Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer- A Retrospective Study With Multi-center Pooled Data Analysis
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 13
- 主要终点
- Operation time
研究概览
简要总结
This study will retrospectively collect and evaluate the surgical outcomes of robotic nipple sparing mastectomy (R-NSM) compared with endoscopic assisted NSM (E-NSM) or conventional NSM (C-NSM) in the management of breast cancer. Multi-centers pooled data analysis would be performed for comparisons of R-NSM compared with C-NSM or E-NSM.
详细描述
Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety. Minimal invasive surgery had become the main stream of operations, and new surgical innovations of NSM, like endoscopic nipple sparing mastectomy (E-NSM) or robotic nipple sparing mastectomy (R-NSM), were emerging and applied in the surgical treatment of breast cancer. E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%). However, the 2-dimensional endoscopic in-line camera produces an inconsistent optical window around the curvature of the breast skin flap, and the internal mobility was limited and the dissection angles were inadequate with traditional endoscopic rigid tips instruments through single access. Due to the limitations of endoscopy instruments and technique difficulty, neither conventional E-NSM nor single access E-NSM was widespread used in breast cancer R-NSM, which introduce da Vinci surgical platform through a small extramammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3- dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM. The preliminary results of R-NSM from current literature reported series and ours were safe, and associated with good cosmetic outcome and high patients' satisfaction. However, evidence comparing R-NSM to conventional NSM (CNSM) or E-NSM was lacking. In this study, the authors aim to investigate and analyze the clinical and aesthetic outcomes as well as the cost effectiveness of R-NSM through a longitudinal cohort study design whereby a retrospective review will be carried out for patients undergoing R-NSM, E-NSM or C-NSM. Multi-centers pooled data analysis would be performed for comparisons of R-NSM compared with C-NSM or E-NSM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (Open Label) Retrospective, non-randomized, non-masking, open label, 3 arms
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A. Indications and selection criteria for nipple sparing mastectomy (NSM) in general and conventional nipple sparing mastectomy (C-NSM).
- •NSM will be offered to patients who are suitable for mastectomy but keen to conserve nipple areolar complex (NAC), with or without reconstruction. Patients must not have clinical or radiological involvement of the NAC. Patients with nipple involvement proven via intra-operative frozen section analysis will receive NAC excision and hence a skin-sparing mastectomy (SSM) performed instead. B. Indications and selection criteria for robotic nipple sparing mastectomy (R-NSM) or endoscopic nipple sparing mastectomy (E-NSM)
- •The general inclusion criteria or pre-requisite for nipple sparing mastectomy apply to R-NSM or E-NSM as well.
- •In addition, R-NSM or E-NSM should only include early stage breast cancer (carcinoma in situ, stage I - III A), a tumor size less than 5 cm, no evidence of multiple lymph node metastasis, and no evidence of nipple, skin or chest wall invasion.
排除标准
- •Contraindications for R-NSM, C-NSM or E-NSM include those with apparent NAC involvement, inflammatory breast cancer, breast cancer with chest wall or skin invasion, locally advanced breast cancer, breast cancer with extensive axillary lymph node metastasis (stage III B or later), and patients with severe co-morbid conditions, such as heart disease, renal failure, liver dysfunction, and poor performance status as assessed by the primary physicians.
- •Relative contraindications include women with large (breast cup size larger than E or breast mastectomy weight >600gm) or ptotic breast as the aesthetic outcomes may be sub-optimal.
结局指标
主要结局
Operation time
时间窗: immediate post operation
Overall operation time (minute), from skin incision to completion of operations. Compared overall operation time between R-NSM, C-NSM and E-NSM.
Skin blister formation
时间窗: within one month (30 days) post operation
rate of skin blister formation between R-NSM, C-NSM and E-NSM groups.
Implant loss rate
时间窗: within one month (30 days) post operation
rate of implant loss between R-NSM, C-NSM and E-NSM groups.
Rate of Surgical margin involvement in specimen pathologic examination
时间窗: post operative 2 weeks after pathologic report available
Rate of Surgical margin involvement in specimen during pathologic examination, and surgical margin involvement was defined as tumor on the ink.
Skin flap ischemia/necrosis rate
时间窗: within one month (30 days) post operation
rate of skin flap ischemia/necrosis between R-NSM, C-NSM and E-NSM groups.
Reconstruction implant volume
时间窗: immediate post operation
Reconstruction implant volume (ml) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)
Wound healing status
时间窗: within one month (30 days) post operation
rate of Delayed wound healing between R-NSM, C-NSM and E-NSM groups.
Grade of Nipple areolar complex ischemia/necrosis
时间窗: evaluated in post operative 2 weeks to 3 months post operation
The perfusion of NAC was evaluated in 2 weeks to 3 months post operation. The survival of NAC was confirmed at post-operative 3 months. The NAC ischemia/necrosis was divided into 5 different grades, which were: 1. No ischemia/necrosis was observed in NAC (Grade I). 2. Transient ischemia recovered without necrosis (Grade II). 3. Partial ischemia/necrosis, recovered without loss of nipple volume (Grade III). 4. Partial NAC necrosis with partial volume loss of nipple (Grade IV). 5. Total NAC necrosis with all volume loss of nipple (Grade V). NAC ischemia/necrosis was segregated into no NAC necrosis (Grade I-III) and NAC necrosis (Grade IV-V). The ischemia/necrosis of NAC between different R-NSM, C-NSM and E-NSM groups were recorded and compared.
Blood loss during operation
时间窗: immediate post operation
Blood loss (ml) during operation was compared between groups (R-NSM, C-NSM and R-NSM)
Aesthetic outcome evaluation-Patient reported cosmetic outcome results
时间窗: 1-3 months after the operation when the wound was healed
- Post-operative aesthetic results will be evaluated by comparing pre-operative and post-operative results. A selfreported questionnaire to evaluate the cosmetic outcome of breast cancer patients with mastectomy following breast reconstruction was conducted 1-3 months after the operation. This questionnaire comprises of 10 questions based on 4 itemized scales, which will be graded as "1, dis-satisfied", "2, fair", "3, satisfied", and "4, very satisfied".
Mean mastectomy weight
时间窗: immediate post operation
Mean mastectomy weight (gm) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)
Seroma formation rate
时间窗: within one month (30 days) post operation
rate of post operative seroma formation needing repeat aspiration between R-NSM, C-NSM and E-NSM groups.
Hospital stay
时间窗: within 2 weeks of operation
Hospital stay (days) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)
Post operation Bleeding/hematoma rate
时间窗: within one month (30 days) post operation
rate of post operative bleeding/hematoma rate between R-NSM, C-NSM and E-NSM groups.
次要结局
- Cost- analysis of C-NSM versus R-NSM or E-NSM(post operation one month)
- Disease free Survival(5 years post operation)
- Overall survival(5 years post operation)