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
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
-
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.