Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265166244
Study information
Scientific title
Sensate DIEP flaps - assessment of breast sensation on quality of life and body image
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
24/06/2005
Overall trial end date
24/03/2008
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
24/06/2005
Recruitment end date
24/03/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary