跳至主要内容
临床试验/NCT01237470
NCT01237470终止不适用

The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.

Nicolaus Copernicus University2 个研究点 分布在 1 个国家目标入组 2,009 人开始时间: 2005年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
2,009
试验地点
2
主要终点
recurrence

研究概览

简要总结

Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. The research to find any new hernioplasty without the use of meshes is still going on.

Desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. These results were comparable with the effects of Lichtenstein technique.

The initial assessment done in our own department revealed good clinical results after hernia treatment with Desarda's method.

To make appropriate and objective clinical assessment of the Desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.

Generally no statistically significant differences were found between these groups. The only difference was higher rate of seroma after Lichtenstein technique and different pain perception in both groups. To the summary it is clear that Desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. The RCT was done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for clinical trials.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • primary inguinal hernia
  • male adults
  • signed informed consent
  • god condition of external oblique aponeurosis (assessed during the operation)

排除标准

  • age < 18
  • recurrent hernia
  • incarcerated hernia
  • diagnosed mental disorder
  • manual reduction of hernia on inpatient
  • infection at groin area
  • wound or scar at the groin
  • no consent

结局指标

主要结局

recurrence

时间窗: 3 years

hernia recurrence after surgical treatement

chronic pain

时间窗: 6 months

persistent chronic pain (lasting longer then 6 months)

次要结局

  • surgical complications(3 years)

研究者

发起方
Nicolaus Copernicus University
申办方类型
Other

研究点 (2)

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