跳至主要内容
临床试验/NCT01776775
NCT01776775撤回不适用

The Effect of Postoperative Abdominal Binder to Reduce Seroma Formation and Improve Early Clinical Outcome After Incisional Hernia Repair.

Hvidovre University Hospital2 个研究点 分布在 1 个国家开始时间: 2016年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Willaume Christoffersen

M.D

Hvidovre University Hospital

研究点 (2)

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