Anastomotic Perfusion Measuring Device, a Pilot Trial

• Conditions: Anastomotic leakage; 10017943

• Registration Number: NL-OMON49771
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

-No informed consent
-Palliative surgery
-Emergency surgery
-Mental handicap

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>/</p><br>