Minimally Invasive Abdominal Wall Reconstruction in Symptomatic Rectus Diastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Rate of recurrence
研究概览
简要总结
The aim of this study is to investigate whether abdominal wall reconstruction through laparoscopic surgery can be recommended as a safe treatment alternative for patients with symptomatic rectus diastasis, and if this type of treatment leads to improved quality of life, trunk stability and reduced pain.
详细描述
Investigate whether surgical reconstruction with laparoscopic technique can lead to improved quality of Life, trunk stability and reduced pain in patients with symptomatic rectus diastasis. The study will also compare two different laparoscopic surgery methods for abdominal wall reconstruction: narrowing of linea alba with continuous suture with or without mesh.
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
- Double (Participant, Investigator)
盲法说明
The randomization process will be initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectus diastasis ≥3 cm
- •BMI =<28 kg/m2
- •non smoker
- •abdominal instability,
- •abdominal wall and/or lower back pain despite physical therapy / structured physical exercise for at least 6 months
排除标准
- •BMI >28 kg/m2
- •Ongoing immunosuppressive therapy
- •Current pregnancy ≥16 weeks gestational age for the last 12 months
- •Pregnant or women who wish to become pregnant
- •Previously extensive abdominal wall surgery incl hernia surgery (NOT including sectio, appendectomy, small umbilical herniae)
结局指标
主要结局
Rate of recurrence
时间窗: 1 year
computed tomography
次要结局
- SF-36 Quality of Life instrument(1 year, 3 years)
- Visual Analog Pain Scale (VAS)(1 year, 3 years)
- Abdominal stability(1 year, 3 years)
- VHPQ is a questionnaire for the assessment of pre- and postoperative pain(1 year, 3 years)
研究者
Anders Thorell
Professor
Karolinska Institutet