A Prospective Study on the Effect of Adhesiolysis During Elective Laparotomy or Laparoscopy on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 752
- 试验地点
- 1
- 主要终点
- Inadvertent Enterotomy
研究概览
简要总结
Official title:
LAPAD - A prospective study on the effect of adhesiolysis during elective laparotomy or laparoscopy on per- and postoperative complication, quality of life and socioeconomic costs
Background:
With improved surgical technology and ageing of the population the number of reoperations in the abdomen dramatically increases. The risk for a repeat laparotomy or laparoscopy is a high as 30% in the first ten years after a laparotomy. In over 95% of reoperations adhesiolysis is required to gain access to the abdominal cavity and operation area. Adhesiolysis significantly increases the risk for inadvertent organ damage, such as enterotomies, leading to higher morbidity, mortality and socioeconomic costs.
Purpose:
To define the impact of adhesiolysis on per- and postoperative complications, quality of life and socioeconomic costs.
Design:
Prospective observational study.
Primary outcomes:
- adhesiolysis time
- inadvertent enterotomy
- seromuscular injury
- miscellaneous organ damage
- Serious adverse events of operation (anastomotic leakage, delayed diagnosed perforation, wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection, abscess, fistula, sepsis, death)
Secondary outcomes:
- Hospital stay
- Intensive care admission
- Reinterventions
- In-hospital costs
- Parenteral feeding
- Short term readmissions (30 days)
- Quality of life (Gastro- intestinal tract complaints, Short Form- 36(SF-36), DASI (Duke Activity Score Index(DASI) )
Estimated enrollment: 800 start study: 1 june 2008 Inclusion completion date: 1 june 2010 Estimated study completion date: 1 february 2011
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Planned elective laparotomy or laparoscopy
- •Mentally competent
- •18 years or older
排除标准
- •Operation cancelled
- •Bad quality of data
结局指标
主要结局
Inadvertent Enterotomy
时间窗: Day of surgery (one day)
Every unintended and iatrogenic full thickness defect of the bowel.
Seromuscular Injury
时间窗: Day of surgery (one day)
Every visible damage to the serosa, without leakage or exposure of the bowel lumen.
Miscellaneous Organ Damage
时间窗: Day of surgery (one day)
Unintended iatrogenic damage to intra- peritoneal organs and structures other than bowel. E.g. Spleen, liver, pancreas or ureter.
Serious Adverse Events
时间窗: 30 days
Complications marked as SAE: anastomotic leakage, delayed diagnosed perforation, wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection, abscess, fistula, sepsis, death
Adhesiolysis Time
时间窗: Day of surgery (one day)
Time required to dissect adhesive tissue.
次要结局
- Hospital stay(From surgery to discharge)
- Reinterventions(30 days after discharge)
- In- hospital Costs(From surgery to discharge)
- Parenteral Feeding(From surgery to discharge)
- Short term readmissions(30 days after discharge)
- Quality of life(6 months post surgery)