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randomised controlled trial surgery

Pouya Nezafati, Ali Shomali, Mahdi Kahrom, Sahar Omidvar Tehrani, Minoo Dianatkhah, Mohammad Hassan Nezafati
BACKGROUND: The present study aimed to compare postoperative complications commonly revealed after sternotomy closure by new sternal ZipFix™ (Synthes GmbH, Oberdorf, Switzerland) implant and conventional steel wire. METHODS: Among the initial 360 subjects, 326 patients enrolled in this randomised control trial who were candidates for cardiac surgery from April 2014 to March 2015. After the surgery, the sternal closure was randomly done with poly-ether-ether-ketone (PEEK) based sternal ZipFix (ZF) on the sternal body (n=168) or with conventional wires (CWs) (n=158)...
February 8, 2018: Heart, Lung & Circulation
Stephen Honeybul, David Anthony Morrison, Kwok M Ho, Christopher R P Lind, Elizabeth Geelhoed
OBJECTIVE: To compare the long-term outcomes of patients who had been randomly allocated to receive primary titanium cranioplasty or autologous bone graft following decompressive craniectomy. METHODS: Sixty-four patients had been previously enrolled and randomised to receive either their own bone graft or a primary titanium cranioplasty. Functional and cosmetic outcomes had previously been assessed at 1-year following the cranioplasty procedure. Hospital records and the Picture Archiving communication system were reviewed to determine how many patients had cranioplasty failure or associated complications such as seizures beyond 1 year-with a minimum of 24-month follow-up...
March 15, 2018: Acta Neurochirurgica
Msj Wilson, P Maniam, A Ibrahim, N Makaram, S R Knight, P Patil
Introduction The use of polymeric clips in securing the appendiceal stump has been increasingly reported as a viable alternative to current methods in emergency laparoscopic appendicectomy. We evaluated the operative outcomes following the use of polymeric clips versus endoscopic ligatures. The primary endpoint was operative time, with secondary outcomes including complications, inpatient stay, and cost analysis. Materials and methods Operative records were retrospectively analysed to identify patients undergoing laparoscopic appendicectomy between January 2014 and June 2015...
March 15, 2018: Annals of the Royal College of Surgeons of England
Giuliano Tosello, Maria Regina Torloni, Bruna S Mota, Teresa Neeman, Rachel Riera
BACKGROUND: Metastatic breast cancer is not a curable disease, but women with metastatic disease are living longer. Surgery to remove the primary tumour is associated with an increased survival in other types of metastatic cancer. Breast surgery is not standard treatment for metastatic disease, however several recent retrospective studies have suggested that breast surgery could increase the women's survival. These studies have methodological limitations including selection bias. A systematic review mapping all randomised controlled trials addressing the benefits and potential harms of breast surgery is ideal to answer this question...
March 15, 2018: Cochrane Database of Systematic Reviews
Matthew L Costa, Juul Achten, Pedro Foguet, Nicholas R Parsons
OBJECTIVE: To compare the medium-term clinical effectiveness of total hip arthroplasty and resurfacing arthroplasty. DESIGN: Single centre, two-arm, parallel group, assessor blinded, randomised controlled trial with 1:1 treatment allocation. SETTING: A large teaching hospital in England. PARTICIPANTS: 122 patients older than 18 years with severe arthritis of the hip joint, suitable for resurfacing arthroplasty of the hip...
March 12, 2018: BMJ Open
Michael Höckel, Sophia Trott, Nadja Dornhöfer, Lars-Christian Horn, Bettina Hentschel, Benjamin Wolf
BACKGROUND: The incidence of vulvar cancer is increasing, but surgical treatment-the current standard of care-often leads to unsatisfactory outcomes, especially in patients with node-positive disease. Preliminary results at our centre showed that locoregional spread of vulvar carcinoma occurs within tissue domains defined by stepwise embryonic and fetal development (ontogenetic cancer fields and associated lymph node regions). We propose that clinical translation of these insights into practice could improve outcomes of surgical treatment of vulvar cancer...
March 9, 2018: Lancet Oncology
Bernadette Brown, Jane Young, David P Smith, Andrew B Kneebone, Andrew J Brooks, Sam Egger, Miranda Xhilaga, Amanda Dominello, Dianne L O'Connell, Mary Haines
BACKGROUND: This study assessed whether a theoretically conceptualised tailored intervention centred on multidisciplinary teams (MDTs) increased clinician referral behaviours in line with clinical practice guideline recommendations. METHODS: Nine hospital Sites in New South Wales (NSW), Australia with a urological MDT and involvement in a state-wide urological clinical network participated in this pragmatic stepped wedge, cluster randomised implementation trial...
March 12, 2018: Implementation Science: IS
Michael Engelhardt, Norah A Rashad, Christian Willy, Christian Müller, Christian Bauer, Sebastian Debus, Tino Beck
Groin wound infections pose a major problem in vascular surgery. Closed-incision negative pressure therapy (ciNPT) was especially designed for the management of incisions at risk of surgical site infections. The aim of this study was to investigate whether ciNPT is able to reduce the incidence of wound infections after vascular surgery. Data on 132 consecutive patients, scheduled for vascular surgery with a longitudinal femoral cutdown, were collected prospectively. All patients were randomised either to the ciNPT group (n = 64) or the control group (n = 68) with conventional dressing...
March 12, 2018: International Wound Journal
Shoaib Hassan, Anjana Haridas, Venki Sundaram
BACKGROUND: Strabismus, or squint, can be defined as a deviation from perfect ocular alignment and can be classified in many ways according to its aetiology and presentation. Treatment can be broadly divided into medical and surgical options, with a variety of surgical techniques being available, including the use of adjustable or non-adjustable sutures for the extraocular muscles. There exists an uncertainty as to which of these techniques produces a better surgical outcome, and an opinion that the adjustable suture technique may be of greater benefit in certain situations...
March 12, 2018: Cochrane Database of Systematic Reviews
Volker Gebhardt, Vera Zawierucha, Oliver Schöffski, Anke Schwarz, Christel Weiss, Marc D Schmittner
BACKGROUND: Both general and spinal anaesthesia with short-acting local anaesthetics are suitable and reliable for knee arthroscopy as an ambulatory procedure. Chloroprocaine (CP) 1% seems to be the ideal spinal local anaesthetic for this indication. OBJECTIVE: The aim of this study was to compare spinal anaesthesia using CP 1% with general for outpatient knee arthroscopy with regard to procedure times, occurrence of pain, patient satisfaction and recovery, and also costs...
March 7, 2018: European Journal of Anaesthesiology
Farid Froghi, Rahul Koti, Kurinchi Gurusamy, Susan Mallett, Douglas Thorburn, Linda Selves, Sarah James, Jeshika Singh, Manuel Pinto, Christine Eastgate, Margaret McNeil, Helder Filipe, Fatima Jichi, Nick Schofield, Daniel Martin, Brian Davidson
BACKGROUND: Patients with liver cirrhosis undergoing liver transplantation have a hyperdynamic circulation which persists into the early postoperative period making accurate assessment of fluid requirements challenging. Goal-directed fluid therapy (GDFT) has been shown to reduce morbidity and mortality in a number of surgery settings. The impact of GDFT in patients undergoing liver transplantation is unknown. A feasibility trial was designed to determine patient and clinician support for recruitment into a randomised controlled trial of GDFT following liver transplantation, adherence to a GDFT protocol, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate the efficacy of GDFT in patients undergoing liver transplantation...
March 7, 2018: Trials
William Syrmis, Russell Richard, Sue Jenkins-Marsh, Siew C Chia, Phillip Good
BACKGROUND: Malignant bowel obstruction (MBO) is a common problem in patients with intra-abdominal cancer. Oral water soluble contrast (OWSC) has been shown to be useful in the management of adhesive small bowel obstruction in identifying patients who will recover with conservative management alone and also in reducing the length of hospital stay. It is not clear whether the benefits of OWSC in adhesive small bowel obstruction are also seen in patients with MBO. OBJECTIVES: To determine the reliability of OWSC media and follow-up abdominal radiographs in predicting the success of conservative treatment in resolving inoperable MBO with conservative management...
March 7, 2018: Cochrane Database of Systematic Reviews
Emil Osman Thybo Karanfil, Ann Merete Møller
INTRODUCTION: Post-operative pulmonary complications are a common cause of morbidity and mortality in patients undergoing heart surgery. The aim of this systematic review was to determine if preoperative inspiratory muscle training could prevent the development of pneumonia and atelectasis in patients undergoing coronary artery bypass grafting (CABG) or heart valve surgery. METHODS: Systematic searches were performed in MEDLINE, Embase and the Cochrane Library. The included studies compared the development of pneumonia and atelectasis in CABG patients or heart valve surgery patients who were prescribed either preoperative inspiratory muscle training or usual care...
March 2018: Danish Medical Journal
Naïk Vietti Violi, Rafael Duran, Boris Guiu, Jean-Pierre Cercueil, Christophe Aubé, Antonia Digklia, Isabelle Pache, Pierre Deltenre, Jean-François Knebel, Alban Denys
BACKGROUND: Radiofrequency ablation is the recommended treatment for patients with hepatocellular carcinoma who have lesions smaller than 3 cm and are therefore not candidates for surgery. Microwave ablation is a more recent technique with certain theoretical advantages that have not yet been confirmed clinically. We aimed to compare the efficacy of both techniques in the treatment of hepatocellular carcinoma lesions of 4 cm or smaller. METHODS: We did a randomised controlled, single-blinded phase 2 trial at four tertiary university centres in France and Switzerland...
March 1, 2018: Lancet. Gastroenterology & Hepatology
Alex Mowat, Declan Maher, Kaven Baessler, Corina Christmann-Schmid, Nir Haya, Christopher Maher
BACKGROUND: Posterior vaginal wall prolapse (also known as 'posterior compartment prolapse') can cause a sensation of bulge in the vagina along with symptoms of obstructed defecation and sexual dysfunction. Interventions for prevention and conservative management include lifestyle measures, pelvic floor muscle training, and pessary use. We conducted this review to assess the surgical management of posterior vaginal wall prolapse. OBJECTIVES: To evaluate the safety and effectiveness of any surgical intervention compared with another surgical intervention for management of posterior vaginal wall prolapse...
March 5, 2018: Cochrane Database of Systematic Reviews
Sibylle Loibl, Joyce O'Shaughnessy, Michael Untch, William M Sikov, Hope S Rugo, Mark D McKee, Jens Huober, Mehra Golshan, Gunter von Minckwitz, David Maag, Danielle Sullivan, Norman Wolmark, Kristi McIntyre, Jose J Ponce Lorenzo, Otto Metzger Filho, Priya Rastogi, W Fraser Symmans, Xuan Liu, Charles E Geyer
BACKGROUND: Although several randomised trials in patients with triple-negative breast cancer have shown that the addition of carboplatin, with or without poly(ADP-ribose) polymerase (PARP) inhibitors, to neoadjuvant chemotherapy increases the likelihood of achieving a pathological complete response, the use of these therapies in this setting has remained controversial. The BrighTNess trial was designed to assess the addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer...
February 28, 2018: Lancet Oncology
Vikki Wylde, Jane Dennis, Rachael Gooberman-Hill, Andrew David Beswick
OBJECTIVE: Approximately 20% of patients experience chronic pain after total knee replacement (TKR). The aim of this systematic review was to evaluate the effectiveness of postdischarge interventions commenced in the first 3 months after surgery in reducing the severity of chronic pain after TKR. DESIGN: The protocol for this systematic review was registered on PROSPERO (registration number: CRD42017041382). MEDLINE, Embase, CINAHL, PsycINFO and The Cochrane Library were searched from inception to November 2016...
February 28, 2018: BMJ Open
Anne-Sophie Bouthors, Benjamin Hennart, Emmanuelle Jeanpierre, Anne-Sophie Baptiste, Imen Saidi, Elodie Simon, Damien Lannoy, Alain Duhamel, Delphine Allorge, Sophie Susen
BACKGROUND: Postpartum haemorrhage (PPH) is the leading cause of maternal death worldwide. Tranexamic acid (TA), an antifibrinolytic drug, reduces bleeding and transfusion need in major surgery and trauma. In ongoing PPH following vaginal delivery, a high dose of TA decreases PPH volume and duration, as well as maternal morbidity, while early fibrinolysis is inhibited. In a large international trial, a TA single dose reduced mortality due to bleeding but not the hysterectomy rate. TA therapeutic dosages vary from 2...
March 1, 2018: Trials
Harriet Riegger, Alexa Hollinger, Burkhardt Seifert, Katharina Toft, Andrea Blum, Tatjana Zehnder, Martin Siegemund
BACKGROUND: Delirium is a neurobehavioural syndrome that frequently develops in the postoperative setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 10 to 80% (Schonauer et al., J Pept Sci. 2017). Delirium was first described more than half a century ago in the cardiac surgery population (Blachy and Starr, Am J Psychiatry 121:371-5, 1964), where it was already discovered as a state that might be accompanied by serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality...
February 26, 2018: Trials
Marcello Di Nisio, Iris M Wichers, Saskia Middeldorp
BACKGROUND: The optimal treatment of superficial thrombophlebitis (ST) of the legs remains poorly defined. While improving or relieving the local painful symptoms, treatment should aim at preventing venous thromboembolism (VTE), which might complicate the natural history of ST. This is the third update of a review first published in 2007. OBJECTIVES: To assess the efficacy and safety of topical, medical, and surgical treatments for ST of the leg in improving local symptoms and decreasing thromboembolic complications...
February 25, 2018: Cochrane Database of Systematic Reviews
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