Sensate DIEP flaps - assessment of breast sensation on quality of life and body image
| ISRCTN | ISRCTN25603476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25603476 |
| Secondary identifying numbers | N0265166244 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 29/01/2015
- 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 L Yap
Scientific
Scientific
Burns & Plastics
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Sensate DIEP flaps - assessment of breast sensation on quality of life and body image |
| Study objectives | 1. To assess how important breast sensation is to patients undergoing breast reconstruction both pre and post operatively and the degree that this impacts on patient quality of life and body image 2. To assess the recovery of sensation in a breast reconstructed with abdominal skin and nerve reattachment, and to compare this to a breast reconstructed with abdominal skin that has not had the nerve reattached, and a bust reconstructed with skin/muscle from the back |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Breast |
| Intervention | Patients preparing for an excision of breast cancer and reconstruction are seen pre-operatively and followed up in our breast reconstruction clinic. These patients are counselled as to the expected loss of breast sensation following surgery. They are then offered a choice of reconstructive options, which include: 1. Implant only 2. Skin and muscle from the back 3. Skin and muscle from the stomach (+ or - nerve reattachment We intend to ask all patients within these three groups how important they think breast sensation is to them before the operation. We also wish to obtain validated measures of anxiety and depression and body image, Following the Operation. We will repeat the questionnaire and body Image assessment to establish how much this does impact upon their everyday life and how much sensory return they achieve. This will be repeated at each clinic visit (3 monthly) for 1 year. The patients who are having reconstructions from their abdominal skin and muscle will be randomised into two groups: those receiving nerve reattachment and those not having nerve reattachment. At present the nerve is reattached occasionally, if it is deemed easy 10 perform intra-operatively. The vast majority of patients do not have the nerve reattached. It will add 30-60 minutes to the operation time. The study will be double blinded. The questionnaire is a VAS addressing the impact of sensation upon quality of life. The wording has been finalised after speaking to a group of patients attending the clinic. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 24/06/2005 |
| Completion date | 24/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | All patients attending the breast reconstruction clinic for one of the three types of breast reconstruction will be seen at the clinic and asked if they wish to participate in the research. They will not have to attend any extra clinics. The questionnaire will simply be given out whilst they are in the waiting room and can be completed before they are called in to see the doctor. Those patients who are having reconstruction with abdominal skin and muscle will be informed of the procedure to reattach the nerve and asked if they would be happy to be randomised into nerve reattachment or no nerve reattachment. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 24/06/2005 |
| Date of final enrolment | 24/03/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK)
No information available
NHS R&D Support Funding
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 |
