A Randomized Multicenter, Open, Prospective, Controlled Study-comparison of the Safety of Immediate One-stage Implant Based Breast Reconstruction(IBBR) Versus Two-stage Expander-Implant IBBR Augmented With TiLoop® Bra.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
- 试验地点
- 11
- 主要终点
- Rate of perioperative complications
研究概览
简要总结
This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.
详细描述
Studies comparing two-stage implant-based breast reconstruction with immediate one-stage implant-based breast reconstruction have inconsistent results and investigators find that there is a lack of high quality evidence focusing on comparing one-stage and two-stage implant-based breast reconstruction with TiLoop®Bra.
This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra in breast cancer patients.
The hypothesis is that one step method is not inferior to two step method in implant based breast reconstruction following skin-sparing and/or Nipple-sparing mastectomy using TiLoop® Bra.
The current study is a randomized multicenter, open labeled, prospective, controlled study.
Participants were enrolled at six hospitals in different places of China. All participants will undergo Skin Sparing Mastectomy(SSM)/Nipple Sparing Mastectomy(NSM) with one-stage or two stage IBBR with TiLoop® Bra.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 histological proven invasive breast cancer or ductal carcinoma in situ;
- •Clinical T1-T2 disease with no distant metastasis;
- •Patient with clinical N0 status;
- •Intent to receive NSM or SSM and implant based breast reconstruction;
- •Signed consent to participate.
排除标准
- •Patient with severe breast ptosis;
- •Patient received ipsilateral breast reduction or enlargement;
- •Locally advanced stage patients who received neoadjuvant chemotherapy or hormone therapy;
- •Patients enrolled in other clinical trial which may as influence the outcome;
- •Patients received neo-adjuvant therapy and will receive radiotherapy.
- •History of breast cancer (ipsilateral, i.e. recurrence, or contralateral breast);
- •Patients of pregnancy or lactation.
研究组 & 干预措施
One step method
Immediate implant reconstruction following mastectomy using TiLoop®Bra (one step method) n=225
干预措施: Immediate IBBR+TiLoop®Bra (Procedure)
Two step method
Immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra (two step method) n=225
干预措施: Immediate-delayed IBBR+TiLoop®Bra (Procedure)
结局指标
主要结局
Rate of perioperative complications
时间窗: Start of randomization until 3 months after surgery
The rate of perioperative complication between the two groups
次要结局
- Angiopathology-related assessment of Tiloop bra(18 months after surgery)
- Quality of life:EORTC QLQ C30 /+ BR23 questionnaire(18 months after surgery)
- Aesthetic score of reconstructed breast(18 months after surgery)
- Patient satisfaction:Breast-Q questionnaire(18 months after surgery)
- Additional surgery(18 months after surgery)
研究者
Jiong Wu
professor
Fudan University