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
| ISRCTN | ISRCTN77366282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77366282 |
| Secondary identifying numbers | CS2005/2169 |
- Submission date
- 14/12/2006
- Registration date
- 09/02/2007
- Last edited
- 03/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gianni Angelini
Scientific
Scientific
Bristol Heart Institute
University of Bristol
Level 7, Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 928 3145 |
|---|---|
| g.d.angelini@bristol.ac.uk |
Study information
| Study design | Multi-centre open randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | SteT |
| Study objectives | 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(s) | NHS Southmead Research Ethics Committee, 11/08/2006, ref: 06/Q2002/53 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 08/01/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 180 |
| Key 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 |
| Key exclusion criteria | 1. No previous cardiac surgery 2. No previous lung surgery 3. Not in another invasive research study |
| Date of first enrolment | 08/01/2007 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- Italy
- Trinidad and Tobago
- United Kingdom
Study participating centre
Bristol Heart Institute
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
United Bristol NHS Healthcare Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
UBHT Research and Effectiveness Department
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
England
United Kingdom
| Website | http://www.ubht.nhs.uk |
|---|---|
"ROR" |
https://ror.org/04nm1cv11 |
Funders
Funder type
Charity
Garfield Weston Trust (UK) (ref: 06-07/1001)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2013 | Yes | No |
