BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Clinician acceptance
研究概览
简要总结
In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. The findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. In the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.
详细描述
Immediate breast reconstruction in women undergoing removal of the whole breast for cancer or risk reduction is most commonly done using breast implants. Surgeons often use a sheet of mesh to cover the implant as standard treatment. It acts like an internal bra and supports the implant and re-creates a natural looking breast.
Natural(biological) or man-made (synthetic) meshes are used routinely in the NHS. Biological ones are made from animal tissue (pig, cow) that have been made safe to use in people and are costly. Synthetic meshes are made from net-like fabric and cost less. The choice about which mesh to use depends on surgeons' personal experience and how much money the hospital has for these operations. The two meshes may have different acceptability issues for patients because of their personal values, religious beliefs, ethnic background or views on animal welfare.
A large UK review of breast reconstruction with implants gathered information up to 3 months after surgery on the use and outcomes of the two meshes. This suggests that both may be equally safe in the short-term. However, this information can be improved by comparing the meshes side-by-side and looking at how safe they are long-term. This is important as some side-effects only appear later after surgery. Clinicians do not know how outcomes impact on patients' health and well-being.
The best proof would come from a randomised surgical study, where a computer allocates patients to receive either the biological or synthetic mesh. Investigators will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery. This type of study would tell us how good each mesh is and if they are safe long-term.
Before starting such a study, investigators will run a smaller one that will help us understand if patients and surgeons would be comfortable taking part.
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
- Single (Participant)
盲法说明
Single blind masking
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
- •Female age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment
排除标准
- •Revision reconstruction surgery Delayed reconstruction surgery
研究组 & 干预措施
Biological Matrix
Participants will undergo immediate breast reconstruction using biological matrix and implant
干预措施: One-stage immediate breast reconstruction (Procedure)
Synthetic Mesh
Participants will undergo immediate breast reconstruction using synthetic mesh and implant
干预措施: One-stage immediate breast reconstruction (Procedure)
结局指标
主要结局
Clinician acceptance
时间窗: 2 years
Proportion of eligible women offered the trial
Patient acceptance
时间窗: 2 years
Proportion of women offered the trial who participate in the trial
Compliance with allocated intervention
时间窗: 2 years
Number of patients not complying with randomisation allocation
Recruitment rate
时间窗: 2 years
Number of patient recruited per year per site
次要结局
未报告次要终点
研究者
Dr Amit Goyal
Chief Investigator
University Hospitals of Derby and Burton NHS Foundation Trust