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