Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/04/2012
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

Dr Michael Swart

ORCID ID

Contact details

South Devon Health Care NHS Trust
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0224135100

Study information

Scientific title

Acronym

Study hypothesis

To determine whether post-operative high dependency care can decrease morbidity and mortality in patients who would otherwise be cared for on a general surgical ward.

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Post operative care

Intervention

Patients are randomised to high dependency care or general surgical ward care.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. The incidence of postoperative mortality and major morbidity (cardiorespiratory) in high dependency unit (HDU) compared to general surgical ward.
2. The duration of postoperative care (on HDU and in the hospital)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/07/2002

Overall trial end date

30/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients scheduled for colorectal surgery. Patients with a low exercise tolerance (AT <11 ml Oxygen/kg/min) recruited into trial.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/07/2002

Recruitment end date

30/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Devon Health Care NHS Trust
Torquay
TQ2 7AA
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

South Devon Healthcare NHS Trust (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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22101443

Publication citations

  1. Results

    Swart M, Carlisle JB, Case-controlled study of critical care or surgical ward care after elective open colorectal surgery., Br J Surg, 2012, 99, 2, 295-299, doi: 10.1002/bjs.7789.

Additional files

Editorial Notes