ISRCTN ISRCTN87878836
DOI https://doi.org/10.1186/ISRCTN87878836
Protocol serial number N0224135100
Sponsor Department of Health
Funder South Devon Healthcare NHS Trust (UK)
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
05/04/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Swart
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Post operative care
InterventionPatients are randomised to high dependency care or general surgical ward care.
Intervention typeProcedure/Surgery
Primary outcome measure(s)

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)

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/03/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteriaAdult patients scheduled for colorectal surgery. Patients with a low exercise tolerance (AT <11 ml Oxygen/kg/min) recruited into trial.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment31/07/2002
Date of final enrolment30/03/2007

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2012 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes