跳至主要内容
临床试验/NCT03786159
NCT03786159Unknown不适用

Prospective Nationwide Audit of the Management of Adhesive Small Bowel Obstruction: a Snapshot Study

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
CT treatment ASBO

研究概览

简要总结

Over 63-90% of patients develop peritoneal adhesions after abdominal or pelvic surgery. Which makes it the most common complication after abdominal or pelvic surgery. Adhesions comprise a lifelong risk of adhesion related complications.The most frequent emergency complication of adhesion is an episode of adhesive small bowel obstruction (ASBO). Over 1 in 5 patients experiences at least 1 episode of ASBO in the 10 years following initial abdominal surgery. Despite the high incidence of ASBO, diagnosis and treatment of an episode of ASBO varies greatly between hospitals and even between doctors. Until now, optimal treatment patterns are unknown. The aim of this study is mapping of care for patients with a suspected episode of ASBO. With the collected data new hypothesis will be generated for the ideal diagnostic and therapeutic workflow for patients with a suspicion of an episode of ASBO.

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

入选标准

  • Suspicion ASBO
  • Age 18 years or older

排除标准

  • Clear other cause of small bowel obstruction (e.g. tumor, hernia)

结局指标

主要结局

CT treatment ASBO

时间窗: February 2021

In how many patients does CT-scan impact initial management of ASBO (i.e. different cause of SBO found, or conservative trial vs. direct surgery)?

Diagnostics ASBO

时间窗: February 2021

How many patients in the Netherlands presenting with adhesive small bowel obstruction have a CT-scan in their diagnostic work-up?

Outcome laparoscopic surgery for ASBO

时间窗: February 2021

What are the outcomes of laparoscopic surgery for ASBO? Days of in hospital stay, postoperative complications (Clavien-Dindo) and 90-day readmissions rates will be compared between patients who underwent open or laparoscopic surgery for ASBO.

Timeframe conservative trial ASBO

时间窗: February 2021

How long do Dutch surgeons continue a conservative trial in patients with persistent obstruction who are not clinically deteriorating? Outcome measures will be based on data from the online Case Report Form (CRF).

Conservative trial > 72 hours ASBO

时间窗: February 2021

Does continuing a conservative trial for more than 72 hours adverse impact final outcomes? Complications as measured by Clavien-Dindo will be registered and compared between groups.

Laparoscopic surgery for ASBO

时间窗: February 2021

How many patients that are surgically treated for ASBO in the Netherlands have laparoscopic surgery?

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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