跳至主要内容
临床试验/NCT00761475
NCT00761475已完成3 期

Primary Mesh Closure of Abdominal Midline Wounds; a Prospective Randomized Multicenter Trial

Erasmus Medical Center12 个研究点 分布在 3 个国家目标入组 480 人开始时间: 2009年2月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
480
试验地点
12
主要终点
incisional hernia occurence

研究概览

简要总结

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge, there has not yet been developed a sufficient method for prevention. One specific group of high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been reported. Retrospective and prospective studies have shown an average risk for incisional hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients. Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. Considering only 50 % of incisional hernia will be clinically evident in the first 12 months, the total incidence will be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can benefit most from prevention. Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomal surgery. However, there has not been performed an adequate randomized controlled trial to study the prevention of incisional hernias. Our hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy is effective in patients with aortic aneurysm and in obese patients with a BMI of more than 27.

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
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • •Every elective midline laparotomy for patients with Abdominal Aortic Aneurysm and patients with a BMI of more than
  • •Signed informed consent

排除标准

  • •Age < 18 years
  • •Emergency procedure
  • •Inclusion in other trials
  • •Aortic reconstruction for obstructive disease
  • •Life expectancy less than 24 months
  • •Pregnant women

研究组 & 干预措施

1

Placebo Comparator

primary closure of the midline

干预措施: primary closure (Procedure)

2

Active Comparator

onlay mesh supported closure

干预措施: mesh supported closure (Procedure)

3

Active Comparator

sublay mesh supported closure

干预措施: mesh supported closure (Procedure)

结局指标

主要结局

incisional hernia occurence

时间窗: 2 years

次要结局

  • complications(1 month)
  • post-operative pain(1 month)
  • quality of life(2 years)

研究者

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

Hasan Eker

Prof. Dr. J.F. Lange

Erasmus Medical Center

研究点 (12)

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