DRKS00017639已完成未知
A novel abdominal wall entry suction device to increase Veress needle safety: a prospective pilot study
Rijnstate Hospital, Arnhem, The Netherlands0 个研究点目标入组 12 人开始时间: 2019年7月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patients aged 18 years and above that are physically fit without known abdominal pathologies, nor prior large abdominal surgeries are eligible for inclusion.Potentially eligible participants that require abdominal CT-examination for any reason are recruited from the Department of Radiology (Rijnstate Hospital, Arnhem, The Netherlands). However, those without a prior abdominal CT-scan or a prior scan older than 6 months are excluded because these scans serve as control. Nevertheless, in participants that require multiple scans (e.g. blank and arterial phase), the AWESD will be applied during one scan, whereas the second acquisition, without device, serves as control. Written informed consent is obtained from all participants upon inclusion.
排除标准
- •Patients with a subcutaneous thickness > 8 centimeters are excluded as their subcutis approximated the AWESD’s height. In this situation it is assumed that only subcutaneous fat will be drawn into device; subsequently, losing the hypothesized peritoneal lifting power. Patients in an emergency setting, alongside pregnant or breast-feeding women are also excluded.
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