Reinforcement of the Abdominal Wall With Acellular Dermal Matrix (Strattice™) After Breast Reconstruction With the Pedicled TRAM-flap
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Abdominal wall function change
研究概览
简要总结
The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. The patient and the investigator is blinded.
The aim is to identify the most optimal method for reinforcement of the abdominal donor-site and thereby contribute to fast and complete rehabilitation of women undergoing breast reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to breast cancer, precursors to breast cancer or an increased risk of developing breast cancer and thereby following preventive removal of the breast tissue.
The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal wall function, the donor site morbidity, the frequency of postoperative complications, the aesthetic appearance of the reconstructed breast and the abdominal wall and costs are evaluated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Immediate or delayed breast reconstruction using the pedicled TRAM-flap
- •Older than 18 years of age
- •Understand enough Danish to comprehend the given information and to complete the study questionnaire
- •Verbal and written informed consent
排除标准
- •Current smokers
- •Not eligible patients, assessed by surgeon
- •High level of co-morbidity, assessed by surgeon or anesthesiologist
结局指标
主要结局
Abdominal wall function change
时间窗: Change from before surgery to 12 and 24 months after surgery
Strength of abdominal wall is assessed by a standardized physical examination developed in collaboration with physiotherapists. A dynamometer is used to get an exact value of muscle strength.
次要结局
- Aesthetics at the abdominal wall(24 months)
- Postoperative complications(Acute <1 month, ≥ 1 month-24 months)
- Abdominal donor site morbidity(24 months)
- Costs(24 months)
研究者
Mette Eline Brunbjerg, MD
MD
Aarhus University Hospital