Envelope Mastectomy and Immediate Reconstruction (EMIR)
Research type
Research Study
Full title
Aesthetic Outcome of Different Techniques of Reconstruction following Nipple-Areola Preserving Envelope Mastectomy with Immediate Reconstruction Without Oncological Compromise - A 10-Year Follow-Up Study.
IRAS ID
80885
Contact name
Dharini Kulendren
Contact email
Sponsor organisation
Mid Essex NHS Trust
Duration of Study in the UK
0 years, 6 months, 27 days
Research summary
Over the past 25 years, the psychological manifestations of women undergoing mastectomy as a treatment for breast cancer has been extensively reported. An increasing number of women now seek breast reconstruction as an integral component of their treatment, often viewed as a ‘reverse mastectomy.’
Traditionally, mastectomy incisions are performed through a peri-areolar incision to avoid visible scars on the breast mound. However, an elliptical skin incision involving a larger area surrounding the nipple may be performed depending on the location and size of the tumour, to gain increased access. These incisions are less amenable to a favourable cosmetic outcome and a resultant ‘circle-within-a-circle’ effect following nipple reconstruction at a later stage is especially noticeable. This can be particularly distressing to the patient, affecting their psychological profile. Hence, an alternative technique referred to as an envelope mastectomy (nipple-sparing) with immediate reconstruction proposed an incision at the lateral aspect of breast with no resultant scarring of the breast skin.
The initial study carried out 10 years ago, invited 61 patients who underwent envelope mastectomy with an immediate reconstruction and were followed up for 48 months. The method of reconstruction used were either non-autologous (implant only) or autologous (patient’s own tissue from the back or abdomen. Evaluation methods included objective applanation tonometry (standardized disk used to obtain a contact print of both breasts and the contact surface area measured to calculate the area of the reconstructed breast as a percentage of the contralateral breast to assess suppleness), clinical evaluation, photography based assessment and patient satisfaction survey. The results confirmed good evaluation scores in all four modalities and the breast remained softer following autologous breast reconstruction.
To date, there are no studies prospectively comparing the long-term aesthetic, psychological and oncological outcome of envelope mastectomy with immediate reconstruction. This information would prove paramount in assessing oncological safety and limit long-term psychological morbidity. This study aims to carry out a 10-year review by recruiting the same patient population and inviting them to attend Broomfield Hospital, Chelmsford to complete the same four assessments.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0404
Date of REC Opinion
24 Sep 2015
REC opinion
Unfavourable Opinion