Abdominal Rectus Diastasis Microscopy and Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- Number of repetitions of deadlift with 20 kilograms
研究概览
简要总结
The goal of this randomised controlled trial is to evaluate the effect of a postoperative rehabilitation program after surgical correction of abdominal rectus diastasis. The main questions to answer are:
- Does structured postoperative abdominal exercise improve abdominal wall function in three months and twelve months after surgical correction of abdominal rectus diastasis
- Does connective tissue components differ in patients with abdominal rectus diastasis when compared to healthy individuals?
详细描述
The investigators want to include patients in Sweden that are eligible for surgical correction of their abdominal rectus diastasis. Patients will be recruited at the surgical clinic at four hospitals in Sweden. After being informed about the study and potential risks, all patient give written informed consent. Randomisation is performed upon inclusion.
All patients undergo surgery by plication of the linea alba. A blood sample is collected prior to the surgery. During the surgery the skin, connective tissue and rectus muscle are biopsied. On the first postoperative day, another blood sample is collected. Follow up is conducted three and twelve months after surgery.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diastasis > 3 cm
- •At least 1 year since child birth
- •One year of steady weight after weightloss
- •BMI < 30
- •Males with diastasis above and below umbilicus
排除标准
- •New planned pregnancy
- •Connective tissue disease
- •Immunosuppressive treatment
- •Umbilical hernia > 2 cm
结局指标
主要结局
Number of repetitions of deadlift with 20 kilograms
时间窗: Three and twelve months after surgery
Abdominal wall function measured
5 times sit to stand test time
时间窗: Three and twelve months after surgery
Abdominal wall function measured with the 5 times sit to stand test
次要结局
- VHPQ(Three and twelve months after surgery)
- PDI-score(Three and twelve months after surgery)
- PGPQ(Three and twelve months after surgery)
- PFDI-20 short form(Three and twelve months after surgery)