Effect of radiotherapy on patients undergoing DIEP reconstructions
Research type
Research Study
Full title
Case control study to evaluate the impact of radiotherapy on patients undergoing DIEP flap breast reconstruction
IRAS ID
168571
Contact name
Jennifer Rusby
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Since 1997, breast cancer has been the most common cancer in the UK, accounting for 31% of all new cancers in women. In the UK, 53% of women with symptomatic breast cancer (i.e. self detected by the patient) and 27% of those with screen-detected breast cancer (i.e. detected on mammogram done as part of the national screening programme) are treated surgically with mastectomy; therefore approximately 21,500 undergo a mastectomy to treat breast cancer each year.
Breast reconstruction is a common, important and emotive subject. Guidelines from the National Institute for Health and Clinical Excellence (NICE) recommend that immediate breast reconstruction is offered to women during the same operation as their mastectomy.
Post-mastectomy radiotherapy (PMRT) is offered to women at high risk of chest wall recurrence of the breast cancer. The perceived detrimental effect of radiotherapy on an immediate breast reconstruction leads some surgeons to recommend delayed reconstruction after mastectomy. This means that in these women who from the outset are known to need radiotherapy after their surgery will be recommended to initially have a mastectomy with no reconstruction or a temporising implant with a view to planned exchange to autologous reconstruction after radiotherapy. An autologous reconstruction is the transfer of tissue from one site of the body to another, in this case the transfer of tissue from the abdomen to the breast which is called a Deep Inferior Epigastric Perforator (DIEP) flap.
There remains significant uncertainty in the published literature about the impact of radiotherapy onto an autologous reconstruction. Some patients will have PMRT to their breast reconstruction because it was not known before the surgery that they would require radiotherapy.
The primary aim is to establish whether patients who have radiotherapy to a DIEP flap reconstructions are significantly less satisfied than patients who have do not have PMRT or have PMRT and a subsequent (therefore un-irradiated) DIEP flap. If patients who have radiotherapy to a DIEP are just as satisfied then this could change practice so that all women are offered an immediate breast reconstruction regardless of whether they will need radiotherapy.
REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0465
Date of REC Opinion
25 Mar 2015
REC opinion
Favourable Opinion