ISRCTN ISRCTN78657174
DOI https://doi.org/10.1186/ISRCTN78657174
Secondary identifying numbers N0650147585
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
08/04/2014
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 T Menon
Scientific

Ormskirk & District General Hospital
Wigan Road
Ormskirk
L39 2AZ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDoes the routine use of drains alter the post operative blood loss and hence influence the need for blood transfusions in hip and knee arthroplasties?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Total joint arthroplasty
InterventionPatients undergoing hip and knee arthroplasties will be randomized into two groups, one with and the other without post-op closed suction drains. Parameters studied will include post-operative blood loss, blood transfusion requirements, duration of hospital stay, complications if any, and the immediate and short term functional outcome. All patients will be consented after providing details of the study. Copy of consent and proforma for study in hard copy file.
Intervention typeProcedure/Surgery
Primary outcome measureVolume of blood loss, volume of blood transfused and functional outcome.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2002
Completion date31/03/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants120
Key inclusion criteria60 hip replacements and 60 knee replacements
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2002
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Ormskirk & District General Hospital
Ormskirk
L39 2AZ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Southport and Ormskirk Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan