Anastomotic Perfusion Measuring Device, a Pilot Trial

Anastomotic Perfusion Measuring Device, a Pilot Trial - APM study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49771

Enrollment

Registered

2020-06-17

Start date

2020-07-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic leakage

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Oral and written informed consent (IC) Age 18 years and older Elective colorectal surgery

Exclusion criteria

Exclusion criteria: -No informed consent -Palliative surgery -Emergency surgery -Mental handicap

Design outcomes

Primary

Measure	Time frame
1. Time needed to measure bowel-brachial index 2. Percentage of successful bowel-brachial index measurements, the percentage needs to be 90% or higher. The APM device needs to display and index and not display an error message. It will be allowed to try multiple times per patient. 3. Safety of the product will be defined as that no adverse events related to the APM measurement are observed.	—

Secondary

Measure	Time frame
/	—

Countries

Netherlands

Outcome results