Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Complication rate of patients with bleeding requiring re-operation
研究概览
简要总结
This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.
详细描述
With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preserves the NAC is called nipple sparing mastectomy (NSM). NSM can provide major psychosocial benefits for patients but is technically demanding and challenging to perform. Total mammary glandular excision in NSM can be technically challenging due to small size of the incision and poor visualization of dissection plane. Recent studies demonstrate feasibility and safety of performing minimally invasive robot-assisted NSM (RNSM). The technique of RNSM is still novel.
This is a single-arm pilot study for feasibility and safety of RNSM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical candidates, per standard of care for:
- •Nipple sparing resection and reconstruction OR
- •Prophylactic mastectomy for risk reduction mastectomy OR
- •Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
- •Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Pregnant or nursing women
- •Patients with:
- •Inflammatory breast cancer
- •Skin involvement with tumor
- •Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor
- •Grade 3 ptosis of nipple
- •Smokers with heavy current use of nicotine (defined as > 20 cigarettes/day)
- •Patients that are high risk for anesthesia, as documented in medical record
- •Patients that do not have the ability to give informed consent
- •Prisoner status at surgical clinic visit
- •Bra cup size greater than C cup
- •Previous thoracic radiation history (for any reason)
研究组 & 干预措施
Supportive care (RNSM, surveys)
RNMS Surveys
干预措施: Robot-assisted Nipple Sparing Mastectomy (Procedure)
Supportive care (RNSM, surveys)
RNMS Surveys
干预措施: Survey Administration (Other)
Supportive care (RNSM, surveys)
RNMS Surveys
干预措施: RNSM (Device)
结局指标
主要结局
Complication rate of patients with bleeding requiring re-operation
时间窗: Up to 1 year
Number of patients with bleeding requiring re-operation after RNSM.
Perioperative Outcomes investigating the length of hospitalization
时间窗: Up to 1 year
Investigate the length of hospitalization for each patient
Perioperative Outcomes investigating length of surgery time
时间窗: Up to 1 year
Investigate the total duration of the operation (surgical time data) of each patient
Feasibility of removal of breast gland en bloc through RNSM
时间窗: Up to 1 year
Measure number of patients who had breast removed en bloc through RNSM incision.
Complication rate of patients with Mastectomy flap (SKIN flap score)
时间窗: Up to 1 year
Number of patients with mastectomy flap or nipple-areolar complex necrosis as measured using the SKIN flap score after surgery. Score of A1 indicates normal skin, D4 indicates total full thickness necrosis.
Complication rate of patients with infection requiring antibiotics or re-operation
时间窗: Up to 1 year
Number of patients with infection after surgery requiring antibiotics or re-operation.
Perioperative Outcomes investigating the total duration of surgical time
时间窗: Up to 1 year
Investigate the total duration of the operation (surgical time data),
次要结局
- Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey(Up to 1 year)
- Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire(Up to 1 year)
- Patient Reported Outcomes(Up to 1 year)
研究者
Sara Myers
Principal Investigator
Ohio State University Comprehensive Cancer Center