The Use of drains in Total Joint Arthroplasty
| ISRCTN | ISRCTN78657174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78657174 |
| Protocol serial number | N0650147585 |
| Sponsor | Department of Health |
| Funder | Southport and Ormskirk Hospital NHS Trust (UK) |
- 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
Scientific
Ormskirk & District General Hospital
Wigan Road
Ormskirk
L39 2AZ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does 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) studied | Surgery: Total joint arthroplasty |
| Intervention | Patients 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 type | Procedure/Surgery |
| Primary outcome measure(s) |
Volume of blood loss, volume of blood transfused and functional outcome. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key inclusion criteria | 60 hip replacements and 60 knee replacements |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ormskirk & District General Hospital
Ormskirk
L39 2AZ
United Kingdom
L39 2AZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |