Condition category
Circulatory System
Date applied
14/12/2006
Date assigned
09/02/2007
Last edited
03/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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 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 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

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

http://www.ubht.nhs.uk

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22944093

Publication citations

  1. 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.

Additional files

Editorial Notes