Abstract
BackgroundSkin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. However, when placing the implant in a subpectoral pocket, a high incidence of breast animation deformity (BAD) has been reported. Besides the nuisance that BAD can cause, lifting of the pectoralis major muscle (PMM) can result in a more extended postoperative recovery period. When placing the implant solely prepectorally leaving the PMM undisturbed, the incidence and severity of BAD might be mitigated. However, new challenges may occur because of thinner skin cover.Methods/designA prospective, multi-centre, randomised controlled trial will be carried out with the primary aim of assessing and comparing the incidence and degree of BAD in women having a direct-to-implant breast reconstruction with either a prepectorally or a subpectorally placed implant. The secondary outcomes are shoulder and arm function, quality of life, aesthetic evaluation, length of stay, complications, need for surgical corrections, and development of capsular contracture. A total of 70 included patients will be followed under admittance and at clinical check-ups 3 months and 1 year after surgery.DiscussionTo our knowledge, this trial is the first randomised controlled trial evaluating and comparing subpectoral and prepectoral implant placement when performing direct-to-implant breast reconstruction following skin-sparing mastectomy. The results will hopefully provide us with a broader knowledge of the outcomes of immediate breast reconstruction, making better preoperative planning possible in the future by providing our patients with a more objective information.Trial registrationClinicalTrials.gov, ID: NCT03143335. Prospectively registered on 8 May 2017.
Highlights
Skin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer
The results will hopefully provide us with a broader knowledge of the outcomes of immediate breast reconstruction, making better preoperative planning possible in the future by providing our patients with a more objective information
The secondary objectives and comparisons between groups are: (1) assessment and comparison of the shoulder and arm function by use of the Constant Shoulder Score (CSS), (2) assessment and comparison of quality of life (QOL) by Breast-Q, (3) assessment of postoperative pain by the patients during the first three postoperative days using a visual analogue scale from 0 to 10, (4) comparison of time to discharge, (5) comparison of time for surgery, (6) registration and comparison of complications, major and minor, (7) aesthetic outcome evaluated by two consultant plastic surgeons, (8) assessment and comparison of the degree of capsular contracture and (9) identification of new breast cancer and breast cancer recurrence after 3 years registered in the National Patient Registry [16]
Summary
Skin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. When placing the implant in a subpectoral pocket, a high incidence of breast animation deformity (BAD) has been reported. An implant is often placed below the Breast animation deformity (BAD), referred to as breast distortion or ‘jumping breast’, is characterised by an unsightly deformation of the whole breast, breast skin or nipple-areolar complex [10]. The theory is that BAD occurs due to the pressure applied by the contracting PMM on the underlying implant. There is a reason to believe that the severity of BAD may be more pronounced in women having a direct-to-implant breast reconstruction; there is less soft tissue to camouflage the muscle and underlying implant
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