging techniques, in particular magnetic resonance imaging (MRI), have improved the possibilities for the diagnosis of OCLs of the ankle. Moreover, these technologies aim at developing new classification systems and modern treatment strategies...
October 21, 2016: Zeitschrift Für Orthopädie und Unfallchirurgie
Felipe Donoso, Helene Engstrand Lilja
Background Since 2005, infants with esophageal atresia (EA) in our unit are given prophylactic proton pump inhibitors (PPI) after repair until 1 year of age. The aims of this study were to identify risk factors for anastomotic strictures (AS) and to assess the efficacy of postoperative PPI prophylaxis in reducing the incidence of AS compared with symptomatic PPI. Methods Patients who underwent EA repair from 1994 to 2013 in our unit were included in this retrospective observational study approved by the local ethics review board...
October 21, 2016: European Journal of Pediatric Surgery
Kathryn L Kreicher, Jeremy S Bordeaux
Importance: Cutaneous surgery is performed by otolaryngologists, plastic surgeons, oculoplastic surgeons, dermatologic surgeons, and some primary care physicians. Practice gaps exist among cutaneous surgeons, as do differences in how different physicians approach preoperative, intraoperative, and postoperative decision-making. Objective: To present the newest and best evidence to close common practice gaps in cutaneous surgery. Evidence Review: We performed a detailed search of peer-reviewed publications that were identified through a search of PubMed/MEDLINE (January 1, 2000, through June 30, 2016) using the literature search terms "cutaneous surgery," "Mohs micrographic surgery," "plastic surgery," in combination with "safety," "cost," "anesthesia," "anti-coagulation," "bleeding," "pain," "analgesia," "anxiety," or "infection," among others...
October 20, 2016: JAMA Facial Plastic Surgery
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