Sensate DIEP flaps - assessment of breast sensation on quality of life and body image

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
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. CONDITION: Surgery: Breast ; Surgery ; Breast PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration 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.
Epistemonikos ID: ad9712ed0ddbc18e029380f4f34b85a2f906cec4
First added on: Aug 21, 2024