Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084151426
Study information
Scientific title
Acronym
Study hypothesis
1. To assess the acceptability and psychological effects of fast-track surgery
2. To perform an economic analysis of fast-track surgery
3. To examine the role of enhanced pre-operative information in fast-track surgery
4. To examine the relationship between the stress response and length of stays
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Colorectal
Intervention
Recruitment for this study will occur in consecutive patients attending preassesment clinics. Randomisation will be performed at a remote site and accessed by telephone. A computer generated permuted block randomisation technique will be employed.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Psychological effects and acceptability will be assessed by Hospital Anxiety and Depression Score (HADS).
2. The economic analysis will be based on the EuroQol.
3. The RCT will be assessed by 6 item Spielberger anxiety inventory
4. Physiological stress will be assessed by salivary IgA levels
Secondary outcome measures
Not provided at time of registration
Overall trial start date
07/09/2004
Overall trial end date
01/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age over 16
2. Undergoing colorectal resections or colostomy/ileostomy formation or closure
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Minimum of 15 patients
Participant exclusion criteria
1. Visual impairment
2. Inadequate comprehension to understand pre-op information and sign consent form
Recruitment start date
07/09/2004
Recruitment end date
01/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The North and South Bank Research and Development Consortium
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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