A novel abdominal wall entry suction device to increase Veress needle safety: a prospective pilot study
- Conditions
- Investigation of a new suction device for abdominal wall entry
- Registration Number
- DRKS00017639
- Lead Sponsor
- Rijnstate Hospital, Arnhem, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in distance from the linea alba to the intestines, vena cava and abdominal aorta between CT-scans with and without AWESD application. These differences will be measured after acquisition of both CT-scans (with and without AWESD application).
- Secondary Outcome Measures
Name Time Method