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randomised controlled trial surgery

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https://www.readbyqxmd.com/read/28094468/long-term-outcomes-of-transobturator-tapes-in-women-with-stress-urinary-incontinence-e-tot-randomised-controlled-trial
#1
Debjyoti Karmakar, Alyaa Mostafa, Mohamed Abdel-Fattah
OBJECTIVES: To assess the long-term (LT) patient-reported outcomes and adverse events(AE) following transobturator tension-free vaginal tape(TO-TVT). DESIGN: Postal follow-up of the E-TOT randomised controlled trial(RCT). SETTING: A tertiary urogynaecology center in the UK; all procedures took place in 2005 to2007. POPULATION: 341 Women were randomised to undergo either "inside-out" TVT-O (Ethicon Inc.,Somerville,NJ,USA) or "outside-in" TOT-ARIS (Coloplast Corp...
January 17, 2017: BJOG: An International Journal of Obstetrics and Gynaecology
https://www.readbyqxmd.com/read/28094198/late-side-effects-and-cosmetic-results-of-accelerated-partial-breast-irradiation-with-interstitial-brachytherapy-versus-whole-breast-irradiation-after-breast-conserving-surgery-for-low-risk-invasive-and-in-situ-carcinoma-of-the-female-breast-5-year-results
#2
Csaba Polgár, Oliver J Ott, Guido Hildebrandt, Daniela Kauer-Dorner, Hellen Knauerhase, Tibor Major, Jaroslaw Lyczek, José Luis Guinot, Jürgen Dunst, Cristina Gutierrez Miguelez, Pavel Slampa, Michael Allgäuer, Kristina Lössl, Bülent Polat, György Kovács, Arnt-René Fischedick, Rainer Fietkau, Alexandra Resch, Anna Kulik, Leo Arribas, Peter Niehoff, Ferran Guedea, Annika Schlamann, Richard Pötter, Christine Gall, Wolfgang Uter, Vratislav Strnad
BACKGROUND: We previously confirmed the non-inferiority of accelerated partial breast irradiation (APBI) with interstitial brachytherapy in terms of local control and overall survival compared with whole-breast irradiation for patients with early-stage breast cancer who underwent breast-conserving surgery in a phase 3 randomised trial. Here, we present the 5-year late side-effects and cosmetic results of the trial. METHODS: We did this randomised, controlled, phase 3 trial at 16 centres in seven European countries...
January 13, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28088218/spinal-versus-general-anaesthesia-in-surgery-for-inguinodynia-spinasia-trial-study-protocol-for-a-randomised-controlled-trial
#3
Willem A R Zwaans, Léon H P M le Mair, Marc R M Scheltinga, Rudi M H Roumen
BACKGROUND: Chronic inguinodynia (groin pain) is a common complication following open inguinal hernia repair or a Pfannenstiel incision but may also be experienced after other types of (groin) surgery. If conservative treatments are to no avail, tailored remedial surgery, including a neurectomy and/or a (partial) meshectomy, may be considered. Retrospective studies in patients with chronic inguinodynia suggested that spinal anaesthesia is superior compared to general anaesthesia in terms of pain relief following remedial operations...
January 14, 2017: Trials
https://www.readbyqxmd.com/read/28087548/early-lens-extraction-with-intraocular-lens-implantation-for-the-treatment-of-primary-angle-closure-glaucoma-an-economic-evaluation-based-on-data-from-the-eagle-trial
#4
Mehdi Javanbakht, Augusto Azuara-Blanco, Jennifer M Burr, Craig Ramsay, David Cooper, Claire Cochran, John Norrie, Graham Scotland
OBJECTIVE: To investigate the cost-effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle closure glaucoma (PACG) compared to standard care. DESIGN: Cost-effectiveness analysis alongside a multicentre pragmatic two-arm randomised controlled trial. Patients were followed-up for 36 months, and data on health service usage and health state utility were collected and analysed within the trial time horizon. A Markov model was developed to extrapolate the results over a 5-year and 10-year time horizon...
January 13, 2017: BMJ Open
https://www.readbyqxmd.com/read/28077412/microvascular-outcomes-after-metabolic-surgery-moms-in-patients-with-type-2-diabetes-mellitus-and-class-i-obesity-rationale-and-design-for-a-randomised-controlled-trial
#5
Ricardo Vitor Cohen, Tiago Veiga Pereira, Cristina Mamédio Aboud, Pedro Paulo de Paris Caravatto, Tarissa Beatrice Zanata Petry, José Luis Lopes Correa, Carlos Aurélio Schiavon, Mariangela Correa, Carlos Eduardo Pompílio, Fernando Nogueira Quirino Pechy, Carel le Roux
INTRODUCTION: There are several randomised controlled trials (RCTs) that have already shown that metabolic/bariatric surgery achieves short-term and long-term glycaemic control while there are no level 1A of evidence data regarding the effects of surgery on the microvascular complications of type 2 diabetes mellitus (T2DM). PURPOSE: The aim of this trial is to investigate the long-term efficacy and safety of the Roux-en-Y gastric bypass (RYGB) plus the best medical treatment (BMT) versus the BMT alone to improve microvascular outcomes in patients with T2DM with a body mass index (BMI) of 30-34...
January 11, 2017: BMJ Open
https://www.readbyqxmd.com/read/28077355/no-evidence-for-the-use-of-stem-cell-therapy-for-tendon-disorders-a-systematic-review
#6
Haiko I M F L Pas, Maarten H Moen, Hidde J Haisma, Marinus Winters
INTRODUCTION: Stem cells have emerged as a new treatment option for tendon disorders. We systematically reviewed the current evidence for stem cell therapy in tendon disorders. METHODS: Randomised and non-randomised controlled trials, cohort studies and case series with a minimum of 5 cases were searched in MEDLINE, CENTRAL, EMBASE, CINAHL, PEDro and SPORTDiscus. In addition, we searched grey literature databases and trial registers. Only human studies were included and no time or language restrictions were applied to our search...
January 11, 2017: British Journal of Sports Medicine
https://www.readbyqxmd.com/read/28076240/effects-of-bariatric-surgery-on-gout-incidence-in-the-swedish-obese-subjects-study-a-non-randomised-prospective-controlled-intervention-trial
#7
Cristina Maglio, Markku Peltonen, Martin Neovius, Peter Jacobson, Lennart Jacobsson, Anna Rudin, Lena M S Carlsson
OBJECTIVES: To assess the long-term effect of bariatric surgery on the incidence of gout and hyperuricaemia in participants of the Swedish Obese Subjects (SOS) study. METHODS: This report includes 1982 subjects who underwent bariatric surgery and 1999 obese controls from the SOS study, a prospective intervention trial designed to assess the effect of bariatric surgery compared with conventional treatment. None of the subjects had gout at baseline. An endpoint on gout incidence was created based on information on gout diagnosis and use of gout medications through national registers and questionnaires...
October 8, 2016: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28069072/pansaid-paracetamol-and-nsaid-in-combination-study-protocol-for-a-randomised-trial
#8
Kasper Højgaard Thybo, Daniel Hägi-Pedersen, Jørn Wetterslev, Jørgen Berg Dahl, Henrik Morville Schrøder, Hans Henrik Bülow, Jan Gottfrid Bjørck, Ole Mathiesen
BACKGROUND: Effective postoperative pain management is essential for the rehabilitation of the surgical patient. No 'gold standard' exists after total hip arthroplasty (THA) and combinations of different nonopioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy. The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen alone and in combination in different dosages after THA. METHODS: PANSAID is a placebo-controlled, parallel four-group, multicentre trial with centralised computer-generated allocation sequence and allocation concealment and with varying block size and stratification by site...
January 10, 2017: Trials
https://www.readbyqxmd.com/read/28065734/laparoscopic-roux-en-y-gastric-bypass-in-adolescents-with-severe-obesity-amos-a-prospective-5-year-swedish-nationwide-study
#9
Torsten Olbers, Andrew J Beamish, Eva Gronowitz, Carl-Erik Flodmark, Jovanna Dahlgren, Gustaf Bruze, Kerstin Ekbom, Peter Friberg, Gunnar Göthberg, Kajsa Järvholm, Jan Karlsson, Staffan Mårild, Martin Neovius, Markku Peltonen, Claude Marcus
BACKGROUND: Severe obesity in adolescence is associated with reduced life expectancy and impaired quality of life. Long-term benefits of conservative treatments in adolescents are known to be modest, whereas short-term outcomes of adolescent bariatric surgery are promising. We aimed to compare 5-year outcomes of adolescent surgical patients after Roux-en-Y gastric bypass with those of conservatively treated adolescents and of adults undergoing Roux-en-Y gastric bypass, in the Adolescent Morbid Obesity Surgery (AMOS) study...
January 5, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28061841/supervised-neuromuscular-exercise-prior-to-hip-and-knee-replacement-12-month-clinical-effect-and-cost-utility-analysis-alongside-a-randomised-controlled-trial
#10
Linda Fernandes, Ewa M Roos, Søren Overgaard, Allan Villadsen, Rikke Søgaard
BACKGROUND: There are indications of beneficial short-term effect of pre-operative exercise in reducing pain and improving activity of daily living after total hip replacement (THR) and total knee replacement (TKR) surgery. Though, information from studies conducting longer follow-ups and economic evaluations of exercise prior to THR and TKR is needed. The aim of the study was to analyse 12-month clinical effect and cost-utility of supervised neuromuscular exercise prior to THR and TKR surgery...
January 6, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28053265/effectiveness-of-open-and-arthroscopic-rotator-cuff-repair-ukuff-a-randomised-controlled-trial
#11
A Carr, C Cooper, M K Campbell, J Rees, J Moser, D J Beard, R Fitzpatrick, A Gray, J Dawson, J Murphy, H Bruhn, D Cooper, C Ramsay
AIMS: The appropriate management for patients with a degenerative tear of the rotator cuff remains controversial, but operative treatment, particularly arthroscopic surgery, is increasingly being used. Our aim in this paper was to compare the effectiveness of arthroscopic with open repair of the rotator cuff. PATIENTS AND METHODS: A total of 273 patients were recruited to a randomised comparison trial (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and general hospitals in the United Kingdom...
January 2017: Bone & Joint Journal
https://www.readbyqxmd.com/read/28053263/the-quality-of-randomised-controlled-trials-involving-surgery-from-the-hand-to-the-elbow-a-critical-analysis-of-the-literature
#12
J M Kim, R M Zimmerman, C M Jones, A Al Muhit, J P Higgins, K R Means
AIMS: Our purpose was to determine the quality of current randomised controlled trials (RCTs) in hand surgery using standardised metrics. MATERIALS AND METHODS: Based on five-year mean impact factors, we selected the six journals that routinely publish studies of upper extremity surgery. Using a journal-specific search query, 62 RCTs met our inclusion criteria. Then three blinded reviewers used the Jadad and revised Coleman Methodology Score (RCMS) to assess the quality of the manuscripts...
January 2017: Bone & Joint Journal
https://www.readbyqxmd.com/read/28052910/acupuncture-and-pc6-stimulation-for-the-prevention-of-postoperative-nausea-and-vomiting-in-patients-undergoing-elective-laparoscopic-resection-of-colorectal-cancer-a-study-protocol-for-a-three-arm-randomised-pilot-trial
#13
Kun Hyung Kim, Dae Hun Kim, Ji Min Bae, Gyung Mo Son, Kyung Hee Kim, Seung Pyo Hong, Gi Young Yang, Hee Young Kim
INTRODUCTION: This study aims to assess the feasibility of acupuncture and a Pericardium 6 (PC6) wristband as an add-on intervention of antiemetic medication for the prevention of postoperative nausea and vomiting (PONV) in patients undergoing elective laparoscopic colorectal cancer resection. METHODS AND ANALYSIS: A total of 60 participants who are scheduled to undergo elective laparoscopic resection of colorectal cancer will be recruited. An enhanced recovery after surgery protocol using standardised antiemetic medication will be provided for all participants...
January 4, 2017: BMJ Open
https://www.readbyqxmd.com/read/28052810/clinical-effectiveness-and-cost-effectiveness-of-surgical-options-for-the-management-of-anterior-and-or-posterior-vaginal-wall-prolapse-two-randomised-controlled-trials-within-a-comprehensive-cohort-study-results-from-the-prospect-study
#14
Cathryn Glazener, Suzanne Breeman, Andrew Elders, Christine Hemming, Kevin Cooper, Robert Freeman, Anthony Smith, Suzanne Hagen, Isobel Montgomery, Mary Kilonzo, Dwayne Boyers, Alison McDonald, Gladys McPherson, Graeme MacLennan, John Norrie
BACKGROUND: The use of mesh in prolapse surgery is controversial, leading to a number of enquiries into its safety and efficacy. OBJECTIVE: To compare synthetic non-absorbable mesh inlay, biological graft and mesh kit with a standard repair in terms of clinical effectiveness, adverse effects, quality of life (QoL), costs and cost-effectiveness. DESIGN: Two randomised controlled trials within a comprehensive cohort (CC) study. Allocation was by a remote web-based randomisation system in a 1 :1 : 1 ratio (Primary trial) or 1 : 1 : 2 ratio (Secondary trial), and was minimised on age, type of prolapse repair planned, need for a concomitant continence procedure, need for a concomitant upper vaginal prolapse procedure and surgeon...
December 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28052313/thromboelastography-teg-or-rotational-thromboelastometry-rotem-to-monitor-haemostatic-treatment-in-bleeding-patients-a-systematic-review-with-meta-analysis-and-trial-sequential-analysis
#15
REVIEW
A Wikkelsø, J Wetterslev, A M Møller, A Afshari
Coagulopathy and severe bleeding are associated with high mortality. We evaluated haemostatic treatment guided by the functional viscoelastic haemostatic assays, thromboelastography or rotational thromboelastometry in bleeding patients. We searched for randomised, controlled trials irrespective of publication status, publication date, blinding status, outcomes published or language from date of inception to 5 January 2016 in six bibliographic databases. We included 17 trials (1493 participants), most involving cardiac surgery...
January 4, 2017: Anaesthesia
https://www.readbyqxmd.com/read/28052186/axillary-treatment-for-operable-primary-breast-cancer
#16
REVIEW
Nathan Bromham, Mia Schmidt-Hansen, Margaret Astin, Elise Hasler, Malcolm W Reed
BACKGROUND: Axillary surgery is an established part of the management of primary breast cancer. It provides staging information to guide adjuvant therapy and potentially local control of axillary disease. Several alternative approaches to axillary surgery are available, most of which aim to spare a proportion of women the morbidity of complete axillary dissection. OBJECTIVES: To assess the benefits and harms of alternative approaches to axillary surgery (including omitting such surgery altogether) in terms of overall survival; local, regional and distant recurrences; and adverse events...
January 4, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28051764/the-use-of-fibrin-sealant-during-non-emergency-surgery-a-systematic-review-of-evidence-of-benefits-and-harms
#17
Steven J Edwards, Fay Crawford, Michelle Helena van Velthoven, Andrea Berardi, George Osei-Assibey, Mariana Bacelar, Fatima Salih, Victoria Wakefield
BACKGROUND: Fibrin sealants are used in different types of surgery to prevent the accumulation of post-operative fluid (seroma) or blood (haematoma) or to arrest haemorrhage (bleeding). However, there is uncertainty around the benefits and harms of fibrin sealant use. OBJECTIVES: To systematically review the evidence on the benefits and harms of fibrin sealants in non-emergency surgery in adults. DATA SOURCES: Electronic databases [MEDLINE, EMBASE and The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and the Cochrane Central Register of Controlled Trials)] were searched from inception to May 2015...
December 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28049491/fenofibrate-in-the-management-of-abdominal-aortic-aneurysm-fame-study-protocol-for-a-randomised-controlled-trial
#18
Sophie E Rowbotham, Doug Cavaye, Rene Jaeggi, Jason S Jenkins, Corey S Moran, Joseph V Moxon, Jenna L Pinchbeck, Frank Quigley, Christopher M Reid, Jonathan Golledge
BACKGROUND: Abdominal aortic aneurysm (AAA) is a slowly progressive destructive process of the main abdominal artery. Experimental studies indicate that fibrates exert beneficial effects on AAAs by mechanisms involving both serum lipid modification and favourable changes to the AAA wall. METHODS/DESIGN: Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME) is a multicentre, randomised, double-blind, placebo-controlled clinical trial to assess the effect of orally administered therapy with fenofibrate on key pathological markers of AAA in patients undergoing open AAA repair...
January 4, 2017: Trials
https://www.readbyqxmd.com/read/28045374/the-role-of-internal-limiting-membrane-peeling-in-epiretinal-membrane-surgery-a-randomised-controlled-trial
#19
Paris Tranos, Stavrenia Koukoula, Davic G Charteris, Georgia Perganda, Athanasios Vakalis, Solon Asteriadis, Ilias Georgalas, Petros Petrou
PURPOSE: To compare the anatomical and functional outcomes after primary idiopathic epiretinal membrane (ERM) peeling with or without internal limiting membrane (ILM) peeling. DESIGN: A two-centre randomised, controlled clinical trial with 12 months of follow-up. METHODS: One hundred and two eyes of 102 patients were included in the analysis and were randomised into two groups (ILM peeling (P) and non-ILM peeling (NP) group). Inclusion criteria were: Idiopathic ERM confirmed on optical coherence tomography, age ≥18 years, binocular distortion, best-corrected visual acuity (BCVA) ≤90 ETDRS letters, intraocular pressure ≤23 mm Hg and informed consent...
October 7, 2016: British Journal of Ophthalmology
https://www.readbyqxmd.com/read/28039127/effectiveness-of-early-compared-with-conservative-rehabilitation-for-patients-having-rotator-cuff-repair-surgery-an-overview-of-systematic-reviews
#20
Bruno Fles Mazuquin, Andrew Charles Wright, Sarah Russell, Puneet Monga, James Selfe, Jim Richards
AIM/OBJECTIVE: The aim is to critically analyse and discuss the current literature and determine the effectiveness of rehabilitation for patients after surgical repair of rotator cuff tears for range of motion (ROM), pain, functional status and retear rates; in addition, an update of new literature is included. DESIGN: Overview of systematic reviews. DATA SOURCES: A search was performed with no restrictions to date of publication and language in the following databases: EBSCO, AMED, CINAHL, SPORTDiscus, EMBASE, Cochrane, LILACS, MEDLINE, PEDro, Scielo, SCOPUS and Web of Knowledge...
December 30, 2016: British Journal of Sports Medicine
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