The Effect of Postoperative Abdominal Binder to Reduce Seroma Formation and Improve Early Clinical Outcome After Incisional Hernia Repair.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- seroma formation
研究概览
简要总结
Postoperative seroma formation is one of the most common complications after ventral hernia repair with mesh. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Abdominal binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain and discomfort after operation. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic incisional hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation. A randomized, controlled, investigator-blinded study supplemented with blinded statistical analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to abdominal binder or no abdominal binder (controls). The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. All patients have a standardized operation with standardized intra- and postoperative medication regimen. Endpoints measurements are clinically detectable seroma formation scored with seroma classification system buý S. Morales-Conde, pain scored with self-registrations with VAS, and quality of life scored with EQ-5D, recurrence and other complications are also registered. Patients are followed until 90 days after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective, primary and recurrent laparoscopic and open incisional hernia repair hernia with mesh reinforcement
- •fascia defects 6-20 cm measured preoperatively by the surgeon at the out-patient clinic
- •patients between 18-80 years
排除标准
- •expected low compliance (language problems, dementia and abuse etc.)
- •fascia defects >20 cm measured at the preoperative clinical examination.
- •acute operation
- •decompensated liver cirrhosis (Child-Pugh 3-4)
- •patients with a stoma
- •if a secondary operation is performed during the hernia repair procedure.
- •if a patient withdraws his inclusion consent
结局指标
主要结局
seroma formation
时间窗: 30 days postoperatively
clinically detectable seroma formation
次要结局
- postoperative pain(pain during the postoperative days 1-3, 7, and 30.)
研究者
Mette Willaume Christoffersen
M.D
Hvidovre University Hospital
