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临床试验/NCT00544583
NCT00544583Unknown2 期

Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study

Heidelberg University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
2 期
入组人数
80
试验地点
2
主要终点
Incisional hernia or burst abdomen within 12 months

研究概览

简要总结

Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity.

详细描述

More than 700.000 open abdominal surgeries (laparotomies) are performed each year in Germany (2). A major surgical complication after laparotomy is abdominal fascia dehiscence which might appear either as early (burst abdomen with evisceration) or as late complication (incisional hernia). These patients usually undergo surgery for secondary fascial closure associated with markedly increased morbidity (3) including high recurrence rates (up to 45%) (4). The applied surgical strategy of abdominal wall closure (i.e. the combination of suture technique and material) is of high relevance for prevention of fascia dehiscence and, moreover, constitutes the main factor directly controllable by the surgeon. While several randomized controlled trials (RCT) (3; 5-8) as well as meta-analyses (9-12) exist that address the issue of optimal fascia closure in elective laparotomies, there is no RCT dealing exclusively with the emergency setting. As a result abdominal fascia closure is performed according to the surgeon's individual preference rather than according to evidence-based data. Therefore, the present RCT is designed to compare the most established strategies (continuous slowly absorbable sutures and interrupted rapidly absorbable sutures) for abdominal wall closure in order to determine differences between both strategies after midline incisions.

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, 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

入选标准

  • Preoperative Inclusion criteria:
  • Age equal or greater than 18 years
  • Expected survival time more than 12 months
  • Patients undergoing primary and emergency midline laparotomy (patients with prior laparoscopy (not colon resections) or minor abdominal operation (e.g. appendectomy, cholecystectomy, hysterectomy, sectio) may be included into the trial)
  • Suspected septic abdominal focus (e.g. perforated stomach ulcer, perforated diverticulitis)
  • Informed consent
  • Intraoperative inclusion criteria before closure:
  • Successful source control
  • Abdominal lavage

排除标准

  • Preoperative exclusion criteria:
  • Participation in another intervention-trial with interference of intervention and outcome of this study
  • Intraoperative exclusion criteria before closure:
  • Planned re-laparotomy

结局指标

主要结局

Incisional hernia or burst abdomen within 12 months

时间窗: 12 months

次要结局

  • Quality of Life(12 months)

研究者

申办方类型
Other

研究点 (2)

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