Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy (OPBC-02/ PREPEC): a Pragmatic, Multicenter, Randomized, Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 382
- 试验地点
- 40
- 主要终点
- Change in BREAST-Q scale
研究概览
简要总结
This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.
详细描述
This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.The aim is to adhere to standard of care as much as possible to follow the pragmatic trial design to generate data that are applicable to today's practice. Therefore, surgeons are allowed to use their preferred Acellular Dermal Matrix (ADM), synthetic meshes, expanders and implants, thereby offering practitioners considerable leeway in deciding how to perform the procedure. For the same reason, both the one- and two-staged IBBR approaches are allowed when studying pre- versus sub-pectoral IBBR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
blinded outcome assessment for aesthetic results
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
- •Written informed consent according to ICH/GCP regulations prior to any trial specific procedures
- •Patients undergoing NSM or SSM and IBBR in the therapeutic or risk-reducing Setting
- •Ability to complete the Quality of Life questionnaires
排除标准
- •No indication for IBBR according to clinical judgment of the treating surgeon
- •Skin flaps inadequate for pre-pectoral IBBR.
结局指标
主要结局
Change in BREAST-Q scale
时间窗: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
compare the Quality of Life (QoL) with respect to long-term physical well-being (chest) after pre-pectoral or sub-pectoral IBBR. The BREAST-Q module specific to breast reconstruction version 2.0 consists of 13 independent scales covering health-related QoL domains and satisfaction domains. Each scale is scored to generate a numerical score on a scale from 0 (worst) to 100 (best).
Change in EQ-5D-5L questionnaire
时间窗: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
The 5-level version of the EQ-5D (EQ-5D-5L) consists of the EQ-5D descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/Depression (5 answer levels each: no problems, slight problems, moderate problems, severe problems and extreme problems), resulting in a 1-digit number that expresses the level for that dimension. The digits for each dimension are combined into a 5-digit number that describes the patient's health state and is subsequently converted into a preference-based quality of life weight (utility) using an algorithm derived from population-based studies. In addition, patients are asked to rate their health on a vertical visual analogue scale (EQ VAS), where the anchors are labelled with 'The best health you can imagine' and 'The worst health you can imagine'.
次要结局
- thromboembolic events(within 24 months of undergoing mastectomy and immediate reconstruction)
- capsular contracture(before and 24 months after the mastectomy)
- Recurrence-free survival (RFS)(until 10 years after mastectomy and IBBR.)
- aesthetic results(before and 24 months after the mastectomy)
- length of hospital stay (index hospitalization and overall)(until 24 months after randomization)
- loss of expander or implant(within 24 months of undergoing mastectomy and immediate reconstruction)
- animation deformity(before and 24 months after the mastectomy)
- aesthetic results evaluated by patients(at baseline and after 24 months)
- surgical complications(within 24 months of undergoing mastectomy and immediate reconstruction)
- patient satisfaction(over 24 months since mastectomy)
- total number of operative procedures(until 24 months after mastectomy)
- total number of outpatient visits at the trial site and the emergency department(from admission for mastectomy until 24 months after randomization)
- aesthetic results evaluated by local physicians(at baseline and after 24 months)