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ISRCTN
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ISRCTN77366282
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of median Sternotomy versus anterolateral left Thoracotomy on morbidity and healthcare resource use in patients having off-pump coronary artery bypass surgery
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Scientific title
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Acronym
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SteT
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Serial number at source
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CS2005/2169 (Sponsor's reference number)
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Study hypothesis
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The primary hypothesis is that off-pump coronary artery bypass thoracotomy (OPCAB-Th) will reduce post-operative morbidity and the amount of hospital resources used compared to off-pump coronary artery bypass sternotomy (OPCAB-St).
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Ethics approval
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Ethics approval received from the NHS Southmead Research Ethics Committee on the 11th August 2006 (ref: 06/Q2002/53)
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Study design
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A multi-centre, open randomised controlled trial
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Countries of recruitment
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Italy, Trinidad, United Kingdom
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Disease/condition/study domain
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Coronary artery disease
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Participants - inclusion criteria
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All adults aged more than 16 years and less than 80 years having non-emergency, scheduled (urgent or elective) first time off-pump surgery represent the target study population.
Specific inclusion criteria:
1. Aged more than 16 and less than 80 years
2. Undergoing non-emergency, scheduled (urgent or elective) isolated coronary artery bypass grafting off-pump on the beating heart
3. Participating surgeon willing to carry out the operation via either surgical method
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Participants - exclusion criteria
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1. No previous cardiac surgery
2. No previous lung surgery
3. Not in another invasive research study
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Anticipated start date
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08/01/2007
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Anticipated end date
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31/12/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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180
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Interventions
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Coronary artery bypass grafting on the beating heart via a conventional median sternotomy (OPCAB-St) versus coronary artery bypass grafting on the beating heart via a left anterolateral thoracotomy (OPCAB-Th).
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Primary outcome measure(s)
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The primary outcome is the time until patients are classified as ‘fit for discharge’. A patient must have a chest X-ray with no evidence of pleural effusion requiring drainage, lung collapse/consolidation or pneumothorax, no suspected infection, normal routine blood tests and temperature in order to be classified as fit for discharge. Susceptibility to bias of these components of the primary outcome will be minimised by documenting objective clinical signs and measurements.
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Secondary outcome measure(s)
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1. Intraoperative measurement of cardiac output measured by Swan-Ganz catheter, when each distal anastomosis is being carried out on the target coronary arteries (consecutive sub-sample only, n = 40)
2. A participant’s judgement about his or her readiness for discharge when the above criteria are met (too soon, about right, could have been discharged earlier)
3. Biochemical inflammatory markers, i.e. complement activation (C3a and C5), interleukin (Interleukin 6 [IL6], Interleukin 8 [IL8] and Interleukin 10 [IL10]); these will be assessed at five time points, i.e. preoperatively, at the end of the operation, and four, 12 and 24 hours post-operatively (consecutive sub-sample only, n = 60)
4. Alveolar/arterial gradient measured preoperatively (in the anaesthetic room), after extubation, and one day after extubation, from arterial blood samples taken through an existing arterial line five minutes after administering oxygen by mask, for each of three different oxygen concentrations (consecutive sub-sample only, n = 40)
5. Pulmonary function tests (PFTs) preoperatively and at discharge
6. Pain score measured with a 10 cm (0 to 100 mm) visual analogue scale, or by verbal response (0 to 100) if a participant is not well enough to use the visual analogue scale at two, 12, 24 and 36 hours after extubation and on discharge
7. The total amount (volume and dose) of local anaesthetic (paravertebral block) and patient-controlled analgesia administered; post-operative days on which paracetamol and non-steroidal anti-inflammatory drugs were dispensed
8. Intensive Care Unit (ICU) and post-operative hospital stay
9. In-hospital mortality and other standard measures of morbidity, e.g. post-operative myocardial infarction (MI), stroke, arrhythmia, need for haemodynamic support, renal failure and wound infection
10. Use of health care resources and associated costs, e.g. duration of operation, ICU/High Dependancy Unit (HDU) and ward stay, additional interventions to treat complications, readmissions
11. Coronary Revascularisation Outcome Questionnaire (CROQ) preoperatively (preoperative version) and at three months (postoperative version)
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Sources of funding
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Garfield Weston Trust (UK) (ref: 06-07/1001)
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Trial website
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Publications
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Contact name
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Prof
Gianni
Angelini
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Address
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Bristol Heart Institute
University of Bristol
Level 7, Bristol Royal Infirmary
Marlborough Street
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City/town
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Bristol
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Zip/Postcode
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BS2 8HW
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Country
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United Kingdom
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Tel
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+44 (0)117 928 3145
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Fax
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+44 (0)117 929 9737
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Email
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g.d.angelini@bristol.ac.uk
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Sponsor
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United Bristol NHS Healthcare Trust (UK)
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Address
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UBHT Research and Effectiveness Department
Bristol Royal Infirmary
Marlborough Street
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City/town
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Bristol
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Zip/Postcode
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BS2 8HW
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Country
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United Kingdom
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Sponsor website:
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http://www.ubht.nhs.uk
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Date applied
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14/12/2006
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Last edited
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14/08/2008
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Date ISRCTN assigned
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09/02/2007
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