A Multidisciplinary Protocol for Planned Skin-Preserving Delayed Breast Reconstruction for Patients With Locally Advanced Breast Cancer Requiring Postmastectomy Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Overall Complication Rate
研究概览
简要总结
The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the standard approach (reconstruction that is not started until radiation treatment is completed).
详细描述
Study Visits and Surgeries:
You will be hospitalized 2-4 times for 1-5 days depending on your condition. If you agree to take part in this study, you will be scheduled for a skin-sparing mastectomy. The following tests and procedures will be performed:
Pre-Operative Visit:
- Your complete medical history will be updated.
- The doctor will determine what type of reconstructive surgery can be done.
- You will have photos taken of your breasts. Your face, hair, or jewelry will not be photographed. These photos will be kept in a password-protected computer accessible only by the principle investigator and people directly involved in this study.
- You will complete a quality of life questionnaire. The questionnaire asks about how satisfied you are with your appearance. The questionnaire will be sent by email, US postal service mail, or in person when you come for your follow up visits. The questionnaire should take about 20 minutes to complete. If sent by US postal service, you will be given a postage-paid envelope to return the questionnaire.
At your Mastectomy Surgery:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with invasive breast carcinoma that are scheduled for a mastectomy with planned postmastectomy XRT. This includes, but is not limited to, clinical stage II, III, and IV.
- •Patient must desire breast reconstruction.
- •Patients must sign the informed consent form and must be deemed by operative surgeon not to have medical contraindications for delayed-delayed approach.
- •Patients must be 18 years of age or older.
排除标准
- •Patients in whom it is not known preoperatively to need postmastectomy radiation therapy.
- •Patients with inflammatory breast cancer.
- •Patients in whom the breast skin can not be spared because of involvement with breast cancer.
- •Any patient deemed by the radiation oncologist during preoperative consultation to be an inappropriate patient for this protocol.
- •Patients that can not commit to receiving postmastectomy radiation treatment in addition to breast reconstructive procedures at MD Anderson Cancer Center or satellite affiliates.
结局指标
主要结局
Overall Complication Rate
时间窗: 6 months
Overall complication defined as any of the following complications post breast reconstruction surgery: seroma, hematoma, wound dehiscence, partial flap loss, total flap loss, infection, flap microvascular thrombosis (arterial or venous), venous congestion of flap, flap fat necrosis, mastectomy skin flap necrosis, exposure breast implant, capsular contracture, and delayed wound healing.
次要结局
未报告次要终点