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临床试验/NCT05343416
NCT05343416Unknown不适用

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.

Hospital del Mar1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年1月1日最近更新:
适应症

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:

  1. 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.
  2. Compare the results of the application or non-application of the open abdomen in non-traumatic patients between the different participating centers.
  3. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amalia Pelegrina

Principal Investigator

Hospital del Mar

研究点 (1)

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