Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications
研究概览
简要总结
The purpose of this study is to:
- Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs
- Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications
详细描述
Primary Endpoint(s)
- Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort
- Compare immediate and delayed reconstruction outcome metrics through retrospective review
Secondary Endpoint(s)
- Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction.
- Compare complications and reoperations between immediate versus delayed reconstruction.
- Compare the hospital costs between immediate versus delayed reconstruction
- Evaluate the effectiveness of risk reduction strategies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
- •Subjects must be breast reconstruction candidates using implant based breast reconstruction.
- •Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Prior breast cancer surgical treatment
- •Prior breast reconstruction
- •Inability to provide written consent
研究组 & 干预措施
Immediate breast reconstruction
The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
干预措施: Immediate Breast Reconstruction (Procedure)
Immediate breast reconstruction
The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
干预措施: Breast-Q questionnaire (Other)
Delayed breast reconstruction
Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
干预措施: Delayed Breast Reconstruction (Procedure)
Delayed breast reconstruction
Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
干预措施: Breast-Q questionnaire (Other)
结局指标
主要结局
optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications
时间窗: Until 1 year post breast reconstruction
Proportion of patients preferring delayed reconstruction.
次要结局
- Major complications(Until 1 year post breast reconstruction)
- Minor complications(Until 1 year post breast reconstruction)
- Number of revision surgeries(Until 1 year post breast reconstruction)
- Hospital cost of the complete reconstruction treatment(Until 1 year post breast reconstruction)
- Change in patient satisfaction(Until 1 year post breast reconstruction)