The effect of enhanced pre-operative information on patient recovery following colorectal surgery: a randomised controlled trial.
| ISRCTN | ISRCTN81232818 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81232818 |
| Secondary identifying numbers | N0084151426 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 04/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Biju Joseph
Scientific
Scientific
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 07/09/2004 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Minimum of 15 patients |
| Key inclusion criteria | 1. Age over 16 2. Undergoing colorectal resections or colostomy/ileostomy formation or closure |
| Key exclusion criteria | 1. Visual impairment 2. Inadequate comprehension to understand pre-op information and sign consent form |
| Date of first enrolment | 07/09/2004 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The North and South Bank Research and Development Consortium
No information available
NHS R&D Support Funding
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 |
