Mapping Arterial Perforators of the Nipple Areolar Complex and the Horizontal Septum During Mammoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Full-thickness (complete or partial) necrosis of nipple-areolar complex
研究概览
简要总结
Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result.
In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery.
We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery.
A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps).
We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply.
In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above.
详细描述
Despite breast cancer being one of the most frequent affecting women worldwide, it is also one of the most curable. Its multimodality treatment is based on surgery, radiotherapy and systemic therapy.
Breast conservation has evolved thanks to the utilization of mammoplasty techniques to achieve better aesthetic results - known collectively as 'oncoplastic' when applied to cancer surgery.
The key considerations in oncoplastic surgery are: tumour characteristics (extent, location) and reconstituting the aesthetically acceptable breast shape as well as nipple-areola complex (NAC) preservation. The former is vital to achieve clear resection margins to optimise local control. Planning is aided by imaging with ultrasound, mammography and often MRI. NAC preservation is a priority and expectation of patients and surgeons alike developed in the field of aesthetic breast surgery by plastic surgeons.
The attachment of any structure to the body by its nourishing blood supply (arteries and veins) is known as a 'pedicle'. The anatomy of the pedicle and its preservation is key to preservation of the NAC which has a well understood blood supply albeit with variations across patients and well-described patterns (ref). To preserve the NAC as part of a cancer resection and aesthetic breast re-shaping, a pedicle must be fashioned and the NAC successfully re-positioned to restore the aesthetic balance of the newly shaped (and often lifted) breast.
The aim of this study is to determine if by use of doppler (acoustic or colour flow modalities) to map the blood vessels supplying the NAC (for each individual patient), surgeons and trainees can construct a safe pedicle with greater confidence and ease, reducing the concern about diminishing its blood supply which could lead to NAC necrosis and loss. We would like to study the nipple blood supply as it pertains to each patient before surgery using acoustic doppler (AD) and colour doppler imaging (CDI). Each modality has its strengths and weaknesses and this evaluation aims to assess the contribution of each.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients >18 years age
- •plan for construction of at least 1 (i.e. unilateral / bilateral) NAC pedicle based on the superficial branches of either the 2nd (superior), 3rd (medial) anterior intercostal, the lateral thoracic (lateral) arteries or a combination thereof.
排除标准
- •Patients planned solely for inferior NAC pedicle reduction mammoplasty
- •patients planned for bilateral nipple/NAC sacrifice
结局指标
主要结局
Full-thickness (complete or partial) necrosis of nipple-areolar complex
时间窗: Within 30 days after surgery
Any amount (as witnessed clinically) of full-thickness necrosis of the nipple-areolar complex of either breast in patients who have undergone breast reduction (for cancer - on the cancer side or matching reduction side)
次要结局
未报告次要终点