Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
04/02/2014
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

Mr Biju Joseph

ORCID ID

Contact details

Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes