Condition category
Surgery
Date applied
12/09/2002
Date assigned
12/09/2002
Last edited
31/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.galatrial.com

Contact information

Type

Scientific

Primary contact

Ms Bridget Colam

ORCID ID

Contact details

Neurosciences Trials Unit
Bramwell Dott Building
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
+44 (0)131 537 2930
gala@skull.dcn.ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2268/1979

Study information

Scientific title

Acronym

GALA

Study hypothesis

A prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy is proposed to determine whether the type of anaesthesia does indeed influence peri-operative morbidity and mortality, quality of life and long term outcome in terms of stroke-free survival.

Please note that as of 29/05/2008 this record was updated to include a longer recruitment period. All changes can be found under the relevant fields, with the update date of 29/05/2008. The anticipated end date of this trial was extended to 30/04/2008. The previous anticipated end date of this trial was 31/12/2006. Randomisation stopped on 31/10/2007 and the presentation of results is expected on 06/09/08.

Ethics approval

Ethics approval received from the Northern and Yorkshire MREC on the 28th August 1998 (pilot phase) and 22nd April 2003 (main phase).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Carotid stenosis (at risk from stroke)

Intervention

Anaesthetic for surgery - local versus general. Randomisation will be by telephone to the trial office. Data will be collected at baseline (prior to randomisation) and this will include demographic details, known risk factors, diagnostic procedures and findings, and indications for surgery. The follow-up data will be collected when the patient is discharged from acute care, and operative details and any early complications will be recorded. At 1 month post-surgery, a stroke physician, blind to the type of anaesthesia, will review the patient. Also the patient will be asked to complete a health related quality of life questionnaire including the widely used EuroQol and Short Form 36, plus a carotid endarterectomy (CEA) specific questionnaire designed to capture patient satisfaction levels with the method of anaesthesia. Length of time spent in the recovery room, intensive care unit (ICU) and high dependency unit (HDU), and length of overall acute hospital stay will be recorded. Annual follow up will be by post to the family doctor and to the patient, seeking details of any strokes.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

The proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction (MI) 30 days post-surgery.

Secondary outcome measures

Proportion alive and stroke free at one year and in the longer term, a comparison of health related quality of life at 30 days and any surgical adverse events, re-operation and re-admission rates, the relative cost of the two methods of anaesthesia, length of stay and intensive and high dependency bed occupancy.

Overall trial start date

01/06/1999

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

The main criterion for entry into this study is that, in the opinion of the responsible clinician, the patient requiring an endarterectomy is suitable for either local or general anaesthesia, and there is no clear indication for either type. All patients with either symptomatic or asymptomatic internal carotid stenosis for whom surgery is advised are eligible. There is no upper age limit.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

5,000 (as of 19/05/08, the total recruited: 3,526)

Participant exclusion criteria

1. Failure to obtain informed consent
2. Patient unable to co-operate with awake testing during local anaesthesia
3. Patient considered unfit for general anaesthesia
4. Patient considered unfit for local anaesthesia
5. Patient requiring simultaneous bilateral carotid endarterectomy
6. Carotid endarterectomy combined with another operative artery bypass surgery
7. Patient has been randomised into the trial previously

Recruitment start date

01/06/1999

Recruitment end date

30/04/2008

Locations

Countries of recruitment

Australia, Austria, Belarus, China, Croatia, Czech Republic, Estonia, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Turkey, Ukraine, United Kingdom

Trial participating centre

Neurosciences Trials Unit
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

The Health Foundation (UK)

Sponsor details

90 Long Acre
London
WC2E 9RA
United Kingdom
+44 (0)20 7257 8000
info@health.org.uk

Sponsor type

Charity

Website

http://www.pppfoundation.org.uk/

Funders

Funder type

Charity

Funder name

The Health Foundation (UK)

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

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18495004
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19041130

Publication citations

  1. Protocol

    Gough MJ, Bodenham A, Horrocks M, Colam B, Lewis SC, Rothwell PM, Banning AP, Torgerson D, Gough M, Dellagrammaticas D, Leigh-Brown A, Liapis C, Warlow C, GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery., Trials, 2008, 9, 28, doi: 10.1186/1745-6215-9-28.

  2. Results

    , Lewis SC, Warlow CP, Bodenham AR, Colam B, Rothwell PM, Torgerson D, Dellagrammaticas D, Horrocks M, Liapis C, Banning AP, Gough M, Gough MJ, General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial., Lancet, 2008, 372, 9656, 2132-2142, doi: 10.1016/S0140-6736(08)61699-2.

Additional files

Editorial Notes