Investigation of a new suction device for abdominal wall entry
Conditions
Interventions
Group 1: This is a single-arm study, with a crossover design in which patients receive a CT-scan with and without AWESD (abdominal wall entry suction device) application.
Sponsors
Rijnstate Hospital, Arnhem, The Netherlands
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands
Contacts
Public ContactJean Daemen
Rijnstate Hospital, Arnhem, The Netherlands
Outcome results
None listed