Prospective randomised study of minimal invasive vs open surgery for treatment of benign breast lesions.
| ISRCTN | ISRCTN28820566 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28820566 |
| Secondary identifying numbers | N0084125093 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 30/07/2013
- 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 Phillip Drew
Scientific
Scientific
Academic Surgical Unit
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
| Phone | +44 (0)1482 875875 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To evaluate comparative cosmetic outcome between open and minimal invasive surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Breast lesions |
| Intervention | Randomised controlled trial (RCT) comparing: 1. Minimally invasive surgery 2. Open surgery |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Cosmetic outcomes |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 10/04/2003 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 40 |
| Key inclusion criteria | 40 patients with benign breast legions will be recruited |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 10/04/2003 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Surgical Unit
Cottingham
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Not defined
The North and South Bank Research and Development Consortium (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
