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 |
| Protocol serial number | N0084151426 |
| Sponsor | Department of Health |
| Funders | The North and South Bank Research and Development Consortium, NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Psychological effects and acceptability will be assessed by Hospital Anxiety and Depression Score (HADS). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 15 |
| 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
- United Kingdom
- England
Study participating centre
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
