We want to show in the current pilot trial that the current market ready automated device is safe and effective to use in humans as the proof of principle prototype, as well as check the instructions for use (IFU).
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
/
Background summary
Anastomotic leakage remains a serious complication following colorectal
surgery. Its reported prevalance varies widely from 1% to 39%. Not only may the
complication result in acute life-threatening condition, cancer patients show a
higher local recurrence rate followinf anastomotic complications with local
abscess formation. Anastomotic complications are thought to be related to an
inadequate perfusion of the anastomosis. Currently, viability of the bowel,
before performing the anastomosis, is usually estimated by the color of the
tissue. This remains very subjective and based on the experience of the
surgeon.
Study objective
We want to show in the current pilot trial that the current market ready
automated device is safe and effective to use in humans as the proof of
principle prototype, as well as check the instructions for use (IFU).
Study design
Prospective PILOT-trial
In the surgical outdoor clinical patietns will be asked by their treating
surgeon whether they wish to take part in the trial. If informed consent is
obtained (and the patient meets al inclusionand exclusion criteria as described
in paragraph 9) the patient will be included in the trial. Patients will
undergo elective colorectal surgery. The operating surgeon will measure the
bowel-brachial index at the site of anastomosis with the APM device.
Study burden and risks
No substantial risk or burden is anticipated for patients participating in this
study. The prototype prior to the current market ready device has been used
before in 215 patients without adverse events. To detect blood pressure i nthe
bowel wall, the device only applies mild pressure on the bowel wall for a short
period of time. The systemic blood pressure is measured by standard NIBP
(non-invasive blood pressure) module.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83178.068.23 |
| Other | tbd |