Randomized Controlled Trial of Minimal Incision Repair of Rectus Abdominis Diastasis Versus Repair of the Entire Diastasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Abdominal trunk function
研究概览
简要总结
Background Postpartum diastasis of the rectus abdominis muscles (DRAM) has gained increasing attention as a condition that may affect abdominal trunk function but that may be alleviated by surgery. Most techniques for surgical reconstruction of DRAM are, however, associated with high costs, postoperative pain and risk of surgical complications. The aim of the present study is to evaluate a Minimal Incision Repair of Rectus Abdominis Diastasis (MIRRAD) in a randomized controlled open label trial. Altogether 120 women will be included.
Population Postpartum women with DRAM of at least 2 cm.
Intervention Plication of Linea alba through a 3-5 centimeter long incision at the level of the umbilicus
Control Plication of the entire Linea alba through a low transverse incision.
Outcome Primary outcome: Abdominal function rated with the Disability Rating Index Secondary outcomes: Operative time, postoperative stay, surgical complications, sick leave, persisting pain orated with the Ventral Pain Hernia Questionnaire, cosmetic outcome rated with BODY-Q
Follow-up Follow-up one month and one year after surgery
Significance If the study shows that MIRRAD is equally effective as plication of the entire Linea alba one year after surgery, it may be introduced as a standard technique for DRAM. If it is not as effective, it may still be an alternative with advantages in terms of cost benefit and the possibility to perform it as a daycare procedure.
详细描述
Background
Diastasis of the rectus abdominis muscles (DRAM) is a well-known phenomenon that until recently has not attracted much attention. It may either develop in high age, often in combination with truncal obesity, or as the result of one or more pregnancies. Several studies, have, however, shown that post-partum DRAM may cause impaired abdominal trunk function, often combined with pelvic floor dysfunction and back pain. Studies have also shown that these problems can be reduced with surgery aimed at restoring the integrity of the Linea alba [1-3] The favorable outcomes in well-selected samples of post-partum women [4] have resulted in a widespread demand for broadened indications and that such surgery should be offered routinely to all post-partum women with abdominal trunk dysfunction. However, concerns have been raised regarding the costs and potential hazards from such a procedure for a condition that is associated with abdominal function impairment but no potential serious morbidity.
The surgical techniques for restoring abdominal wall function in women with postpartum DRAM are mainly based on experience from ventral hernia surgery. The aim of ventral hernia surgery is ultimately to reduce the hernia sac to the abdominal cavity and closing the hernia defect in a way that the risk of recurrences is minimized. This may either be carried with an open or endoscopic technique, and with or without mesh reinforcement. Most studies on DRAM surgery are thus focused on strengthening the entire Linea alba and minimizing the risk for recurrence. In case of restoring the abdominal trunk function in DRAM, however, the aim should rather be to prevent the rectus muscles from separating during tension and thereby leaving room for the midline bulge of the abdominal trunk and loss of tonus in the abdominal wall.
Surgery for DRAM should thus aimed at being cost-effective and atraumatic enough to be offered for a very large number of women in need of treatment for DRAM as well as to be safe enough to ensure that postoperative complications and early recurrences are not seen. For that purpose, we intend to evaluate a surgical technique that limits the surgical trauma and could be carried out in a large scale without need of great resources.
Study design
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women having undergone at least one pregnancy
- •Age 20 - 50 years
- •Minimum 2 cm diastasis of rectus abdominis muscle at the level of the umbilicus
- •BMI < 30
- •Treatment failure after six months of structured training
排除标准
- •Nulliparous women
- •Less than one year since last pregnancy
- •Women who have not undergone structured training for at least six months
- •Previous abdominal surgery through open midline incision
- •Presence of excessive skin folds
- •Future planned pregnancies
结局指标
主要结局
Abdominal trunk function
时间窗: One year
Abdominal function assessed with Abdominal Trunk Function Protocol one year after surgery
次要结局
- Surgical complications(Thirty days)
- Pain from abdominal wall(One year)
- Abdominal Trunk function(One month)
- Cosmetic satisfaction(One year)
- Operation time(Two hours)
- Postoperative pain 4 hours after surgery(Four hours)
- Postoperative nausea 4 hours after surgery(Four hours)
- Time from surgery to discharge(Seven days)
- Postoperative sick leave(Thirty days)
- Postoperative seroma(Thirty days)
研究者
Gabriel Sandblom
Associate Professor
Karolinska Institutet