Contact information
Type
Scientific
Primary contact
Prof Gianni Angelini
ORCID ID
Contact details
Bristol Heart Institute
University of Bristol
Level 7
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3145
g.d.angelini@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CS2005/2169
Study information
Scientific title
Acronym
SteT
Study hypothesis
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).
Ethics approval
NHS Southmead Research Ethics Committee, 11/08/2006, ref: 06/Q2002/53
Study design
Multi-centre open randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Coronary artery disease
Intervention
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).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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.
Secondary outcome measures
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 participants 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 4, 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 1 day after extubation, from arterial blood samples taken through an existing arterial line 5 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 2, 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 healthcare 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 3 months (postoperative version)
Overall trial start date
08/01/2007
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant exclusion criteria
1. No previous cardiac surgery
2. No previous lung surgery
3. Not in another invasive research study
Recruitment start date
08/01/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Italy, Trinidad and Tobago, United Kingdom
Trial participating centre
Bristol Heart Institute
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
United Bristol NHS Healthcare Trust (UK)
Sponsor details
UBHT Research and Effectiveness Department
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Garfield Weston Trust (UK) (ref: 06-07/1001)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22944093
Publication citations
-
Results
Rogers CA, Pike K, Angelini GD, Reeves BC, Glauber M, Ferrarini M, Murphy GJ, An open randomized controlled trial of median sternotomy versus anterolateral left thoracotomy on morbidity and health care resource use in patients having off-pump coronary artery bypass surgery: the Sternotomy Versus Thoracotomy (STET) trial., J. Thorac. Cardiovasc. Surg., 2013, 146, 2, 306-16.e1-9, doi: 10.1016/j.jtcvs.2012.04.020.