Examining the Cosmetic Results and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy of Ptotic Breast Followed by Delayed-immediate Submuscular Implant Based- Breast Reconstruction Surgery, and Comparing it to Submuscular Delayed- Immediate Implant- Based Breast Reconstruction Procedures After Skin- Sparing Mastectomy. Response-adaptive, Prospective Randomized Clinical Trial

Introduction The indication of total breast removal is primarily the part of a correct oncological therapy, but secondly the removal of the full parenchyma can be prophylactic among high risk patients with positive genetic testing. In modern breast surgery, mastectomy means the removal of the entire glandular tissue. Surgery can be done in the absence of contraindication (eg. skin infiltration, mastitis carcinomatosis), by preserving the nipple-areola complex (NAC) and the skin layer above the parenchyma (nipple-sparing mastectomy, NSM) by removal of the whole or a part of the NAC (skin-sparing mastectomy, SSM) or by removal of the nipple but with the preservation of the areola (areola-sparing mastectomy, ASM). It is important to emphasize that similarly to the classic simplex mastectomy in the cases of SSM, ASM and NSM techniques provided by an experienced and qualified breast surgeon, the complete oncological removal of the mammary gland is done[1].

The essence of advanced mastectomy techniques is that they ensure the combination of radical oncological resection and immediate (immediate breast reconstruction, IBR) or delayed-immediate breast reconstructive surgery (delayed immediate breast reconstruction, D-IBR) (insertion of a tissue expander during the first operation, then as a second step replace it with a silicone implant). It avoids all the burden and negative effects of distant flap surgery, like donor scars, loss of movements etc. One or two-step post-mastectomy breast reconstructive surgeries are mainly implant-based techniques and less commonly autologous tissue techniques like distant pedicle flaps or free flaps. The tissue expander or silicone implant is placed primarily in a submuscular position but also can be inserted in a subcutaneous position in front of the large pectoral muscle. The coverage of the lower pole or even the entire surface of the implant may be strengthened with biological (so-called acellular dermal matrix) or synthetic materials (Ultrapro mesh) to reduce the pressure load of the implant on the preserved skin, the consequent skin perforation and so the loss of the implant.

The international literature of immediate or delayed-immediate postmastectomy breast reconstructive techniques is extensive and the correlation between these procedures and the oncological treatments (such as adjuvant radiotherapy) are well known [2]. According to the currently available evidence, reconstructive techniques do not adversely affect oncological outcome, so these breast surgical techniques are nowadays considered standard procedures in advanced breast cancer surgery[3]. Postmastectomy breast reconstruction surgeries are well-known as effective rehabilitation procedures, with significant psycho-oncological benefits to patients with low complication rates and high patient satisfaction. [4, 5]. Postmastectomy breast reconstructive surgery however require more sophisticated surgical techniques, special expertise, longer surgical time and significantly higher costs than simplex mastectomies.

Selecting the type of advanced mastectomy (SSM/NSM/ASM) of breast cancer depends on the location of the lesion, the size of the breast and its ptosis. Absolute contraindications of NSM are Paget disease of the nipple, bloody discharge, skin and nipple infiltration. Relative contraindications comprise pendolous/ptotic or large/larger sized breast and a distance between the nipple and tumor of less than 2cm. To achieve best cosmetic results, sparing the NAC became of prime importance, with widespread use of skin-sparing mastectomies. Sparing the skin layer and the NAC during removal of the entire glandular tissue promotes the efficiency of breast reconstruction by avoiding the reduction of projection, nipple reconstruction surgery and nipple tattoo. The cosmetic results and quality of life of those patients who had SSM instead of having NSM due to pendolous/ptotic breast are provenly unfavorable [6]. Numerous studies have proven that NSM with proper technique is an oncologically reliable method, hence it has become the part of several international protocols [7]. In the case of the high volume pendulous/ ptotic breasts, NSM and optimal implant-based breast reconstruction are achievable only by reduction of the skin-layer of the breast. The optimal surgical technique of skin-reducing nipple sparing mastectomy (SRNSM) has not been standardized yet. Due to the lack of high quality evidence and knowledge relating to the blood supply of NAC, safety of the procedure, complication rate, and oncological radicality the technique has not gained widespread popularity[8, 9].

Our present study validates the SRNSM operative technique, and also compares its results to that of classic SSM and delayed- immediate reconstruction in a response- adaptive prospective study.