CTRI/2024/10/074797招募中不适用
An open-label, parallel-group randomized controlled trial comparing post-mastectomy prepectoral and subpectoral implant based breast reconstruction in breast cancer patients
AIIMS NEW DELHI2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To compare the overall postoperative outcomes of implant-based breast reconstruction between prepectoral and subpectoral surgical techniques
研究概览
简要总结
In India, there is significant variability in breast reconstruction practices. This underscores the need for randomized clinical trials to methodically assess postoperative outcomes and quality of life associated with prepectoral and subpectoral implant-based breast reconstruction techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •ECOG 0 and 1 Patient undergoing mastectomy for breast cancer and risk reducing surgery Presumptive adequate skin flap thickness greater than 8mm on mammogram Patient should be well oriented and coherent Both unilateral and bilateral breast surgery cases will be included.
排除标准
- •Patients with intraoperatively inadequate skin flaps Metastatic/Recurrent Breast cancer Pregnant or lactating women Patient refused for consent for the study.
结局指标
主要结局
To compare the overall postoperative outcomes of implant-based breast reconstruction between prepectoral and subpectoral surgical techniques
时间窗: 10th day, 30th day, 60th day, and 90th day
次要结局
- To compare between the 2 groups mentioned above:
研究者
Dr Gajendra Pandit
AIIMS
研究点 (2)
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