NaROA STUDY: OBSERVATIONAL, PROSPECTIVE, MULTICENTRIC, NATIONAL OPEN ABDOMEN REGISTRY FOR THE ANALYSIS OF INDICATIONS AND PRONOTIC FACTORS OF MORBI-MORTALITY IN PATIENTS UNDERGOING EMERGENCY SURGERY BY GENERAL SURGERY.
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- OPEN ABDOMEN: NON-TRAUMATIC ABDOMINAL EMERGENCIES
研究概览
简要总结
National Register of Open Abdomen Open Abdomen Procedure (Observational and Prospective Study)
详细描述
The open abdomen technique has widely been proven useful in the treatment of traumatic patients, but its indication in non-traumatic patients with catastrophic abdomen (peritonitis, ischaemia, pancreatitis) generates controversy. Its heterogeneous implementation is based on insufficient evidence and originated in health systems very different from ours. Its low prevalence imposes the need for a multicentre study.
AIMS : Establish a national, prospective, multi-centre national registry of non traumatic patients with open abdominal indication whether or not they undergo damage control surgery and open abdomen for:
- Describe in real time the indications, surgical technique, materials, time, risk factors, definitive closure, reinterventions and complications according to the Clavien-Dindo classification and mortality.
- Compare the results of the application or non-application of the open abdomen in non-traumatic patients between the different participating centers.
- Set the limits of the open abdomen in non-traumatic patients indication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication to Open Abdomen in non-trauma patients
- •Informed consent
排除标准
- •Open Abdomen in trauma patients
- •No indication to Open Abdomen
- •Informed consent refusal
结局指标
主要结局
OPEN ABDOMEN: NON-TRAUMATIC ABDOMINAL EMERGENCIES
时间窗: two years
The open abdomen technique has widely been proven useful in the treatment of traumatic patients, but its indication in non-traumatic patients with catastrophic abdomen (peritonitis, ischaemia, pancreatitis) generates controversy. Its heterogeneous implementation is based on insufficient evidence and originated in health systems very different from ours. Its low prevalence imposes the need for a multicentre study.
次要结局
未报告次要终点
研究者
Amalia Pelegrina
Principal Investigator
Hospital del Mar
